Open Label Extension Trial of Ozanimod Confirms Disease Stability at 6-7 Years

Data from 2 phase 3 trials and one open label extension study (OLE) used to evaluate long-term efficacy by patient age group were presented at the Americas Committee for Treatment & Research in Multiple Sclerosis (ACTRIMS) Forum 2023. The randomized parent trials SUNBEAM (NCT02294058) and RADIANCE (NCT02047734) enrolled adults (18-55 y) with relapsing multiple sclerosis (MS) who received either 0.46 or 0.92 mg/d oral ozanimod (Zeposia; Bristol Myers Squibb, New York, NY) or intramuscular interferon β-1a (IFN) 30 µg/wk for >12 or 24 months. Patients who completed the phase 3 trials were eligible to enroll in the OLE DAYBREAK trial (NCT02576717) and were administered oral ozanimod 0.92 mg/d.

Patients who received oral ozanimod 0.92 mg/d in a parent trial and in the OLE (n=760) were included in the post hoc analysis which assessed clinical and radiologic outcomes by age group (18 < 25, n=118;  > 25 to < 35, n=268;  > 35 to < 49, n=312; and > 50 y, n=62) at parent trial baseline compared with DAYBREAK OLE data cutoff date February 1, 2022. Adjusted annualized relapse rate (ARR) was below 0.2 in the parent trials and remained low in the OLE in patients treated with continuous ozanimod regardless of age group. Similarly, regardless of age group, the adjusted mean number of gadolinium-enhancing (GdE) lesions per scan remained either stable or decreased over the 6-7 years of continuous ozanimod treatment. The adjusted mean number of new or enlarging T2 lesions per scan relative to OLE baseline remained stable or decreased in patients treated with continuous ozanimod, regardless of age group.