The following article is a part of conference coverage from the Advances in Inflammatory Bowel Diseases 2021 Annual Meeting , held from December 9 to 11, 2021. The team at Gastroenterology Advisor will be reporting on the latest news and research conducted by leading experts in gastroenterology. Check back for more from AIBD 2021.
Patients with moderate to severe ulcerative colitis (UC) treated with ozanimod had a higher incidence of clinical remission, clinical response, and endoscopic improvement compared with patients who received placebo, according to research presented at the Advances in Inflammatory Bowel Diseases (AIBD) 2021 Annual Meeting, held from December 9 to 11, 2021, in Orlando, Florida and virtually.
The double-blind, phase 3 True North trial included 167 North American patients who were randomly assigned to receive ozanimod 0.92 mg or placebo. An additional 80 patients underwent an open-label 10-week induction period with ozanimod 0.92 mg. Upon completion of the first 10 weeks, patients with clinical response to ozanimod were randomly assigned 1:1 to continue ozanimod or switch to placebo through week 52 (ClinicalTrials.gov Identifier: NCT02435992).
The primary endpoint assessed clinical remission after 10 and 52 weeks of treatment, while secondary outcomes involved clinical response and endoscopic improvement.
Of those enrolled, 107 patients received double-blind ozanimod and 60 received placebo. At baseline 41.1% of patients in the ozanimod group had received prior UC treatment with biologics compared with 48.3% of patients in the placebo group.
A significantly higher proportion of patients in the ozanimod treatment arm achieved clinical remission compared with patients receiving placebo. This disparity was observed at week 10 (15.9% vs 3.3%) and also week 52 (39.3% and 12.2%). Similarly, rates of clinical response (46.7% vs 15.0%) and endoscopic improvement (26.2% vs 10.0%) were notably higher in the ozanimod treatment group at week 10 compared with placebo. Rates favoring the ozanimod group for clinical response and endoscopic improvement continued into week 52.
Researchers note that the results for the North American group are consistent with those observed in the more diverse international population.
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Hudesman D, Long M, Wolf D, et al. Ozanimod for moderate-to-severe ulcerative colitis: North American population results during induction and maintenance in the phase 3 True North study. Presented at: AIBD 2021 Annual Meeting; December 9-11, 2021; Orlando, FL and virtual. Abstract P035.