Long-term safety and efficacy of ozanimod in relapsing MS

In the open-label extension DAYBREAK study, ozanimod was associated with low annualised relapse rate (ARR) and low new and enlarging T2 and gadolinium-enhancing (Gd+) multiple sclerosis (MS) lesion counts over time. Most participants were relapse-free and did not experience disability progression. Ozanimod was generally well tolerated and no new safety concerns emerged with long-term use. 

Ozanimod, an oral selective sphingosine 1-phosphate (S1P) receptor modulator, has recently been approved for treatment of adults with relapsing forms of MS (FDA) or relapsing-remitting MS (EMA). In controlled phase 3 trials of relapsing MS, ozanimod significantly reduced annualised relapse rate (ARR), new and enlarging T2 and Gd+ lesion count, and brain volume loss compared with interferon-β-1a and was well tolerated. Participants with relapsing MS who completed a phase 1–3 ozanimod trial were eligible for the ongoing open-label extension DAYBREAK study. The objective is to characterise the long-term safety and efficacy of ozanimod in participants with relapsing MS.

The current interim analysis included almost 2,500 participants with mean ozanimod exposure of 35.4 months during the open-label extension [1]. At DAYBREAK entry, mean age was 37.7 years and 66.9% were female. Adjusted ARR was 0.112 for the total DAYBREAK population. At month 24 and month 36, 79% and 75% of patients were relapse-free, respectively. By data cut-off, 3-month confirmed disability progression was observed in 10.8% of open-label extension participants , 6-month confirmed disability progression in 8.6%. Mean number of new and enlarging T2 and Gd+ lesion was low.

In the open-label extension study, 81.8% of participants had treatment-emergent adverse events, most common being nasopharyngitis, headache, and upper respiratory tract infection. Observed rates were similar to those reported in parent trials, and did not differ across parent trial treatment groups. No new safety concerns emerged with long-term use.

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. ECF 28^th Annual Meeting. Abstract 18.

Posted on 16 December 202016 February 2024