Vedolizumab in IBD–Lessons From Real-world Experience; A Systematic Review and Pooled Analysis

Vedolizumab [VDZ] is an anti-integrin monoclonal antibody effective in ulcerative colitis [UC] and Crohn's disease [CD]. Several real-world experience [RWE] studies with VDZ have been published to date. The aim of this systematic review was to summarise the available real-life experience with VDZ. We performed a systematic review of the available RWE studies of VDZ in CD and UC. We performed a pooled analysis of the available efficacy and safety data for induction and maintenance treatment in adult cohorts. A narrative review of VDZ use in special clinical settings was also performed. Nine studies including 1565 [571 UC, 994 CD] adult patients were identified. In CD, clinical response and remission were achieved in 54% (95% confidence interval [CI] 41–66%) and 22% [95% CI 13–35%] by Week 6 and in 49% [95% CI 37–51%] and 32% [95% CI 23–42%] by Week 14; at Week 52, 45% [95% CI 28–64%] and 32% [95% CI 12–62] of the patients responded, and were in clinical remission, respectively. In UC, clinical response and remission were achieved in 43% [95% CI 37–49] and 25% [95% CI 12–45] by Week 6, respectively, and in 51% [95% CI 43–61%]and 30% [95% CI 24–36%] by Week 14/22, respectively; at week 52, clinical response and remission were achieved in 48% and 39% of the patients, respectively. Adverse effects were mostly minor and occurred in 30.6% of the patients; infections were reported in 3.4% of the patients. VDZ is efficacious in CD and UC and has a favourable safety profile in RWE studies.