title: Efficacy and safety of adalimumab for the Crohn's disease: a systematic review and meta-analysis of published randomized placebo-controlled trials.
abstract: OBJECTIVE
  The aim of this study was to evaluate the efficacy and safety of adalimumab (ADA) for Crohn's disease.
  
  
  METHODS
  Electronic databases, including PubMed, Embase, the Cochrane Library, and the Science Citation Index, were searched to retrieve relevant trials. We estimated pooled estimates of the odds ratio (OR) and relevant 95% confidence interval (CI) using fixed effects model or random effects model as appropriate.
  
  
  RESULTS
  Six randomized placebo-controlled studies met the selection criteria. Short-term clinical response/remission and long-term remission were better in the ADA groups than in the control groups (P < 0.05), both in anti-TNF-naive patients and in subjects who lost their response and/or became intolerant to infliximab (IFX). And ADA was also effective for patients who were previously treated with IFX, and its efficacy in infliximab-exposed patients was probably less than in infliximab-naive patients. In patients with active Crohn's disease (CD), ADA therapy was more effective than placebo for obtaining complete fistula closure. In comparison with placebo, ADA does not increase the risk of serious adverse events.
  
  
  CONCLUSIONS
  ADA appears to be effective in achieving short-term clinical response/remission, long-term remission, and complete fistula healing in CD, including patients not manageable with IFX, and appears to have a favorable safety profile. A longer duration of follow-up and a larger number of patients are required to better assess the safety profile of ADA in CD.
authors.affiliation: Department of Gastroenterology, Shanghai First People's Hospital, Shanghai Jiao Tong University, Shanghai, 200080, China.
authors.forename: Yun-Na
authors.initials: YN
authors.lastname: Song
authors.forename: Ping
authors.initials: P
authors.lastname: Zheng
authors.forename: Jun-Hua
authors.initials: JH
authors.lastname: Xiao
authors.forename: Zhan-Jun
authors.initials: ZJ
authors.lastname: Lu
mesh_terms: D000068879:Adalimumab; D000893:Anti-Inflammatory Agents / Q000009:adverse effects / Q000627:therapeutic use*; D000911:Antibodies, Monoclonal / Q000627:therapeutic use; D061067:Antibodies, Monoclonal, Humanized / Q000009:adverse effects / Q000627:therapeutic use*; D003424:Crohn Disease / Q000188:drug therapy*; D006801:Humans; D000069285:Infliximab; D007412:Intestinal Fistula / Q000188:drug therapy; D016032:Randomized Controlled Trials as Topic; D016896:Treatment Outcome
chemical_list: D000893:Anti-Inflammatory Agents; D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000069285:Infliximab; D000068879:Adalimumab