Ozanimod Effective in Biologic-Exposed UC Patients
A post hoc analysis of the Phase 3 TRUE NORTH trial and its open-label extension (OLE) published in The American Journal of Gastroenterology demonstrated that ozanimod is effective and safe for biologic-exposed patients with ulcerative colitis (UC), though these patients may require additional time to respond. The findings provide critical insights for managing patients with UC who have experienced prior biologic failure.
The analysis included 376 biologic-exposed patients. During the randomized, placebo-controlled trial, significantly more patients treated with ozanimod achieved a clinical response by Week 10 compared to placebo, regardless of the number or type of prior biologics used. Notably, patients exposed to 1 prior biologic demonstrated higher efficacy rates than those exposed to 2 or more.
Efficacy rates improved further by Week 52 and were consistent across subgroups regardless of prior biologic exposure. "Significantly greater proportions of ozanimod vs placebo patients achieved symptomatic response by Week 5 (P=0.0173) and symptomatic remission by Week 10 (P=0.0207)," the study noted.
Among patients who did not respond to ozanimod by Week 10 but continued treatment in the OLE, 61% achieved a symptomatic response after an additional 10 weeks. Durable efficacy was observed over 3 years of continuous treatment for Week 52 responders who entered the OLE. Safety data revealed no new safety signals over the extended treatment period.
The study’s authors emphasized that while ozanimod is effective for patients with biologic-exposed UC, delayed response times should be considered during treatment planning. “Ozanimod efficacy was durable for approximately three years of continuous treatment,” the study stated, highlighting its long-term benefits.
Reference
Sands BE, Rubin DT, Loftus EV Jr, et al. Impact of prior biologic exposure on ozanimod efficacy and safety in the phase 3 true north clinical trial. Am J Gastroenterol. Published online January 8, 2025. doi:10.14309/ajg.0000000000003310
