Efficacy and safety of ozanimod in multiple sclerosis: Dose-blinded extension of a randomized phase II study
The result's identifiers
Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216208%3A11110%2F19%3A10396282" target="_blank" >RIV/00216208:11110/19:10396282 - isvavai.cz</a>
Result on the web
<a href="https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=o1uofVIY.G" target="_blank" >https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=o1uofVIY.G</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1177/1352458518789884" target="_blank" >10.1177/1352458518789884</a>
Alternative languages
Result language
angličtina
Original language name
Efficacy and safety of ozanimod in multiple sclerosis: Dose-blinded extension of a randomized phase II study
Original language description
Background: Ozanimod, an oral immunomodulator, selectively targets sphingosine 1-phosphate receptors 1 and 5. Objective: Evaluate efficacy, safety, and tolerability of ozanimod in relapsing multiple sclerosis. Methods: In the RADIANCE Part A phase II study (NCT01628393), participants with relapsing multiple sclerosis were randomized (1:1:1) to once-daily ozanimod hydrochloride (0.5 or 1 mg) or placebo. After 24 weeks, participants could enter a 2-year, dose-blinded extension. Ozanimod-treated participants continued their assigned dose; placebo participants were re-randomized (1:1) to ozanimod hydrochloride 0.5 or 1 mg (equivalent to ozanimod 0.46 and 0.92 mg). Results: A total of 223 (89.6%) of the 249 participants completed the blinded extension. At 2 years of the extension, the percentage of participants who were gadolinium-enhancing lesion-free ranged from 86.5% to 94.6%. Unadjusted annualized relapse rate during the blinded extension (week 24-end of treatment) was 0.32 for ozanimod hydrochloride 0.5 mg -> ozanimod hydrochloride 0.5 mg, 0.18 for ozanimod hydrochloride 1 mg -> ozanimod hydrochloride 1 mg, 0.30 for placebo -> ozanimod hydrochloride 0.5 mg, and 0.18 for placebo -> ozanimod hydrochloride 1 mg. No second-degree or higher atrioventricular block or serious opportunistic infection was reported. Conclusion: Ozanimod demonstrated sustained efficacy in participants continuing treatment up to 2 years and reached similar efficacy in participants who switched from placebo; no unexpected safety signals emerged.
Czech name
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Czech description
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Classification
Type
J<sub>imp</sub> - Article in a specialist periodical, which is included in the Web of Science database
CEP classification
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OECD FORD branch
30103 - Neurosciences (including psychophysiology)
Result continuities
Project
—
Continuities
I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace
Others
Publication year
2019
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data specific for result type
Name of the periodical
Multiple Sclerosis Journal
ISSN
1352-4585
e-ISSN
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Volume of the periodical
25
Issue of the periodical within the volume
9
Country of publishing house
GB - UNITED KINGDOM
Number of pages
8
Pages from-to
1255-1262
UT code for WoS article
000478623000010
EID of the result in the Scopus database
2-s2.0-85052392880