Ozanimod's Consistent Efficacy in Long-Term Treatment for Multiple Sclerosis: Jeffrey Cohen, MD

WATCH TIME: 4 minutes

"In the long term extension, the effects on relapses in MRI lesion activity increased and reached the same level as those patients that had been on ozanimod, previously. Then, when we looked at those results as a function of age, there was very little difference in the groups based on their age.”

In phase 3 randomized trials (SUNBEAM, NCT02294058; RADIANCE, NCT02047734) ozanimod (Zeposia; BMS), an approved disease-modifying therapy, was associated with lower adjusted annualized relapse rate (ARR) and fewer gadolinium-enhancing (GdE) lesions and new/enlarging T2 lesions compared with interferon (IFN) beta-1a in patients with relapsing multiple sclerosis (RMS). Participants who completed phase 1‒3 trials investigating ozanimod were eligible to enroll in an open-label extension (OLE) trial (DAYBREAK, NCT02576717). In the phase 3 trials, adults with RMS received oral ozanimod 0.46 or 0.92 mg/d or intramuscular IFN beta-1a 30 µg/wk for at least 12 or 24 months, and in the OLE participants received ozanimod 0.92 mg/d.

In a recent ad hoc analysis of the phase 3 trials and OLE, findings showed that clinical and radiologic measures of disease activity remained stable or improved in ozanimod-treated patients with RMS over 7‒8 years of continuous treatment regardless of age category.¹ Among 2257 patients from SUNBEAM/RADIANCE enrolled in the OLE, 760 continued on ozanimod 0.92 mg. In the parent trials and OLE, the adjusted ARR was less than 0.2 on ozanimod, and adjusted mean number of GdE lesions remained lower than at parent trial baseline after 7 to 8 years on ozanimod treatment, both regardless of age category.

These findings were presented at the 2024 Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum, February 29 to March 2, in West Palm Beach, Florida, by senior author Jeffrey Cohen, MD, director, Mellen Center for MS Treatment and Research, Cleveland Clinic. Cohen sat down with NeurologyLive® in an interview to discuss how ozanimod’s efficacy in reducing relapses and MRI lesion activity holds up in long-term treatment for patients with MS. He also talked about the role that age may play in the evolving MS disease process and the impact of medications like ozanimod. Despite the positive findings from the analysis, Cohen shared a notable limitation that the study acknowledges, and how it can affect result interpretation.

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REFERENCES
1. Cree BA, Selmaj KW, Steinman L, et al. Long-term Efficacy of the Sphingosine 1-Phosphate Receptor Modulator Ozanimod by Age Category in Patients With Relapsing Multiple Sclerosis: Final Results From Two Phase 3 Trials and an Open-label Extension Trial. Presented at ACTRIMS Forum 2024; February 29 to March 2; West Palm Beach, Florida. P091.