Evaluating the Effectiveness and Safety of Vedolizumab in Moderate to Severe Ulcerative Colitis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

Ulcerative colitis (UC) significantly affects patients' lives, and treatment options may be constrained due to severe side effects. Vedolizumab, a monoclonal antibody that specifically targets the α4β7 integrin, has recently demonstrated potential as a gut-specific therapy with fewer adverse effects compared to other biological treatments. We conducted a systematic review and meta-analysis to evaluate the efficacy and safety of vedolizumab in adults with moderate to severe UC. The research team reviewed three prominent databases - PubMed, Google Scholar, and Cochrane Central Register of Controlled Trials (CENTRAL) - adhering to Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) criteria, to identify randomized controlled trials that compared vedolizumab with placebo or other treatments for moderate to severe UC. A total of 1,571 preliminary studies were screened, resulting in the inclusion of six trials with 1,618 people. The primary outcomes included clinical remission, mucosal healing, clinical response, corticosteroid-free remission, and adverse events such as infections and infusion site responses. Data indicate that vedolizumab markedly enhanced endoscopic remission relative to placebo, nearly doubling the likelihood of remission for patients (risk ratio (RR) = 2.25; p = 0.01). Despite the prevalence of clinical remission in the vedolizumab cohort, this outcome lacks statistical significance (RR = 2.10; p = 0.07). No substantial advantage was observed in corticosteroid-free remission (RR = 1.69; p = 0.58). Vedolizumab exhibited an acceptable safety profile, with adverse event rates comparable to those of a placebo. Nonetheless, minor infections and infusion responses occurred with slightly greater frequency. Vedolizumab enhances endoscopic healing and clinical response in individuals with moderate to severe UC while maintaining an acceptable safety profile. This therapeutic option is particularly significant for individuals who experience difficulties with alternative therapies. Future head-to-head trials comparing vedolizumab with other biological therapies may elucidate its role in treatment regimens.