Comparative efficacy and safety of subcutaneous vedolizumab versus other targeted inflammatory bowel therapies in patients with moderate to severe ulcerative colitis: a network meta-analysis update

The growing number of targeted inflammatory bowel disease (IBD) therapies available for the treatment of moderate to severe ulcerative colitis has increased the complexity of treatment decisions for clinicians. Clinical decision-making is further hindered by a paucity of head-to-head clinical trials comparing the relative efficacy and safety of available targeted IBD therapies; however, network meta-analyses (NMAs) can indirectly compare treatments. Networks of evidence were formed from 29 randomized controlled trials of targeted IBD therapies. To address differences in study design, adjustments were made to the treat-through trials in order to mimic a re-randomization design. A Bayesian NMA was conducted with the primary analysis using fixed-effect models to estimate odds ratios (ORs) and 95% credible intervals (CrIs) for efficacy and safety outcomes. There was no significant difference in the maintenance of clinical response or clinical remission of any targeted IBD therapy relative to vedolizumab 108 mg every 2 weeks (Q2W) subcutaneously (SC), except for adalimumab 40 mg every other week (EOW) SC, which had significantly lower odds (clinical response: OR, 0.36; 95% CrI, 0.17–0.76; clinical remission: OR, 0.35; 95% CrI, 0.16–0.75). The odds of experiencing overall adverse events were significantly higher for patients receiving placebo and treatment regimens for six targeted IBD therapies (adalimumab, etrasimod, golimumab, infliximab, ozanimod, and tofacitinib) than those receiving vedolizumab 108 mg Q2W SC. The odds of serious adverse events were not significantly different between any targeted IBD therapy and vedolizumab 108 mg Q2W SC. The odds of overall infections were significantly higher for those receiving treatment regimens for three targeted IBD therapies (golimumab, ozanimod, and tofacitinib) than those receiving vedolizumab 108 mg Q2W SC; the odds for other treatments were not significantly different. The results of this NMA update indicate that vedolizumab SC demonstrates efficacy that is either superior or not significantly different from other targeted IBD therapies, including established biologics and novel oral therapies, and a safety profile that is superior or not significantly different with regard to overall adverse events and overall infections. The efficacy and safety of intravenous vedolizumab is equivalent to that of vedolizumab SC.