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Adverse Events Associated With Common Therapy Regimens for Moderate-to-Severe Crohn’s Disease Josh Marehbian , MPH1 , H. Michael Arrighi , PhD2 , Steve Hass , PhD2 , Haijun Tian , PhD1 and William J. Sandborn , MD3 Am J Gastroenterol 2009; 104:2524–2533 R2 Chae jungmin INTRODUCTION Crohn ’ s disease (CD) • • chronic inflammatory condition of the gastrointestinal tract persistent inflammation progresses to complications of strictures, fistulas, and abscesses The goals of medical therapy for CD • induce and maintain remission of the symptoms of CD eliminate long-term corticosteroid use • Medications with a low risk of side effects, such as mesalamine and antibiotics, are ineffective Medications shown to be effective for CD (steroids, azathioprine, 6-mercaptopurine, infliximab, adalimumab, certolizumab pegol) all have the potential for rare but serious adverse events INTRODUCTION Steroids • abdominal abscess and sepsis Azathioprine and 6-mercaptopurine • bone marrow suppression, neutropenic sepsis, and non-Hodgkin ’ s lymphoma, EBV-linked post-transplant lymphoproliferative disorder Anti-TNF therapy with infliximab and adalimumab • opportunistic infections (OIs) including tuberculosis (TB) INTRODUCTION The objectives of this retrospective cohort study • CD itself is associated with an increased risk of morbidity from a variety of infectious, malignant, and neurological adverse events • monotherapy with any treatments increases the risk of adverse event • the risk of combination therapy with these agents is greater than monotherapy METHODS - data 1 January 2002 and 31 December 2005 covering ~ 8 million individuals across the Southern, Western, and Midwestern United States claims for in-patient, outpatient, professional, pharmacy, emergency department, and ancillary services Data included member demographics, service dates, setting of the care episode, diagnosis codes, procedure codes, and prescription medications dispensed or administered METHODS – subject selection excluded : a history of HIV infection solid organ transplant recipients had < 1 year of follow-up Matching was based on: age ± 2 years gender health plan availability of follow-up CD patient ’ s index date METHODS – CD therapy identification and classification METHODS – study endpoints RESULTS – matched cohort analysis The two groups were similar in age and gender proportions and distribution by the geographic location • CD patients had a mean age of 47 ( ± 16, s.d.) years their matched controls 48 ( ± 16) years the majority of patients were women (55 % ) with geographic distribution of 11, 26, and 62 % for the Midwestern, Southern, and Western regions • All adverse events CD > controls RESULTS – longitudinal cohort The longitudinal cohort of CD patients had age and gender characteristics similar to the larger CD patient population mean age was 48 ( ± 16) years Women accounted for 56 % The geographic distribution was 9, 25, 67 % for the Midwestern, Southern, and Western regions 74 % had no comorbid conditions , 6 % had 1 comorbid condition 13 % had 2 comorbid conditions, 7 % had 3 or more Steroids were the m/c used medication RESULTS RESULTS RESULTS RESULTS For infectious endpoints Combination therapy > monotherapy CONCLUSION Treatment with steroids, ISs, or anti-TNF agents singly and in combination in patients with CD is associated with increased risks of infection, demyelinating disorders, and cervical dysplasia