Maintenance of Efficacy Outcomes at Week 52 among Etrasimod Induction Responders: An Analysis from the Phase 3 ELEVATE UC 52 Trial.

Abstract

Introduction: Most trials studying advanced therapies for ulcerative colitis (UC) adopted a responder re‑randomization design. By contrast, a treat-through design was utilized in the ELEVATE UC 52 trial to assess etrasimod, an oral, once-daily, selective sphingosine 1 phosphate (S1P) receptor modulator. It is therefore important to contextualize the efficacy of etrasimod given this different study design. We evaluated the efficacy of etrasimod versus placebo at week 52 among induction clinical responders.

Methods: In this post hoc analysis of ELEVATE UC 52, selected efficacy endpoints were evaluated at week 52 among all week 12 clinical responders (induction responders), defined as a ≥ 2‑point and ≥ 30% decrease from baseline in modified Mayo score, with a ≥ 1‑point decrease from baseline in rectal bleeding subscore (or an absolute value ≤ 1).

Results: In total, 182 patients receiving etrasimod and 52 patients receiving placebo were induction responders. Of these patients, a greater proportion who received etrasimod versus placebo met the criteria for clinical remission (48.9% vs 19.2%; p < 0.001) and all other endpoints assessed at week 52 (p < 0.05). Greater proportions of induction responders compared with the total trial population treated with etrasimod met criteria for clinical remission (48.9% vs 32.5%), endoscopic improvement (56.6% vs 39.1%), and all other endpoints.

Conclusion: Greater efficacy was observed among etrasimod induction responders for all assessed endpoints at week 52 when compared with the total ELEVATE UC 52 population, contextualizing the efficacy of etrasimod given the treat-through design of the study.

Clinicaltrials: gov identifier: NCT03945188.