Ozanimod in Relapsing Multiple Sclerosis: New Insights

Ozanimod is an approved treatment for relapsing forms of multiple sclerosis (RMS) that has been shown to reduce relapses, new brain lesions, and brain volume loss relative to intramuscular interferon (IFN) β-1a. This article summarizes selected data from clinical trials of ozanimod in RMS, which were presented at the 40th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) held in Denmark in September 2024 and the Annual Meeting of the European Charcot Foundation held in Italy in November 2024. Final safety data were presented for the completed open-label extension (OLE) study of ozanimod in adults with RMS (DAYBREAK), showing that rates of adverse events (AE) remained stable or decreased over 8 years of ozanimod treatment. These findings confirm the established safety profile of ozanimod. An analysis of brain volume changes across DAYBREAK and parent trials were also presented, demonstrating that the annualized rate of brain volume loss in participants treated with continuous ozanimod for up to 7 years was below the pathologic cutoff and was similar to those previously reported from healthy controls. Data were presented from a retrospective, observational study into the effects of switching from fingolimod to ozanimod in patients with RMS due to safety or intolerance reasons. The authors concluded that this study confirms that switching from fingolimod to ozanimod for safety reasons such as lymphopenia or hypertransaminasemia may be a good strategy to continue sphingosine-1-phosphate receptor (S1PR)-modulating drug therapy. Finally, an ad hoc interim analysis of patients with early RMS from ENLIGHTEN showed promising results, demonstrating that more than three-quarters of patients had either stable or improved cognitive processing speed after 1 year of ozanimod 0.92 mg.