Impact of Prior Biologic Exposure on Ozanimod Efficacy and Safety in the Phase 3 True North Clinical Trial Am J Gastroenterol. 2025 Jan 8. doi: 10.14309/ajg.0000000000003310. Online ahead of print. Bruce E Sands 1, David T Rubin 2, Edward V Loftus Jr 3, Douglas C Wolf 4, Remo Panaccione 5, Jean-Frederic Colombel 1, Axel Dignass 6, Miguel Regueiro 7, Severine Vermeire 8, Anita Afzali 9, Garrett Lawlor 10, Harris A Ahmad 10, Hsiuanlin Wu 10, Mark T Osterman 10, Anjali Jain 10, Geert D'Haens 11 |
Author information 1Icahn School of Medicine at Mount Sinai, New York, NY, USA. 2University of Chicago Medicine Inflammatory Bowel Disease Center, Chicago, IL, USA. 3Mayo Clinic College of Medicine and Science, Rochester, MN, USA. 4Center for Crohn's Disease & Ulcerative Colitis, Atlanta Gastroenterology Associates, Atlanta, GA, USA. 5Inflammatory Bowel Disease Clinic, Calgary, AB, Canada. 6Agaplesion Markus Hospital, Goethe University, Frankfurt, Germany. 7Cleveland Clinic, Cleveland, OH, USA. 8University Hospitals Leuven, Leuven, Belgium. 9University of Cincinnati, Inflammatory Bowel Diseases Program, Cincinnati, OH, USA. 10Bristol Myers Squibb, Princeton, NJ, USA. 11Inflammatory Bowel Disease Center, Amsterdam University Medical Centers, Amsterdam, Netherlands. Abstract Introduction: Patients with ulcerative colitis (UC) and prior biologic failure may have reduced or delayed efficacy with subsequent advanced therapies. This analysis evaluated the efficacy and safety of ozanimod during the True North (TN) study and its open-label extension (OLE) in biologic-exposed patients with UC. Methods: TN was a randomized, placebo-controlled 52-week trial (10-week induction, 42-week maintenance period). Eligible patients could enter the OLE. Clinical outcomes were assessed at TN Week (W) 10 and W52 and OLE W46 and W94. Symptomatic efficacy was evaluated through induction and in the OLE until W94. Safety was assessed. Results: This analysis included 376 biologic-exposed patients. In the placebo-controlled cohort, more ozanimod-treated patients achieved clinical response than placebo at W10 regardless of the number or type of prior biologics; patients who used 1 versus ≥2 prior biologics achieved higher efficacy rates. Efficacy rates were higher at W52 than W10 and were similar across subgroups regardless of the number or type of prior biologics. Significantly greater proportions of ozanimod vs placebo patients achieved symptomatic response by W5 (P=0.0173) and symptomatic remission by W10 (P=0.0207). Among biologic-exposed TN W10 ozanimod nonresponders who entered the OLE, 61% achieved symptomatic response with an extra 10 weeks of ozanimod treatment. Ozanimod efficacy was durable for ∼3 years of continuous treatment in biologic-exposed W52 clinical responders who entered the OLE. No new safety signals were observed. Conclusions: Ozanimod was effective and safe in biologic-exposed patients with UC, but these patients may require more time to respond to treatment. |
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