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

Result code in IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00064165%3A_____%2F25%3A10505556" target="_blank" >RIV/00064165:_____/25:10505556 - isvavai.cz</a>

Alternative codes found

RIV/00216208:11110/25:10505556

Result on the web

<a href="https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=cWCsy4RjCK" target="_blank" >https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=cWCsy4RjCK</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1177/13524585251382796" target="_blank" >10.1177/13524585251382796</a>

Result language

angličtina

Original language name

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

Original language description

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 &apos;parent&apos; 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 infections (4.3%), herpes zoster infections (2.0%), confirmed macular oedema cases (0.2%), and cardiac TEAEs (4.1 %) were infrequent. Adjusted annualized relapse rate was 0.098 (95% confidence interval, 0.082-0.117). In total, 69.1% of participants remained relapse-free and 84.8% were free from 6-month confirmed disability progression at DAYBREAK completion. Adjusted mean numbers of new/enlarging T2 lesions/scan and gadolinium-enhancing lesions were low and remained relatively stable.Conclusions: Long-term ozanimod treatment had a favourable safety and tolerability profile and provided sustained control of clinical and MRI disease activity in participants with RMS.Registries: ClinicalTrials.gov ID: NCT02576717; EudraCT: 2015-002500-91.

Czech name

—

Czech description

—

Type

J_imp - Article in a specialist periodical, which is included in the Web of Science database

CEP classification

—

OECD FORD branch

30103 - Neurosciences (including psychophysiology)

Project

<a href="/en/project/LX22NPO5107" target="_blank" >LX22NPO5107: National institute for Neurological Research</a><br>

Continuities

V - Vyzkumna aktivita podporovana z jinych verejnych zdroju

Publication year

2025

Confidentiality

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Name of the periodical

Multiple Sclerosis Journal

ISSN

1352-4585

e-ISSN

1477-0970

Volume of the periodical

31

Issue of the periodical within the volume

13

Country of publishing house

GB - UNITED KINGDOM

Number of pages

15

Pages from-to

1557-1571

UT code for WoS article

001610986400013

EID of the result in the Scopus database

2-s2.0-105020806738