Infliximab and other immunomodulating drugs in patients with inflammatory bowel disease and the risk of serious bacterial infections

S. Schneeweiss, J. Korzenik, D. H. Solomon, C. Canning, Joy Lee, B. Bressler

Research output: Contribution to journalArticle

150 Citations (Scopus)

Abstract

Summary Background There remain concerns about the safety of infliximab therapy in patients with inflammatory bowel disease (IBD). Aim To assess the association between the initiation of infliximab and other immunomodulating drugs and the risk of serious bacterial infection in the treatment of IBD. Methods We assembled a cohort study of patients with IBD, including Crohn's disease (CD) and ulcerative colitis (UC). All patients initiating an immunomodulating drug between January 2001 and April 2006 were identified in British Columbia from linked health care utilization databases. Exposure of interest was initiation of infliximab or corticosteroids compared with initiation of other immunosuppressive agents, including azathioprine, mercaptopurine (MP) and methotrexate (MTX). Outcome of interest was serious bacterial infections requiring hospitalization, including Clostridium difficile. Results Among 10 662 IBD patients, the incidence rate of bacteriaemia ranged from 3.8 per 1000 person-years (95% confidence interval 2.1-6.2) for other immunosuppressive agents to 7.4 (3.3-19.3) for infliximab with slightly higher rate for serious bacterial infections resulting in an adjusted relative risk 1.4 (0.47-4.24). Clostridium difficile infections occurred in 0/1000 (0-5.4) among 521 infliximab initiations and 14/1000 (10.6-18.2) for corticosteroids. Corticosteroid initiation tripled the risk of C. difficile infections (RR = 3.4; 1.9-6.1) compared with other immunosuppressant agents. This corticosteroid effect was neither dose-dependent nor duration-dependent. Bacteriaemia and other serious bacterial infections were not increased by corticosteroids or infliximab (5 events). Conclusions In a population-based cohort of patients with IBD, we found no meaningful association between infliximab and serious bacterial infections, although some subgroups had few events. Corticosteroid initiation increased the risk for C. difficile infections in these patients.

Original languageEnglish (US)
Pages (from-to)253-264
Number of pages12
JournalAlimentary Pharmacology and Therapeutics
Volume30
Issue number3
DOIs
StatePublished - Aug 1 2009
Externally publishedYes

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Inflammatory Bowel Diseases
Bacterial Infections
Adrenal Cortex Hormones
Clostridium difficile
Clostridium Infections
Pharmaceutical Preparations
Immunosuppressive Agents
Bacteremia
Patient Acceptance of Health Care
6-Mercaptopurine
British Columbia
Azathioprine
Infliximab
Ulcerative Colitis
Methotrexate
Crohn Disease
Hospitalization
Cohort Studies
Databases
Confidence Intervals

ASJC Scopus subject areas

  • Pharmacology (medical)

Cite this

Infliximab and other immunomodulating drugs in patients with inflammatory bowel disease and the risk of serious bacterial infections. / Schneeweiss, S.; Korzenik, J.; Solomon, D. H.; Canning, C.; Lee, Joy; Bressler, B.

In: Alimentary Pharmacology and Therapeutics, Vol. 30, No. 3, 01.08.2009, p. 253-264.

Research output: Contribution to journalArticle

Schneeweiss, S. ; Korzenik, J. ; Solomon, D. H. ; Canning, C. ; Lee, Joy ; Bressler, B. / Infliximab and other immunomodulating drugs in patients with inflammatory bowel disease and the risk of serious bacterial infections. In: Alimentary Pharmacology and Therapeutics. 2009 ; Vol. 30, No. 3. pp. 253-264.
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N2 - Summary Background There remain concerns about the safety of infliximab therapy in patients with inflammatory bowel disease (IBD). Aim To assess the association between the initiation of infliximab and other immunomodulating drugs and the risk of serious bacterial infection in the treatment of IBD. Methods We assembled a cohort study of patients with IBD, including Crohn's disease (CD) and ulcerative colitis (UC). All patients initiating an immunomodulating drug between January 2001 and April 2006 were identified in British Columbia from linked health care utilization databases. Exposure of interest was initiation of infliximab or corticosteroids compared with initiation of other immunosuppressive agents, including azathioprine, mercaptopurine (MP) and methotrexate (MTX). Outcome of interest was serious bacterial infections requiring hospitalization, including Clostridium difficile. Results Among 10 662 IBD patients, the incidence rate of bacteriaemia ranged from 3.8 per 1000 person-years (95% confidence interval 2.1-6.2) for other immunosuppressive agents to 7.4 (3.3-19.3) for infliximab with slightly higher rate for serious bacterial infections resulting in an adjusted relative risk 1.4 (0.47-4.24). Clostridium difficile infections occurred in 0/1000 (0-5.4) among 521 infliximab initiations and 14/1000 (10.6-18.2) for corticosteroids. Corticosteroid initiation tripled the risk of C. difficile infections (RR = 3.4; 1.9-6.1) compared with other immunosuppressant agents. This corticosteroid effect was neither dose-dependent nor duration-dependent. Bacteriaemia and other serious bacterial infections were not increased by corticosteroids or infliximab (5 events). Conclusions In a population-based cohort of patients with IBD, we found no meaningful association between infliximab and serious bacterial infections, although some subgroups had few events. Corticosteroid initiation increased the risk for C. difficile infections in these patients.

AB - Summary Background There remain concerns about the safety of infliximab therapy in patients with inflammatory bowel disease (IBD). Aim To assess the association between the initiation of infliximab and other immunomodulating drugs and the risk of serious bacterial infection in the treatment of IBD. Methods We assembled a cohort study of patients with IBD, including Crohn's disease (CD) and ulcerative colitis (UC). All patients initiating an immunomodulating drug between January 2001 and April 2006 were identified in British Columbia from linked health care utilization databases. Exposure of interest was initiation of infliximab or corticosteroids compared with initiation of other immunosuppressive agents, including azathioprine, mercaptopurine (MP) and methotrexate (MTX). Outcome of interest was serious bacterial infections requiring hospitalization, including Clostridium difficile. Results Among 10 662 IBD patients, the incidence rate of bacteriaemia ranged from 3.8 per 1000 person-years (95% confidence interval 2.1-6.2) for other immunosuppressive agents to 7.4 (3.3-19.3) for infliximab with slightly higher rate for serious bacterial infections resulting in an adjusted relative risk 1.4 (0.47-4.24). Clostridium difficile infections occurred in 0/1000 (0-5.4) among 521 infliximab initiations and 14/1000 (10.6-18.2) for corticosteroids. Corticosteroid initiation tripled the risk of C. difficile infections (RR = 3.4; 1.9-6.1) compared with other immunosuppressant agents. This corticosteroid effect was neither dose-dependent nor duration-dependent. Bacteriaemia and other serious bacterial infections were not increased by corticosteroids or infliximab (5 events). Conclusions In a population-based cohort of patients with IBD, we found no meaningful association between infliximab and serious bacterial infections, although some subgroups had few events. Corticosteroid initiation increased the risk for C. difficile infections in these patients.

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