Updated Study Data for Ozanimod in Relapsing Multiple Sclerosis

Ozanimod is an approved treatment for relapsing 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 the latest data, and several new analyses, of clinical trials of ozanimod in RMS, which were presented at the 9th Joint European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS)-ACTRIMS Meeting in 2023, and the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2024. ENLIGHTEN is a prospective, open-label study of ozanimod in patients with early RMS (≤5 years after diagnosis of multiple sclerosis [MS]) who have received ≤1 MS disease-modifying therapy (DMT). In an ad hoc interim analysis, conducted after 1 year, cognitive processing speed improved or remained stable in the majority of patients. This suggests that ozanimod may prevent cognitive decline during the first year of use. In addition, decline in whole brain volume (WBV), which is often accelerated in patients with MS, was minimal, indicating that brain volume was preserved during the first year of ozanimod treatment in patients with early RMS. Final data were presented for the completed open-label extension (OLE) study of ozanimod in adults with RMS (DAYBREAK). Long-term follow-up of participants indicated that the majority remained free of confirmed disability progression (CDP), and a post hoc analysis found no evidence of disease rebound in participants who discontinued ozanimod. Ozanimod was generally well tolerated with sustained efficacy over a treatment period of approximately 6 years, demonstrating a low relapse rate and control of disability progression.