To determine safety and effectiveness of ozanimod in a real-world cohort of people with multiple sclerosis (PwMS) with up to two years of follow-up.

Data were collected for PwMS receiving ozanimod at our MS centers, including baseline data from the year prior. PwMS or clinically isolated syndrome, ≥1 dose of ozanimod, and age ≥18 years at ozanimod initiation were included. Demographic, disease history, relapse, side effect, imaging, infection, and performance test data were collected.

The cohort included 205 PwMS with an average age of 47.2 years and average disease duration of 12.5 years. There were 51 (25%), 60 (29%), and 17 (8.3%) individuals with hypertension, hyperlipidemia, and type 2 diabetes, respectively. Two-year data were available for 92 PwMS in the cohort. The annualized relapse rate for the entire cohort was 0.03, an incident rate ratio of 0.3 compared to baseline (p<0.001). There were 48 MRIs obtained at 24 months and 3 (6.3%) showed a new or enlarging T2 lesion (odds ratio compared to baseline=0.10, p<0.001) while none showed a gadolinium-enhancing lesion. There were no significant differences in performance tests relative to baseline. Tolerability concerns were reported by 16% of the cohort at 2 years, with headache being most common. Upper respiratory infections were most common, cumulatively affecting 40% of the cohort over 2 years. Ozanimod was discontinued in 59 (28.8%) individuals by 2 years after a mean duration of 247.9 days.

This real-world ozanimod-treated cohort included individuals who were older, had longer disease duration, and had more comorbidities than in the clinical trials. Ozanimod was effective with no new safety or tolerability signals.