title: Vedolizumab for induction and maintenance of remission in ulcerative colitis: a Cochrane systematic review and meta-analysis.
abstract: BACKGROUND
  We performed a systematic review to evaluate the efficacy and safety of vedolizumab for induction and maintenance of remission in ulcerative colitis.
  
  
  METHODS
  A literature search to June 2014 identified all applicable randomized trials. Outcome measures were clinical and endoscopic remission, clinical and endoscopic response, quality of life, and adverse events. The risk ratio (RR) and 95% confidence intervals (CI) were estimated for each outcome. Study quality was evaluated using the Cochrane risk of bias tool. The GRADE criteria were used to assess the quality of the evidence.
  
  
  RESULTS
  Four studies (606 patients) were included. The risk of bias was low. Pooled analyses indicated that vedolizumab was significantly superior to placebo for induction of remission (RR = 0.86, 95% CI, 0.80-0.91), clinical response (RR = 0.82, 95% CI, 0.75-0.91), endoscopic remission (RR = 0.82, 95% CI, 0.75-0.91), and for achieving remission at 52 weeks in week 6 responders (RR = 2.73, 95% CI, 1.78-4.18). GRADE analyses suggested that the overall quality of the evidence was high for induction of remission and moderate for maintenance therapy (due to sparse data consisting of 246 events). No statistically significant difference was observed in the incidence of adverse events between vedolizumab and placebo.
  
  
  CONCLUSIONS
  Vedolizumab is superior to placebo as induction and maintenance therapy for ulcerative colitis. Future studies are needed to define long-term efficacy and safety of this agent.
authors.affiliation: *Robarts Clinical Trials, Robarts Research Institute, Western University, London, ON, Canada; †Department of Medicine, King Abdulaziz University, Jeddah, Saudi Arabia; ‡Center for Inflammatory Bowel Diseases, Richmond, Virginia; §UVA Digestive Health Center of Excellence, University of Virginia Health Systems, Charlottesville, Virginia; and ‖Carolinas Medical Center, University of North Carolina Charlotte Campus, Charlotte, North Carolina.
authors.forename: Mahmoud H
authors.initials: MH
authors.lastname: Mosli
authors.forename: John K
authors.initials: JK
authors.lastname: MacDonald
authors.forename: Stephen J
authors.initials: SJ
authors.lastname: Bickston
authors.forename: Brian W
authors.initials: BW
authors.lastname: Behm
authors.forename: David J
authors.initials: DJ
authors.lastname: Tsoulis
authors.forename: Jianfeng
authors.initials: J
authors.lastname: Cheng
authors.forename: Reena
authors.initials: R
authors.lastname: Khanna
authors.forename: Brian G
authors.initials: BG
authors.lastname: Feagan
mesh_terms: D061067:Antibodies, Monoclonal, Humanized / Q000627:therapeutic use*; D003093:Colitis, Ulcerative / Q000188:drug therapy*; D005765:Gastrointestinal Agents / Q000627:therapeutic use*; D006801:Humans; D060828:Induction Chemotherapy; D060046:Maintenance Chemotherapy; D011379:Prognosis; D012074:Remission Induction
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D005765:Gastrointestinal Agents; C543529:vedolizumab