Bristol Myers’ ozanimod shows efficacy and safety in multiple sclerosis trial

Bristol Myers announced new results from the Phase 3 DAYBREAK open-label extension trial, demonstrating the long-term efficacy and safety profile of Zeposia – ozanimod – in patients with relapsing forms of multiple sclerosis. These data and nine additional abstracts will be presented at the 9th annual Americas Committee for Treatment and Research in Multiple Sclerosis Forum 2024 in West Palm Beach February 29 to March 2. In the DAYBREAK long-term extension study, treatment with Zeposia demonstrated a low annualized relapse rate of 0.098. Three- and six-month confirmed disability progression was absent in 82.8% and 84.8% of participants in the trial respectively. In the DAYBREAK trial, 2,494 participants were exposed to Zeposia for an average of 60.9 months; 2,219 participants had any treatment-emergent adverse event, 381 had a serious TEAE and 98 discontinued the study due to a TEAE. No new safety signals emerged; data from this long-term observational study of patients treated for up to 81.5 months were consistent with the established safety profile of Zeposia. Additionally, a separate analysis was conducted to assess the risk of rebound after Zeposia discontinuation in the DAYBREAK trial. No post-treatment relapse was associated with rebound effect, characterized by severe exacerbation of disease or severe persistent increase in disability.