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Long-term safety and efficacy of ozanimod in RMS


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Conference
MS Virtual 2020
Trial
Phase 3, DAYBREAK
In the ongoing DAYBREAK trial, ozanimod was associated with low annualised relapse rate (ARR) and low new/enlarging T2 and gadolinium-enhancing lesion counts in relapsing MS patients over time [1]. Most participants were relapse-free and did not experience disability progression. Ozanimod was generally well tolerated; no new safety concerns emerged with long-term use. DAYBREAK is an open-label extension (OLE) study of relapsing MS patients who participated and completed an ozanimod phase 1, 2, or 3 trial. In the OLE, patients received ozanimod 0.92 mg/day, equivalent to ozanimod HCl 1 mg. The analysis included 2,494 participants with a mean ozanimod exposure of 35.4 (range 0.03–50.2) months in the OLE. Ozanimod was associated with a low (adjusted) ARR in the OLE of 0.112 (95% CI 0.093–0.135). After 24 months, 79% ...


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