Long-term efficacy of ozanimod in relapsing multiple sclerosis in DAYBREAK: An open-label extension of the phase 3 SUNBEAM and RADIANCE trials

Background and aims: Ozanimod, a sphingosine 1-phosphate receptor 1/5 modulator, significantly reduced annualised relapse rate (ARR) in phase 3 relapsing multiple sclerosis (RMS) trials. We evaluated long-term efficacy of ozanimod in RMS in an open-label extension (OLE) trial. Methods: RMS participants who completed a phase 3 double-blind ozanimod trial (SUNBEAM [≥12 months], RADIANCE [24 months]) were eligible to enrol in an OLE (DAYBREAK) of ozanimod HCl 1mg/day. In this OLE interim analysis (data cutoff 31/1/2019), ARR, time to 1st relapse, number of new/enlarging T2 and gadoliniumenhancing (GdE) MRI brain lesions, and 3- and 6-month confirmed disability progression (CDP) were analysed descriptively by randomisation to intramuscular interferon β-1a 30μg/wk or oral ozanimod HCl 0.5 or 1mg/d in the double-blind trials. Results: Of 2,666 participants enrolled, 2,394 completed the phase 3 parent trials and 2.257 entered DAYBREAK (interferon: n=741; ozanimod 0.5mg:n=756; ozanimod 1mg:n=760). In DAYBREAK, ARR and numbers of new/ enlarging T2 and GdE lesions remained low in the continuous ozanimod 1mg group and were reduced versus parent trials in those who switched to ozanimod 1mg in DAYBREAK from ozanimod 0.5mg or interferon in the parent trials (Figures 1-3). Median time to 1st relapse in the continuous ozanimod 1mg group was 1,750 days. CDP rates were low and comparable between parent-treatment groups. Conclusion: Participants on continuous ozanimod 1mg had sustained low ARR and lesion counts. ARR and lesion counts decreased among those who switched from ozanimod 0.5mg and interferon to ozanimod 1mg in DAYBREAK. (Figure Presented).