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Inflammatory Bowel Disease:
Why Should I Take My
Medications?
Sunanda V. Kane, MD, MSPH
Associate Professor of Medicine
Mayo Clinic College of Medicine
Rochester, Minnesota
The Spectrum of IBD
1–2 Million Americans
ULCERATIVE COLITIS
CROHN’S DISEASE
– Continuous
inflammation
– Colon only
– Superficial
inflammation
– Variable involvement
– Risk of cancer
– Strictures (cancer)
– Extraintestinal
manifestations
– Patchy inflammation
– Mouth to anus
involvement
– Full-thickness
inflammation
– Variable involvement
– Fistulas
– Strictures
– Extraintestinal
manifestations
Indeterminate colitis
10%–15%
Potential Causes of IBD
Immune
System
Abnormalities
Genetic
Predisposition
Environmental
Factors
Environmental Triggers
Infections
Antibiotics
NSAIDs
IBD
Diet
Smoking
Stress
NSAIDs=nonsteroidal anti-inflammatory drugs.
Diagnosing IBD
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Clinical history
Physical examination
Laboratory tests
Endoscopy (gastroscopy/colonoscopy)
Findings on X-ray films
Tissue biopsy (pathology)
Questions Frequently Missed
During History-Taking
•
•
•
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Family history for second-degree relatives
NSAID use
Antibiotic use
Recent/previous infections
Clues in the Physical Examination
• Clues are present from head to toe
– Aphthous oral ulcers
– Pale conjunctiva, red eyes
– Skin rashes
– Abdominal mass
– Perianal abnormalities
Ulcerative Colitis
Proctitis
Left-sided colitis
Pancolitis
• The small intestine is not involved
Symptoms of
Ulcerative Colitis
• Symptoms depend on extent and severity of
inflammation
– Rectal bleeding and urgency to evacuate
– Diarrhea
– Abdominal cramping
– Extraintestinal (systemic) symptoms
Joint pain/swelling
Eye inflammation
Skin lesions
Common Symptoms of
Crohn’s Disease
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•
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•
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Diarrhea
Abdominal pain and tenderness
Loss of appetite and weight loss
Fever
Fatigue
Rectal bleeding and anal ulcers
Stunted growth in children
Laboratory Tests
• Routine laboratory tests are ordered first
– Complete blood count to rule out infection and
anemia
– C-reactive protein to assess for active inflammation
– Chemistry panel for electrolytes and proteins
– Thyroid-stimulating hormone for weight loss
– Celiac testing of the physician’s choice
• Stool studies
– Ova and parasite examinations, but yield may be low
– Clostridium difficile toxin
– White blood cell count, lactoferrin, and calprotectin
Diagnostic Studies:
Small Bowel Series
• A long stricture in
the terminal ileum
(Kantor’s string
sign)
Endoscopy
Ulcerative colitis
Crohn’s disease
Endoscopy
Management Goals for IBD
Address
psychosocial
issues
Identify dysplasia
and detect cancer
Improve daily
functioning
Relieve
symptoms
Establish
Diagnosis
Replenish
nutritional
deficits
Treat
inflammation
Treat
complications
Minimize
treatment
toxicity
Maintain remission
Medical Therapies for IBD
• 5-aminosalicylic acid (5-ASA) agents
– Mesalamine
Delayed release tablets, Lialda®
Delayed release tablets, Asacol®
Controlled-release capsules, Pentasa®
Rectal suspension (Rowasa® enema)
Rectal suppository (Canasa®)
– Sulfasalazine (Azulfidine®)
– Balsalazide (Colazal®)
– Olsalazine (Dipentum®)
Medical Therapies for IBD
• Antibiotics
– Ciprofloxacin (Cipro®)
– Metronidazole (Flagyl®)
• Steroids
– Adrenocorticotropic hormone
– Budesonide
– Methylprednisolone (Medrol®)
– Prednisone
– Hydrocortisone (Cortenema®, Cortifoam®)
Medical Therapies for IBD
• Immunologic agents
– Azathioprine (Imuran®, Azasan®)
– 6-Mercaptopurine (Purinethol®)
– Cyclosporine (Neoral®)
– Methotrexate
• Biologic agents
– Infliximab (Remicade®)
– Adalimumab (Humira®)
– Natalizumab (Tysabri®)
Drugs don’t work in patients who
don’t take them.
― C.
Everett Koop, MD
Former US Surgeon General
Factors that Affect Adherence
• Adherence is taking medications over a long period of time
• Extent, duration, and severity of disease affect adherence
• People who are more likely to adhere to therapy
– Have more disease flare-ups
– Are more knowledgeable about their treatment
• Clear instructions and educational materials provided by
healthcare professionals increases knowledge about
– Importance of treatment
– Risks of non-adherence
Hall A, et al. Gastrointestinal Nurs. 2006;4:31-40.
Lopez-Sanroman A, Bermejo F. Aliment Pharmacol Ther. 2006;24(Suppl 3):45-49.
Kane SV. Aliment Pharmacol Ther. 2006;23:577-585.
Risk Factors for Non-Adherence
Risk Factor
Odds Ratio (95% CI)
Married
Recent procedure
Greater extent of disease
0.46 (0.39-0.57)
0.96 (0.93-0.99)
0.55 (0.22-1.3)
Male gender
Taking more than 4 medications
2.1 (1.2-4.8)
2.5 (1.4-5.7)
Kane SV, et al. Am J Gastroenterol. 2001;96:2929-2932.
National Quality Forum Report
• Goals
– Improve medication adherence by creating standards to
change the way healthcare professionals interact with
patients
– Develop standard performance measures that could be
implemented in patient care settings to improve adherence
• Recommendations
– Adherence needs to be evaluated as a vital sign, every time
a patient is seen by a physician or nurse
– Ask the questions: Are you taking the medication, how are
you taking it, and what is the dose?
Traynor K. Am J Health-Syst Pharm. 2005;62:2440-2442.
Significant Factors Associated with
Risk of Not Refilling 5-ASA at
3 Months
Patients
More Likely
to be Adherent
Rectal 5-ASA*
Glucocorticoid use*
Patients
Less Likely
to be Adherent
Copay (per $1 increase)
Lower daily pill load (per 1 pill decrease)
Male gender
Mail order
Psychiatric history*
3,574 UC patients with 5-ASA prescriptions; 1,530 (42.8%) patients did not refill at 3 months.
*  12 months prior to index date.
Kane S, et al. Gastroenterology. 2007;132(4 Suppl 2):M1033.
Adherence Decreases Risk of
Relapse
Patients Remaining in
Remission, %
100
Adherent
75
50
Non-adherent
25
0
Time (months) 0
Adherent n = 40
Non-adherent n = 59
12
36
32
24
32
28
From Kane S, et al. Am J Med. 2003;114:39-43; with permission.
36
Adherence Decreases Risk of
Relapse
• Prospective study in patients with UC in
remission and taking mesalamine found
chance of remission was
– 89% in adherent patients
– 39% in non-adherent patients
Kane S, et al. Am J Med. 2003;114:39-43.
Non-Adherence is Associated with
Recurrence
No Recurrence
Recurrence
Medication Refilled in
Previous 6 Months, %
90
80
70
60
50
40
30
20
10
0
6 Months
12 Months
24 Months
Follow-up
From Kane S, et al. Am J Med. 2003;114:39-43; with permission.
Non-Adherence is Associated with
Recurrence
• 82% of patients with recurrence
had not taken their medication
• 34% of patients remaining in remission had
not taken their medication
Kane S, et al. Am J Med. 2003;114:39-43.
Other Factors that Affect Adherence
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Adverse reactions to medications
Need for many medications
Effectiveness of treatment
Convenience of treatment
Hall A, et al. Gastrointestinal Nurs. 2006;4:31-40.
Lopez-Sanroman A, Bermejo F. Aliment Pharmacol Ther. 2006; 24(Suppl 3):45-49.
Kane SV. Aliment Pharmacol Ther. 2006;23:577-585.
To Increase Treatment Adherence
• Simplify the treatment regimen
• Continue taking the medications
• Find support for emotional and social issues
Hall A, et al. Gastrointestinal Nurs. 2006;4:31-40.
Lopez-Sanroman A, Bermejo F. Aliment Pharmacol Ther. 2006;24(Suppl 3):45-49.
Kane SV. Aliment Pharmacol Ther. 2006;23:577-585.
Patient-Centered
Self-Management Training
Self-Guided
Group
Control
Group
P-Value
14.8 h
49.6 h
<0.0001
Outpatient visits
0.9
2.9
<0.0001
Time spent visiting a doctor
1h
6.2 h
<0.0001
Time to treat relapses
• Patients preferred guided self-management over traditional
outpatient care
• Patient-centered self-management resulted in
– Earlier treatment of relapses
– Fewer hospital and primary care visits
– Less time spent during a visit with a doctor
Robinson A, et al. Lancet. 2001;358:976-981.
Why Take Your Medications?
• Possible decreased risk of colorectal cancer
• Decreased risk of disease progression
• Increased chance of disease regression
Velayos FS, et al. Am J Gastroenterol. 2005;100:1345-1353.
Pica R, et al. Inflamm Bowel Dis. 2004;10:731-736.
Picco MF, et al. Inflamm Bowel Dis. 2006;12:537-542.