BMS presented long-term data of Zeposia in patients with Relapsing Forms of Multiple Sclerosis
Bristol Myers Squibb Unveils Latest Findings from Extended DAYBREAK Study Highlighting Zeposia's (ozanimod) Effectiveness and Safety in Patients with Relapsing Forms of Multiple Sclerosis.
New data from the Phase 3 DAYBREAK open-label extension trial further solidifies the long-term efficacy and safety profile of Zeposia (ozanimod) for individuals with relapsing forms of multiple sclerosis (MS), as announced by Bristol Myers Squibb.
Throughout the DAYBREAK long-term extension study, Zeposia exhibited sustained efficacy, with an annualized relapse rate as low as 0.098. Notably, 67% of patients remained free from relapses at the six-year mark. Furthermore, disability progression remained absent in a significant proportion of participants, with 82.8% and 84.8% showing no signs of confirmed disability progression at three and six months, respectively. At the 60-month mark, there was consistency in the number of new/enlarging T2 lesions per scan and gadolinium-enhancing lesions across patient cohorts.
During the DAYBREAK trial, which involved 2,494 participants exposed to Zeposia for an average of 60.9 months, the safety profile remained consistent with previous findings and the established safety profile of Zeposia, reflecting nearly a decade of clinical experience. While treatment-emergent adverse events (TEAEs) were observed in 89.0% of participants, serious TEAEs were reported in 15.3%, leading to study discontinuation in 3.9% of cases. Common TEAEs included nasopharyngitis, headache, COVID-19 infection, and upper respiratory tract infection, with no emergence of new safety signals.
A separate analysis explored the risk of rebound after discontinuing Zeposia in the DAYBREAK trial. Of the 544 participants who prematurely discontinued the study, approximately 2.2% experienced relapse after permanently stopping Zeposia, with most relapses occurring between 29 and 90 days post-discontinuation. Importantly, there was no evidence of a rebound effect associated with post-treatment relapse, with most relapses being mild to moderate and patients typically achieving complete recovery.