Impact of Prior Biologic or Janus Kinase Inhibitor Therapy on Efficacy and Safety of Etrasimod in the ELEVATE UC 52 and ELEVATE UC 12 Trials.
Publication Title
J Crohns Colitis
Document Type
Article
Publication Date
6-15-2024
Keywords
washington; swedish
Abstract
Background and aims: Etrasimod is an oral, once daily, selective sphingosine 1-phosphate [S1P]1,4,5 receptor modulator for the treatment of moderately to severely active ulcerative colitis [UC]. This subgroup analysis evaluated the efficacy and safety of etrasimod 2 mg once daily vs placebo by prior biologic/Janus kinase inhibitor [bio/JAKi] exposure in ELEVATE UC 52 and ELEVATE UC 12.
Methods: Pre-defined efficacy endpoints were assessed at Weeks 12 and 52 in ELEVATE UC 52 and Week 12 in ELEVATE UC 12 in bio/JAKi-naïve and -experienced patients, and at Week 12 [pooled] based on prior advanced therapy exposure mechanism.
Results: In the ELEVATE UC 52 and ELEVATE UC 12 analysis populations, 80/274 [29.2%] and 74/222 [33.3%] patients receiving etrasimod and 42/135 [31.1%] and 38/112 [33.9%] patients receiving placebo, respectively, were bio/JAKi-experienced. In both bio/JAKi-naïve and -experienced patients, a significantly greater proportion receiving etrasimod vs placebo achieved clinical remission (p<0.05) in ELEVATE UC 52 at Weeks 12 [naïve: 30.9% vs 9.7%; experienced: 17.5% vs 2.4%] and 52 [naïve: 36.6% vs 7.5%; experienced: 21.3% vs 4.8%]; in ELEVATE UC 12, this was observed only for bio/JAKi-naïve patients [naïve: 27.7% vs 16.2%, p=0.033; experienced: 18.9% vs 13.2%, p=0.349]. Similar patterns were observed for most efficacy endpoints. Among patients with prior anti-integrin exposure [N=90], a significantly greater proportion achieved clinical response [54.1% vs 27.6%, p=0.030], but not clinical remission [9.8% vs 3.4%, p=0.248], with etrasimod vs placebo.
Conclusions: Bio/JAKi-naïve and -experienced patients had clinically meaningful induction and maintenance treatment benefits with etrasimod vs placebo.
Keywords: Ulcerative colitis; advanced therapies; etrasimod.
Clinical Institute
Digestive Health
Specialty
Gastroenterology
DOI
10.1093/ecco-jcc/jjae079
Recommended Citation
Vermeire, Séverine; Sands, Bruce E; Peyrin-Biroulet, Laurent; D'Haens, Geert R; Panés, Julian; Yarur, Andres J; Wolf, Douglas C; Ritter, Timothy; Schreiber, Stefan; Woolcott, John C; Modesto, Irene; Keating, Michael; Shan, Kevin; Wu, Joseph; Chiorean, Michael; Baert, Filip; Dubinsky, Marla C; Goetsch, Martina; Danese, Silvio; and Feagan, Brian G, "Impact of Prior Biologic or Janus Kinase Inhibitor Therapy on Efficacy and Safety of Etrasimod in the ELEVATE UC 52 and ELEVATE UC 12 Trials." (2024). Articles, Abstracts, and Reports. 8944.
https://digitalcommons.providence.org/publications/8944
10.1093/ecco-jcc/jjae079
