Download Adverse Events Associated With Common Therapy Regimens for

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
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The goals of medical therapy for CD
•
induce and maintain remission of the symptoms of CD
eliminate long-term corticosteroid use
•

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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
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abdominal abscess and sepsis
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Azathioprine and 6-mercaptopurine
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bone marrow suppression, neutropenic sepsis, and non-Hodgkin ’ s
lymphoma, EBV-linked post-transplant lymphoproliferative disorder

Anti-TNF therapy with infliximab and adalimumab
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opportunistic infections (OIs) including tuberculosis (TB)
INTRODUCTION

The objectives of this retrospective cohort study
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CD itself is associated with an increased risk of morbidity from a
variety of infectious, malignant, and neurological adverse events
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monotherapy with any treatments increases the risk of adverse event
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the risk of combination therapy with these agents is greater than
monotherapy
METHODS - data
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1 January 2002 and 31 December 2005
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covering ~ 8 million individuals across the Southern, Western,
and Midwestern United States
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claims for in-patient, outpatient, professional, pharmacy,
emergency department, and ancillary services
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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
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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