P316 Ozanimod is an efficacious oral therapy after, 5-ASA failure in immunomodulator- and biologic-naive patients with ulcerative colitis: post hoc analysis from True North. (21st January 2022)

• Record Type: Journal Article
• Authors: Sands, B E; Dignass, A; Irving, P; Chiorean, M; Long, M; Eren, D; Ahmad, H A; Osterman, M T; Petersen, A; Elegbe, A; Ritter, T; Danese, S
• Is Part Of: Journal of Crohn's and colitis. Volume 16(2022)Supplement 1
• Page Start: i339
• Page End: i340
• Publication Date: 2022-01-21
• Subjects: Inflammatory bowel diseases -- Periodicals; 616.344005
• DOI: 10.1093/ecco-jcc/jjab232.443
• Languages: English
• ISSNs: 1873-9946

Abstract

Abstract: Background: Oral, 5-aminosalicylates (5-ASA) and corticosteroids (CS) are often the first-line treatment for ulcerative colitis (UC), and patients (pts) who fail these agents typically advance to chronic immunosuppressives. Ozanimod, an oral sphingosine, 1-phosphate receptor modulator, is approved for treating adults with moderately to severely active UC in the US. This post-hoc analysis from the pivotal phase, 3 True North randomised controlled trial evaluated the efficacy of ozanimod at week (wk), 10 (end of induction) in immunomodulator- and biologic-naive pts with moderate to severe UC who failed, 5-ASA with or without concomitant CS. Methods: True North consisted of a, 10-wk induction period. Pts in Cohort, 1, stratified by CS use at screening, were randomised to either ozanimod, 0.92 mg (equivalent to ozanimod HCl, 1 mg; n=429) or placebo (n=216) once daily in a double-blind manner; pts in Cohort, 2 (n=367) received open-label daily ozanimod, 0.92 mg. At enrollment, pts were required to be on stable doses of oral, 5-ASA and/or CS for >2 wk and continued on the same dose throughout induction. Pts who received tofacitinib within, 2 wk of screening were excluded. This analysis focused on clinical remission, clinical response, endoscopic improvement, and mucosal healing efficacy outcomes in immunomodulator- and biologic-naive, 5-ASA exposed pts. Results: Of, 464 pts treated with, 5-ASA and were immunomodulator- and biologic-naive, with or without CS, 205 were on ozanimod and, 105 were on placebo in Cohort, 1;, 158 received open-label ozanimod in Cohort, 2. Baseline characteristics were similar between groups in Cohort, 1. Compared with placebo at wk, 10, a higher proportion of ozanimod-treated patients achieved clinical remission (23.4% vs, 8.9%), clinical response (53.7% vs, 30.7%), endoscopic improvement (35.6% vs, 14.9%), and mucosal healing (18.0% vs, 5.0%; Figure, 1) in this subgroup. These results are consistent with previously published results of the overall study population, 1 which demonstrated significantly greater proportions of patients receiving ozanimod vs placebo achieving clinical remission (18.4% vs, 6.0%), clinical response (47.8% vs, 25.9%), endoscopic improvement (27.3% vs, 11.6%), and mucosal healing (12.6% vs, 3.7%). Additionally, all efficacy endpoints were achieved by a greater proportion of patients on ozanimod vs placebo regardless of CS use at baseline (Figure, 2). Results were similar for open-label ozanimod-treated patients in Cohort 2. Conclusion: Ozanimod demonstrated efficacy at wk, 10 in immunomodulator- and biologic-naive patients with UC who had failed, 5-ASA, regardless of CS use at baseline. Reference: 1. N Engl J Med, 2021;385:1280.