Efficacy and safety of ozanimod in multiple sclerosis : Dose-blinded extension of a randomized phase II study
Cohen, Jeffrey A. (Cleveland Clinic. Mellen Center for Multiple Sclerosis Treatment and Research)
Comi, Giancarlo (Vita-Salute San Raffaele University)
Arnold, Douglas Lorne (McGill University, Montreal)
Bar-Or, Amit (University of Pennsylvania. Center for Neuroinflammation and Experimental Therapeutics and Department of Neurology)
Selmaj, Krzysztof W. (Center for Neurology, Łódź, Poland)
Steinman, Lawrence (Stanford University Medical Center)
Havrdova, Eva K (Charles University. Department of Neurology and Center for Clinical Neuroscience)
Cree, Bruce A. C. (University of California. UCSF Weill Institute for Neurosciences)
Montalbán, Xavier (Universitat Autònoma de Barcelona. Departament de Medicina)
Hartung, Hans-Peter (Heinrich Heine University. Department of Neurology)
Huang, Vivian (Celgene Corporation, San Diego, CA)
Frohna, Paul (Celgene Corporation, San Diego, CA)
Skolnick, Brett E. (Celgene Corporation, San Diego, CA)
Kappos, Ludwig (University Hospital Basel (Basilea, Suïssa))

Data:	2018
Resum:	Ozanimod, an oral immunomodulator, selectively targets sphingosine 1-phosphate receptors 1 and 5. Evaluate efficacy, safety, and tolerability of ozanimod in relapsing multiple sclerosis. 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). 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. 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.
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Matèria:	Clinical trial ; Disease-modifying therapies ; MRI ; Relapsing/remitting ; T2 lesions ; Multiple sclerosis
Publicat a:	Multiple sclerosis, Vol. 25 (july 2018) , p. 1255-1262, ISSN 1477-0970

DOI: 10.1177/1352458518789884
PMID: 30043658

8 p, 976.6 KB

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