Journal
JOURNAL OF CROHNS & COLITIS
Volume 15, Issue 7, Pages 1120-1129Publisher
OXFORD UNIV PRESS
DOI: 10.1093/ecco-jcc/jjab012
Keywords
Ozanimod; ulcerative colitis; clinical trial
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Funding
- Bristol Myers Squibb
- NIDDK [P30 DK120515]
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The study examined the long-term safety and efficacy of Ozanimod in patients with moderately to severely active ulcerative colitis, showing continued benefits in clinical response, endoscopic improvement, and biomarker measures with 1 mg daily dosage. The high rate of study participation and long-term benefit indicates the potential of Ozanimod as a treatment option for UC patients.
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 2TOUCHSTONE 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 z 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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