Long-term safety and efficacy of ozanimod in relapsing multiple sclerosis: Final analysis of the DAYBREAK open-label extension trial.

ABSTRACT:

Background

Ozanimod, a selective, oral sphingosine 1-phosphate receptor 1 and 5 modulator, is approved in multiple countries for adults with relapsing forms of multiple sclerosis (RMS).

Objective

To characterize the long-term safety and efficacy of ozanimod.

Methods

Participants were eligible for an open-label extension study of ozanimod 0.92 mg/d (DAYBREAK) if they completed a phase 1-3 RMS ozanimod 'parent' trial. DAYBREAK began 16 October 2015, and ended 5 January 2023.

Results

DAYBREAK included 2494 participants with a mean of 60.9 (range 0.03‒81.5) months of ozanimod exposure. During DAYBREAK, 2219 participants (89.0%) had treatment-emergent adverse events (TEAEs), 381 (15.3%) had a serious TEAE and 98 (3.9%) discontinued treatment due to TEAEs. Serious in

SUBMITTER: Selmaj KW 

PROVIDER: S-EPMC12589670 | biostudies-literature | 2025 Nov

REPOSITORIES: biostudies-literature