PGI1 - Comparative efficacy and safety of golimumab, infliximab and adalimumab for the treatment of moderate to severe ulcerative colitis: A bayesian indirect treatment comparison meta-analysis

Abstract

To compare the relative efficacy and safety of golimumab, infliximab and adalimumab for the treatment of moderate-to-severe ulcerative colitis using indirect treatment comparison (ITC) meta-analysis. A systematic literature search identified five randomized controlled trials. Outcomes of interest included clinical remission, clinical response, mucosal healing, sustained remission/response, serious adverse events (SAEs), and discontinuation due to adverse events (DAEs). Data was synthesized using Bayesian indirect treatment comparison (ITC) meta-analysis. The analysis incorporated advanced intention-to-treat with baseline priors to account for the alternative design of the golimumab trial. After the induction phase, each treatment had significantly greater efficacy than placebo all endpoints, with the exception of adalimumab for mucosal healing. No statistical differences were observed between golimumab and infliximab. Adalimumab had significantly lower efficacy measures compared to infliximab for clinical remission (odds ratio [OR] 0.42, 95% credible interval [CrI] 0.17-0.97), clinical response (OR 0.45, 95% CrI 0.23-0.89), and mucosal healing (OR 0.46, 95% CrI 0.25-0.84) after the induction period. During the maintenance phase, each biologic agent exhibited significantly greater efficacy compared to placebo for clinical remission, clinical response, and mucosal healing. Golimumab 100mg was significantly better than adalimumab for clinical response (OR 1.80, 95% CrI 1.01-3.21) and mucosal healing at 54 weeks (OR 1.88, 95% CrI 1.01-3.49). No statistical differences were observed between adalimumab and infliximab. Both golimumab 100mg and infliximab were significantly better than adalimumab in terms of sustained clinical response (OR 2.40, 95% CrI 1.17-4.86 and OR 1.93, 95% CrI 1.04-4.06), respectively. For SAEs, there were no statistical differences between any of the biologics and placebo. Although all biologics were generally safe, golimumab 100mg had statistically significantly higher DAEs when compared to adalimumab (OR 2.09, 95% CrI 1.07-4.17). In the context of ITC meta-analysis, both golimumab and infliximab appear to demonstrate superior efficacy-safety profiles compared with adalimumab.