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.
Ozanimod appears to be an effective treatment for moderate to severe ulcerative colitis (UC), 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. Independent of prior biologics exposure, ozanimod was associated with clinical response and remission over 1 year of therapy.
The phase 3 True North study consisted of 2 cohorts. In cohort 1, patients with UC were randomly assigned 1:1 to once-daily ozanimod 0.92 mg or placebo. In cohort 2, patients received open-label once-daily ozanimod 0.92 mg. Patients in either cohort who responded to ozanimod after a 10-week induction phase were re-randomized to double-blind maintenance with ozanimod 0.92 mg or placebo through week 52.
Outcomes of interest were clinical remission, clinical response, endoscopic improvement, and mucosal healing. Results were stratified by prior biologic exposure and prior biologic type. Patients with previous exposure to a Janus kinase (JAK) inhibitor only were excluded from analyses.
A total of 992 patients were enrolled, among whom 616 were biologic-naïve, 162 had prior exposure to 1 biologic, and 214 had prior exposure to 2 or more biologics. At baseline, patients with prior biologic exposure had more prior corticosteroid use, longer disease duration, and more extensive disease compared against patients without prior biologic exposure. Among patients who were biologic-naïve, the clinical remission rates at week 10 were 23% with ozanimod vs 6.6% with placebo. These respective rates were 17.2% vs 8.3% with 1 prior biologic and 3.7% vs 2.5% with 2 or more biologics.
Clinical response at week 10 was achieved in 53% vs 28% in ozanimod vs placebo in the biologic-naïve group, 50% vs 33% in the 1 prior biologic group, and 27% vs 15% in the 2 or more prior biologics groups.
At week 52, the proportion of patients on ozanimod with clinical response was 61%, 60%, and 55% in the biologic-naïve, 1 prior biologic, and 2+ prior biologics groups, respectively. The rates of clinical remission, endoscopic improvement, and mucosal healing with ozanimod were also similar among groups at week 52.
Among patients with inadequate response to prior anti-tumor necrosis factor (TNF) agents, vedolizumab, or both, ozanimod outperformed placebo by every metric during induction and maintenance.
In this study, ozanimod improved clinical, endoscopic, and histologic outcomes in patients with moderate to severe UC. While response after induction was generally higher without prior biologic exposure, remission rates were comparable among patient groups by week 52. Per these findings, patients with prior biologic exposure may require more time to respond to ozanimod treatment. Ozanimod also appeared effective regardless of prior use of anti-TNF agents and vedolizumab.
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Sands B, Pondel M, Silver M, et al. Impact of prior biologic exposure on response to ozanimod for moderate-to-severe ulcerative colitis in the phase 3 True North study. Presented at: AIBD 2021 Annual Meeting; December 9-11, 2021; Orlando, FL and virtual. Abstract P031.