Multiple Sclerosis Relapse Activity After Ozanimod Discontinuation in DAYBREAK Trial Participants.
Ralf Gold, Krzysztof W Selmaj, Regina Berkovich et al.
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In 30 seconds
This exploratory analysis of DAYBREAK, a single-arm, open-label extension trial, examined relapse activity after ozanimod discontinuation in participants with relapsing multiple sclerosis. Among 1,679 participants with follow-up who did not promptly start commercial ozanimod, 55 (3.3%) had a known post-treatment relapse. Most participants did not relapse within 90 days, and investigators observed no post-treatment relapse cases suggestive of rebound. Follow-up duration varied after protocol amendments, and 30.6% had 60 days or less of post-treatment follow-up.
Key findings
- Fifty-five of 1,679 participants (3.3%) had a known relapse after stopping ozanimod.
- Forty-two participants (76.4%) fully recovered, 11 (20.0%) partially recovered, and 2 (3.6%) did not recover.
- One relapse (1.8%) was judged severe by the investigator; the participant partially recovered within 36 days.
- No post-treatment relapse cases suggestive of a rebound effect were observed.
Why it matters
Disease activity after stopping a disease-modifying therapy is clinically relevant in multiple sclerosis. These findings provide information about observed relapses and recovery after ozanimod discontinuation, while distinguishing the reported events from cases suggestive of rebound. The results should be interpreted in light of incomplete and variable post-treatment follow-up.
What to keep in mind
The analysis was exploratory and based on a single-arm, open-label extension. Follow-up varied, and 30.6% of the analyzed participants had 60 days or less of post-treatment follow-up.