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A Method of Trigonometric Modelling of Seasonal Variation Demonstrated with Multiple Sclerosis Relapse Data
Published on: December 9, 2015
Multiple Sclerosis Relapse Activity After Ozanimod Discontinuation in DAYBREAK Trial Participants
Ralf Gold1, Krzysztof W Selmaj2,3, Regina Berkovich4
1Neurologische Universitätsklinik, St. Josef Hospital, Bochum, Germany.
Most multiple sclerosis patients discontinuing ozanimod did not experience disease activity rebound. Post-treatment relapses were infrequent and generally mild, with most patients recovering fully.
Area of Science:
- Neurology
- Immunology
- Pharmacology
Background:
- Discontinuing disease-modifying therapies (DMTs) for multiple sclerosis (MS) can lead to disease activity return.
- Some MS DMTs are linked to a higher-than-expected disease activity, known as rebound, post-discontinuation.
- Ozanimod is an MS DMT, and its discontinuation effects require assessment.
Purpose of the Study:
- To explore disease activity and the risk of rebound after discontinuing ozanimod.
- To characterize post-treatment relapses in participants who stopped ozanimod therapy.
Main Methods:
- Analysis of data from the DAYBREAK open-label extension trial (NCT02576717) involving participants with relapsing MS.
- Participants received ozanimod 0.92 mg/d and had extended safety follow-up periods (up to 90 days).
- Confirmed post-treatment relapses were identified and characterized, including severity and recovery.
Main Results:
- Of 1679 participants with follow-up, 3.3% (55 participants) experienced a post-treatment relapse.
- Most relapses (54/55) occurred when participants were not taking another MS DMT.
- Relapses typically involved mild to moderate increases in Expanded Disability Status Scale (EDSS) scores, with most participants recovering fully or partially.
Conclusions:
- A low incidence of relapse was observed within 90 days of ozanimod discontinuation.
- No clear cases suggestive of a rebound effect were identified following ozanimod cessation.
- Ozanimod discontinuation appears to have a manageable safety profile regarding disease activity return.
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