P687 Clinical remission demonstrated with oral ozanimod in the overall population and across multiple subgroups of patients with moderately to severely active ulcerative colitis in the TOUCHSTONE trial

Abstract

Background: Ozanimod is an oral immunomodulator that selectively targets sphingosine 1-phosphate receptors 1 and 5. TOUCHSTONE, a randomized, double-blind, placebo-controlled phase 2 trial that evaluated patients with moderately to severely active ulcerative colitis (UC) showed significantly higher rates of clinical remission, clinical response, and endoscopic mucosal healing (Mayo endoscopic subscale score of 0/1) at weeks 8 and 32 in patients assigned to ozanimod HCl 1 mg compared with those assigned to placebo (Sandborn et al. N Engl J Med. 2016). Clinical remission at week 32 also was assessed across subgroups of interest. Method(s): Patients were randomized 1:1:1 and received ozanimod HCl 1 mg, ozanimod 0.5 mg, or placebo. Mayo score, based on stool frequency, rectal bleeding, mucosal appearance at endoscopy, and physician rating of disease activity was calculated at baseline, end of induction (week 8), and end of maintenance (week 32). Clinical remission was defined as total Mayo score 1. A post hoc subgroup analysis evaluated clinical remission rates at week 32 according to baseline Mayo score, years since UC diagnosis, and body mass index (BMI). Result(s): A total of 197 patients were randomized and treated with ozanimod HCl 1 mg (n=67), 0.5 mg (n=65), or placebo (n=65), with 103 (52.3%) entering a maintenance period based on response criteria and 91 (88.3%) completing the period. Differences in the proportion of patients in clinical remission with ozanimod HCl 1 mg versus placebo by subgroup illustrate that the treatment effect favored ozanimod HCl 1 mg in every subgroup analyzed (Figure 1). The 95% confidence intervals for the treatment difference between ozanimod 1 mg and placebo exclude 0 for the overall population and subgroups of baseline Mayo score >8, years since UC diagnosis >6, and BMI >21. Conclusion(s): In the TOUCHSTONE trial, ozanimod therapy was consistently more efficacious than placebo for induction of clinical remission across a wide range of patient subtypes, including those with relatively long disease duration and high disease activity. Reference: Sandborn WJ, Feagan BG, Wolf DC, D'Haens G, et al. Ozanimod induction and maintenance treatment for ulcerative colitis. N Engl J Med. 2016;374(18):1754?1762. [Figure Presented]Copyright © 2019 European Association for the Study of the Liver. All rights reserved.