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Long-term safety and efficacy of ozanimod in RMS

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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