We describe one of the largest case series of PG among patients with IBD. The variety of treatment strategies used highlights the lack of clear guidelines in managing this complex group of patients.
Background
Given rapid innovation in advanced therapies for moderately to severely active ulcerative colitis, we investigated their comparative efficacy and safety during induction and maintenance through network meta-analysis.
Methods
Using Bayesian methods, endpoints of clinical remission and clinical response per Full Mayo score, and endoscopic improvement were assessed in bio-naïve and bio-exposed populations. Safety was assessed in overall populations by all adverse events, serious adverse events, discontinuation due to adverse events, and serious infections. Phase 3 randomised controlled trials were identified via systematic literature review, including the following advanced therapies: infliximab, adalimumab, vedolizumab, golimumab, tofacitinib, ustekinumab, filgotinib, ozanimod, and upadacitinib. Random effects models were used to address between-study heterogeneity. Intent-to-treat efficacy rates were calculated by adjusting maintenance outcomes by likelihood of induction response.
Results
Out of 48 trials identified, 23 were included. Across all outcomes and regardless of prior biologic exposure, intent-to-treat efficacy rates were highest for upadacitinib, owing to its highest ranking for all efficacy outcomes in induction and for all but clinical remission during maintenance among bio-naïve induction responders. For all advanced therapies versus placebo, there were no significant differences in serious adverse events or serious infections across therapies. For all adverse events, golimumab had higher odds vs placebo during maintenance; for discontinuation due to adverse events, upadacitinib had lower odds vs placebo during induction, while ustekinumab and vedolizumab had lower odds vs placebo during maintenance.
Conclusions
Upadacitinib may be the most efficacious therapy for moderately to severely active ulcerative colitis based on intent-to-treat analyses, with similar safety across advanced therapies.
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