Risk-Benefit Profile of Ozanimod for Multiple Sclerosis Did Not Change With COVID-19

In the open-label extension DAYBREAK study (NCT02576717) among participants in 4 clinical trials of ozanimod (Zeposia; Bristol Myers Squibb, New York, NY) for multiple sclerosis (MS), the effect of COVID-19 was evaluated. The 2,494 participants in DAYBREAK comprised 94.5% of participants in the randomized controlled clinical trials of ozanimod. 

As of May 2021, 8.7% of participants reported confirmed (n=160) or suspected (n=30) COVID-19, the majority of which (176, 92.7%) were not serious. Treatment with ozanimod was continued by 119 (62.6%) of the individuals who developed COVID-19, and all who discontinued ozanimod and survived COVID-10 later resumed treatment. There were 3 (1.58%) deaths related to COVID-19 symptoms or complications.

Participants were all treated with ozanimod 0.92 mg/day (equivalent to 1 mg ozanimod HCl) for a mean 46.8 (range, 0.03-62.7) months and had a mean adjusted annualized relapse rate (ARR) of 0.103 (95% CI, 0.086‒0.123). Adjusted mean gadolinium-enhancing and T2 lesions were 0.06 to 0.12 and 0.85 to 1.03, respectively, which was similar to that seen at baseline for the open-label extension study.

Although 298 (11.9%) individuals had a serious treatment-emergent adverse event, only 75 (3.0%) discontinued treatment with ozanimod. The incidence of all adverse events was 85.9%, similar to what was seen in the randomized portions of the clinical trials. 

These results were presented at The Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum, February 24-26, 2022.