A systematic review and meta-analysis of randomized controlled trials (RCTs) supported the use of Vedolizumab as an important therapeutic option for inflammatory bowel disease (IBD)-affected patients. Hui-Jun Tang et al. aimed to assess the safety and efficacy of Vedolizumab in treating IBD.

For relevant literature search, Cochrane databases, Embase, and PubMed were explored. The focus was on RCTs that assessed the safety and effectiveness of Vedolizumab in IBD.

A random effects model was utilized to estimate the risk ratio (RR) and 95% confidence intervals (CI) for each outcome. Among the selected studies, a total of 12 RCTs involving 4,865 individuals satisfied the inclusion criteria. During the induction phase, Vedolizumab exhibited greater efficacy compared to placebo in achieving clinical remission (RR=2.09) and clinical response (RR=1.54) for patients with ulcerative colitis and Crohn's disease.

In the maintenance therapy group, Vedolizumab demonstrated greater rates of clinical remission (RR=1.98) and clinical response (RR=1.78) compared to the placebo group. Notably, Vedolizumab showed remarkable improvements in clinical remission (RR=2.07) and clinical response (RR=1.84) specifically for patients who had previously failed tumor necrosis factor (TNF) antagonist treatment. When considering corticosteroid-free remission, Vedolizumab illustrated superior effectiveness over placebo in individuals with IBD (RR=1.98).

For people with Crohn's disease, Vedolizumab proved more efficient contrasted to placebo in promoting mucosal healing (RR=1.78).  In terms of adverse events, Vedolizumab exhibited a profound decline in the risk of IBD exacerbation as opposed to placebo (RR=0.60). When contrasted with a placebo, Vedolizumab was associated with an elevated risk of nasopharyngitis in Crohn's disease patients (RR=1.77).

No discernable differences were witnessed in other adverse events. Despite potential inherent risks, such as selection bias, the findings of the current study support the safe and effective use of Vedolizumab as a biological treatment for IBD, specifically for individuals who have experienced treatment failure with TNF antagonists.