A Network Meta-Analysis to Compare Efficacy of Filgotinib and Other Treatments in Biologic-Naïve Patients with Moderate to Severely ACTIVE Ulcerative Colitis

Author(s)

ABSTRACT WITHDRAWN

OBJECTIVES: To compare the efficacy of filgotinib to different first-line (biologic-naïve) agents for treatment of moderate to severely active ulcerative colitis in a systematic review and network meta-analysis.

METHODS: A systematic review was conducted in November 2020 for randomized trials and post-hoc analysis of adults with moderate to severe ulcerative colitis treated with anti-TNFs, vedolizumab, tofacitinib, ustekinumab and filgotinib. Included studies reported induction and maintenance efficacy. Analyses were conducted for Mayo clinical score (MCS) response, remission or endoscopic-mucosal healing in biologic-naïve patients. The induction phases were consistent in the design and baseline characteristics and a standard approach to NMA of induction results could be undertaken. Due to heterogeneity in the design of the included maintenance studies, maintenance data from trials with treat-through response designs were re-calculated to correspond to re-randomized arms. A Bayesian approach to estimation was adopted whereby posterior distributions for treatment effects were estimated using a generalised linear model framework to synthesise data. Both fixed and random effects models were used. Absolute model fit was considered through examination of the total residual deviance.

RESULTS: A total of 17 trials were eligible for NMA. In the induction phase, patients on all treatments had a statistically significantly greater probability of achieving MCS response, remission and mucosal healing than patients on placebo. At the end of maintenance phase, patients on filgotinib 200mg showed numerically higher probabilities of achieving endoscopic-mucosal healing than other active treatments, and numerically higher or similar probabilities of achieving MCS response/remission than other active treatments, however, the differences were not statistically significant.

CONCLUSIONS: Filgotinib has a similar efficacy to other treatments in biologic-naïve patients. Filgotinib provides an efficacious option for patients with ulcerative colitis.

Conference/Value in Health Info

2021-05, ISPOR 2021, Montreal, Canada

Value in Health, Volume 24, Issue 5, S1 (May 2021)

Code

PGI4

Topic

Clinical Outcomes

Topic Subcategory

Comparative Effectiveness or Efficacy

Disease

Gastrointestinal Disorders

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