PRISMA-Efficacy and Safety of Vedolizumab for Inflammatory Bowel Diseases A Systematic Review and Meta-Analysis of Randomized Controlled Trials

Vedolizumab is an anti-inflammatory monoclonal antibody that exclusively targets the alpha 4 beta 7 integrin. We aimed to systematically review the efficacy and safety of vedolizumab for patients with inflammatory bowel diseases (IBDs). PubMed, EMBASE, and the Cochrane Library were searched up to May 2014. Randomized controlled trials examining the efficacy or safety of vedolizumab in patients with IBDs were eligible for inclusion. Data were extracted independently by 2 investigators and pooled using Review Manager 5.0 software (The Cochrane Collaboration, Copenhagen). Results were expressed as the relative risk (RR) with 95% confidence intervals (CIs). Six randomized controlled trials involving 2815 patients were eligible for inclusion. Vedolizumab was more effective than placebo for patients with ulcerative colitis and Crohn disease (CD) in clinical response (RR = 1.82, 95% CI, [1.43, 2.31]; RR = 1.46, 95% CI [1.18,1.81]) and clinical remission (RR = 2.23, 95% CI [1.35, 3.68]; RR = 1.71, 95% CI [1.25, 2.34]) during induction therapy. A superior effect was found during maintenance therapy in durable clinical/CD Activity Index-100 response (RR = 2.22, 95% CI [1.62, 3.05]; RR = 1.48, 95% CI [1.13, 1.94]) and clinical remission (RR = 2.55, 95% CI [1.38, 4.70]; RR = 1.15, 95% CI [0.75, 1.77]). However, vedolizumab may be associated with serious adverse events (RR = 1.25, 95% CI [1.03, 1.52]) and nasopharyngitis (RR = 1.56, 95% CI [1.08, 2.25]) for patients with CD. Vedolizumab was more effective than placebo as induction and maintenance therapy for IBDs, with an acceptable short-term safety profile, and achieving cure, although it may be associated with serious adverse events and nasopharyngitis for patients with CD.