title: Risk for Overall Infection with Anti-TNF and Anti-integrin Agents Used in IBD: A Systematic Review and Meta-analysis.
abstract: The overall risk for infection with contemporary biological agents in treating Crohn's disease (CD) and ulcerative colitis (UC) has not been systematically assessed.
  
  
  
  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.
  
  
  
  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.
  
  
  
  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.
authors.affiliation: *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.
authors.forename: Eric D
authors.initials: ED
authors.lastname: Shah
authors.forename: Jeremy P
authors.initials: JP
authors.lastname: Farida
authors.forename: Corey A
authors.initials: CA
authors.lastname: Siegel
authors.forename: Kelly
authors.initials: K
authors.lastname: Chong
authors.forename: Gil Y
authors.initials: GY
authors.lastname: Melmed
mesh_terms: D000068879:Adalimumab / Q000009:adverse effects; D000911:Antibodies, Monoclonal / Q000009:adverse effects; D001688:Biological Products / Q000009:adverse effects*; D003093:Colitis, Ulcerative / Q000188:drug therapy*; D003424:Crohn Disease / Q000188:drug therapy*; D005765:Gastrointestinal Agents / Q000009:adverse effects*; D006801:Humans; D007239:Infections / Q000139:chemically induced*; D000069285:Infliximab / Q000009:adverse effects; D016023:Integrins / Q000037:antagonists & inhibitors; D016032:Randomized Controlled Trials as Topic; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors
chemical_list: D000911:Antibodies, Monoclonal; D001688:Biological Products; D005765:Gastrointestinal Agents; D016023:Integrins; D014409:Tumor Necrosis Factor-alpha; C529000:golimumab; D000069285:Infliximab; D000068879:Adalimumab