Long-term safety and efficacy of ozanimod in RMS

In the ongoing DAYBREAK trial, ozanimod was associated with low annualised relapse rate (ARR) and low new/enlarging T2 and gadolinium-enhancing lesion counts in relapsing MS patients over time [1]. Most participants were relapse-free and did not experience disability progression. Ozanimod was generally well tolerated; no new safety concerns emerged with long-term use.

DAYBREAK is an open-label extension (OLE) study of relapsing MS patients who participated and completed an ozanimod phase 1, 2, or 3 trial. In the OLE, patients received ozanimod 0.92 mg/day, equivalent to ozanimod HCl 1 mg. The analysis included 2,494 participants with a mean ozanimod exposure of 35.4 (range 0.03–50.2) months in the OLE.

Ozanimod was associated with a low (adjusted) ARR in the OLE of 0.112 (95% CI 0.093–0.135). After 24 months, 79% of participants were relapse-free; after 36 months this was 75%. Six-month confirmed disability progression was observed in 8.6%. Mean number of new/enlarging T2 lesions per scan was low and remained similar throughout (range 1.57–1.90 at month 36), as was mean number of gadolinium-enhancing lesions (range 0.2 ‒0.4).

No new safety concerns emerged. In the OLE, 2,039 participants (81.8%) had any treatment-emergent adverse event (AE), 236 (9.5%) had a serious treatment-emergent AE, and 56 (2.2%) discontinued treatment due to a treatment-emergent AE. The most common treatment-emergent AEs were nasopharyngitis (17.9%), headache (14%), upper respiratory tract infection (9.9%), and lymphopenia (9.6%). There were no serious opportunistic infections. During the parent trials and DAYBREAK combined, 1.2% of participants exposed to either dose of ozanimod developed malignancies, which is consistent with malignancy rates among patients treated with other disease-modifying treatments.

1. Selmaj K, et al. Long-term safety and efficacy of ozanimod in relapsing multiple sclerosis in DAYBREAK: an open-label extension study of ozanimod phase 1−3 trials. MSVirtual 2020, Abstract P0217.