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Risk for Overall Infection with Anti-TNF and Anti-integrin Agents Used in IBD: A Systematic Review and Meta-analysis

Shah, Eric D. MD, MBA; Farida, Jeremy P. MD; Siegel, Corey A. MD, MS; Chong, Kelly PhD; Melmed, Gil Y. MD, MS

doi: 10.1097/MIB.0000000000001049
Original Clinical Articles

Background: The overall risk for infection with contemporary biological agents in treating Crohn's disease (CD) and ulcerative colitis (UC) has not been systematically assessed.

Methods: We performed a PubMed and Cochrane database literature search to evaluate randomized, placebo-controlled trials of biologics in treating UC and CD. Meta-analysis was performed using a DerSimonian and Laird random effects model. We determined relative risk (RR) of harm against placebo; number needed to harm (NNH) was reported when appropriate. Heterogeneity and publication bias were assessed.

Results: Fourteen trials (6 UC and 8 CD) evaluating 5107 patients were included. For anti–tumor necrosis factor agents used in the treatment of UC, golimumab {NNH of 9.3, RR = 1.4 (95% confidence interval [CI], 1.04–1.8)} and pooled studies of infliximab and adalimumab (NNH = 17.2, RR = 1.2 [95% CI, 1.0–1.3]) had a statistically significant higher risk for any infection versus placebo. Risk was not significantly increased in anti–tumor necrosis factor trials in CD (RR = 1.1 [95% CI, 0.8–1.5]). By contrast, anti-integrin agents in UC (RR = 1.0 [95% CI, 0.9–1.2]) or CD (RR = 1.1 [95% CI, 0.97–1.3]) did not confer a statistically significant excess risk of infection versus placebo.

Conclusions: Anti–tumor necrosis factor therapy but not anti-integrin therapy is associated with a greater infection risk than placebo in treating UC. Neither class of therapy is associated with increased infection risk over placebo in treating CD. Our findings can help guide patient-centered discussions regarding the risk for infection with biological agents.

Published online 22 February 2017

*Division of Gastroenterology, University of Michigan, Ann Arbor, Michigan;

Section of Gastroenterology, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire;

Department of Internal Medicine, University of New Mexico School of Medicine, Albuquerque, New Mexico; and

§Division of Gastroenterology, Department of Medicine, Cedars-Sinai Medical Center, Los Angeles, California.

Address correspondence to: Eric D. Shah, MD, MBA, 1500 East Medical Center Drive, 3912 Taubman Center, SPC 5362, Ann Arbor, MI 48109 (e-mail:

C. A. Siegel has served as a consultant and on the advisory board for AbbVie, Given Imaging, Janssen, Prometheus, and Takeda, has delivered CME talks for AbbVie and Janssen, and has received grant support from AbbVie, Janssen, Salix, UCB, and Warner-Chilcott. G. Y. Melmed has served as a consultant and on the advisory board for AbbVie, Celgene, Given Imaging, Janssen, and Luitpold and has conducted research on behalf of Pfizer. The remaining authors have no conflict of interest to disclose.

Received September 23, 2016

Accepted January 6, 2017

© Crohn's & Colitis Foundation of America, Inc.
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