The following article is part of conference coverage from the 8th Joint American Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) and European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) MSVirtual2020 event. Neurology Advisor‘s staff will be reporting breaking news associated with research conducted by leading experts in neurology. .
Ozanimod may be a safe and well-tolerated treatment for relapsing forms of multiple sclerosis (RMS), according to study results presented at the 8th Joint American Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) and European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) MSVirtual2020 event, held September 11-13, 2020.
Ozanimod is an oral sphingosine 1-phosphate receptor 1 and 5 modulator approved to treat RMS. The objective of this study was to evaluate the long-term safety and efficacy of ozanimod in patients with this disease.
In this open-label extension trial called DAYBREAK, patients with RMS who completed a phase 1, 2, or 3 ozanimod clinical trial received 0.92 mg/d ozanimod and were monitored for treatment-emergent adverse events (TEAE).
Study researchers revealed that of the 2639 participants who completed the parent trials, 2494 of them participated in DAYBREAK and were exposed to ozanimod for an average of 35.4 months (range, 0.03-50.2). The adjusted annualized relapse rate was 0.112 (95% CI, 0.093-0.135). At 24 and 36 months, respectively, 79% and 75% of patients were relapse-free. The average number of new or enlarging T2 lesions (range 1.57-1.90) and gadolinium-enhancing brain lesions (range 0.2-0.4) per scan at 24 months was similar to that observed during parent trials.
Approximately 81.8% (n=2039) of participants had any TEAE, 9.5% (n=236) had a serious TEAE, and 2.2% (n=56) discontinued due to a TEAE. Nasopharyngitis, headache, upper respiratory tract infection, and lymphopenia were the most common adverse events, which were largely the same as those observed during the parent trials.
The study researchers concluded that over time, ozanimod was associated with low rates of annualized relapse, low new or enlarging T2 lesions, and low gadolinium-enhancing brain lesions. They added that the therapy “was generally safe and well tolerated” when used long-term to treat RMS.
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Selmaj K, Steinman L, Comi G, et al. Long-term safety and efficacy of ozanimod in relapsing multiple sclerosis in DAYBREAK: an open-label extension study of ozanimod phase 1-3 trials. Presented at: 8th Joint American Committee for Treatment and Research in Multiple Sclerosis and European Committee for Treatment and Research in Multiple Sclerosis MSVirtual2020 event; September 11-13, 2020, 2020. Abstract P0217.