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Advancing Ig Nursing and Pharmacy Practice this program book has been sponsored by September 18-20, 2015 Hyatt Regency Capitol Hill Washington, DC Welcome Dear Colleagues, IgNS Committees and Advisory Board President Jan Ellen Jones, RN MSN, IgCN IgNS Executive Leadership Committee Kelly Bertolazzi, RN, MSN, IgCN Lou Anne Epperson, MSN, RN, IgCN Jan Ellen Jones, RN, MSN, IgCN Jane Kirmse, MS, APRN, CNS Susan Kondik, BSN, RN, CRNI, IgCN Carol Lee Koski, MD Kenneth Paris, MD, MPH Tom Schleis, MS, RPh IgNS National Conference Committee Louanne Epperson RN, MSN, IgCN, Chair Kelly Bertolazzi, RN, MSN, IgCN Michelle Greer RN, MBA Ashar Hassan RPh, MBA Alan Huber PharmD, MBA Susan Kondik, BSN, RN, CRNI, IgCN Kathy Puglise, MSN/ED, BSN, RN, CRNI Tom Schleis MS, RPh IgNS Steering Committee Lisa Betts, PharmD Don Fillibeck, PharmD, MBA Ashar Hassan, RPh, MBA James Markis, PharmD Anne Martens, RN, IgCN Deborah Meyer, RN, BSN Stacey Ness, PharmD, RPh, CSP, MSCS, AAHIVP Leslie J. Vaughan, RPh IgCN Credentialing Board Amy Clarke, RN, IgCN (Chair) Becky Gamez, RN, BSN, IgCN Debbie Manning, RN, BSN, IgCN Felicia Schaps, BSN, RN, CRNI, OCN, CNSC, IgCN 2 2 We are pleased to welcome you to the 4th National Conference, September 18-20, 2015, at the Hyatt Regency Capitol Hill, in Washington, DC! This year, we are very excited to announce that Nurses and Pharmacists have joined forces at IgNS! The inter-professional nurse-pharmacist collaboration and teamwork is critical to patient success across all clinical fields and sites of care. IgNS 2015 4th National Conference offers advanced, specialized education that includes plenary sessions and clinical tracks specifically for nurses and pharmacists, as well as nursing and pharmacy CE, IgCN recertification units, and CRNI recertification units. A lively poster reception will offer a chance to learn about the latest research in the Ig field. Product Theater and Corporate Symposia will provide fantastic opportunities to discover and learn about a variety of products, clinical studies, and news in the Ig field. Our Exhibit Hall will feature the leading companies in the Ig field, as well as patient and advocacy resources – a highly anticipated networking and education time during our conference! For nurses seeking their IgCN Credentials, we are excited to offer the Ig Academy: IgCN Preparation Course, on the last day of our meeting, Sunday, September 20th. We look forward to a fantastic meeting! Warm Regards, Jan E. Jones, RN, MSN, IgCN IgNS President Table of Contents IgNS Committees and Advisory Board..........................2 Welcome........................................................................2 Agenda..................................................................... 4-10 IgNS 2015 General Sessions.............................................................. 4-9 Friday, September 18th.............................................................. 4-5 Saturday, September 19th.......................................................... 6-7 Sunday, September 20th............................................................ 8-9 Ig Academy: Ig Certified Nurse Examination Preparation Course..........10 Sunday, September 20th Maps .................................................................... 11-12 General Overview Floor Plan................................................................11 Exhibit Hall Floor Plan..........................................................................12 Faculty Biographies............................................... 13-23 Joseph A. Bellanti, MD.........................................................................14 Kelly Bertolazzi, RN, MSN, IgCN...........................................................14 Lisa McNelis Betts, PharmD.................................................................14 Julie Birkofer.......................................................................................14 Jane Colona, RN, CCTC........................................................................15 M. Cathy Dragistity, RN, CRNI, IgCN.....................................................15 Carla Duff, CPNP-PC, MSN, CCRP, IgCN................................................15 Lou Anne Epperson, MSN, RN, IgCN.....................................................15 Alexandra Freeman, MD .....................................................................15 R. Becky Gamez, RN, BSN, lgCN, CNO, CEO..........................................16 Sergei A. Grando, MD, PhD, DSci.........................................................16 Terry Harville, MD, PhD .......................................................................16 Ashar Hasan, RPh, MBA ......................................................................17 Alan Huber, PharmD, MBA ..................................................................17 Jan Ellen Jones, MSN, IgCN.................................................................17 Sean M. Kearns, PhD...........................................................................17 Jane Kirmse, MS, APRN, CNS, IgCN ....................................................18 David Kisor, PharmD............................................................................18 Susan Kondik, BSN, RN, CRNI, IgCN ....................................................18 Isaac Melamed, MD.............................................................................18 Itay Melamed, MD...............................................................................20 Kenneth Metcalf .................................................................................20 Linda Payne ........................................................................................20 Kathy Puglise, MSN/ED, BSN, RN, CRNI................................................20 Neil Ross ............................................................................................21 Felicia Schaps, RN, MSN-Ed, CRNI, OCN, CNSC, IgCN...........................21 Tom Schleis, MS, RPh..........................................................................21 Linda Schneider, RN, BSN, CPN, IgCN..................................................21 Jeanette Scott, RN, BSN......................................................................22 Dominick Spatafora ............................................................................22 Michael D. Tarantino, MD ....................................................................22 Theoharis C. Theoharides, BA, MS, MPhil, PhD, MD, FAAAAI ................23 Kendall Van Pool .................................................................................23 Leslie Vaughan, RPh ...........................................................................23 Alison Walsh, MD.................................................................................23 Corporate Partners & Exhibitors........................... 29-36 Acta Medical, LLC................................................................................31 Armada Health Care, LLC.....................................................................31 Baxalta Incorporated...........................................................................31 Baxalta Medical Affairs........................................................................31 Biofusion.............................................................................................31 BioTek reMEDys..................................................................................31 Biotest Pharmaceuticals......................................................................32 Bio Products Laboratory (BPL).............................................................32 BriovaRX.............................................................................................32 CSL Behring........................................................................................32 EMED Technologies.............................................................................32 Envoy Innovations...............................................................................32 GBS/CIDP............................................................................................32 Grifols.................................................................................................33 Horizon Pharma...................................................................................33 Immune Deficiency Foundation (IDF)....................................................33 Innovatix & Essensa............................................................................33 IntraPump Infusion Systems................................................................33 Kedrion Biopharma, Inc. ......................................................................33 Matrix Health Group.............................................................................33 Medmonk............................................................................................34 Managed Health Care Associates, Inc. (MHA).......................................34 MOOG Medical Group..........................................................................34 NuFactor Specialty Pharmacy..............................................................34 Octapharma........................................................................................34 OptionCare..........................................................................................34 Platelet Disorder Support Association (PDSA).......................................35 Pentec Health......................................................................................35 Reimbursement Concepts, Inc. ...........................................................35 RMS Medical Products........................................................................35 Road Runner Specialty Group, Inc. ......................................................35 Santa Barbara Specialty Infusion.........................................................35 Smiths Medical ..................................................................................36 Specialty Pharmacy Nursing Network, Inc. (SPNN)...............................36 Zyno Medical.......................................................................................36 Poster Abstracts.................................................... 37-47 Continuing Education & Recertification......................47 Agenda Friday, September 18, 2015 TimeTopic 8:00 AM – 8:30 AM OPENING REMARKS (0.5 CE) The State Of IgNS Jan Jones, RN, MSN, IgCN - President of IgNS, IgNS Leadership Team 8:30 AM – 10:00 AM PLENARY SESSION 1 (1.5 CE) Room Regency A Regency A Ig Industry: Manufacturing, Legislative, and Clinical Updates Julie A. Birkofer - VP North America, Plasma Protein Therapeutics Association (PPTA) Kendall Van Pool - VP of Legislative Affairs, National Home Infusion Association Ashar Hasan, RPh, MBA - Chief Business Development Officer, Medmonk, Inc. Neil Ross - IgNS Patient Advocacy Committee; Director, Patient Advocacy and Support 10:00 AM – 10:30 AM BREAK & EXHIBITS 10:30 AM – 11:00 AM BAXALTA Product Theater Presentation (No CE) Columbia ABC Regency A Initiating and Managing the Infusion Susan Kondik, RN, IgCN, CRNI 11:00 AM - 12:30 PM PLENARY SESSION 2 (1.5 CE) Ig Therapy in Dermatology: Acute Blistering Mucocutaneous Disorders Sergei Grando, MD, PhD - Professor of Dermatology, University of California, Irvine A Patient’s Journey Kenny Metcalf 12:30 PM – 2:00 PM LUNCH & EXHIBITS 2:00 PM - 2:30 PM CSL BEHRING Product Theater Presentation (No CE) Expect More From Your Ig Therapy: Partnering With Patients to Offer a Lifetime of Possibilities Debbie Manning, RN, BSN, IgCN 2:30 PM – 3:30 PM Breakout Sessions (1 CE) 4 Regency A Columbia Foyer/Columbia ABC Session 101 Individualizing Therapy – Patients, Products and Routes Management of Patients Transitioning from IVIG to SCIG M. Cathy Dragisity, RN, CRNI, IgCN - Coram CVS/specialty infusion services Regency A Congressional A Agenda Friday, September 18, 2015 TimeTopic Session 102 Session 103 Session 104 3:30 PM – 4:00 PM BREAK & EXHIBITS 4:00 PM – 5:00 PM Breakout Sessions (1.0 CE) Session 105 Session 106 Session 107 Session 108 5:00 PM – 6:30 PM Room Congressional B Autoimmunity and Immunoglobulin Mechanism of Action Alison Walsh, MD - Associate Clinical Professor of Neurology, Jefferson University Everglades Immune System and Primary Immunodeficiency Joseph A. Bellanti, MD - Professor of Pediatrics and Microbiology-Immunology, Georgetown University Medical Center Congressional CD Creating Patient Education Tools to Maximize Comprehension and Independence Kathy Puglise, MSN/ED, BSN, RN, CRNI - IgNS Committee Member, Clinical Manager, Home Infusion, Smiths Medical Congressional A Individualizing Therapy – Patients, Products and Routes M. Cathy Dragisity, RN, CRNI, IgCN - Coram CVS/specialty infusion services Congressional B Autoimmunity and Immunoglobulin Mechanism of Action Alison Walsh, MD - Associate Clinical Professor of Neurology, Jefferson University Everglades Immune System and Primary Immunodeficiency Joseph A. Bellanti, MD - Professor of Pediatrics and Microbiology-Immunology, Georgetown University Medical Center Congressional CD Creating Patient Education Tools to Maximize Comprehension and Independence Kathy Puglise, MSN/ED, BSN, RN, CRNI - IgNS Committee Member, Clinical Manager, Home Infusion, Smiths Medical Poster Session & Reception Bunker Hill/Lexington Supported by Home Solutions September 18-20, 2015 Hyatt Regency Capitol Hill • Washington, DC 5 Agenda Saturday, September 19, 2015 TimeTopic 7:00 AM - 9:00 AM BAXALTA BREAKFAST SYMPOSIUM (No CE) 7:00 AM Doors Open | 7:30 Program Begins Patient-Centered Immunoglobulin Treatment in Patients With Primary Immunodeficiency: A Collaborative Approach Room Regency A Jan Ellen Jones, RN, MSN, IgCN (Chair/Moderator) Raffi Tachdjian, MD, MPH Amy E. Clarke, RN, IgCN Leslie J. Vaughan, RPh 9:00 AM - 10:30 AM PLENARY SESSION 3 (1.5 CE) Hematologic, Inflammatory and Vascular Disorders Michael D. Tarantino, MD - Medical Director & President, The Bleeding and Clotting Disorders Institute, Professor of Pediatrics and Medicine, University of Illinois College of Medicine-Peoria 10:30 AM - 11:00 AM BREAK & EXHIBITS 11:00 AM - 11:30 AM GRIFOLS PRODUCT THEATER PRESENTATION (No CE) 11:30 AM - 1:00 PM PLENARY SESSION 4 (1.5 CE) The Role of Immunoglobulin in Solid Organ Transplantation 1:00 PM - 2:30 PM LUNCH & EXHIBITS 2:30 PM - 3:00 PM BPL PRODUCT THEATER PRESENTATION (No CE) Kavita Aggarwal, PharmD 3:00 PM - 4:00 PM Breakout Sessions (1.0 CE) Session 201 6 Columbia ABC Regency A Help Patients Choose… IV or Sub-Q Elena E. Perez, MD, PhD, FAAI Maria C. Rodriguez, RN, BSN Regency A Regency A Jane Colona, RN, CCTC - Director of Clinical Transplant Programs, BiologicTx Columba Foyer/Columbia ABC Regency A The Role of 5% IVIG in the Treatment of PI Establishing Immunoglobulin Competency for Pharmacists Lisa Betts, PharmD - Ig National Program Director, OptionCare Alan Huber, PharmD, MBA - IgNS National Conference Planning Committee Member Leslie Vaughan, RPh - Senior Vice President, Clinical Programs, Nufactor Congressional CD Agenda Saturday, September 19, 2015 TimeTopic Session 202 Session 203 4:00 PM - 4:30 PM BREAK & EXHIBITS 4:30 PM - 5:30 PM Breakout Sessions (1.0 CE) Congressional A Establishing Immunoglobulin Competency for Nurses LouAnne Epperson, MSN, RN, IgCN - Chair, IgNS Educational Development Committee, Manager Nursing Education, Infusion, Coram CVS/specialty infusion services Jan Jones, MSN, RN, IgCN - IgNS President, Director of Nursing, Biofusion Congressional B Management of Adverse Reactions with IVIG and SCIG Tom Schleis, MS, RPh - IgNS Editor-In-Chief; President, Schleis Professional Services Session 204 Columbia ABC Congressional CD Establishing Immunoglobulin Competency for Pharmacists Lisa Betts, PharmD - Ig National Program Director, OptionCare Alan Huber, PharmD, MBA - IgNS National Conference Planning Committee Member Leslie Vaughan, RPh - Senior Vice President, Clinical Programs, Nufactor Session 205 Session 206 Room Congressional A Establishing Immunoglobulin Competency for Nurses LouAnne Epperson, MSN, RN, IgCN - Chair, IgNS Educational Development Committee, Manager Nursing Education, Infusion, Coram CVS/specialty infusion services Jan Jones, MSN, RN, IgCN - IgNS President, Director of Nursing, Biofusion Congressional B Management of Adverse Reactions with IVIG and SCIG Tom Schleis, MS, RPh - IgNS Editor-In-Chief; President, Schleis Professional Services September 18-20, 2015 Hyatt Regency Capitol Hill • Washington, DC 7 Agenda Sunday, September 20, 2015 TimeTopic Room Regency A 7:00 AM – 8:30 AM INVITED GUEST LECTURE – BREAKFAST SYMPOSIUM (No CE) The Breadth of Pharmacogenomics: Drug Therapy and Related Implications David Kisor, PharmD - Professor and Chair, Department of Pharmaceutical Sciences, Manchester University Regency A 8:30 AM – 10:00 AM PLENARY SESSION 5 (1.5 CE) The Cross-Talk Between the Nervous system and the Immune System Theoharis Theoharides MS, PhD, MD, FAAAAI - Professor of Pharmacology and Internal Medicine, Department of Integrative Physiology and Pathobiology, Tufts University School of Medicine Isaac Melamed, MD - President/Owner, ImmunoE Health and Research Centers Itay Melamed, MD - Managing Physician, Advanced Brain & Spine 10:00 AM – 10:30 AM BREAK & EXHIBITS 10:30 AM – 11:30 AM PLENARY SESSION 6 (1.0 CE) Treating Primary Immunodeficiency with Secondary Autoimmune Manifestations 11:30 PM -1:00 PM LUNCH & EXHIBITS IgNS Exhibitor Raffle Drawing -12:30 PM 1:00 PM – 2:00 PM Breakout Sessions (1.0 CE) Session 301 Session 303 8 Columbia ABC Regency A Terry Harville, MD, PhD - Associate Professor of Pathology, Associate Professor of Pediatrics, University of Arkansas for Medical Sciences Columbia Foyer/Columbia ABC Congressional A CGD With Inflammatory Complications Alexandra Freeman, MD - National Institutes of Health Session 302 Congressional B Hot Topics and Updates on Immunoglobulin Reimbursement and Access Linda Payne - President, Reimbursement Concepts Dominick Spatafora - President, Neuropathy Action Foundation (NAF) Kendall Van Pool - VP of Legislative Affairs, National Home Infusion Association Quality of Life Assessments for Patients on Immunoglobulin Therapy Sean M. Kearns, PhD - Advisor, Registry Program, Coram CVS/specialty infusion services Congressional CD Agenda Sunday, September 20, 2015 TimeTopic 2:00 PM – 3:00 PM Breakout Sessions (1.0 CE) Session 304 Room Congressional A CGD With Inflammatory Complications Alexandra Freeman, MD - National Institutes of Health Session 305 Congressional B Hot Topics and Updates on Immunoglobulin Reimbursement and Access Linda Payne - President, Reimbursement Concepts Dominick Spatafora - President, Neuropathy Action Foundation (NAF) Kendall Van Pool - VP of Legislative Affairs, National Home Infusion Association Session 306 Congressional CD Quality of Life Assessments for Patients on Immunoglobulin Therapy Sean M. Kearns PhD - Advisor, Registry Program, Coram CVS/specialty infusion services KEEP LIFE FLOWING Kedrion is dedicated to supporting patients and families in need throughout the world. ©2015 Kedrion Biopharma Inc. All Rights Reserved. August 2015 CO-0210-00-2015A September 18-20, 2015 Hyatt Regency Capitol Hill • Washington, DC 9 Ig Academy Agenda Sunday, September 20, 2015 Ig Academy will be held in the Concord/Lexington/Bunker Hill Room TimeTopic 10:15 am – 10:30 am Opening Remarks IgCN Examination Overview Jan E Jones, RN, MSN, IgCN Kelly Bertolazzi, RN, MSN, IgCN 10:30 am – 11:30 am Overview of Immunoglobulin Products Practice Examination Tom Schleis, MS, RPh 11:30 am – 12:00 am Patient Advocacy and Resources Practice Examination Becky Gamez, RN, BSN, IgCN, CNO 12:00 pm – 1:30 pm Lunch and Exhibits 1:30 pm – 3:00 pm Overview of Disorders Treated with Ig Practice Examination Carla Duff, CPNP-PC, MSN, CCRP, IgCN Becky Gamez, RN, BSN, IgCN, CNO Jane Kirmse, MS, APRN, CNS, IgCN 3:00 pm – 3:45 pm IVIG Administration and Management Practice Examination Linda Schneider, RN, BSN, CPN, IgCN Kathy Puglise, MSN/ED, BSN, RN, CRNI 3:45 pm – 4:30 pm SCIG Administration and Management Practice Examination Jeanette Scott, RN, BSN Susan Kondik, RN, IgCN, CRNI 4:30 pm Adjourn The Ig Academy is a rigorous, oneday course that offers in-depth, evidence-based education on the most critical and relevant aspects of Ig nursing. The Ig Academy serves a dual purpose: 1. A must for anyone who wishes to successfully prepare for and pass the IgCN Credentialing Examination. 2. A critical educational course to bring Ig Nurse’s knowledge, competence and skills up to the current standards. LEARNING OBJECTIVES: • Prepare for the IgCN Credentialing Exam • Provide an overview of Ig therapy • Discuss appropriate clinical uses • Learn appropriate prevention and management of adverse reactions •Discuss administration methods Maps General Overview Floor Plan CONFERENCE LEVEL 2ND FLOOR GRAND TETON RESTROOMS EVERGLADES GLACIER YELLOWSTONE BREAKOUT SESSIONS YOSEMITE HYATT REGENCY CAPITOL HILL WASHINGTON, D.C . REDWOOD BRYCE SEQUOIA GRAND CANYON OLYMPIC LOBBY LEVEL CAPITOL ROOM A CAPITOL ROOM B ARTICLE ONE GRILL RESTROOMS ARTICLE ONE LOUNGE DESIGN CENTER STAIRS ESCALATORS MAIN LOBBY CONGRESSIONAL C / D FEDEX / KINKOS GIFT SHOP CONGRESSIONAL FOYER RESTROOMS CONCIERGE BREAKOUT SESSIONS FRONT DESK CONGRESSIONAL B CONGRESSIONAL A BELLSTAND BALLROOM LEVEL POSTERS COLUMBIA C BUNKER HILL LEXINGTON CONCORD RESTROOMS COAT CHECK HALL OF BATTLES REGENCY D EXHIBITS COLUMBIA B COLUMBIA A COLUMBIA FOYER REGENCY B REGENCY C REGENCY FOYER REGENCY BALLROOM REGENCY A GENERAL SESSIONS September 18-20, 2015 Hyatt Regency Capitol Hill • Washington, DC 11 Maps Exhibit Hall Floor Plan Biofusion Horizon Pharma 400 401 BriovaRx BioTek reMEDys Matrix 402 403 404 Baxalta Octapharma 406 116 SPNN Pentec Health 115 117 MOOG 114 LOBBY BPL 112 EME vatix 113 110 A irs CSL Beh ring pum p 107 Intra 100 Affa ical r 206 ls 204 -CID 101 acto Grifo 105 GBS 208 NuF Road Runner RMS Zyn Med o ica LLC l Med est 109 Affa 102 Bax Biot CSL Beh ring 106 alta 111 irs ADA 108 ical 306 ARM PDS Med IDF/ INGID D Inno P Smit Med hs ical 200 Acta M & Sa edical Ba nta Pha rbara rma cy 305 Optio n Care 202 304 MHA 300 Med mon E Inno nvoy k vatio ns 301 Reim burs Con ement cepts 303 Ked rion 302 CONCORD 12 Faculty Biographies 13 Faculty Biographies Joseph A. Bellanti, MD Joseph Bellanti is Professor of Pediatrics and Microbiology and Immunology and Director of the International Center for Interdisciplinary Studies of Immunology (ICISI) at Georgetown University Medical Center. He received his MD degree from the University of Buffalo, followed by residency training at the Children’s Hospital of Buffalo, post-doctoral training in developmental immunology at the University of Florida School of Medicine, Gainesville, Florida, and in viral immunology at Walter Reed Army Institute of Research, Washington, DC. Following military service, he was recruited at Georgetown University School of Medicine as Assistant Professor of Pediatrics and Microbiology. Dr. Bellanti’s investigative efforts have focused on antimicrobial research, evaluation of new vaccine strategies and developmental immunology. This work resulted in a succession of seminal research contributions including the characterization of the IgM response of the newborn, the identification of the antiviral role of secretory IgA in respiratory secretions, and the cellular immune responses to viral infections following immunization or natural infection. Dr. Bellanti is the recipient of the prestigious E. Mead Johnson Award for Research in Pediatrics, for outstanding scientific contributions, the Humanitarian Award from the American College of Allergists, and the Distinguished Medical Alumnus Award from the State University of Buffalo, New York. He has also held leadership roles for numerous organizations, including the Society for Pediatric Research, American Board of Allergy and Immunology, INTERASMA, the American College of Allergy, Asthma and Immunology, the Association of Medical Laboratory Immunologists, and the American Association of Certified Allergists. Kelly Bertolazzi, RN, MSN, IgCN Kelly Bertolazzi is an immune globulin subject matter expert with 10 years in home infusion industry, clinical sales, nursing, and pharmacy trainer experience. Kelly has served as a speaker at regional and national conferences in chronic disease state management in IG therapies, and has given numerous talks as faculty and invited speaker at patient advocacy groups and clinical conferences. Ms. Bertolazzi is an Immunoglobulin Certified Nurse. She serves on the Educational Development Committee at Ig National Society, and is a member of AAAAI, AANEM, Sigma Theta Tau national honor society, and INS. Lisa McNelis Betts, PharmD Dr. Lisa Betts currently serves as the National Program Director of Immune Globulin (IG) for Optioncare. In this position Dr. Betts oversees the clinical management, operations and national marketing of immunoglobulin therapy. Prior to this, Dr. Betts was the founder and owner of Rx Solutions Inc. before its sale to Walgreens Co. in 2009. Rx Solutions Inc. was a home infusion, specialty company focusing on the clinical management of IG specific acute and chronic disease states. Rx Solutions Inc. grew exponentially and became a national footprint in immunoglobulin disease state management. Dr. Betts has spent 23 years in the home infusion industry. During her career she has held several clinical and operational management positions for national home infusion companies. In addition to founding her own Ig specialty company she has served in positions ranging from National Director of Professional Pharmacy Services to Regional VP of Operations. Dr. Betts has spoken across the U.S. on numerous pharmacy and health care topics. Her publications include clinical abstracts and studies in the Journal of Parenteral and Enteral Nutrition (JPEN) and US Neurology. She has authored many clinical and operational training programs for home infusion pharmacists and pharmacy student internship programs. Dr. Betts is an Illinois Registered Pharmacist having received her Doctorate of Pharmacy degree from the University of Illinois at Chicago – College of Pharmacy. Julie Birkofer Julie Birkofer has more than 20 years of government relations experience, primarily focusing on the health care industry. Her areas of expertise include coalition building, strategic planning, Medicare reimbursement, public affairs, issue analysis, and grassroots networking. Ms. Birkofer assumed the leadership role as head of the North American division of the Plasma Protein Therapeutics Association (PPTA) in October 2004. She is the liaison to the North America Board of Directors, coordinates the PPTA’s federal and state health policy activities, and administers the North America programs – notably the Patient Notification System. Julie Birkofer Senior Vice President, PPTA North America Prior to joining PPTA as the Director of Health Policy, she served in the office of former Pennsylvania Gov. Tom Ridge as the Associate Director of Domestic and Health Policy. In addition, Ms. Birkofer served as a sworn member of the U.S. Department of Health and Human Services (HHS) Advisory Committee on Blood Safety and Availability for six years. s more than 20 years of government relations experience primarily focusing on industry. Her areas of expertise include coalition building, strategic planning, ursement, public affairs, issue analysis, and grassroots networking. been with the Plasma Protein Therapeutics Association (PPTA) since 2001. Ms. d the leadership role as head of the North American division in October 2004. ica division is responsible for federal and state affairs, stakeholder relations, as cations within the United States. omplishments, Ms. Birkofer was awarded the "Unsung Hero" Award from the ociation of New Jersey. Early in her career at PPTA, Ms. Birkofer received an d from the Alpha-1 Foundation. PPTA as the Director of Health Policy, she served in the office of former ov. Tom Ridge as the Associate Director of Domestic and Health Policy. Ms. en promoted several times during her tenure at PPTA and currently holds the or Vice President, North America. In this role, she is the liaison to the North of Directors, coordinates the federal and state health policy activities of the ministers the North America programs – notably the Patient Notification System nct pleasure of coordinating outreach to consumer organizations. In addition, Ms. as a sworn member of the U.S. Department of Health and Human Services (HHS) ttee on Blood Safety and Availability (ACBSA) for six years. 14 ghmark, Inc., Ms. Birkofer was their Senior Government Affairs Representative major health insurance issues such as the Patients' Bill of Rights and Medicare Faculty Biographies Jane Colona, RN, CCTC Jane Colona, RN, CCTC, is the Director of Clinical Transplant Programs at BiologicTx. She is a graduate of Jackson Memorial Hospital School of Nursing in Miami, where she worked in a number of capacities. Her most recent position was Nurse Manager of Transplant for Kidney and Pancreas at the University of Miami, where she performed miracles in staff development, protocol implementation and training. She played a leading role in helping the Miami Transplant Institute Kidney Pancreas Transplant Program achieve national acclaim for patient care and outcomes. Ms. Colona is the author and co-author of many scientific publications, including journal articles, book chapters, and papers for national and international presentation. This record of achievement in nursing leadership brought her to BiologicTx, where she has assumed the role of nursing informatics domain expert and program director. She works on Sequence and MatchGrid software development, laboratory integration as well as clinical trial and research management. Her guidance has led to the development of a groundbreaking approach to following patient responses to oral and IV home therapy. M. Cathy Dragistity, RN, CRNI, IgCN Mileva Dragistity has been a nurse for over 30 years, having spent the last 20 years of her career in inufison nursing. She began her career in critical care nursing and in the 1990s moved her focus to home care and became a CRNI. In 2014, she received certification as an immunoglobulin certified nurse (IgCN). Ms. Dragistity is currently a Branch Manager with Coram CVS/specialty infusion services, and has been with them since 2002. Carla Duff, CPNP-PC, MSN, CCRP, IgCN Carla Duff is a Clinical Advanced Registered Nurse Practitioner at the University of Florida, Department of Pediatrics, Division of Allergy, Immunology, and Rheumatology. She has over 15 years’ experience in the care and treatment of patients with primary immunodeficiency diseases (PIDD). As an expert in immunoglobulin replacement therapy, she has taught many patients about IVIG/SCIG infusion. Ms. Duff is Chair of the Nurse Advisory Committee for the Immune Deficiency Foundations and is the Vice President of the International Nursing Group for Immunodeficiencies. She has been an invited speaker at many national and international conferences and has published on the subject of immunoglobulin replacement therapy. Lou Anne Epperson, MSN, RN, IgCN Lou Anne Epperson, MSN, RN, is the Nurse Educator at Coram CVS/specialty infusion services, where she has practiced for the past 15 years. She is responsible for the orientation and ongoing education for nursing staff in more than 80 Coram branches in the country. In addition, Lou Anne is the Lead Nurse Planner for the Continuing Education department, and is instrumental in the development of Ig orientation and educational courses for nurses as well as phamacists. Ms. Epperson also teaches in undergraduate and post-graduate nursing programs at Regis University, with an emphasis on leadership, community health and health care policy. Ms. Epperson serves on the Executive Leadership Committee for IgNS and is the Chair of the Educational Planning Committee for IgNS. She has presented to local and national audiences regarding home care, home infusion of Ig, nursing competency and education. Ms. Epperson also has published articles in peer-reviewed journals related to home infusion therapy. Alexandra Freeman, MD Dr. Alexandra Freeman graduated from Georgetown University Medical School magna cum laude in 1997. She then completed her pediatric residency at Yale New Haven Children’s Hospital and her pediatric infectious diseases fellowship at Northwestern University in Chicago, with research focused on Kawasaki disease. Dr. Freeman joined NIAID at NIH in 2005 focusing on hyper IgE syndromes. Since 2014, she has been the co-director of the primary immunodeficiency clinic at NIAID, NIH. She has published over 90 peer-reviewed manuscripts, primarily focused on primary immunodeficiencies, and has spoken at many academic conferences primarily on hyper IgE syndromes and antimicrobial management of primary immunodeficiencies. September 18-20, 2015 Hyatt Regency Capitol Hill • Washington, DC 15 Faculty Biographies R. Becky Gamez, RN, BSN, lgCN, CNO, CEO R. Becky Gamez has held a wide variety of clinical and clinical lead roles in both acute care and home care settings. After being asked in 2004 to establish an infusion division for a home health agency, she focused her energy on exploring the impact of life-long infusion therapy on patient outcomes. Then one year later, Ms. Gamez dived into entrepreneurship, establishing Altruistix Nursing Services, a home health and infusion nurse staffing agency, with her friend, business partner and fellow RN, Pam Brown. As CEO and Chief Nursing Officer, Ms. Gamez remains a highly motivated and dedicated infusion nurse. She has actively worked to ensure that evidence-based best practices are integrated into the patient care, clinical and staffing practices offered by her staff every day. Her team of highly skilled and dedicated infusion nurses average 900 hours of immunoglobulin therapy a month. It was this dedication to improving patient outcomes that led Ms. Gamez to IgNS, where she has been honored to participate as presenter, adviser, and committee member since 2012, and is proud to be one of the first to hold the distinction of IgCN. Sergei A. Grando, MD, PhD, DSci Sergei A. Grando, MD, PhD, DSci, is Professor of Dermatology at the University of California, Irvine. A specialist in autoimmune blistering diseases, he is considered the most experienced doctor in pemphigus, having treated hundreds of patients with this rare disease. Dr. Grando is currently Vice Chair of the Medical Advisory Board of the International Pemphigus and Pemphigoid Foundation. In 2010, he received the “Doctor of the Year” award from this foundation. Previously, Dr. Grando utilized pemphigus patients’ IgGs as a probe to identify the pathophysiologically relevant target antigens. He has published more than 240 papers, monographs or book chapters, and received research grants from NIH and other funding agencies. The results of his work have altered the way physicians throughout the world understand the mechanisms of pemphigus. Dr. Grando has pioneered the comprehensive treatment of autoimmune blistering diseases using a combination of IVIg with a cytotoxic immunosuppressive drug. This approach prevents a relapse of the disease due to maintenance of pathogenic antibodies at the subclinical level. In contrast to any other existing method of treatment, the combined IVIg/immunosuppressor regimen leads to not only stable clinical remission in practically all patients, but also provides for cure, defined as drug-free remission over 5 years post-treatment. Dr. Grando has published results of his pilot clinical trial of the combined IVIg/immunosuppressor regimen in pemphigus patients. In addition to autoimmune blistering diseases, Dr. Grando is also using IVIg in other autoimmune skin diseases, such as dermatomyositis, scleroderma and chronic urticaria. Most recently, he has completed the proof-of-concept clinical trial of IVIg in patients with cutaneous lupus erythematosus, showing very promising results. Dr. Grando’s report of this trial has been accepted for publication. Terry Harville, MD, PhD Terry Harville, MD, PhD, is Associate Professor of Pathology at the University of Arkansas for Medical Sciences (UAMS) and Associate Professor of Pediatrics at the Arkansas Children’s Hospital, both in Little Rock, AR. In addition, he is Medical Director for the Special Immunology Laboratory and Molecular Diagnostics Laboratory at Arkansas Children’s Hospital, and Medical Director for the Histocompatibility Laboratory and the Immunogenetics and Transplantation Laboratory at UAMS. He received a PhD degree in biochemistry and molecular biology from the University of Florida (UF) and an MD degree from the UF College of Medicine. Following a residency in pediatrics and fellowship training in pediatric immunology, rheumatology and transplantation biology at UF, he completed fellowship training in pediatric allergy and immunology at Duke University in Durham, NC. Among his clinical and research interests are immunodeficiency disorders, autoimmune and rheumatologic disorders, as well as organ and bone marrow transplantation. 16 Faculty Biographies Ashar Hasan, RPh, MBA Ashar Hasan is a highly accomplished executive with over 17 years experience in management and treatment of chronic immune mediated disorders with Immunoglobulin therapy. He is currently the Chief Business Development Officer of Medmonk, Inc., and the Chief Executive Officer of Envoy Innovations. Alan Huber, PharmD, MBA Alan Huber, PharmD, MBA, has served in management roles for both nationally accredited home infusion companies and the plasma pharmaceutical industry. He was educated as a clinical pharmacist with a BA in Pharmacy and Zoology from the University of Maryland, a PharmD from Shenandoah University, and an MBA from the George Washington University School of Business. After completing a 2-year internship in IV therapy at the National Institutes of Health in Bethesda, Maryland, he began his career in the Specialty Pharmacy field, where he has worked for the past 15 years. Dr. Huber has been an Adjunct Assistant Professor of Pharmacy Practice at the University of Southern California School of Pharmacy, where he lectured on immunoglobulin therapy. He also was a preceptor for several pharmacy schools where he taught many pharmacy students about immunoglobulin therapy. Dr. Huber has presented widely on the topic of immunoglobulin therapy at many national conferences over the years. Jan Ellen Jones, MSN, IgCN Jan Jones was educated at UCLA and Pasadena City College, where she received her nursing degree in 1993. After completing her Masters of Science in Nursing in 2003, she ran her own specialized nursing agency from 2004 to 2010. Ms. Jones became affiliated with BioFusion in 2005, first as an expert Ig infusion RN. In this role, she trained other nurses to become expert Ig infusion RNs. She assisted with the development of BioFusion’s first infusion suite in the greater Los Angeles Area in 2006, and later was a consultant in RN Staff development before joining the company as Director of Nursing in December of 2011. Ms. Jones oversees all nursing services for BioFusion, including patient training. She has qualified BioFusion to be a continuing education provider for nursing through the California Board of Registered Nursing. Ms. Jones also recorded an educational webinar “Clinical Consideration for the Administration of Intravenous Immune Globulin (IVIG) Treatment” for the Baxalta-sponsored website on Ig Care (http://IgCare.com/igcare/home). Ms. Jones currently is serving as President of the Immune Globulin Nurses Society. Among the key initiatives IgNS is sponsoring under her leadership is the publication of the Standards of Care for Immune Globulin Therapy in late 2015. Sean M. Kearns, PhD Sean Kearns, PhD, is an advisor for Coram CVS/specialty infusion services, and the program manager of the Patient Registry Programs, including the Immunoglobulin Diagnosis, Evaluation and key Learnings (IDEaL) Patient Registry. He received his PhD in cell biology and neuroscience from the University of Florida. Dr. Kearns has overseen a variety of clinical trial programs over the last 6 years, including the last 4 as the IDEaL program manager. He has been heavily involved in training the field sales staff in the biology of Ig therapy and the disease states in which it is used. He has worked with numerous nurses and pharmacists within the company to collect and analyze patient outcomes data for internal and external publications. Dr. Kearns has presented data from the IDEaL Registry at the American Academy Asthma, Allergy, and Immunology, the Clinical Immunology Society, and the American Academy of Neurology, in addition to Grand Rounds. September 18-20, 2015 Hyatt Regency Capitol Hill • Washington, DC 17 Faculty Biographies Jane Kirmse, MS, APRN, CNS, IgCN Jane Kirmse is a Certified Clinical Nurse Specialist in the infusion therapy specialty for the Department of Nursing at Mayo Clinic in Rochester, Minnesota. She is a master’s degree Advanced Practice Registered Nurse with 24 years of experience, the past 13 years in infusion therapy. Ms Kirmse currently oversees the nursing practice of an ambulatory infusion center in which intravenous immunoglobulin (IGIV) and subcutaneous immunoglobulin (IGSC) are administered, in addition to many other medications. Ms Kirmse has presented nationally on Ig administration at the Infusion Nurses Society, American Academy of Allergy, Asthma and Immunology, as well as having coordinated workshops on IGIV and IGSC administration. She has also published and presented posters on IGIV and IGSC administration. Additionally, Ms Kirmse has authored and coauthored articles on the subject of immunoglobulin administration that have appeared in the Journal of Infusion Nursing, Allergy and Home Healthcare Nurse. Ms Kirmse is past President of the Immunoglobulin Nursing Society. David Kisor, PharmD Dr. David Kisor is Professor and Chair of Pharmaceutical Sciences at the Manchester University College of Pharmacy in Fort Wayne, IN, where he is responsible for facilitating teaching, scholarly activity, and service in the department. Dr. Kisor came to Manchester University from the Raabe College of Pharmacy at Ohio Northern University. He received his Bachelor’s degree in pharmacy from the University of Toledo and his PharmD from Ohio State University. Dr. Kisor has integrated PGx into pharmacokinetic subject matter since 1998. His research is related to the pharmacokinetics and pharmacogenomics of various compounds in the in vitro and in vivo settings. Dr. Kisor has authored more than 40 peer-reviewed publications and textbooks. He is a member of the Clinical Pharmacogenetics Implementation Consortium (CPIC), American Society for Clinical Pharmacology and Therapeutics (ASCPT), the American College of Clinical Pharmacology (ACCP), among other professional organizations. Susan Kondik, BSN, RN, CRNI, IgCN Susan Kondik, BSN, RN, CRNI, IgCN, has been involved with IgNS since 2013. She is currently a member of the Executive Leadership Committee and has co-chaired the Regional Ig Academy for certification preparation. Ms. Kondik received her ADN from Marymount College of Virginia and her BSN from Capella University. She has over 30 years of experience in the home infusion industry, with the past 25 years with Coram/CVS Specialty Infusion Services and most recently with Home Solutions. She has provided education to HCP on PIDD and the administration of Ig therapy products. Ms. Kondik currently serves on the Baxalta Primary Immunodeficiency Nurse Advisory Board. Isaac Melamed, MD Isaac Melamed, MD, has focused on clinical practice and research for over 20 years. He has published more than 100 papers and presented and lectured in national and international settings. Dr. Melamed is a physician in private practice focusing on primary immune deficiency and the interaction between the immune system and nervous system-neuroimmune connection. Fifteen years ago, he founded an independent clinical research facility in Centennial, Colorado, IMMUNOe International Research Center, which is linked with the health clinics. Dr. Melamed has been a principal investigator in over 250 clinical trials, including multiple Ig trials for PID and neurologic conditions. Prior to private practice, Dr. Melamed was in academia for 25 years and conducted research on nerve growth factor (NGF) as a neuroimmune adaptor. 18 BECOME IgCN https://www.ig-ns.org/ig-nursing-national-certification-program Immunoglobulin Certified Nurse Credentialing September 18-20, 2015 Hyatt Regency Capitol Hill • Washington, DC 19 Faculty Biographies Itay Melamed, MD Dr. Itay Melamed is the founding neurosurgeon of Advanced Brain & Spine, providing neurosurgical care to the Denver and Colorado community. After completing medical school at the University of Colorado Health Sciences Center, Dr. Melamed completed a neurosurgery residency at the University of Missouri in Columbia. During his residency, he trained with orthopedic spine surgeons and helped establish a vascular microsurgery workshop. He then completed a two-year endovascular surgical neuroradiology fellowship with the Indianapolis Neurosurgical Group. Following his fellowship, Dr. Melamed served as an Assistant Associate Professor at the Indiana University School of Medicine. During that time, he performed a variety of cases to include vascular, endovascular, brain tumor treatments, radiosurgical treatments, peripheral nerve cases, and minimally invasive spine cases, among others. Kenneth Metcalf In 2004, Kenny Metcalf experienced a loss of energy and sores appeared in his mouth and on the outside of his body. Diagnosed with pemphigus vulgaris, he was told at the time that the average lifespan was only 5-6 years. Within 2 years, he became gravely ill and his family rushed him to the burn unit at the University of California, Irvine (UCI), which had treated 5 previous PV patients. Through their help and “a miracle,” he was released after 6 weeks in the ICU. For the next 9 years, under the care of Dr. Grando of UCI, home health nurses administered IVIG to Mr. Metcalf at home. In May 2015, Dr. Grando removed Mr. Metcalf from all medications. Today, Mr. Metcalf is a successful Elton John impressionist and performer, appearing as “Kenny Metcalf as Elton and the Early Years Band.” He has appeared twice on AXSTV’s “The World’s Greatest Tribute Bands,” watched by a total of 90 million nationwide viewers. Linda Payne Linda Payne is the Founder and President of Reimbursement Concepts, LLC, and is a highly recognized professional in the field of infusion, DME, and AIC reimbursement for over 20 years. Prior to starting Reimbursement Concepts, LLC, Ms Payne held senior management positions with several of the nation’s leading homecare companies including Accredo Health Services and Gentiva Health Services. Ms Payne has developed innovative solutions and key partnerships in many areas of reimbursement, including reimbursement department design, process improvement, A/R management, system analysis and implementation, government and corporate compliance, and productivity goals and analysis. Kathy Puglise, MSN/ED, BSN, RN, CRNI Kathy Puglise has been a registered nurse for 26 years and has clinical experience in emergency room, critical care, and infusion nursing. Ms. Puglise holds a Master of Science in Nursing with a specialization in health care education. Ms. Puglise is a Clinical Manager of Home Infusion for Smiths Medical. She educates home infusion customers on the CADD Solis VIP pump, a medication safety software driven pump. Ms. Puglise served as President of the Infusion Nurses Board of Directors from 2012-2013. In addition, she served on the Infusion Nursing Certifications RN council as an expert in question development and evaluation of the CRNI (certified registered nurse infusion) from 20032011. Currently, she is Director of Nursing for the Specialty Pharmacy Certification Board and an incoming Director for the Infusion Nurses Certification Corporation. 20 Faculty Biographies Neil Ross Mr. Ross has over fifteen years experience in the Specialty Pharmacy market. He was a pioneer in the development of the subcutaneous (SCIG) route of administration for immune globulin (IgG). Mr. Ross has experience in all aspects of the Specialty Pharmacy business. As a patient with PI and multiple autoimmune issues, he is utilizing his experience and passion to help patients living with chronic diseases achieve an enhanced quality of life. Mr. Ross is a founding member of the Executive Advisory Committee of the Immune Globulin Nursing Society (IgNS), a past Advisory Committee member and Peer Support Volunteer for the Immune Deficiency Foundation (IDF), an Advisory Committee member for the GBS/CIDP Foundation and the Myasthenia Gravis Foundation. He also has been a consultant for the Alliance for Patient Advocacy, EMED Technologies, and CSL Behring for the launch of Vivaglobin, and an Allied Health Committee member with the Clinical Immunology Society (CIS). Mr. Ross also has been a patient speaker for numerous Ig manufacturers. Felicia Schaps, RN, MSN-Ed, CRNI, OCN, CNSC, IgCN Felicia Schaps is the National Director of Nursing Operations for Bioscrip, Inc. She has been an RN for 31 years, primarily in the area of home infusion, including administration and management of Ig therapies. Ms. Schaps has a master’s degree in nursing with a focus in nursing education. She has made many presentations around the country for the National Home Infusion Association (NHIA) and other professional organizations. Ms. Schaps is currently a member of the IgNS exam council, the education committee of NHIA, the Infusion Nurses Certification Council (INCC) exam council, and the National Board of Nutrition Support Certification (NBNSC) exam council. She also is the Director of Nursing for the Virginia chapter of the American Society for Parenteral and Enteral Nutrition (ASPEN). Ms. Schaps has published articles on topics related to infusion nursing in Infusion Magazine and Specialty Pharmacy Continuum. Tom Schleis, MS, RPh Mr. Schleis holds Bachelor’s and Master’s Degrees in chemistry and a Bachelor’s Degree in pharmacy. His background includes 7 years of hospital-based pharmacy experience followed by 16 years as the Director of Pharmacy at Northwest Medical Specialties in Tacoma, Washington. In that position, he established and managed an immune globulin therapy program and gained experience with all brands of products. Mr. Schleis then served for 7 years as the Director of Medical Affairs and as a Local Drug Safety Officer for one of the immune globulin manufacturers. He is currently the President of Schleis Professional Services, a consulting firm specializing in immune globulin therapy. Linda Schneider, RN, BSN, CPN, IgCN Linda Anastasia Schneider is the Clinical Nurse Expert for the Day Medicine Unit at The Children’s Hospital of Philadelphia. The Day Medicine Unit is an outpatient, hospital-based, infusion /diagnostic center that provide services to multiple sub-specialties. Ms. Schneider is a member of the Nurse Advisory Committee of the Immune Deficiency Foundation and has presented at its National Conferences. She also has been involved with other IDF activities. Ms. Schneider is active within the Immune Globulin Nurse Society where she has helped create the Certification Exam and develop the Standards of Practice. She has presented at previous IgNS national conferences and has been on the faculty of the IgCN Academy. September 18-20, 2015 Hyatt Regency Capitol Hill • Washington, DC 21 Faculty Biographies Jeanette Scott, RN, BSN Jeanette Scott is a registered nurse of 30 years. Her most current position is Senior Clinical Consultant for Baxalta (formally Baxter Bioscience) in Immunology Global Medical Affairs. In this role, she is focusing her passion for education and training on IgG therapies in the field of immunology, both within the company as well as among external health care professionals. Ms. Scott has many years’ experience personally as well as professionally educating, infusing, and training patients and families with IGG therapies. Of her four grown children, two have a primary immune deficiency. She has served on the Nurse Advisory Board of the Immune Deficiency Foundation for 5 years, assisting with updates of materials as well as teaching at IDF national conferences. Currently she is contributing her time to the Immune Globulin National Society to help increase the knowledge and expertise of other health care professionals. Dominick Spatafora Dominick Spatafora is founder and president of the Neuropathy Action Foundation (NAF). He received a master’s in public administration from American University in Washington, DC. After working for Congressman J. Dennis Hastert on major healthcare reform efforts, he joined the Arizona Medical Board as Legislative and Regulatory Affairs director. He served as CEO of the Los Angeles County Medical Association before joining Pfizer in 2009, where he is Director of Advocacy and Professional Relations. At age 30, Mr Spatafora was diagnosed with multifocal motor neuropathy. He had difficulties in accessing appropriate treatment, especially because his neuropathy is atypical and does not fall neatly within standard treatment guidelines. After going 3 months without IGIV treatment, he lost the use of his right hand. Working with his physician, he was able to resume treatment and regained the use of his hand. His commitment to help neuropathy patients obtain appropriate individualized care led him to found the NAF. Michael D. Tarantino, MD Dr. Tarantino has 25 years of experience in his field, with five years as the Founder, Medical Director, and President of the Bleeding & Clotting Disorders Institute. For over two decades he has devoted his medical career to the management of bleeding and clotting disorders as well as non-malignant hematology,. On a daily basis, he is responsible for directing BCDI, the only federally recognized Center of Excellence for the care of children and adults with bleeding or clotting disorders in Illinois south of Chicago. Dr. Tarantino serves as the medical director of the Anticoagulation Consultation Service at St. Francis Medical Center where he also co-chairs the Anti-thrombosis subcommittee. Since 2008, Dr. Tarantino has been a tenured Professor of Pediatrics and Medicine at the University of Illinois College of Medicine in Peoria and is active in teaching medical students, residents and allied health professionals. Dr. Tarantino earned an MD from the University of Wisconsin School of Medicine and Public Health in 1987. He then completed a residency in pediatrics from the University of Arizona in 1990 and a fellowship in pediatric hematology and oncology from the University of Wisconsin in 1993. He is board certified in Pediatric Hematology and Oncology. He is a longstanding member of the Medical and Scientific Advisory Council of the National Hemophilia Foundation and a member of the Medical Advisory Board of the Platelet Disorder Association. He was honored as a physician of the year by the National Hemophilia Foundation from 2012-2013. In 2014 the University of Illinois College of Medicine presented him with an Alpha Omega Alpha Teaching Award. Dr. Tarantino has authored or co-authored over 100 peer-reviewed papers, reviews, and book chapters and over 120 scientific abstracts. 22 Faculty Biographies Theoharis C. Theoharides, BA, MS, MPhil, PhD, MD, FAAAAI Dr. Theoharides is Professor of Pharmacology and Internal Medicine as well as Director of Molecular Immunopharmacology and Drug Discovery at Tufts University School of Medicine in Boston. He was born in Thessaloniki, Greece, where he graduated from Anatolia College. Dr. Theoharides received all his degrees with Honors from Yale University, and was awarded the Dean’s Research Award and the Winternitz Prize in Pathology. He trained in internal medicine at New England Medical Center, which awarded him the Oliver Smith Award “recognizing excellence, compassion and service.” He also received a Certificate in Global Leadership from the Tufts Fletcher School of Law and Diplomacy, and completed a Fellowship at the Harvard Kennedy School of Government. He is a member of 15 academies and scientific societies. Dr. Theoharides has published 372 papers, 3 textbooks, and with 21,637 citations is in the top 5% of authors most cited in pharmacological and immunological journals. His research first showed that mast cells, known for causing allergic reactions, are critical for inflammation, especially in the brain, and most recently in the pathogenesis of autism and brain fog. Dr. Theoharides has been awarded 17 patents. He was inducted into the Alpha Omega Alpha National Medical Honor Society and the Rare Diseases Hall of Fame. He has received the Tufts Alumni Award for Faculty Excellence, the Tufts Distinguished Faculty Recognition Award, and Boston Mayor’s Community Award, among other prestigious awards. Kendall Van Pool Kendall Van Pool is the Vice President of Legislative Affairs at the National Home Infusion Association, a trade association that represents and advances the interests of organizations providing infusion and specialty pharmacy products and services to the entire spectrum of home-based patients. Mr. Van Pool has been instrumental in developing and promoting the legislative and regulatory policy agenda of NHIA. He directs a wide spectrum of advocacy activities focused on clinical and business best practices that may be subject to legislation, regulation, accreditation, practices of health plans/third party payers, and more. Mr. Van Pool has over 15 years of experience working on Capitol Hill and in various health care advocacy positions. As a professional staff member of the Senate Special Committee, he directed the Committee’s Medicaid and long-term care agenda. In the private sector, he has advocated on behalf of several health care associated organizations, including the Blue Cross and Blue Shield Association, American Diabetes Association, and clients of the Bockorny Group. Leslie Vaughan, RPh Leslie Vaughan is Senior Vice President of Clinical Programs for NuFACTOR Specialty Pharmacy, a nationwide company that provides specialty products and care for infusion patients. Prior to joining NuFACTOR, she served as senior vice president of the Chronic Treatments Division for Crescent Healthcare, and held the position of National Director of Infusion Services for Apria Healthcare. She received her pharmacy degree from the University of New Mexico in Albuquerque, and she is currently licensed as a pharmacist in 21 states. As a lecturer and author, Ms. Vaughan has focused on “real world” uses of intravenous immunoglobulin (IVIG) in neurological disorders. She has also investigated the adverse events of IVIG for neurologic patients in home care settings, and clinical response to therapy with IVIG in neurological indications. Ms. Vaughan has held professional and committee memberships in the American Society of Health-System Pharmacists, the National Home Infusion Association, and the Home Infusion Electronic Data Interchange Coalition. She is also a member of the American Association of Neuromuscular & Electrodiagnostic Medicine and the American Academy of Neurology. Alison Walsh, MD Dr. Alison Walsh completed her medical school training, neurology residency, neurophysiology fellowship, and neuromuscular track, at Thomas Jefferson University Hospital in Philadelphia. She is board certified in neurology and practices as a Clinical Instructor in the Department of Neurology at Jefferson Hospital, specializing in neuromuscular medicine. Dr. Walsh is currently co-investigator in a number of research studies involving patients with myasthenia gravis, dermatomyositis, chronic inflammatory demyelinating polyradiculoneuropathy, and Guillain-Barré syndrome, among others. September 18-20, 2015 Hyatt Regency Capitol Hill • Washington, DC 23 AAonce-a-month once-a-month subcutaneous subcutaneousIG?! IG?! With With HYQVIA, HYQVIA, patients patients have have more more infusion-free infusion-free days days each each month, month, giving giving them them more more timetime to focus to focus on living on living their their lives. lives. As the Asfithe rst and first only and only once-a-month once-a-month subcutaneous subcutaneous immunoglobulin immunoglobulin (IG) for (IG)the fortreatment the treatment of primary of primary immunodefi immunodefi ciency ciency in adults, in adults, HYQVIA HYQVIA [Immune [Immune Globulin Globulin Infusion Infusion 10%10% (Human) (Human) with with : 1: Recombinant Recombinant Human Human Hyaluronidase] Hyaluronidase] offersoffers added added freedom freedom with with only1only Adjust Adjust the frequency the frequency and and number number of infusion of infusion sitessites taking taking into into consideration consideration volume, volume, totaltotal infusion infusion time, time, 1 1 and and tolerability tolerability NEEDLE NEEDLE INFUSION INFUSION SITESITE TIMETIME A MONTH A MONTH Indication Indication and and Usage Usage HYQVIA HYQVIA is anisimmune an immune globulin globulin with with a recombinant a recombinant human human hyaluronidase hyaluronidase indicated indicated for the fortreatment the treatment of Primary of Primary Immunodefi Immunodefi ciency ciency (PI) (PI) in adults. in adults. This This includes, includes, but is butnot is limited not limited to, common to, common variable variable immunodefi immunodefi ciency ciency (CVID), (CVID), X-linked X-linked agammaglobulinemia, agammaglobulinemia, congenital congenital agammaglobulinemia, agammaglobulinemia, Wiskott-Aldrich Wiskott-Aldrich syndrome, syndrome, and severe and severe combined combined immunodefi immunodefi ciencies. ciencies. Limitation Limitation of Use: of Use: Safety Safety and effi andcacy efficacy of chronic of chronic use of use recombinant of recombinant human human hyaluronidase hyaluronidase in HYQVIA in HYQVIA havehave not been not been established established in conditions in conditions otherother thanthan PI. PI. Detailed Important RiskRisk Information Detailed Important Information BOXED BOXED WARNING: WARNING: THROMBOSIS THROMBOSIS Thrombosis: Thrombosis: Thrombosis Thrombosis may may occuroccur following following treatment treatment with with immune immune Thrombosis Thrombosis may occur may occur with immune with immune globulin globulin products, products, including including HYQVIA. HYQVIA. globulin globulin products, products, including including HYQVIA. HYQVIA. Risk factors Risk factors may include may include advanced advanced Risk Risk factors factors may may include include advanced advanced age,age, prolonged prolonged immobilization, immobilization, age, age, prolonged prolonged immobilization, immobilization, hypercoagulable hypercoagulable conditions, conditions, history history of of hypercoagulable hypercoagulable conditions, conditions, history history of venous of venous or arterial or arterial thrombosis, thrombosis, venous venous or arterial or arterial thrombosis, thrombosis, use ofuse estrogens, of estrogens, indwelling indwelling central central vascular vascular use of use estrogens, of estrogens, indwelling indwelling vascular vascular catheters, catheters, hyperviscosity, hyperviscosity, and and catheters, catheters, hyperviscosity, hyperviscosity, and cardiovascular and cardiovascular risk factors. risk factors. Thrombosis Thrombosis cardiovascular cardiovascular risk factors. risk factors. Thrombosis Thrombosis may may occuroccur in theinabsence the absence of may of may occuroccur in theinabsence the absence of known of known risk factors. risk factors. known known risk factors. risk factors. For patients For patients at riskatofrisk thrombosis, of thrombosis, administer administer HYQVIA HYQVIA Immunogenicity Immunogenicity of Recombinant of Recombinant Human Human Hyaluronidase Hyaluronidase (PH20): (PH20): at theatminimum the minimum dosedose and infusion and infusion rate practicable. rate practicable. Ensure Ensure adequate adequate Non-neutralizing Non-neutralizing antibodies antibodies to thetorecombinant the recombinant human human hyaluronidase hyaluronidase hydration hydration in patients in patients before before administration. administration. Monitor Monitor for signs for signs and symptoms and symptoms component component can develop. can develop. The potential The potential existsexists for such for such antibodies antibodies to crossto crossof thrombosis of thrombosis and assess and assess bloodblood viscosity viscosity in patients in patients at riskatofrisk hyperviscosity. of hyperviscosity. reactreact with with endogenous endogenous PH20, PH20, whichwhich is known is known to betoexpressed be expressed in adult in adult CONTRAINDICATIONS CONTRAINDICATIONS malemale testes, testes, epididymis, epididymis, and sperm. and sperm. The clinical The clinical signifi signifi cancecance of these of these HYQVIA HYQVIA is contraindicated: is contraindicated: in patients in patients who have who have a history a history of anaphylactic of anaphylactic antibodies antibodies or whether or whether they interfere they interfere with fertilization with fertilization in humans in humans is unknown. is unknown. or severe or severe systemic systemic hypersensitivity hypersensitivity reactions reactions to thetoadministration the administration of Human of Human Aseptic Aseptic Meningitis Meningitis Syndrome Syndrome (AMS): (AMS): AMSAMS has been has been reported reported to occur to occur Immune Immune Globulin Globulin (IgG);(IgG); in IgA-defi in IgA-defi cient cient patients patients with antibodies with antibodies to IgAtoand IgA and with with IgG treatment IgG treatment administered administered intravenously intravenously and subcutaneously. and subcutaneously. a history a history of hypersensitivity; of hypersensitivity; and inand patients in patients with known with known systemic systemic hypersensitivity hypersensitivity Discontinuation Discontinuation of IgG of treatment IgG treatment has resulted has resulted in remission in remission of AMS of AMS to hyaluronidase to hyaluronidase or Recombinant or Recombinant Human Human Hyaluronidase Hyaluronidase of HYQVIA. of HYQVIA. within within several several daysdays without without sequelae. sequelae. WARNINGS WARNINGS and PRECAUTIONS and PRECAUTIONS Hemolysis: Hemolysis: AcuteAcute intravascular intravascular hemolysis hemolysis has been has been reported reported following following Hypersensitivity: Hypersensitivity: Severe Severe hypersensitivity hypersensitivity reactions reactions may may occur,occur, eveneven in intravenously in intravenously administered administered IgG products, IgG products, including including Immune Immune Globulin Globulin patients patients who who havehave tolerated tolerated previous previous treatment treatment with with IgG. IgG. IgA-defi IgA-defi cientcient Infusion Infusion 10% 10% (Human) (Human) administered administered intravenously, intravenously, and delayed and delayed hemolytic hemolytic patients patients with antibodies with antibodies to IgAtoare IgAatare greater at greater risk ofrisk developing of developing potentially potentially anemia anemia can develop can develop due to due enhanced to enhanced RBC RBC sequestration. sequestration. IgG products, IgG products, severe severe hypersensitivity hypersensitivity and anaphylactic and anaphylactic reactions. reactions. including including HYQVIA, HYQVIA, contain contain bloodblood group group antibodies antibodies which which may may causecause a positive a positive directdirect antiglobulin antiglobulin reaction reaction and hemolysis. and hemolysis. Please Please see additional see additional Detailed Detailed Important Important RiskRisk Information Information on facing on facing pagepage and Brief and Brief Summary Summary of Prescribing of Prescribing Information, Information, including including Boxed Boxed Warning, Warning, on the onfollowing the following pages. pages. Find Findout outmore moreatat # 406 Boot Booth h# 406 Reference: Reference: 1. HYQVIA 1. HYQVIA Prescribing Prescribing information. information. Westlake Westlake Village,Village, CA: CA: Baxter Baxter Healthcare Healthcare Corporation; Corporation; September September 2014. 2014. Detailed Detailed Important Important RiskRisk Information Information (cont’d) (cont’d) RenalRenal Dysfunction/Failure: Dysfunction/Failure: AcuteAcute renalrenal dysfunction/failure, dysfunction/failure, acuteacute tubular tubular Interference Interference with with Laboratory Laboratory Tests: Tests: FalseFalse positive positive serological serological test test necrosis, necrosis, proximal proximal tubular tubular nephropathy, nephropathy, osmotic osmotic nephrosis, nephrosis, and death and death results, results, with the withpotential the potential for misleading for misleading interpretation, interpretation, may result may result fromfrom may occur may occur uponupon use ofuse IgGofproducts IgG products administered administered intravenously, intravenously, especially especially the transitory the transitory rise of rise theofvarious the various passively passively transferred transferred antibodies antibodies in thein the thosethose containing containing sucrose. sucrose. HYQVIA HYQVIA doesdoes not contain not contain sucrose. sucrose. Ensure Ensure that that patient’s patient’s bloodblood after after infusion infusion of IgG. of Passive IgG. Passive transmission transmission of antibodies of antibodies patients patients are not arevolume not volume depleted depleted prior prior to thetoinitiation the initiation of infusion of infusion of HYQVIA. of HYQVIA. to erythrocyte to erythrocyte antigens antigens (e.g.,(e.g., A, B,A, and B, D) andmay D) may causecause a positive a positive directdirect Monitor Monitor renalrenal function function and urine and urine output output and consider and consider lower,lower, moremore frequent frequent or indirect or indirect antiglobulin antiglobulin (Coombs’) (Coombs’) test. test. dosing dosing in patients in patients who are whoatare riskatofrisk developing of developing renalrenal dysfunction dysfunction because because ADVERSE ADVERSE REACTIONS REACTIONS of pre-existing of pre-existing renalrenal insuffi insuffi ciency ciency or predisposition or predisposition to acute to acute renalrenal failure. failure. The most The most common common adverse adverse reactions reactions observed observed in > 5% in > of 5% patients of patients in in Spread Spread of Localized of Localized Infection: Infection: Do not Doinfuse not infuse HYQVIA HYQVIA into or intoaround or around the clinical the clinical trialstrials were:were: local local adverse adverse reactions reactions (52%), (52%), headache headache (21%), (21%), an infected an infected or acutely or acutely inflamed inflamed area area due to due potential to potential risk of risk spreading of spreading antibody antibody formation formation against against recombinant recombinant human human hyaluronidase hyaluronidase (18%), (18%), a localized a localized infection. infection. fatigue fatigue (11%), (11%), nausea nausea (7%),(7%), pyrexia pyrexia (7%),(7%), and vomiting and vomiting (7%).(7%). No serious No serious Transfusion-Related Transfusion-Related AcuteAcute LungLung InjuryInjury (TRALI): (TRALI): Non-cardiogenic Non-cardiogenic pulmonary pulmonary adverse adverse reactions reactions occurred occurred during during the HYQVIA the HYQVIA clinical clinical trials.trials. edema edema has been has been reported reported in patients in patients following following treatment treatment with intravenously with intravenously administered administered IgG products, IgG products, including including Immune Immune Globulin Globulin Infusion Infusion 10%10% (Human). (Human). TRALITRALI is characterized is characterized by severe by severe respiratory respiratory distress, distress, pulmonary pulmonary edema, edema, hypoxemia, hypoxemia, normal normal left ventricular left ventricular function, function, and fever. and fever. Transmittable Transmittable Infectious Infectious Agents: Agents: Because Because the Immune the Immune Globulin Globulin Infusion Infusion 10%10% (Human) (Human) of HYQVIA of HYQVIA is made is made fromfrom human human plasma, plasma, it may it may carrycarry a a risk of risk transmitting of transmitting infectious infectious agents, agents, e.g., viruses e.g., viruses and other and other pathogens, pathogens, and theoretically, and theoretically, the Creutzfeldt-Jakob the Creutzfeldt-Jakob disease disease (CJD)(CJD) agent. agent. No cases No cases of viral of viral transmission transmission or CJD or CJD havehave beenbeen associated associated with with HYQVIA. HYQVIA. Baxalta Baxalta and Hyqvia and Hyqvia are trademarks are trademarks of Baxalta of Baxalta Incorporated. Incorporated. August August 2015 2015 USBS/MG89/15-0098 USBS/MG89/15-0098 T:6.875” BRIEF SUMMARY OF PRESCRIBING INFORMATION INDICATIONS AND USAGE HYQVIA is an immune globulin with a recombinant human hyaluronidase indicated for the treatment of Primary Immunodeficiency (PI) in adults. This includes, but is not limited to, common variable immunodeficiency (CVID), X-linked agammaglobulinemia, congenital agammaglobulinemia, WiskottAldrich syndrome, and severe combined immunodeficiencies. Limitation of Use: Safety and efficacy of chronic use of recombinant human hyaluronidase in HYQVIA have not been established in conditions other than PI. BOXED WARNING: THROMBOSIS • Thrombosis may occur with immune globulin products, including HYQVIA. Risk factors may include advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity and cardiovascular risk factors. Thrombosis may occur in the absence of known risk factors. • For patients at risk of thrombosis, administer HYQVIA at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. • Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk of hyperviscosity. CONTRAINDICATIONS HYQVIA is contraindicated in: • patients who have had a history of anaphylactic or severe systemic reactions to the administration of IgG. • IgA deficient patients with antibodies to IgA and a history of hypersensitivity. • patients with known systemic hypersensitivity to hyaluronidase or Recombinant Human Hyaluronidase of HYQVIA. GAMA15CDNY1048_A_HyQvia_MBS_6.875x9.875_Aug2015_r6_FSU.indd 1 ADVERSE REACTIONS Common adverse reactions observed in clinical trials in >5% of subjects were: local reactions, headache, antibody formation against recombinant human hyaluronidase (rHuPH20), fatigue, nausea, pyrexia, and vomiting. Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in clinical studies of a product cannot be directly compared to rates in the clinical studies of another product and may not reflect the rates observed in clinical practice. Immune Globulin Infusion 10% (Human) administered intravenously: Prior to initiation of treatment with HYQVIA, 87 patients received 365 infusions of Immune Globulin Infusion 10% (Human) encompassing 22.2 patient-years. 8/10/15 4:03 PM T:9.875” WARNINGS AND PRECAUTIONS Hypersensitivity—Severe hypersensitivity reactions may occur, even in patients who have tolerated previous treatment with IgG. In case of hypersensitivity, discontinue the HYQVIA infusion immediately and institute appropriate treatment. Immune Globulin Infusion 10% (Human) of HYQVIA contains trace amount of IgA (average concentration of 37μg/mL). Patients with antibodies to IgA potentially are at greater risk of developing potentially severe hypersensitivity and anaphylactic reactions. Thrombosis—Thrombosis may occur following treatment with immune globulin products, including HYQVIA. Risk factors may include advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling central vascular catheters, hyperviscosity, and cardiovascular risk factors. Thrombosis may occur in the absence of known risk factors. Consider baseline assessment of blood viscosity in patients at risk for hyperviscosity, such as those with cryoglobulins, fasting chylomicronemia/ markedly high triacylglycerols (triglycerides), or monoclonal gammopathies. For patients at risk of thrombosis, administer HYQVIA at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity. [see Boxed Warning, Dosage and Administration (2), Patient Counseling Information (17) in full prescribing information]. Immunogenicity of Recombinant Human Hyaluronidase (PH20)—Eighteen percent (15 of 83) of subjects receiving HYQVIA in clinical studies developed non-neutralizing antibodies to the recombinant human hyaluronidase component. The potential exists for such antibodies to cross-react with endogenous PH20, which is known to be expressed in the adult male testes, epididymis, and sperm. It is unknown whether these antibodies may interfere with fertilization in humans. The clinical significance of these antibodies is not known. Aseptic Meningitis Syndrome (AMS)—AMS has been reported to occur with IgG products, including Immune Globulin Infusion 10% (Human) administered intravenously and subcutaneously. Discontinuation of IgG treatment has resulted in remission of AMS within several days without sequelae. The syndrome usually begins within several hours to two days following intravenously administered IgG, perhaps more frequently in association with high dose (2 g/kg) intravenously administered IgG. AMS is characterized by the following signs and symptoms: severe headache, nuchal rigidity, drowsiness, fever, photophobia, painful eye movements, nausea and vomiting [see Patient Counseling Information (17) in full prescribing information]. Cerebrospinal fluid (CSF) studies frequently reveal pleocytosis up to several thousand cells per mm3, predominantly from the granulocytic series, and elevated protein levels up to several hundred mg/dL, but negative culture results. Conduct a thorough neurological examination on patients exhibiting such symptoms and signs, including CSF studies, to rule out other causes of meningitis. Hemolysis—IgG products, including HYQVIA, contain blood group antibodies which may act as hemolysins and induce in vivo coating of red blood cells (RBC) with IgG. These antibodies may cause a positive direct antiglobulin reaction and hemolysis. Acute intravascular hemolysis has been reported following intravenously administered IgG, including Immune Globulin Infusion 10% (Human) administered intravenously, and delayed hemolytic anemia can develop due to enhanced RBC sequestration [see Adverse Reactions (6) in full prescribing information]. Monitor patients for clinical signs and symptoms of hemolysis. If signs and/or symptoms of hemolysis are present after HYQVIA infusion, perform appropriate confirmatory laboratory testing [see Patient Counseling Information (17) in full prescribing information]. Renal Dysfunction/Failure—Acute renal dysfunction/failure, acute tubular necrosis, proximal tubular nephropathy, osmotic nephrosis and death may occur upon use of IgG products administered intravenously, especially those containing sucrose. HYQVIA does not contain sucrose. Acute renal dysfunction/failure has been reported in association with Immune Globulin Infusion 10% (Human) administered intravenously. Ensure that patients are not volume depleted prior to the initiation of infusion of HYQVIA. In patients who are at risk of developing renal dysfunction because of pre-existing renal insufficiency or predisposition to acute renal failure (such as diabetes mellitus, age greater than 65, volume depletion, sepsis, paraproteinemia, or patients receiving known nephrotoxic drugs), monitor renal function and consider lower, more frequent dosing. Periodic monitoring of renal function and urine output is particularly important in patients judged to be at increased risk for developing acute renal failure. Assess renal function, including measurement of blood urea nitrogen (BUN) and serum creatinine, before the initial infusion of HYQVIA and again at appropriate intervals thereafter. If renal function deteriorates, consider discontinuation of HYQVIA. Spread of Localized Infection—Infusion into or around an infected area can spread a localized infection. Do not infuse HYQVIA into these areas due to potential risk of spreading a localized infection. Transfusion-Related Acute Lung Injury (TRALI)—Non-cardiogenic pulmonary edema (TRALI) may occur with intravenously administered IgG and has been reported to occur with Immune Globulin Infusion 10% (Human) administered intravenously. TRALI is characterized by severe respiratory distress, pulmonary edema, hypoxemia, normal left ventricular function, and fever. Symptoms typically occur within 1 to 6 hours after treatment. Monitor patients for pulmonary adverse reactions [see Patient Counseling Information (17) in full prescribing information]. If TRALI is suspected, conduct an evaluation, including appropriate tests for the presence of anti-neutrophil and anti-HLA antibodies in both the product and patient serum. TRALI may be managed using oxygen therapy with adequate ventilatory support. Transmittable Infectious Agents—Because Immune Globulin Infusion 10% (Human) of HYQVIA is made from human plasma, it may carry a risk of transmitting infectious agents, e.g., viruses, the variant CJD (vCJD) agent, and theoretically, the classic Creutzfeldt-Jakob disease agent. This also applies to unknown or emerging viruses and other pathogens. No cases of transmission of viral diseases or vCJD have been associated with HYQVIA. Report all infections thought to be possibly transmitted by HYQVIA to Baxalta US Inc., at 1-800-423-2090 (in the U.S.). Interference with Laboratory Tests—After infusion of IgG, the transitory rise of the various passively transferred antibodies in the patient’s blood may yield false positive serological testing results, with the potential for misleading interpretation. Passive transmission of antibodies to erythrocyte antigens (e.g., A, B, and D) may cause a positive direct or indirect antiglobulin (Coombs’) test. T:6.875” Among the 87 patients treated, 56 (64.4%) experienced 1 or more adverse reactions. Among the 365 intravenous infusions, 158 adverse reactions occurred for a rate per infusion of 0.43. A total of 1359 infusions of HYQVIA were administered during the trial; 230 of these infusions occurred during the ramp-up period and the other 1129 occurred during the observation period. During the observation period, 81 patients received 1129 infusions of HYQVIA, of those, 67 (82.7%) experienced one or more adverse reactions. Among the 1129 HYQVIA infusions, 456 adverse reactions occurred for a rate per infusion of 0.40. Seven of these adverse reactions were severe defined as marked impairment of function or can lead to temporary inability to resume normal life pattern; requires prolonged intervention or results in sequelae. Adverse reactions occurring in greater than 5% of subjects associated with infusions of HYQVIA vs. Immune Globulin Infusion 10% (Human) given intravenously are shown in Table 1. The majority of these adverse reactions were mild to moderate in severity and did not necessitate discontinuing the infusions. Mild is defined as transient discomfort that resolves spontaneously or with minimal intervention; moderate is defined as limited impairment of function and resolves spontaneously or with minimal intervention with no sequelae. No serious adverse reactions occurred during the HYQVIA clinical trials. Table 1 Adverse Reactionsa in greater than 5% of Subjects Associated with Infusions of HYQVIA vs. Immune Globulin Infusion 10% (Human) (IGIV) Given Intravenously HYQVIA IGIV Given Intravenously Number of Adverse Reactions per Infusion (Ratec) N = 1129 Number of Subjects (%) N = 87 Number of Adverse Reactions per Infusion (Rate) N = 365 Local ARs 42 (51.9%) 234 (0.21) 4 (4.6%) 4 (0.01) Systemic ARs 55 (67.9%) 222 (0.20) 54 (62.1%) 154 (0.42) Headache 17 (21%) 40 (0.04) 22 (25.3%) 42 (0.12) Fatigue 9 (11.1%) 16 (0.01) 8 (9.2%) 10 (0.03) Nausea 6 (7.4%) 12 (0.01) 10 (11.5%) 10 (0.03) Pyrexia 6 (7.4%) 11 (0.01) 6 (6.9%) 7 (0.02) Vomiting 6 (7.4%) 11 (0.01) 5 (5.7%) 7 (0.02) Adverse Reactionsb Causally related adverse events and/or temporally associated adverse events occurring within 72 hours. b Excluding infections. c Rate = total number of events divided by total number of infusions. a Six subjects, 2 children and 4 adults, withdrew from the trial during the efficacy treatment period with HYQVIA due to mild to moderate adverse reactions. One child withdrew due to local pain and one due to fever, vomiting, and headaches. Of the four adults, two withdrew due to local pain and swelling, one had moderate swelling that transiently extended from the abdominal infusion site to the genitalia, and one had back injury. Antibodies binding to rHuPH20: A total of 15 out of 83 subjects who were treated with HYQVIA developed an antibody capable of binding to recombinant human hyaluronidase in the clinical trials. These antibodies were not capable of neutralizing recombinant human hyaluronidase. In the clinical trial, no temporal association between adverse reactions and the presence of antibodies capable of binding to the Recombinant Human Hyaluronidase of HYQVIA could be demonstrated. There was no increase in incidence or severity of adverse reactions in subjects who developed antibodies to Recombinant Human Hyaluronidase of HYQVIA. In all subjects, antibody titers decreased despite continued treatment. The effect of exposure to antibodies capable of binding to Recombinant Human Hyaluronidase of HYQVIA for periods longer than this clinical trial has not been evaluated. The local adverse reactions are listed by frequency in Table 2. Mild swelling around the infusion site was present in most infusions due to the large volumes infused, but in general was not considered to be an adverse reaction unless it caused discomfort. Among the 234 local adverse reactions, three were severe (infusion site pain, infusion site swelling and infusion site edema that GAMA15CDNY1048_A_HyQvia_MBS_6.875x9.875_Aug2015_r6_FSU.indd 2 Table 2 Most Frequent Local Adverse Reactions Reported in greater than 1% of Infusion During Treatment With HYQVIA Infusion Site Reaction Number and Rate of Reactions per Infusion N = 1129 Discomfort/pain 122 (0.11) Erythema 32 (0.03) Swelling/Edema 35 (0.03) Pruritus 22 (0.02) Rate per infusion = total number of events divided by total number of infusions During the combined efficacy and extension trials encompassing more than 3 years, the local adverse reaction rate was 2.6 per patient-year. During the first 12 month period (months 1-12), the rate was 3.68 local adverse reactions per patient-year. During the subsequent 12 month period (months 13-24), the rate declined to 2.12 local adverse reactions per patient-year. Finally, during the third 12 month period (months 25-36), the rate further declined to 0.37 local adverse reactions per patient-year. Sixty-six of the 68 subjects who completed the efficacy clinical trial enrolled in a prospective, open-label, multicenter extension trial to assess the long-term safety and tolerability of HYQVIA. Sixty-three of 66 subjects enrolled received HYQVIA and 3 received IGIV. Of the 63 subjects who received HYQVIA, 48 completed the extension trial. The cumulative exposure of HYQVIA across the two trials was 188 subject-years and 2959 infusions, and a maximum exposure of 188 weeks or up to approximately 3.5 years. There were no clinically observable changes in the skin or subcutaneous tissue in either the efficacy or extension clinical trials. Postmarketing Experience Because postmarketing reporting of adverse reactions is voluntary and from a population of uncertain size, it is not always possible to reliably estimate the frequency of these reactions or establish a causal relationship to product exposure. Postmarketing Experience of Immune Globulin Products The following adverse reactions have been identified and reported during the postmarketing use of Immune Globulin products administered intravenously: Hematologic Leukopenia, Pancytopenia Neurological Transient ischemic attack, Tremor, Burning sensation, Cerebral vascular accident, Coma, Seizures, Loss of consciousness Cardiovascular Hypotension, Hypertension, Myocardial infarction, Chest pain, Cardiac arrest, Vascular collapse Respiratory Pulmonary edema, Dyspnea, Oxygen saturation decreased, Cyanosis, Hypoxemia, Bronchospasm, Apnea, Acute Respiratory Distress Syndrome (ARDS) Gastrointestinal Abdominal pain, Hepatic dysfunction Integumentary Hyperhidrosis, Allergic dermatitis, Bullous dermatitis, Epidermolysis, Erythema multiforme, Stevens-Johnson Syndrome Psychiatric Anxiety, Insomnia Musculoskeletal Back Pain General/ Body as a Whole Edema, Rigors Baxalta and Hyqvia are trademarks of Baxalta Incorporated. August 2015 USBS/MG89/15-0098 8/10/15 4:03 PM T:9.875” Number of Subjects (%) N = 81 extended from the abdominal infusion site to the genitalia); all were transient and resolved without sequelae. More than 98% of local reactions were either mild (70.5%) or moderate (28.2%) in severity. IgNS Exhibitor Raffle Be sure to turn in your completed raffle card by 10:30 am Sunday, September 20 and be present at 12:30 pm for the drawing. new from EMED TECHNOLOGIES SCIg60 INFUSION SYSTEM THE • The only Subcutaneous Infusion System specifically designed for Immune Globulin (Human) Hizentra® • Use with Infuset fixed rate control sets or VersaRate® variable rate control device EMED Technologies Corporation Toll Free Telephone: 888-550-6500 x 118 1264 Hawk’s Flight Court, Suite 200 El Dorado Hills, CA 95762 www.emedtc.com • Optimize your SCIg infusion therapy by using EMED’s patented Soft-Glide® Safety Needle Sets • Covered under HCPCS reimbursement code E0779 • Non-electric, requires no batteries, 3 year limited warranty • Nylon travel case included Join lgNS and become a member today! Connect with leading healthcare professionals, get access to specialized education and publications, and stay informed on the news and events in our industry! BECOME A MEMBER TODAY! Individual and corporate memberships are available to fit your needs. IgNS members enjoy: • Access to continuing education courses for nurses and pharmacists • News magazine and publications • Discounts on Ig Certified Nurse Credentialing examination and recertification • Discounts on future IgNS National Conference registration For more information, please visit us at https://www.ig-ns.org/membership or call (888) 855-4443. Bringing innovative therapies to patients around the world For over 30 years, we have been focused on developing high-quality, life-saving products that support the health and well-being of patients around the world. Get to know Octapharma better Visit www.octapharma.com ©2015 Octapharma USA, Inc. All rights reserved. Date of preparation, 2/15. OCTA-044-COTb-h Corporate Partners & Exhibitors 29 IgNS Thanks Our Corporate Partners Whose Support is Critical To Our Initiatives! TH TH TH TH AN AN AN AN K YO U! K YO U! K YO U! K YO U! IntraPump INFUSION SYSTEMS © Kedrion Biopharma Inc. All Rights Reserved. August 2015 CO-0210-00-2015B Corporate Partners & Exhibitors BOOTH 304 Acta Medical Products offers a history of Quality, Innovative, and Affordable products in the areas of IV and Subcutaneous Administration sets, Enteral Administration Products and USP 797 Cleanroom Disposables. We pride ourselves in developing creative solutions for Caregivers, Pharmacist, and Physicians In both Gravity and Pump sets, including our Safety Sub-Q Administration sets and IVIG specific IV start kits. Please feel free to stop by and discuss your needs with our team. BOOTH 111 Armada Health Care, LLC (Armada) is the industry’s largest specialty pharmacy group contracting and service organization. Armada provides comprehensive and cost-effective access to the nation’s $100+ billion specialty pharmacy industry. Armada offers pharmacy providers, manufacturers, health plans and wholesale distributors a total channel management solution through customized patient programs, prescription data management services, online platforms, and unique cost effective purchasing agreements on specialty pharmacy products. Armada is also the founder and host of the nation’s largest annual specialty pharmacy summit. For more information, visit Armada at www. armadahealthcare.com. BOOTH 406 Baxalta Incorporated is a global biopharmaceutical leader developing, manufacturing and commercializing transformative, market-leading therapies to treat orphan and underserved disease conditions in hematology, immunology and oncology. Our targeted innovation strategy and cutting-edge science, combined with strategic partnerships, come together to spark discovery and deliver innovation for patients with limited treatment options. Come visit Baxalta’s booth, where our specialists will be available to answer your questions about Baxalta products and our commitment to the field of immunology. For more information on Baxalta’s products and services, please visit www.baxalta.com. BOOTH 208 Baxalta US, Inc – Medical Affairs The Immunology Medical Affairs booth will be staffed by Baxalta Medical Affairs representatives who are able to answer medical and scientific questions about Baxalta’s immune globulin products. For more information on Baxalta, please visit www.Baxalta.com. BOOTH 400 Biofusion is a leading specialized provider of IgG therapy. Our clinical expertise, pharmacy and reimbursement services are reasons why physicians choose Biofusion to provide IgG therapy to their patients. As Biofusion, our integrated and personal care approach means patients will have a healthcare team committed to their specific needs. BOOTH 403 BioTek reMEDys is a leading specialty pharmacy that delivers superior service at a lower cost through comprehensive clinical programs, supply chain management efficiencies and cutting edge technology. By servicing very specific disease states, our expert team can focus on patient care, making sure that treatment protocols are appropriate. Through compassion, knowledge and excellent customer service, our immunoglobulin therapy program is designed to promote better patient outcomes. Immunoglobulin reMEDys program: • Educate, support and care for our patients. • Provide experienced nursing and pharmacy services. • Obtain Prior-Authorizations. • Act as a Partner to prescriber’s office. • Determine if Rx meets payer coverage policies. • Assist payers to control medication costs. • Coordinate access to Patient Assistance Programs. • Support manufacturer patient programs. • Deliver appropriate medication and dosage on time. September 18-20, 2015 Hyatt Regency Capitol Hill • Washington, DC 31 Corporate Partners & Exhibitors BOOTH 109 Biotest Pharmaceuticals researches and manufactures biotherapeutic products with a specialization in immunology and hematology. Biotest Pharmaceuticals is a leader in the collection of source plasma. Established in 2007, Biotest Pharmaceuticals owns and manages plasmapheresis centers across the United States and operates a state-of-the-art manufacturing facility in Boca Raton, Florida. BOOTH 112 Bio Products Laboratory (BPL) is a global company with 60 years of history in plasma research, technology, and manufacturing. Originally part of the world-famous Lister Institute, BPL has a full line of products derived from plasma collected at 35 company-owned collection centers across the US. For more information, please visit www.bpl-us.com. www.BriovaRx.com BOOTH 402 BriovaRx™ is a truly patient-centric specialty pharmacy, dedicated to making a meaningful impact on every patient’s well-being. We offer comprehensive, personalized specialty pharmacy care, including drug reimbursement verification and advocacy, confidential overnight delivery, patient education and emergency support for patients, competitive pricing and access to many limited distribution medications. BOOTH 107 CSL Behring is a global leader in the plasma protein biotherapeutics industry. We research, develop, manufacture and market biotherapies that are used to treat serious and rare conditions. Users of our therapies rely on them for their quality of life and, in many cases, for life itself. Our commitment to saving lives and improving the quality of life for people with serious and rare conditions is evident in everything we do. Whether we are manufacturing and marketing safe and effective products or researching and developing innovative biotherapies, we are first and foremost focused on fulfilling our customers’ needs. BOOTH 113 EMED Technologies designs, develops and markets a broad range of patented and proprietary medical devices, including the SCIg60 Infusion System. BOOTH 301 Envoy is HIPAA compliant clinical management program dedicated to helping specialty and home infusion pharmacies grow and excel in the new era of healthcare. Our customizable solution guides pharmacists and nurses through disease and drug specific assessments and care plans, complemented with a flexible and robust reporting engine. This data can then be analyzed for an individual patient or a patient population. Secure portals for physicians, payers and patients allow the pharmacy to share insights with their stakeholders and strengthen business relationships. Envoy is easy to integrate into existing billing and compounding solutions to create a seamless workflow. BOOTH 101 Our commitment is our story. It all began with eight people sitting around a dining room table 35 years ago. Through the hard work and determination of our founder, Estelle Benson, the Foundation grew larger and has been since supported thousands of patients, family members, friends, and caregivers. We support those touched by Guillain-Barré syndrome (GBS), chronic inflammatory demyelinating polyneuropathy (CIDP) and related variants such as multifocal motor neuropathy (MMN). We work for a future when no one with GBS, CIDP or related syndromes such as MMN suffers alone and that everyone has access to the right diagnosis and the right treatment, right away. 32 Corporate Partners & Exhibitors BOOTH 204 Grifols is a global healthcare company whose mission is to improve the health and well being of people around the world. We accomplish this mission by producing life-saving protein therapies for patients and providing hospitals, pharmacies and healthcare professionals with the tools they need to deliver expert medical care. We have three primary divisions – Bioscience, Diagnostic and Hospital – which develop, produce and market our innovative products and services to medical professionals in more than 100 countries around the world. BOOTH 401 Horizon Pharma is committed to improving patients’ lives by identifying, developing, acquiring and commercializing differentiated and accessible medicines that address unmet medical needs. The company markets seven medicines through its orphan, primary care and specialty business units. BOOTH 306 The Immune Deficiency Foundation is the national patient organization dedicated to improving the diagnosis, treatment and quality of life of persons with primary immunodeficiency diseases through advocacy, education and research. BOOTH 110 Innovatix & Essensa are leading group purchasing organizations serving the non-acute care marketplace. Today, we help thousands of members throughout the United States and Puerto Rico achieve substantial savings on their daily purchases. We are dedicated to maintaining and growing an industry-leading contract portfolio of products and services that supports your goal of reducing expenses, while helping you maintain and enhance the quality of services and care you provide to your beneficiaries. IntraPump INFUSION SYSTEMS BOOTH 102 See the CRONO S-PID50 and CRONO Super PID pumps – the smallest and most accurate pump on the market designed specifically for subcutaneous infusions of immunoglobulin - providing patients with a quality infusion experience. Also view, neria™multi – a line of subcutaneous multi-furcated infusion sets that work with any SQ pump on the market. neria™multi has the only Pre Attached Adhesive – providing comfort, convenience and quality infusions – no need for extra tape. BOOTH 302 Kedrion Biopharma Inc. is a biopharmaceutical company that focuses on therapies derived from human plasma. Kedrion has over 40 years of experience and dedication to our patients and the communities we serve. Please visit www.kedrion.us. © Kedrion Biopharma Inc. All Rights Reserved. August 2015 CO-0210-00-2015B BOOTH 404 Matrix Health Group is a family of speciality pharmacies “Dedicated to Making a Difference” for individuals Dedicated to Making a Difference! with primary immunodeficiency and other chronic conditions. National in reach, but local in scope, we are focused on providing care beyond dispensing. By pairing individualized pharmacy services with social support, Matrix Health Group encourages patients to pro-actively manage their condition, promoting treatment adherence and a better quality of life. September 18-20, 2015 Hyatt Regency Capitol Hill • Washington, DC 33 Corporate Partners & Exhibitors BOOTH 301 Medmonk is based on the premise that it’s in everyone’s best interest for medications to be used regardless of the price. We equip specialty and infusion pharmacists to instantly provide financial assistance to patients who are unable to afford the out-of-pocket cost of their medication. Assistance is provided based on a patient’s expression of need. Removing barriers selectively ensures assistance is targeted to patients who face financial challenges to prescription fulfillment. Our copay assistance programs are simple: -No delays in treatment -No card activation or coupon number -No lengthy pre-enrollment/approval process Patient assistance is just a click away…Everything is done electronically and instantly adjudicated for both medical and pharmacy benefits: keeping the process neat, quick, and easy. BOOTH 300 Managed Health Care Associates, Inc. (MHA) is a leading health care service and technology company that offers a growing portfolio of services and solutions to support the diverse and complex needs of the alternate site healthcare provider. Through the delivery of innovative and targeted health care services and solutions, we help our members increase operational efficiency, maximize business growth and provide optimum care for patients. MHA’s Clinical Therapy Management tool offers members an innovative proprietary application that provides a clinical support pathway to help you enhance your patient care and facilitates the collection of clinical and dispensing metrics for specialty reporting. BOOTH 114 Moog Medical Group believes that by working together with our customers and their patients strengthening connection in every direction - we can improve healthcare delivery. By increasing our understanding of the context in which our products are used, we can enhance our customers’ usage experience, safety, and the overall quality of patient care. BOOTH 206 Since 1995, NuFACTOR has been the nationwide provider of the specialty products and care that infusion patients deserve. A committed member of the immune deficiency community, NuFACTOR supports local, regional and national programs dedicated to helping people with immune deficiencies. For our commitment to excellence, NuFACTOR has earned The Joint Commission accreditation and its Gold Seal of Approval. BOOTH 116 Octapharma USA is a subsidiary of Octapharma AG, a global human protein products manufacturer. The company is dedicated to the research and manufacture of human proteins and has been committed to patient care and medical innovation for more than 30 years. Its core business is the development, production and sale of human proteins from human plasma and human cell-lines. Patients are treated with Octapharma products in the therapeutic areas of hematology, immunotherapy, and critical care. Octapharma USA is headquartered in Hoboken, N.J. Octapharma operates two state-of-the-art production sites licensed by the U.S. Food and Drug Administration (FDA), providing a high level of production flexibility. For more information, please visit www.octapharmausa.com, www.octagamus.net, www. octaplasus.com or www.wilateusa.com. BOOTH 202 OptionCare is a leading provider of immunoglobulin (IG) therapy for patients of all ages, with more than 1700 nurses and pharmacists nationwide who specialize in IG care. We offer expert IG therapy services for patients, healthcare providers and managed care organizations through our IG Therapy Management Program. We manage more than 80,000 IG infusions each year and have provided infusion therapy to more than 4 million patients since 1978. 34 Corporate Partners & Exhibitors BOOTH 108 The Platelet Disorder Support Association is dedicated to enhancing the lives of people with immune thrombocytopenia (ITP) and other platelet disorders through education, advocacy, research and support. BOOTH 117 For 30 years, Pentec Health has been an industry leader in providing Specialty Infusion Services nationwide to patients who require access to complex pharmaceutical products and services outside of the hospital setting. Please visit www.pentechealth.com. BOOTH 303 Due to an apparent void in strategic partnerships between providers and billing services, Linda Payne formed Reimbursement Concepts, Inc. in 2003. Since then, Reimbursement Concepts, Inc., has been able to successfully bridge the gap by partnering with our clients to provide ongoing support services through consulting and outsourcing. The 100+ staff at Reimbursement Concepts, Inc., are trained extensively to ensure appropriate reimbursement for the services that your company provides. Our teams have expertise in, and undergo continuing education and training on, all government as well as non-government payers. Our internal compliance and audit programs ensure that the functions we perform meet all State and Federal guidelines. From our humble beginnings, the Reimbursement Concepts’ philosophy has grown to serve many of the nation’s largest homecare corporations. We have been, and continue to be, a pioneer in the consulting and outsourcing business, as was our original vision years ago. BOOTH 105 Repro-Med Systems, Inc., operating as RMS Medical products, is a leading developer and manufacturer of medical devices and supplies. Repro-Med was incorporated in March, 1980. Its stock is publicly traded in the over-thecounter market and is quoted through the National Daily Quotation Service. Its stock symbol is REPR. The company maintains offices, manufacturing facilities, and warehouse space in Chester, New York. Devices and supplies manufactured and sold by RMS Medical Products are subject to Food and Drug Administration regulation. Our manufacturing facilities and record-keeping must meet FDA standards, and are subject to periodic FDA inspection. In addition, the company’s plant is certified by the appropriate ISO international standards for quality in product development, manufacturing, distribution and customer support of its medical devices. RMS manufactures medical devices used in emergency care, hospital settings, nursing homes, other medical facilities and home care. The company’s principal products are the FREEDOM60® Syringe Infusion System and the RES-Q-VAC® Emergency Medical Suction System. In 2011, the company received FDA approval to market in the U.S. it’s HIgH-Flo Subcutaneous Needle Sets™. Road Runner Specialty Group, Inc. BOOTH 305 Road Runner Specialty Group, Inc., located in the greater Washington, D.C. area, is a national healthcare agency that provides highly skilled R.N. staffing for specialty and homecare pharmacies, physician practices and individuals. We provide education, marketing and management of IV therapy programs for the medical community. We also offer Geriatric Care Management Services. Robin Belle, RN, IgCN, LNC, is the President and CEO of Road Runner Specialty Group, Inc. Ms. Belle is Chair, National Membership Committee, Member of the Exam Committee and a Member of the Standards Committee for IGNS. She is a Clinical Nurse Educator with VMS Biomarketing and a Legal Nurse Consultant serving as an expert witness for the defense. BOOTH 304 Santa Barbara Specialty Infusion provides Immune Therapy and other infusion therapies to patients in their home and other post-acute settings. We are committed to providing superior clinical care to our patients and exceptional customer service to our healthcare partner Providers and Payers. Founded and led by industry veterans, our Team strives everyday to exceed our patients’ expectations for high-quality, reliable and efficient specialty infusion care. September 18-20, 2015 Hyatt Regency Capitol Hill • Washington, DC 35 Corporate Partners & Exhibitors 75 YEARS OF IMPROVING THE HEALTH & WELL-BEING OF PEOPLE WORLDWIDE At Grifols, we are proud of our pioneering spirit and history of innovation. In 1940, we founded a company that has helped transform hematology. Today, we are a global leader providing live-saving protein therapies, diagnostic solutions, and other tools that hospitals, pharmacies, and healthcare professionals need to deliver expert medical care. Grifols is a leader in Neurology and Immunology Learn more about Grifols at www.grifols.com 36 BOOTH 200 Smiths Medical is a global manufacturer of medical devices providing solutions to home infusion and alternate care for over 60 years. Our reliable technologies have set the standard for medication delivery and safety that clinicians and patients depend on. BOOTH 115 Specialty Pharmacy Nursing Network, Inc. (SPNN) is a minority owned, URAC accredited nursing network consisting of CRNI®, OCN®, IgNC, PICC and IV certified registered nurses who provide therapy management for patients with rare, chronic and ultra-orphan disorders. BOOTH 100 Zyno Medical provides a portfolio of ambulatory and large-volume infusion pump products to enhance patient safety and work flow productivity. Zyno Medical’s market focus is the alternate care and ambulatory infusion market, where there is a need for durable, advanced technology pumps designed specifically for these markets’ unique infusion needs. The mission of Zyno Medical is to design and manufacture advanced infusion systems while applying a commitment to quality, simplicity, durability, connectivity and upgradability in order to deliver extraordinary benefits in patient safety, work flow efficiency and low total cost of ownership. Poster Abstracts 37 Poster Abstracts 010 | Frequent Doses of Subcutaneous Immunoglobulin Ameliorated Worsening Joint Pain in Primary Immunodeficiency Disease Patients with Rheumatologic Disorders Authors: Koterba A, Stein M Introduction: Intravenous immunoglobulin (IVIg) replacement therapy has been associated with back and joint pain. Patients with primary immunodeficiency disease (PIDD) and existing rheumatologic disease may be sensitive to increasing pain following immunoglobulin G (IgG) infusion. IVIg doses may result in high peak serum IgG levels, which may increase the likelihood of systemic adverse events (AEs) occurring, whereas subcutaneous immunoglobulin (SCIg) provides a more stable, steady-state IgG level and is associated with a lower incidence of systemic AEs, including pain. Rationale: We sought to investigate whether improved tolerability may be achieved by using more frequent SCIg dosing in PIDD patients with rheumatologic disease and joint pain. Methods: Three patients who experienced acute severe joint pain with standard IVIg or SCIg therapy were switched to daily SCIg administration. Results: Case 1: Following multiple infections, a 51-year-old man with common variable immunodeficiency (CVID) and juvenile rheumatoid arthritis was started on IVIg at a dose of 500 mg/kg. He experienced back and joint pain and hypertension after the first dose that persisted, and one week later the pain resulted in restricted mobility and he was unable to work. His IgG regimen was subsequently changed to 2 g SCIg daily for 6 days per week, which he received without pain. He remained free of infection with stable IgG levels (850 mg/dL). Case 2: A 51-year-old man with CVID, calcinosis, Raynaud’s phenomenon, esophageal dysfunction, sclerodactyly, and telangiectasias (CREST) syndrome, and monoclonal gammopathy started SCIg therapy but developed severe tremors and chills with syncope soon after his first dose, followed by severe muscle and joint pain. His SCIg regimen was modified to approximately 1 g SCIg/ day, which was well tolerated. After 2 years the dose was titrated to 3 g three times per week, and recently the patient was able to receive weekly treatment. His IgG levels remained stable (1000 mg/dL). Case 3: Upon starting SCIg therapy, a 50-yearold woman with fibromyalgia and specific antibody deficiency reported increased fibromyalgia pain. This was relieved by changing to 1 g SCIg daily. After successfully changing SCIg dosing to every other day, the patient later switched to IVIg, which was also well tolerated. Conclusions: These cases suggest the need for caution when starting PIDD patients with rheumatologic disease and joint pain on SCIg or IVIg. Daily or more frequent, smaller doses of SCIg provide an alternative strategy for patients who are unable to tolerate standard regimens. Author Affiliations: Allergy Associates of the Palm Beaches, North Palm Beach, FL, USA. 011 | Intravenous Immunoglobulin Infusion Times, Titration Rates, and Impact of Pre-Medication: Insights From an Intravenous Immunoglobulin Nurse Advisory Board Authors: Runken MC1, Nisbet PA2 Rationale: Current infusion practices for IVIg products are extremely variable. Qualitatively understanding the issues and nuances in this diverse process as well as the concerns confronting infusion nurses may help improve IVIg treatment outcomes. Introduction: This study aims to identify the current norms in the intravenous immunoglobulin (IVIg) infusion process; gain understanding of the patient’s perspective in relation to their treatment; and identify opportunities to improve the patient’s experience while receiving infusions. Methods: Researchers conducted two 90-minute advisory boards with infusion attendees at the 2014 IGNS Conference in Las Vegas, NV. A total of 22 nurses from inpatient, outpatient, and home-infusion sites participated. Each attendee had ≥5 years of IVIg experience with multiple brands. Results: Typical infusion times for IVIg treatment were reported as 10-15 minutes for pre-workup (recording vitals, last treatment review, inserting peripheral line), possible 15 minutes to mix and/or pool IVIg, then infusion time: all totaling 4-5 hours for treatment of chronic inflammatory demyelinating polyneuropathy and 2–3 hours for treatment of primary immunodeficiency. Vital signs were initially taken every 15 minutes and decreased in frequency over time. Pre-medication (eg, NSAID and/or 38 hydrocortisone-5) and hydration added 30 minutes to the front end of the infusion process for some patients. Infusion rates varied widely, often being set by a physi cian or an institutional protocol. The majority of nurses started infusions at 50 cc/ hr, increasing about every 15-30 minutes up to the maximum tolerable rate (usually 150 cc/hr). Most nurses started patients at 50 cc/hr despite having good long-term experience and tolerability. However, a select group of nurses began infusions at rates higher than 50 cc/hr and increased rates to over 400 cc/hr in select patients with good tolerability histories. Nurses reported patients’ primary complaints with IVIg therapy were time needed to infuse and medication cost. Despite this, two segments of patients exist. One group wants to take their time infusing for fear of side effects, while another wants to shorten the process. Conclusions: Infusion specialists have differing opinions and comfort levels concerning IVIg infusion rates. Typically, IVIg infusion rates are predicated by a patient’s tolerance and past medication experiences. However, IVIg products and infusion techniques have evolved over the past 20 years. Hydration and premedication can directly impact infusion time. Identifying processes or patient characteristics that can minimize infusion time will not only reduce infusion costs but also improve patient satisfaction. Author Affiliations: 1Grifols SSNA, Research Triangle Park, NC, USA; 2One Research, LLC, Charleston, SC, USA. 012 | Development of a New Infusion Pump Delivery Mode Targeted for Safer and Smarter IVIG Therapy Authors: Seiberlich L, Puglise K, Ward-Welisevich M, Dave DeBelser D, Kersch M, Sours D, Hetchler C Introduction: Intravenous immunoglobulin (IVIG) therapy has been used to treat immunodeficiencies and autoimmune disorders for the past 35 years. Autoimmune disease affects approximately 50 million Americans. Due to patients’ differences in tolerance to the products being infused, clinician monitoring of the entire IVIG infusion continues to be recommended practice. Rationale: Current infusion technology requires manual monitoring and multiple interactions with the infusion pump if a patient is intolerant to the therapy and/or requires a change in the delivery rate. Methods: Engineers evaluated multiple programming sequences, U.S. Food and Drug Administration published drug inserts, physician orders, and consulted with pharmacy and nursing experts to develop a new delivery mode specifically targeted to improve the delivery of IVIG infusions. Programs evaluated included a generic step, staircase step, incremental step, and an interval and step approach. Step attributes assessed were infusion volume, initial rate, rate increment, plateau rate, step duration, number of steps, alerts, step down technique, infusion duration, reservoir volume, programmed delays and keep vein open rates. Usability testing was conducted to confirm the validity of the design. Results: Review of the step up/down scenarios in combination with the literature and clinician feedback created a program with linear step increments that met 100% of IG drug insert attribute requirements. Infusions will start at the initial rate, notify the users 5 minutes before each programmed rate increase, automatically step up per the programmed rate, and eventually plateau as programmed until the infusion volume is delivered. If an adverse reaction occurs, the program allows clinicians to step down to the previous rate without stopping the pump or re-programming the infusion. Clinicians have the ability to enter a security code and increase the delivery rate (step up) at any time, unless already at the plateau rate. The pump programming is also defined within a drug library that contains maximum and minimum limits for the drug being infused to improve safety and help prevent pump programming errors. Conclusions: A new delivery mode has been developed and incorporated into a commercially available electromechanical ambulatory infusion pump to meet drug insert attribute requirements, match physician orders, and minimize the need for clinician interactions while monitoring the infusion. Future research should be conducted to assess the clinician and patient satisfaction with the delivery mode, confirm ease of use, and validate the improved safety of pump programming using a drug library for IVIG therapy. Author Affiliations: Smiths Medical, ASD, Inc. St. Paul, MN, USA. Poster Abstracts 013 | The Immunoglobulin Diagnosis, Evaluation, and Key Learnings (IDEaL) Patient Registry: Analysis of Serum and Subclass IgG levels, Pneumococcal Vaccine Response, and Therapy Outcomes in Patients with Primary Immune Deficiency Authors: Kristofek L1, Kearns S1, Bolgar B1, Seidu L2 Introduction: The IDEaL Patient Registry collects longitudinal information on patients receiving immunoglobulin (Ig) replacement therapy from Coram CVS/specialty infusion services in an alternate care setting. Rationale: This poster is focused on serum and subclass levels, vaccine response, and therapy outcomes, including infection rates, in primary immune deficiency (PID) patients. Methods: Patients of our 140 investigators are eligible for the Registry. We entered consented patient information from July 2010 onward that had been collected by Coram nursing and pharmacy into the IDEaL database. Results: In the enrolled population, 71% had IgG levels below reference minimums, with an average of 508 mg/dL. Patients with serum and subclass deficiencies constituted 42% of the population. A pneumococcal vaccine challenge showed an approximate 30% response rate. We noted a weak correlation between serum levels and pneumococcal response, but did find that in subclass-deficient patients with blunted vaccine response, 67% had low IgG2 levels. Overall, patients averaged about 3 infections per year. Conclusions: Primary immune deficiencies have an extremely variable presentation, and the initial presentation can have an impact on the patient’s outcomes on Ig therapy. We found a weak correlation between serum IgG levels and pneumococcal vaccine response, but did find that specific subclass deficiency, mainly in IgG2, may have a larger role in the initial presentation of PID. Author Affiliations: 1Coram Clinical Trials, Denver, CO, USA; 2Omni Allergy, Immunology and Asthma, Atlanta, GA, USA. 014 | Efficacy and Safety of Gammaplex® 5% in Children and Adolescents with Primary Immunodeficiency Diseases Authors: Melamed IR1, Gupta S2, Bobbitt MS3, Gillanders K3, Hyland N3, Moy JN4 Introduction: Primary immunodeficiency diseases (PIDs) are heterogeneous and characterized by an intrinsic immune system defect manifesting as hypogammaglobulinemia and/or specific defective antibody production and increased susceptibility to infections. In PID patients, intravenous immunoglobulin (IGIV) or subcutaneous immunoglobulin are used as replacement therapy to decrease the frequency of serious infections and hospitalizations and improve quality of life. Rationale: Efficacy and safety of Gammaplex® 5% (IGIV 5%) have been demonstrated in a 12-month, open-label, phase 3 study of 50 PID patients. However, the study included only 7 children or adolescents (aged 9-17 years). This report presents the results of a prospective, noncomparative study evaluating the efficacy, safety, and tolerability of IGIV 5% in pediatric and adolescent PID subjects. Methods: In this open-label, nonrandomized phase 4 study, subjects with PID received IGIV 5% (300-800 mg/kg per infusion) every 21 or 28 days (depending on subject’s prior IGIV schedule) for 12 months with a 3-month follow-up. The primary outcome was the number of serious acute bacterial infections (SABIs) per patient/year. Secondary outcomes included days off from school/nursery, acute care visits or hospitalizations, nonserious infections, antibiotic use, trough immunoglobulin G (IgG) levels, and safety. Results: Of the 25 subjects enrolled, 14 were on 21-day and 11 were on 28-day infusion schedules; all subjects completed the study except for 1 subject who withdrew consent and discontinued after 4 infusions. Three subjects were aged 2-5 years, 12 were 6-11 years, and 10 were 12-16 years, with a median age of 11 years; 24% of subjects were female. Two SABIs of pneumonia were reported, resulting in an annual SABI event rate of 0.09 per patient (upper 1-sided 99% confidence limit, 0.36), which is lower than the US FDA guideline of 0.5 per patient/year. Trough IgG levels were comparable for the 2 infusion schedules and remained >7.00 g/L after the second infusion. The most common adverse reaction (defined as an adverse event occurring within 72 hours of an infusion; possibly, probably, or definitely related to study drug; and/or had a missing or indeterminate investigator causality assessment) was headache, which occurred in 11 of 25 subjects (44%) and 21 of 368 infusions (6%). Adverse event frequency increased with increasing infusion rate, and no serious September 18-20, 2015 Hyatt Regency Capitol Hill • Washington, DC product-related adverse events were observed. Conclusions: Consistent with previous results, these data demonstrate that IGIV 5% provides therapeutic levels of IgG and is effective and well tolerated for the management of PID in children and adolescents. Author Affiliations: 1IMMUNOe, Centennial, CO, USA; 2University of California, Irvine, CA, USA; 3Bio Products Laboratory Ltd., Elstree, UK; 4Rush University Medical Center, Chicago, IL, USA. Support: Bio Products Laboratory Ltd., Elstree, UK. 015 | Dosing, Side Effects, and Long-Term Outcomes for IVIg Use in Treatment of Neurological Conditions: Data From the Immunoglobulin Diagnosis, Evaluation, and Key Learnings (IDEaL) Patient Registry Authors: Kile S1, Kearns S1, Kristofek L1, Bolgar B1, Seidu L2 Introduction: The IDEaL Patient Registry collects longitudinal information on patients receiving Ig replacement therapy from Coram CVS/specialty infusion services in an alternate care setting. Rationale: Intravenous immunoglobulin (IVIg) is approved for use in treating several neuropathy indications, including chronic inflammatory demyelinating polyneuropathy (CIDP) and multifocal motor neuropathy (MMN). Our objective is to present data focused on dosing, side effects, and outcomes in the Registry’s neurological patient population. Methods: All patients were consented using an IRB-approved consent. Data from these patients’ pharmacy and nursing visits was combined with quality-of-life (QOL) data directly reported by the patients every 6 months. As of fall 2014, 26 patients enrolled in the Registry were being treated with IVIg for a neurological condition. Results: The majority of these neurological patients were diagnosed with CIDP; in that population, the most common maintenance dosing was 50 grams of IVIg every 2 weeks (average of 644 mg/kg). Overall, patients reported good outcomes on treatment. Patients did not report side effects in the majority of doses administered (82%). A slight majority (59%) of administered doses were not preceded by pre-medication use; in 20% of doses, patients reported the use of acetaminophen and diphenhydramine. Data from the QOL surveys showed that patients exhibited a 28% increase from baseline to 12 months in their perception of health improvement from their Ig infusions. SF-36 data showed an improvement of 15% in patients’ physical component scores (PCS) from baseline to 12 months. In 73% of monthly reports, patients reported a decrease in difficulty with ambulation and mobility. Conclusions: The data presented provides information on IVIg dosing for IDEaL neurological subjects, and indicates that most patients did not report side effects from their IVIg therapy. The quality-of-life and outcomes data show improvements in overall physical function scores as well as in acute symptoms for patients receiving IVIg therapy. Author Affiliations: 1Coram Clinical Trials, Denver, CO, USA; 2Omni Allergy, Immunology and Asthma, Atlanta, GA, USA. 016 | Impact of the Clinical Therapy Management Program for Immune Globulin on Adherence for Patients at Barnes Precision Specialty Pharmacy Authors: Ness S1, Ford J2 Introduction: Managing immune globulin therapy is multifaceted. Clinical product variations, administration considerations, patient monitoring, reimbursement challenges, and increasing data needs of all stakeholders must be considered when managing this population. Rationale: In order to meet the needs of patients, prescriber referral sources, manufacturers, payers, accreditation bodies, and internal clinical management, Barnes Precision Specialty Pharmacy implemented MHA’s Clinical Therapy Management (CTM) program to track and monitor Immune Globulin patients. CTM allows clinicians to follow a clinical support pathway to help enhance their specialty patient care and to facilitate the collection of clinical and dispensing metrics for specialty reporting. Methods: Barnes Precision Specialty Pharmacy implemented the professionally peer-reviewed CTM program in September 2014. 178 patients who had at least one prescription dispensed for immune globulin therapy in either of the study periods were 39 Poster Abstracts included. The first study period was from 3/1/2014 through 8/31/2014 (6 months pre-CTM implementation) and the second study period was from 10/1/2014 through 3/31/2015 (6 months post-CTM implementation). Adherence for immune globulin therapy was measured by average number of fills per patient and total number of fills prior to CTM implementation and post-CTM implementation. The average number of grams per patient in each of the study periods was also analyzed and compared. Results: The total number of fills prior to the CTM program was 696 compared to 943 after implementation. The average number of fills prior to the CTM program was 3.91 compared to 5.3 after implementation (p=0.001). The average number of grams increased from 168.54 g in the first study period to 246.29 g per patient post CTM implementation (p=0.015). Conclusions: Implementation of the CTM program had a significant impact on adherence as measured by the average number of fills per patient and the total number of fills in each study period. Average number of grams per patient also increased significantly in this study. While data on how this may have impacted clinical outcomes is yet to be determined, it is hypothesized that the increased focus on adherence and persistency by utilizing the CTM program to manage immune globulin patients would provide clinical benefit. Further analysis needs to be done to characterize the patient population, dosing, and outcomes. The CTM program is one strategy that Barnes Precision Specialty Pharmacy uses to manage a complex therapeutic category and work towards visibility into actionable clinical data, optimal patient outcomes, and excellent customer service to all stakeholders. Author Affiliations: 1Managed Health Care Associates (MHA), Florham Park, NJ, USA; 2 Barnes Precision Specialty Pharmacy, Valdosta, GA, USA. 017 | Assessing Infection Risk and Developing Care Planning for Immunosuppressed Patients, During and After Transition of Care: A Study to Consider the Development of a Standardized Method to Document Risk and Implement an Education Pathway to Infection Risk Reduction Author: Embry T Introduction: A patient’s specific immune deficiency status adds an element of infection risk as they are exposed to many infectious organisms while receiving care and while transitioning from a healthcare setting. The objectives of this study were to: a) characterize the individual risk factors; b) evaluate the existence of a standard assessment mechanism for dealing with these risks, and; c) develop an individualized education pathway to help reduce healthcare-acquired infections. Rationale: Antibiotic-resistant organisms are increasing, and approximately 1 in 25 people in the U.S. develop infections in hospitals while being treated for something other than infections. Immune deficient patients have even higher risks. A standard means of assessing a patient’s specific risks, needs and requirements and communicating a “tailored” risk reduction plan is helpful in preventing healthcare-acquired infections for all patients. Methods: The study focused on acute care facilities, post-acute care and home care providers. Discharge planning activity was evaluated via survey, observation, peer-topeer and post-discharge discussions. A review of admission charts was performed to determine what evidence of infection risk and patient education was offered to patients as part of their discharge plans. The objectives were: a) perform a gap analysis of activities and tools to identify risk of infections; b) document proactive steps to reduce infections, and; c) determine what means of communication were employed during the patient’s transition of care. A case study was created to demonstrate how a Risk Analysis Tool could be utilized to direct education, improve communication with patients and reduce healthcare-acquired infections and readmission due to such infections. Results: 25% of acute-care facilities evaluated for the study incorporated hand-hygiene discussion in their discharge planning rounds; 100% of post-acute RNs indicated they teach hand hygiene but did not evaluate ability to perform the steps per WHO/CDC guidelines; 100% of patients surveyed did not have infection prevention teaching related to their discharge environment and 0% of chart audits found infection risk education and education needs communicated when referred for home infusion. Conclusion: A means to predict and document infection prevention strategy related to hospital readmissions associated with healthcare-acquired infections by using a standard Risk Analysis Tool to create pathways for individualized education planning did 40 not exist. The study demonstrates the use of an IP Risk Analysis Tool that incorporates these steps during the planning stage of transition of care and should be considered to reduce hospital readmissions attributed to healthcare acquired infections. Author Affiliations: Home Solutions Infusion Services, Hammonton, NJ, USA. 018 | Patient Perception of Disease Symptom Maintenance While Using Subcutaneous Immunoglobulin for Neuropathic Disorders Author: Dudenhoeffer CE Introduction: Immunoglobulin (Ig) is a primary therapy for immune-mediated neuropathy disorders such as chronic inflammatory demyelinating polyneuropathy (CIDP) and myasthenia gravis (MG). Ig is administered either as an intravenous (IV) or subcutaneous (SC) therapy, but only certain Ig products have FDA approval for the treatment of these disorders. SCIg therapies are not currently FDA approved. SCIg therapy is an alternate treatment option that has a favorable side effect profile; it also increases a patient’s independence with treatment. Rationale: There is limited experience and published data on the use of SCIg for maintenance dosing for immune-mediated neuropathies. The purpose of this study was to look at compliance and symptom management in a small population of patients receiving SCIg in the home for a neurological diagnosis. Methods: A retrospective chart review was conducted at a branch of a national home infusion company. Between January 2012 and May 2015, a clinical progress report (CPR) was performed by the pharmacist every 30–90 days. The CPR asks patients their perception of common neuropathy symptom changes, as well as therapy compliance and adverse reactions. Results: Five patient charts were reviewed. The patient population was all female, with an average age of 52 years. The mean weekly infusion dose was 32.8 g, and the mean weekly mg/kg dose was 442.6 mg/kg. Average length of treatment was 23.2 months. There were 116 pharmacist-completed CPR forms. Patients did not report any missed, delayed, or incomplete doses (n=107 completed/116 total). For adverse drug reactions, only 6/116 were noted, across 3 patients. For symptom maintenance, 86/116 CPR forms were completed. Of these, 73/86 times (85%) reported symptoms unchanged or improved. Of the 13/86 reports with symptom worsening, the most common was increased falls. Conclusions: This study was designed to examine infusion compliance and patient perception of symptom maintenance while on SCIg therapy. Patients showed good compliance, few side effects, and symptom stability. All 5 patients reported symptom stability or improvement 85% of the time when they were asked about symptom changes. Further studies with a larger patient population, more consistent data, and objective clinical endpoints would allow for better assessment of SCIg in patients with immune-mediated neuropathic disorders. Author Affiliations: Coram CVS/specialty infusion services, St. Louis, MO, USA. 019 | Safety of Intravenous Immunoglobulin Therapy in Patients With Probable Alzheimer’s Disease: A Randomized, PlaceboControlled Clinical Study Authors: Gelmont D1, Thomas RG2, Dyck-Jones JA1, Fritsch S3, Aisen P2, Relkin N4 Introduction: Intravenous immunoglobulin (IGIV) contains polyclonal human antibodies that bind to Aβ aggregates, foster the dissolution of Aβ fibrils, and enhance microgliamediated phagocytosis of amyloid deposits in vitro. Rationale: We hypothesized that IGIV might reduce cognitive decline and preserve functional abilities in patients with Alzheimer’s disease. Methods: This was a placebo-controlled, double-blind, multicenter study in patients aged 50–89 years with mild to moderate Alzheimer’s disease (mini-mental state examination score 16–26). Patients were randomized 1:1:1 to receive biweekly infusions of 400 mg/kg, 200 mg/kg IGIV, or 0.25% human albumin over 18 months. Clinical assessments and biomarker measurements were conducted throughout the study. Results: Primary and secondary efficacy endpoints were not met. Common non-serious adverse events in treated patients included headache, rash, infusion-site extravasation, and diarrhea. Statistically significant risk ratios for IGIV were chills (3.85) and rash (3.08). Of the 16 serious adverse drug reactions in 13 patients, a lower number occurred Poster Abstracts with high-dose (n=4) versus low-dose (n=7) IGIV 10% versus placebo (n=5). The rate of thromboembolic events was lower in treated patients (1.9% versus 5% in control patients). The rate of new or worsening renal failure was similar in all patients and there were no cases of respiratory failure. The rate of infections was lower in treated patients (34.0% versus 47.9% in control patients). Conclusions: Eighteen months of treatment with IGIV was well tolerated in elderly patients, and no new safety signals were identified. Author Affiliations: 1Baxalta US, Inc., Westlake Village, CA, USA; 2ADCS Alzheimer’s Disease Cooperative Study, UCSD, La Jolla, CA, USA; 3Baxalta Innovations GmbH, Vienna, Austria; 4Weill Cornell Medical College, New York, NY, USA. 020 | Retrospective Review of Needle Length During Hyaluronidase-facilitated Subcutaneous Administration of Immune Globulin G Authors: Gruenemeier P1, Ernst C2, Duff K3 Introduction: Patients requiring immune globulin G (IgG) replacement may receive IgG intravenously (IGIV) every 3−4 weeks; subcutaneously (IGSC; conventional), usually every 1−2 weeks (multiple needle sticks); or subcutaneously, facilitated by recombinant human hyaluronidase (IGHy; HYQVIA) every 3−4 weeks (1−2 needle sticks). Needle length is an important consideration to enhance local tolerability and prevent IgG leakage. Currently, needle length selection for IGHy administration is based on best clinical judgment. No objective data exists for IGSC replacement, for which infusion volumes can be as low as 10mL or as high as 600mL. Rationale: To present retrospective data on needle length in relation to tolerability and body mass index (BMI) in IGHy-treated patients to assist in providing guidance for choosing appropriate needle length. Methods: Data were collected from IGHy-treated patients affiliated with the BioRx specialty pharmacy. Patient characteristics, IGHy dosing, number of infusion sites, infusion tolerability and correlation of needle length to BMI are reported. Results: Overall, 66 patients (aged 13−74 years; mean BMI 29.3 [15.1−61.4]) received IGHy. Patients previously received IGIV (26%), conventional IGSC (42%) or were treatment-naive (32%). Patients completing IGHy ramp-up (N=58) were evaluated. For patients using a 9mm- or 12mm-length needle, mean IgG infusion volumes were 325mL and 385mL and mean sites/infusion were 1.39 and 1.22, respectively. Patients initiated IGHy using 6mm- (n=2), 9mm- (n=62) or 12mm- (n=2) length needles; 14% switched from 9mm to 12mm. A trend for a direct relationship between needle length and BMI was observed. Conclusions: This study provides insight into needle length considerations in patients treated with IGHy, particularly when switching from IGSC, since IGHy allows for larger infusion volumes into a single site. Data from IGHy-treated patients suggest that, although the majority of patients switching from IGSC do well with their original needle length, some (particularly those with a higher BMI) may require a longer needle for improved tolerability and leakage prevention at the infusion site. Author Affiliations: 1BioRx, Cincinnati, OH, USA; 2BioRx, Alexandria, KY, USA; 3Baxalta US, Inc, Cleveland, OH, USA. in preparation for college, he elected to transition to conventional subcutaneous IgG 20% (IGSC 20%) (IgG weekly dose, 10 g). After starting college, the patient became noncompliant due to burden of treatment (i.e., frequency of infusions and local site reactions) and out of frustration threatened to stop IgG treatment altogether. In response, his physician suggested a switch to recombinant human hyaluronidase− facilitated subcutaneous infusion of immunoglobulin G (IGHy; HYQVIA). After 3 training sessions the patient attained proficiency (as determined by the training nurse according to pharmacy guidelines) in self-infusion with IGHy into a single infusion site every 4 weeks. During the initial IGHy ramp-up phase, the patient complained of a burning sensation during infusion (which he also experienced with conventional IGSC); this resolved after the nurse suggested switching from a 9-mm to a 12-mm needle. Overall, the patient is pleased with the monthly frequency and the complete resolution of any local site reactions within 24 hours, and has been treatment-compliant since initiating IGHy. Conclusions: IGHy provided the autonomy and characteristics (i.e., less frequent infusions and faster resolution of local infusion site reactions, versus conventional IGSC) that allowed this patient to attain compliance with his IgG regimen. Author Affiliations: 1Clinical Resources for Nursing LLC, Denville NJ, USA; 2Baxalta US, Inc., Cleveland, OH, USA. 021 | Improved Compliance With Monthly Infusion of Immunoglobulin G Facilitated by Recombinant Human Hyaluronidase in a Body Image-Conscious College Student Authors: Martens A1, Duff K2 Introduction: Immunoglobulin G (IgG) replacement therapy is a lifelong commitment for many individuals with primary immunodeficiency diseases. The goal of IgG treatment is to provide protection against infection. Patient compliance with IgG treatment is key to achieving this goal. Providing alternate treatment options may allow for improvements in compliance. Rationale: To present an alternative treatment option for a patient with PIDD who was noncompliant on his current IgG regimen. Results: The patient is a slim (body mass index, 21.4), 19-year-old male college student who lost a kidney due to delayed diagnosis of X-linked agammaglobulinemia at the age of 10 years. He was initially placed on intravenous IgG and then, at age 16, September 18-20, 2015 Hyatt Regency Capitol Hill • Washington, DC 41 Poster Abstracts 022 | Case Study Review of an Infusion Center Experience With Transitioning an Adult Patient With a Primary Immunodeficiency From Intravenous to Recombinant Human Hyaluronidase− Facilitated Subcutaneous Infusion of Immunoglobulin G Authors: Needham K1, Duff K2 Introduction: Patients who require immunoglobulin G (IG) replacement to treat primary immunodeficiencies (PIDD) may not always be candidates for home infusion due to complications related to adverse events when receiving intravenous IG (IGIV). Systemic adverse reactions (ARs) may require healthcare professional monitoring and intervention in a controlled clinical setting. Patients now have an alternative treatment option with recombinant human hyaluronidase−facilitated subcutaneous infusion of immunoglobulin G (IGHy; HyQvia), which may decrease systemic ARs. Rationale: To present an alternative treatment option for a patient with PIDD who may suffer debilitating systemic ARs following IGIV administration. Results: A 42-year-old, slender male diagnosed with a PIDD (common variable immunodeficiency) in August 2013, initiated monthly IGIV. Infusions were associated with systemic ARs (eg, patient-reported history of aseptic meningitis, severe [debilitating] headaches and mild-to-severe body aches), even after switching IGIV formulations. The patient refused to try conventional subcutaneous IgG due to increased infusion frequency and need for multiple needles. AR management included several medications plus intravenous hydration before, during, and after infusions. Despite the medications, severe headaches impeded this patient’s ability to work and engage in personal activities. Because systemic ARs are thought to be associated with the high serum IG peak resulting from IGIV, his physician offered the option of IGHy. Although the patient was initially reluctant to try a new treatment, after education and setting realistic expectations, IGHy was started on the titration dose ramp-up schedule with a final target dose of 40 g every 4 weeks into 1 infusion site. Thus far, he has successfully completed ramp-up and is infusing his full IGHy dose. After his first IGHy infusion, the patient was extremely happy to report that he no longer experienced headaches. This allowed him to return to his normal routine. The patient stopped taking most of his post-infusion medications, and his physician will identify how to eliminate his pre/post medications based on tolerability. This patient desires to remain in the infusion center to receive his treatment due to other associated benefits (eg, support from his healthcare team and other patients with PIDD). Conclusions: After switching to IGHy, this patient no longer reports the body aches and debilitating headaches that he experienced following his IGIV infusions. This has allowed the patient to stop taking post-infusion medications and to explore removal of pre-medications in the future. The patient has experienced less interference with his activities of daily living relative to his history with IGIV. Author Affiliations: 1Optimed Infusion, Columbus, OH, USA; 2Baxalta US, Inc, Cleveland, OH, USA. 023 | A Novel IGSC Treatment: Design of a Phase III Study to Evaluate the Efficacy, Safety, and Tolerability of Recombinant Human Hyaluronidase-Facilitated Subcutaneous Immunoglobulin in Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy Authors: Sommer C1, England J2, Jakobsen J3, Reeve R4, Oh M5, Gelmont D5, Ngo LY5 Introduction: Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) is an acquired, immune-mediated, progressive or relapsing peripheral neuropathological condition with significant disease burden. Corticosteroids, plasma exchange, and intravenously administered immunoglobulin (IGIV) are current treatment options, each with its limitations (eg, adverse events; time commitment). Recombinant human hyaluronidase (rHuPH20)−facilitated subcutaneous immunoglobulin (IGHy; HYQVIA) is a novel subcutaneous immunoglobulin product that may be self-administered at rates, volumes, and frequencies similar to IGIV but with better systemic tolerability. Rationale: The design of a phase III, prospective, multicenter study for the evaluation of the efficacy, safety, and tolerability of IGHy as maintenance therapy to prevent relapse of neuromuscular disability and impairment in patients with CIDP is presented. Methods: Adults (N=174) with typical or atypical CIDP receiving stable IGIV for ≥3 months prior to screening will be randomized 1:1 to IGHy or placebo with rHuPH20 for 42 6 months. Treatment will be administered subcutaneously (SC) every 2, 3, and 4 weeks at the same monthly immunoglobulin dose (IGHy) (or matching infusion volume for placebo group) as the subject’s pre-enrollment IGIV treatment. To gradually increase the subcutaneous infusion volume, a dose ramp-up schedule will be utilized until the patient’s full dose is reached. After the ramp-up period, subcutaneous infusions may take place at the study site, infusion center, or at the patient’s home or other suitable location; after successful completion of training, patients can opt for self-infusion. Subjects who relapse during SC treatment will be provided IGIV to restore functional ability. The primary efficacy outcome measure is worsening of functional disability at study completion or last study visit, relative to pre-treatment baseline. Secondary/ exploratory outcome measures include time to relapse, activities of daily living, hand grip strength, muscle strength, quality of life, health resource utilization, and treatment satisfaction. Conclusions: IGHy may provide an alternative maintenance treatment option enabling self-administration of a full therapeutic dose every 2–4 weeks in patients with CIDP. Enrollment of patients into this phase III study is planned for Q4 2015. Author Affiliations: 1University of Würzburg, Würzburg Germany; 2Louisiana State University School of Medicine, New Orleans, LA, USA; 3Department of Neurology, Rigshospitalet, Copenhagen, Denmark; 4Quintiles Inc, Durham, NC, USA; 5Baxalta, Westlake Village, CA, USA. 024 | Efficacy, Safety, and Tolerability of Human Immune Globulin Subcutaneous, 20%: Interim Analysis of a Phase 2/3 Study in Patients With Primary Immunodeficiencies in North America Authors: Suez D1, Melamed I2, Hussain I3, Stein M4, Gupta S5, Paris K6, Fritsch S7, McCoy B7, Yel L8 Introduction: Human immune globulin subcutaneous, 20% (IGSC 20%) is a subcutaneously administered, ready-for-use, liquid preparation of highly purified human immunoglobulin G (IgG). Rationale: We report results from a study of IGSC 20% in patients aged ≥2 years with primary immunodeficiencies in North America. Methods: Epoch 1 (13 weeks): immunoglobulin G 10% was administered intravenously at prestudy doses every 3–4 weeks. Epochs 2–4: IGSC 20% was administered weekly (Epoch 2 [for approximately 12–16 weeks], 145% of the weekly equivalent Epoch 1 dose; Epoch 3 [12 weeks], dose adjusted per AUC assessments in Epochs 1–2; Epoch 4 [40 weeks], dose adapted individually per Epoch 3 serum IgG trough levels). The primary endpoint is the rate of validated acute serious bacterial infections (VASBIs). Results: Currently, patient study participation has finished, and 67 of 77 patients have completed the study. As of the 3rd interim analysis in November 2014, during IGSC 20% treatment in 74 patients aged 3–83 years: no VASBIs were reported; the all-infection rate was 2.30/patient-year; there were no serious or severe related adverse events (AEs); and the percentage of affected infusions with related local AEs was 1.4% (related local AEs occurred in 17 of 74 [23.0%] patients). Of 2805 IGSC 20% infusions, 99.7% were completed without slowing the rate or interrupting/stopping administration. Mean serum IgG trough level under IGSC 20% (1-week interval; n=70) was 16.1 g/L. Conclusions: IGSC 20% provided an effective, well-tolerated therapy. This study is ongoing to confirm the efficacy, safety, tolerability, and pharmacokinetics of IGSC 20% over a 12 to 16-month treatment period. Author Affiliations: 1Allergy, Asthma & Immunology Clinic, PA, Irving, TX, USA; 2 IMMUNOe Health Centers, Centennial, CO, USA; 3Vital Prospects Clinical Research Institute, PC, Tulsa, OK, USA; 4Allergy Associates of the Palm Beaches, North Palm Beach, FL, USA; 5University of California at Irvine, Irvine, CA, USA; 6LSU Health Sciences Center, Children’s Hospital of New Orleans, New Orleans, LA, USA; 7Baxalta Innovations GmbH, Vienna, Austria; 8Baxalta US Inc., Westlake Village, CA, USA. 026 | Long-Term Safety, Efficacy, and Tolerability of Recombinant Human Hyaluronidase−Facilitated Subcutaneous Infusion of Immunoglobulin G in Pediatric Patients Aged ≤16 Years With Primary Immunodeficiencies Authors: Wasserman RL1, Melamed I2, Stein M3, Kobrynski L4, Puck J5, Gupta S6, Engl W7, McCoy B7, Leibl H7, Yel L8 Poster Abstracts Introduction: Recombinant human hyaluronidase (rHuPH20)−facilitated subcutaneous infusion of immunoglobulin G (IgG) (IGHy; HYQVIA) is approved for the treatment of primary immunodeficiencies (PIDs) in adults and can be administered at rates, volumes and frequencies similar to intravenous IgG (IGIV) but with better systemic tolerability. Rationale: We report the efficacy, safety and tolerability of IGHy in pediatric patients aged ≤16 years who were treated for up to approximately 3.5 years in the IGHy pivotal phase 3 study and its extension. Methods: Pediatric patients aged ≤16 years with PID received IGIV for 3 months, then IGHy every 3 or 4 weeks for approximately 18 months followed by up to an additional 21 months. rHuPH20 was discontinued after up to approximately 3.5 years of exposure. Results: A total of 17/24 pediatric patients (aged 4–15 years) completed the pivotal study; 13 continued in the extension. Patients were exposed to IGHy for a maximum of up to approximately 3.5 years (44 patient-years). Adverse reactions (ARs; defined as causally and/or temporally associated adverse events [AEs] occurring within 72 hours) per infusion were 0.088 (local) and 0.150 (systemic) with IGHy, and 0.635 (systemic) with IGIV. No serious AEs related to IGHy were reported. The infection rate with IGHy was 2.77/patient-year. Of 652 IGHy infusions, 96% required no administration changes. Two patients had binding, but not neutralizing, anti-rHuPH20 antibody titers ≥1:160 on ≥1 occasion with no associated ARs; titers declined despite continued treatment. Conclusions: In pediatric patients aged ≤16 years treated with IGHy for up to approximately 3.5 years, infection rates were low, infusions were well-tolerated and, despite infusion volumes and rates similar to IGIV, systemic AE rates were lower with IGHy than with IGIV. Data on pediatric patients are similar to the adult and total patient datasets. Author Affiliations: 1Allergy Partners of North Texas Research, Dallas, TX, USA; 2 IMMUNOe Health Centers, Centennial, CO, USA; 3Allergy Associates of the Palm Beaches, North Palm Beach, FL, USA; 4Emory University, Atlanta, GA, USA; 5University of California, San Francisco, San Francisco, CA, USA; 6University of California, Irvine, Irvine, CA, USA; 7Baxalta Innovations GmbH, Vienna, Austria; 8Baxalta US Inc., Westlake Village, CA, USA. 028 | Patient Satisfaction with a New Combination Subcutaneous Immune Globulin + Hyaluronidase Therapy for Primary Immune Deficiency Authors: Broyles R, Ernst C, Gruenemeier P Background: Primary immunodeficiency diseases (PI) are a group of more than 200 rare, chronic disorders in which part of the body’s immune system is missing or functions improperly, creating an increased susceptibility to infection. Several immune globulin (IG) products are currently approved by the FDA for the treatment of PI. The products differ by their route (intravenous [IVIG] or subcutaneous [SCIG]) and frequency (monthly for IVIG, weekly for SCIG) of administration. A new entrant to the market is a combination product (IG + hyaluronidase) that allows a larger volume of solution to be administered into a single subcutaneous site every 3 to 4 weeks, compared to weekly SCIG treatment. Purpose: The objective of this study was to assess satisfaction with treatment among PI patients receiving the new combination IG + hyaluronidase product. Methods: A total of 72 PI patients prescribed the combination immune globulin infusion 10% (Human) with Recombinant Human Hyaluronidase product, HyQvia (Baxalta) were evaluated over an 8 month period from November, 2014 to June, 2015. Data collected included age, gender, prescribed dose and past history with IG therapy, self-infusion versus nurse-infused, frequency of administration, length of infusion, number of needle sticks per infusion and patient satisfaction with treatment method. Results: 63 patients (88%) of the 72 patients in the evaluation remained on therapy with IG + hyaluronidase at the end of 8 months. Nine patients discontinued therapy due to: leakage (x2 patient would only infuse in the thighs), breakthrough sinusitis during ramp-up phase x1, elevated blood pressure x1, complaints about site reaction x 1, patient did not like SCIG x1 and patient dissatisfaction with product x3. The average patient was 47 years old, and received an average dose of 37.5 grams every 3-4 weeks. Patients used 1-2 needle sticks with average infusion time of 2.5 hours after ramp-up phase completed. Twelve patients (19%) had a nurse infuse, and 51 (81%) self-infused with an average of four teaching visits needed. Forty (63%) patients responded to the satisfaction survey. Of these, 45% found it “easy or very easy” to self-infuse the combination product, which was preferred over their previous treatments (either IV or September 18-20, 2015 Hyatt Regency Capitol Hill • Washington, DC traditional SC) for the following reasons: preferred frequency of administration (92%); preferred number of needle sticks per month (85%); preferred total time spent for treatment per month (78%); prefer the ability to fit the treatment into their own schedule (64%). Overall, 89% prefer the convenience of the IG + hyaluronidase product and 100% plan to continue receiving this drug. Discussion: Despite the large volume of drug deposited into 1 or 2 sites, the majority of patients preferred this treatment approach, including the 36.5% (N=23) who had previously received traditional SCIG, the 28.5% (N=18) who had previously received IVIG, and the 35% (N=22) that never received Ig therapy. Conclusions: The addition of a treatment option with a 3-4 week dosing regimen and a choice of self-infusion or nurse administered was well-received by our PI patients, however the sample size was small and bears further evaluation. As treatment burden has the potential to impact compliance, future research should examine how new ways to administer immune globulin therapy could reduce treatment burden in PI patients. Author Affiliations: BioRx, Cincinnati, OH, USA. 029 | Successful Treatment of Pregnant Patients with Common Variable Immunodeficiency Using 20% Subcutaneous Immunoglobulin Authors: Duff CM1, Ghably J2, Krishnaswamy G3 Introduction: Common variable immunodeficiency (CVID) is characterized by hypogammaglobulinemia and impaired antibody responses, which causes increased susceptibility to infection. Clinical studies have shown that immunoglobulin G (IgG) replacement therapy is an effective treatment for patients with primary immunodeficiencies and subcutaneous (SC) administration is becoming increasingly Enhancing Healthcare. Enriching Lives. FLEXIBLE • IV and subcutaneous infusion delivery • Single administration set type delivers all rates • Rate adjustments as needed SIMPLE • Pump-guided programming • Easy standard protocols setup SAFE & ACCURATE • Adjustable high pressure alarms • On display in-line pressure monitoring PLEASE VISIT US AT BOOTH 114 For more information on Moog’s infusion therapy devices, please contact our customer support at +1 800.970.2337 or visit our website at www.moog.com/medical 43 Poster Abstracts common due to the ease of administration, low rates of systemic adverse reactions, and steady plasma IgG levels. However, there are currently no guidelines regarding IgG dosing during pregnancy and few studies have examined the safety and efficacy of SCIg in pregnant patients. Rationale: Data regarding the safety and efficacy of SCIg in pregnancy are lacking. Here, we investigated the outcomes of women with CVID who received SCIg throughout their pregnancies. Methods: Medical records of 3 pregnant patients with CVID who were treated at two different institutions were reviewed. Patients received 20% SCIg throughout their pregnancies and data regarding safety, efficacy, IgG levels, and pregnancy outcomes were recorded. In addition, a literature review on the use of SCIg in pregnancy was conducted. Results: Three pregnant female subjects with CVID, ranging from 23–28 years of age, were included in the study. Two subjects had sub-therapeutic IgG levels in the third trimester and required an IgG dose adjustment. The third experienced two minor urinary tract infections in the first trimester, despite having normal IgG levels. No pregnancyrelated adverse effects were recorded and none of the subjects experienced serious or life-threatening infections, premature labor, eclampsia, intrauterine growth retardation, or febrile complications. All 3 subjects delivered healthy infants at full term and none of the infants experienced complications. Post-delivery, the dose of IgG was decreased to the pre-pregnancy dose and long-term follow-up of the patients and their offspring continues. Review of the literature revealed only 2 previous reports of successful use of SCIg in pregnancy. Conclusions: Based on this case series, 20% SCIg appears safe and effective during pregnancy in patients with CVID. The use of SCIg in pregnant women carries a category C classification because randomized studies have not yet been conducted, although in selected cases the benefits may outweigh the risks. Further research on the use of IgG therapy, particularly SCIg, in pregnant women with CVID is required. Author Affiliations: 1University of South Florida, St. Petersburg, FL, USA; 2Quillen College of Medicine and East Tennessee State University, Johnson City, TN, USA; 3Wake Forest School of Medicine and Wake Baptist Hospital, Winston Salem, NC, USA. 030 | Considerations for Selecting Needle Length for Subcutaneous Immunoglobulin Therapy (IgSC) Authors: Duff C1, Clarke A2 Introduction: This is an education piece providing an overview of body types, site selection and methods by which needle length can be determined based on the use of body mass index (BMI) as primary determining factor. Rationale: There is very little written on how to choose the most appropriate site and needle length for IgSC and IgHY therapy. Methods: Overview of dermal and epidermal length provided. Key points presented on unique attributes of each body type (ectomorph, endomorph, mesomorph) and site options (arms, abdomen, flanks and thighs) listed. Formula for determining BMI explored with examples provided ([Weight in Pounds / Height in (inches)2] x 703). A table on needle length selection based on BMI included (·6 mm BMI < 15; 9 mm BMI 15-25; 12 mm BMI 26-30; 14 mm BMI >30). Considerations concerning site and needle length selection discussed. Results: This education piece provides rationale and methods by which a needle site or needle length might be chosen for therapy. Conclusion: The purpose of this poster is to further mitigate conjecture on why and how needle lengths are chosen for IgSC and IgHY therapy but providing a more concrete approach to needle length selection through the use of BMI. Author Affiliations: 1University of South Florida, Pediatrics, Asthma and Allergy, Parrish, FL, USA; 2Diplomat Specialty Pharmacy, Flint, MI, USA. 031 | Effective Use of 20% Subcutaneous Immunoglobulin Therapy in an Adult Male with Pre-existing Thrombi Authors: Duff C, Sher M, Leiding JW Rationale: Immunoglobulin replacement therapy is prescribed for patients with immunodeficiency characterized by hypogammaglobulinemia and/or the inability to make antibodies to recall antigens. Administration can occur intravenously or 44 Poster Abstracts subcutaneously. Currently there is a black box warning on all immunoglobulin replacement products indicating a possible increased risk of thrombogenic events. Data regarding the use of Ig therapy in patients with known thrombotic events is limited. Methods: A 36 year old Caucasian male with cystic fibrosis was diagnosed with selective antibody deficiency based on absent pneumococcal responses (0/14 protective serotypes) with intact tetanus and diphtheria responses and normal immunoglobulin profile (IgG 1020mg/dl, IgA, IgM). He is the survivor of a double lung transplant at 24 years and a single lung transplant at 33 years. A left leg deep vein thrombosis and sagittal vein thrombosis developed two years after second transplant. Causes of primary thrombophilia were excluded. In parallel recurrent bacterial pneumonias, primarily caused by S. pneumonia led to multiple hospitalizations. Based on poor antibody responses and clinical status, immunoglobulin replacement therapy was initiated. Results: Based on data that indicates more frequent, smaller doses of Ig therapy may decrease the potential risk of a thrombotic event, the decision was made for the patient to receive 20% SCIG was administered twice weekly. Concurrent treatment of thrombi continued with warfarin maintaining INR at a therapeutic level of 2-3 units. No bleeding or bruising occurred at infusion sites. A magnetic resonance angiogram performed 6 months after starting SCIG showed no increase in size or new thrombi. Protective pneumococcal titers were measured and were found to be protective to 10/14 serotypes and the patient has had only one hospitalization for bacterial pneumonia since starting SCIG. Conclusion: While there is an associated risk with thrombosis and Ig replacement therapy, SCIG was safely and effectively administered to this individual patient with thrombi receiving anticoagulant therapy. Concurrent use of anticoagulant medications did not increase the occurrence of local site reactions with the use of 20% SCIG treatment in this patient. Further research on the use of SCIG therapy in patients with thrombi are needed. Author Affiliations: Division of Allergy, Immunology, and Rheumatology, Department of Pediatrics, University of South Florida, St. Petersburg, FL, We currently have several RN positions open across the U.S. For more information, please contact us at 877-330-7766 or www.spnninc.com 032 | The Benefits of Variable Flow Rate Control with Mechanical Pumps during SCIg Infusion Therapy Authors: de Beer N, Barbrie J, Gutierrez C, Lambert P Introduction: Despite the fact that IgG is a well-established replacement therapy for primary immunodeficiencies (PI), a number of challenges remain when considering the optimal treatment regimen. IgG trough levels required to prevent infections vary between patients, indicating a need for individual dosing. Subcutaneous (SCIg) rather than intravenous immunoglobulin administration has also been shown to reduce variation in peak and trough serum IgG levels, as well as minimizing end-of-cycle loss of efficacy (wear-off). Individual dosing is accomplished by selection of appropriate SCIg product concentration and dosage volume. In addition, appropriate flow rates for individual dosing play an important role in minimizing adverse events and improving patient comfort. Indeed, prescribing information to patients for SCIg products often indicate a lower flow rate for initial infusions, followed by increasing flow rates for subsequent infusions. In other cases where pre-infusion with recombinant human hyaluronidase is applied, a dynamic increase of flow rate is prescribed throughout the duration of treatment. Furthermore, intended flow rates are prone to fluctuations in patient and environmental conditions. Temperature, for example has a significant effect on the viscosity and subsequently the flow rate of SCIg products. Therefore, in order to provide patients the ability to control intended flow rate variations as well as compensate for unintended fluctuations in flow rates when administering SCIg infusions with mechanical pumps, an alternative to typical fixed rate control tubing sets is needed. Objective: This study investigated the capabilities and benefits of an adjustable flow regulator device (VersaRate®, EMED Technologies, El Dorado Hills, CA) in combination with mechanical infusion pumps (SCIg60 Infuser, EMED Technologies and the Freedom60 pump, RMS Medical Products, Chester NY) as an alternative to fixed rate control tubing sets (Infuset-190, Infuset-290, Infuset-430, Infuset-650, Infuset-820, Infuset-930, Infuset-1850, EMED Technologies; and RMS Rate sets: F45, F60, F275, F600, F900, F1200, F2400, RMS Medical Products) for the administration of viscous IgG fluids. Member Success Starts Here MHA Specialty Pharmacy Solutions is dedicated to optimally position specialty pharmacy members and business partners to succeed in an increasingly dynamic health care environment. Invested in member needs, we can help you maximize opportunities for success through our full spectrum of specialty services and solutions including: • • • • • Contracting Clinical Services and Education Technology Solutions Data Collection and Reporting Association and Strategic Partnerships To learn more about MHA Specialty Pharmacy Solutions offerings, visit www.mhainc.com or contact us at 800.642.3020 x 2870 or [email protected]. © MHA Specialty Pharmacy Solutions September 18-20, 2015 Hyatt Regency Capitol Hill • Washington, DC 45 Poster Abstracts Methods: The VersaRate® variable flow control device was tested under laboratory conditions to simulate actual use and evaluate its capability to provide variable and accurate controlled flow rates. Usability studies and interaction with patients and clinicians provided further feedback regarding usage benefits. Results: Analysis of SCIg product viscosities showed a temperature dependency ranging from 15.5cP at 20°C to 12.5cP at 25°C, indicating temperature change can have a significant impact on flow rate. Testing of VersaRate® in combination with mechanical pumps (SCIg60 Infuser and Freedom60) achieved different stable flow rates at different VersaRate® position settings. Testing with 1-6 needle sites achieved flow rates ranging from 6.5ml/hr (SUB-109-G24 needle set, VersaRate® position 1) to 220ml/hr (SUB-612-G24, VersaRate® position 6). In order to achieve this range in flow rates, at least 6 different fixed rate control tubing sets were needed. Testing and usability studies revealed that (in comparison to fixed rate tubing) VersaRate made it much easier to prime the administration set while providing more control to achieve dry priming. Conclusions: It is significant to note that a drop off in patient compliance occurs when subcutaneous problems (like flow rate control) arise. This results in a change from a less costly method to a more costly one, and a degradation of patient benefits (lifestyle and side effects). Figures indicate that almost 1 out of 5 PI patients (19%) are reported to discontinue immunoglobulin therapy because of treatment-related adverse events. Additionally, a recent patient survey highlighted the importance of providing access to different treatment options and modes of administration to meet their needs and improve health-related quality of life. The VersaRate® adjustable flow regulator has the potential to provide increased flexibility, comfort and reduce adverse events for patients during their SCIg therapy. Further cost and logistical benefits are apparent in the fact that one device has the ability to perform the function of several fixed rate control sets. Author Affiliations: EMED Technologies Corporation, El Dorado Hills, CA, USA. 033 | IgNS 2015 National Registry Survey Authors: Jones J1, Epperson L2, Kondik S3, Schleis T4 Introduction: One of the major IgNS goals is the development of systematic, standardized educational programs, certification, and standards of practice that adequately address the needs of healthcare professionals who work with Immunoglobulin (Ig) therapy. Today, among employers, there is a critical lack of requirements, support, and access to ongoing Ig training and education for healthcare professionals. Conversely, healthcare professionals report significant needs for rigorous education and better support and preparedness for their clinical practice. The goals of the IgNS Registry Survey are to determine, measure, and improve professional and educational advancement and competency needs, educational fulfillment trends, areas of practice, and industry trends. Methods: The Ig National Registry survey is a questionnaire that collects data regarding Ig areas of practice, educational trends, gaps, and unmet needs. Eligible participants included healthcare professionals who administer and manage Ig therapy. Answers were provided using the Likert scale and multiple-choice methods. Results: 468 responses to the 25-question survey were obtained. 85% of respondents were nurses, and 15% pharmacists. Forty-nine percent of respondents reported working in the specialty infusion/home infusion/nursing agency setting; 25% hospital; and 13% in physician’s office and infusion suite. Only 15% of respondents’ employers were reported to provide formal Ig therapy competency training, leaving 85% clinical staff with no training upon hiring, and 66% learning to manage Ig patients by “shadowing a nurse, Ig manufacturer information, and “learning on their own”. Fewer than 30% of respondents reported getting adequate ongoing educational support for complex clinical situations. 90% of healthcare professional have no requirements to maintain and advance their Ig therapy competence. 82% said becoming an Ig Certified Nurse would improve clinical competence and patient safety. The top three most impactful IgNS educational offerings were web-based programs, regional meetings, and national conference. Our promise has never been stronger. Using the latest technologies, CSL Behring is unlocking the potential of biotherapies to save lives and protect the health of people living with rare and serious medical conditions. Visit us at Booths 106 & 107. 46 Poster Abstracts Conclusions: The strong need for formal education and continuous advancement of knowledge and competency was expressed by the overwhelming majority of respondents, regardless of level of education or years of experience. The requirements for Ig education, training, and competency at the employer level are significantly lacking. Robust, systematic educational programs through IgNS, and documentation of expertise through IgCN certification would be critical to improving patient care and outcomes. Author Affiliations: 1Biofusion Inc.; 2Coram/CVS Health; 3Home Solutions; 4Schleis Professional Services 034 | Long-Term Safety, Efficacy, and Tolerability of Recombinant Human Hyaluronidase-Facilitated Subcutaneous Infusion of Immunoglobulin G in Patients Aged ≥16 Years with Primary Immunodeficiencies Authors: Wasserman R , Stein M , Kobrynski L , Gupta S , Grant A , Rubinstein A , Engl W7, McCoy B7, Leibl H7, Yel L8 Introduction: Recombinant human hyaluronidase (rHuPH20)facilitated subcutaneous infusion of immunoglobulin G (IgG) (IGHy; HYQVIA) is approved for the treatment of primary immunodeficiencies (PIDs) in adults. IGHy overcomes some of the limitations associated with conventional subcutaneously administered IgG. Rationale: We report the efficacy, safety, and tolerability of IGHy in adult patients aged ≥16 years who were treated for up to approximately 3.5 years in the IGHy pivotal phase 3 study and its extension. Methods: Patients with PID received IGIV for 3 months, then IGHy every 3 or 4 weeks for approximately 18 months followed by up to an additional 21 months. rHuPH20 was discontinued after up to approximately 3.5 years of exposure. Results: A total of 54/63 patients aged ≥16 years completed the pivotal study; 53 patients participated in the extension. Maximum IGHy exposure was approximately 3.5 years (144 patient-years). Adverse reactions (ARs; defined as causally and/or temporally associated adverse events [AEs] occurring within72 hours) per infusion were 0.191 (local) and 0.186 (systemic) with IGHy, and 0.346 (systemic) with IGIV. No serious AEs related to IGHy were reported. The infection rate with IGHy was 3.05/ patient-year. Of 2307 IGHy infusions, 98% required no administration changes. Thirteen patients developed binding anti-rHuPH20 antibody titers ≥1:160 on ≥1 occasion with no associated ARs; titers declined to levels observed in the normal population in all patients who continued on treatment with IGHy. No patient developed neutralizing anti-rHuPH20 antibodies. Conclusions: In adult patients aged ≥16 years who were treated with IGHy for up to approximately 3.5 years, infection rates were low, infusions were well-tolerated and, despite infusion volumes and ratessimilar to IGIV, systemic AE rates were lower with IGHy than with IGIV. Author Affiliations: 1Allergy Partners of North Texas Research, Dallas, TX, USA; 2Allergy Associates of the Palm Beaches, North Palm Beach, FL, USA; 3Emory University, Atlanta, GA, USA; 4University of California, Irvine, Irvine, CA, USA; 5University of Texas Medical Branch, Galveston, TX, USA; 6Albert Einstein College of Medicine and Montefiore Hospital, Bronx, NY, USA; 7Baxalta Innovations GmbH, Vienna, Austria; 8Baxalta US Inc., Westlake Village, CA, USA 1 2 3 4 5 Continuing Education & Recertification IgNS is pleased to announce online CE tracking. Please visit the website below to complete your Session Evaluations and print your CE Certificate. ce.exceedevents.com/events/IGNS2015/ 6 IgNS 2015 National Conference Pharmacists Educational Review Systems is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. This program is approved for up to 16 hours (1.6 CEUs) of continuing pharmacy education credit. Proof of participation will be posted to your NABP CPE profile within 4 to 6 weeks to participants who have successfully completed the post-test. Participants must participate in the entire presentation and complete the course evaluation to receive continuing pharmacy education credit. UAN # 0761-9999-15-230-L01-P to 0761-9999-15-247-L01-P Nursing Education Review Systems is an approved approver of continuing nursing education by the Alabama State Nursing Association, an accredited approver by the American Nurses Credentialing Center’s Commission on Accreditation. Provider # 5-115. This program is approved for 16 hours of continuing nursing education. Educational Review Systems is also approved for nursing continuing education by the state of California, the state of Florida and the District of Columbia. Ig Academy – Ig Certified Nurse Preparation Course Nursing Education Review Systems is an approved approver of continuing nursing education by the Alabama State Nursing Association, an accredited approver by the American Nurses Credentialing Center’s Commission on Accreditation. Provider # 5-115. This program is approved for 4.75 hours of continuing nursing education. Educational Review Systems is also approved for nursing continuing education by the state of California, the state of Florida and the District of Columbia. Recertification IgNS 2015 provides -30 IgCN Recertification Units -5 CRNI Recertification Units September 18-20, 2015 Hyatt Regency Capitol Hill • Washington, DC 47 11500 Olympic Boulevard, Suite 400 • Los Angeles, CA 90064 Tel: (888)855-4443 • Fax: (888)855-4443 E-mail: [email protected] • www.Ig-NS.org www.Ig-NS.org
