Abstract

Long-Term Efficacy and Safety of Ozanimod in Moderately to Severely Active Ulcerative Colitis: Results From the Open-Label Extension of the Randomized, Phase 2 TOUCHSTONE Study

J Crohns Colitis. 2021 Jul 5;15(7):1120-1129. doi: 10.1093/ecco-jcc/jjab012.

William J Sandborn 1, Brian G Feagan 2, Stephen Hanauer 3, Severine Vermeire 4, Subrata Ghosh 5, Wenzhong J Liu 6, AnnKatrin Petersen 6, Lorna Charles 6, Vivian Huang 6, Keith Usiskin 6, Douglas C Wolf 7, Geert D'Haens 8

 
     

Author information

1Division of Gastroenterology, University of California San Diego, La Jolla, CA, USA.

2Western University, London, Ontario, Canada.

3Feinberg School of Medicine, Chicago, IL, USA.

4University of Leuven, Leuven, Belgium.

5University of Calgary, Alberta, Canada.

6Bristol Myers Squibb, Princeton, NJ, USA.

7Center for Crohn's Disease & Ulcerative Colitis, Atlanta Gastroenterology Associates, Atlanta, GA, USA.

8Inflammatory Bowel Disease Center, Amsterdam University Medical Center, Amsterdam, the Netherlands.

Abstract

Background and aims: This analysis examined the long-term safety and efficacy of ozanimod in patients with moderately to severely active ulcerative colitis [UC] with ≥ 4 years of follow-up in the phase 2 TOUCHSTONE open-label extension [OLE].

Methods: Patients receiving placebo or ozanimod HCl 0.5 mg or 1 mg during the double-blind period could enter the OLE [ozanimod HCl 1 mg daily]. Partial Mayo score [pMS] clinical response and remission were assessed through OLE week 200 and summarized descriptively using observed cases [OC] and non-responder imputation [NRI]. Endoscopy was required at OLE week 56 and the end of treatment. Parameters associated with endoscopy were summarized at weeks 56 and 104 [OC], and week 56 [NRI]. C-reactive protein and faecal calprotectin were assessed. Adverse events were monitored throughout the study.

Results: Of 197 patients receiving double-blind treatment, 170 entered the OLE. Discontinuation rates were 28% at year 1 and 15-18% annually through year 4. Partial Mayo measures indicated clinical response and remission rates at OLE week 200 of 93.3% and 82.7%, respectively, using OC and 41% and 37% with the more conservative NRI analysis. At weeks 56 and 104, respectively, histological remission rates were 46.3% and 38.5%, and endoscopic improvement rates were 46.4% and 46.5% [OC]. No new safety signals were identified during ≥ 4 years of follow-up.

Conclusions: There was a high rate of continued study participation and long-term benefit with ozanimod HCl 1 mg daily based on clinical, histological and biomarker measures in patients with moderately to severely active UC in the TOUCHSTONE OLE. 

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