The researchers evaluated the size and duration of interferon-induced changes in cortical grey matter volume (CGMV) for a study. In addition, they examined the long-term effects of switching to ozanimod in relapsing multiple sclerosis (RMS) patients. In the phase 3 SUNBEAM (NCT02294058) and RADIANCE (NCT02047734) studies of ozanimod, as well as an ongoing extension trial, CGMV was measured (DAYBREAK, NCT02576717). In people with RMS, 2 randomized, double-blind trials compared oral ozanimod 0.92 and 0.46 mg/day to intramuscular interferon 30 μg/week. In DAYBREAK, completers were eligible for open-label ozanimod 0.92 mg/day. MRIs were done at 6 months (SUNBEAM), 12 months (RADIANCE/SUNBEAM), and 24 months (RADIANCE), and then every 12 months after that (DAYBREAK). In addition, CGMV was studied during month 36 of DAYBREAK. During the double-blind studies, the rate of CGMV loss was significantly (nominal P<0.001) higher with interferon than with ozanimod 0.92 mg: least square mean percentage change from baseline was -0.67% vs -0.02% at month 6 and -1.04% vs -0.16% at month 12 in SUNBEAM, and -0.80% vs -0.13% at month 12 and -1.26% vs -0.53% at month 24 in RADIANCE. In the first year of the extension study, switching from interferon to ozanimod reversed CGMV loss, with CGMV increasing by 0.07% and 0.11% from DAYBREAK baseline, respectively, among patients who entered from RADIANCE and SUNBEAM. Following that, the yearly rates of CGMV loss in DAYBREAK were comparable across those who switched from interferon to those who continued to be treated with ozanimod. Patients continuously treated with ozanimod lost less CGMV relative to RADIANCE/SUNBEAM baseline at months 24 and 36 of DAYBREAK than patients initially treated with interferon. The switch from interferon to ozanimod helped reverse CGMV loss. Over 45 years, earlier treatment with ozanimod resulted in decreased CGMV loss, demonstrating the benefit of early treatment.
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