Achievement of clinical, endoscopic, and histologic outcomes in patients with ulcerative colitis treated with etrasimod, and association with fecal calprotectin and C-reactive protein: results from the Phase 2 OASIS trial.
Document Type
Article
Publication Date
1-20-2024
Publication Title
J Crohns Colitis
Keywords
S1P receptor modulator; endoscopic improvement-histologic remission; etrasimod; mucosal healing; ulcerative colitis. swedish; washington
Abstract
BACKGROUND AND AIMS: Etrasimod is an oral, selective sphingosine 1-phosphate receptor 1,4,5 [S1P1,4,5] modulator in development for ulcerative colitis [UC]. This post hoc analysis of the phase 2 OASIS trial [NCT02447302] evaluated its efficacy for endoscopic improvement-histologic remission [EIHR] and assessed correlation between fecal calprotectin [FCP] and C-reactive protein [CRP] levels with efficacy outcomes.
METHODS: 156 adults with moderately to severely active UC received once-daily etrasimod [1 mg [n=52]; 2 mg [n=50]] or placebo [n=54] for 12 weeks. Clinical, endoscopic, and histologic variables were evaluated at baseline and Week 12. EIHR was defined as achievement of endoscopic improvement [endoscopic subscore ≤1, without friability] and histologic remission [Geboes score
RESULTS: Achievement of EIHR was significantly higher in patients who received etrasimod 2 mg versus placebo [19.5% vs 4.1%; Mantel-Haenszel estimated difference, 15.4%; p=0.010]. In the etrasimod 2-mg group, median FCP and CRP levels at Week 12 were significantly lower in patients who achieved clinical remission, endoscopic improvement, histologic remission, and EIHR versus patients who did not [all p250 μg/g.
CONCLUSIONS: Etrasimod was effective for inducing EIHR in patients with UC. FCP and CRP may be useful, noninvasive biomarkers to monitor treatment response.
Clinical Institute
Digestive Health
Department
Gastroenterology
Department
Gastroenterology
Department
Pharmacy
Recommended Citation
Yarur, Andres J; Chiorean, Michael; Panés, Julián; Jairath, Vipul; Zhang, Jinkun; Rabbat, Christopher J; Sandborn, William J; Vermeire, Séverine; and Peyrin-Biroulet, Laurent, "Achievement of clinical, endoscopic, and histologic outcomes in patients with ulcerative colitis treated with etrasimod, and association with fecal calprotectin and C-reactive protein: results from the Phase 2 OASIS trial." (2024). Articles, Abstracts, and Reports. 8467.
https://digitalcommons.providence.org/publications/8467