Long-term safety and efficacy of ozanimod in relapsing multiple sclerosis : Up to 5 years of follow-up in the DAYBREAK open-label extension trial
Cree, Bruce A. C (University of California)
Selmaj, Krzysztof W. (University of Warmia and Mazury in Olsztyn)
Steinman, Lawrence (Stanford University)
Comi, Giancarlo (Vita-Salute San Raffaele University)
Bar-Or, Amit (University of Pennsylvania)
Arnold, Douglas Lorne (McGill University)
Hartung, Hans-Peter (Medical University of Vienna)
Montalban, Xavier (Hospital Universitari Vall d'Hebron)
Kubala Havrdova, Eva (Charles University)
Sheffield, James K. (Bristol-Myers Squibb Company)
Minton, Neil (Bristol-Myers Squibb Company)
Cheng, Chun Yen (Bristol-Myers Squibb Company)
Silva, Diego (Bristol-Myers Squibb Company)
Kappos, Ludwig (University of Basel)
Cohen, Jeffrey A. (Cleveland Clinic)
Universitat Autònoma de Barcelona

Data:	2022
Descripció:	19 pàg.
Resum:	Background: Ozanimod, an oral sphingosine 1-phosphate receptor 1 and 5 modulator, is approved in multiple countries for treatment of relapsing forms of MS. Objective: To characterize long-term safety and efficacy of ozanimod. Methods: Patients with relapsing MS who completed a phase 1‒3 ozanimod trial were eligible for an open-label extension study (DAYBREAK) of ozanimod 0. 92 mg/d. DAYBREAK began 16 October 2015; cutoff for this interim analysis was 2 February 2021. Results: This analysis included 2494 participants with mean 46. 8 (SD 11. 9; range 0. 033‒62. 7) months of ozanimod exposure in DAYBREAK. During DAYBREAK, 2143 patients (85. 9%) had treatment-emergent adverse events (TEAEs; similar in nature to those in the parent trials), 298 (11. 9%) had a serious TEAE, and 75 (3. 0%) discontinued treatment due to TEAEs. Serious infections (2. 8%), herpes zoster infections (1. 7%), confirmed macular edema cases (0. 2%), and cardiac TEAEs (2. 8%) were infrequent. Adjusted annualized relapse rate was 0. 103 (95% confidence interval, 0. 086‒0. 123). Over 48 months, 71% of patients remained relapse free. Adjusted mean numbers of new/enlarging T2 lesions/scan and gadolinium-enhancing lesions were low and similar across parent trial treatment subgroups. Conclusions: This long-term extension of ozanimod trials confirmed a favorable safety/tolerability profile and sustained benefit on clinical and magnetic resonance imaging measures of disease activity.
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:	Adverse events ; Clinical efficacy ; Extension study ; Multiple sclerosis ; Ozanimod ; Sphingosine 1-phosphate receptor modulators
Publicat a:	Multiple sclerosis, Vol. 28 Núm. 12 (2022) , p. 1944-1962, ISSN 1477-0970

DOI: 10.1177/13524585221102584
PMID: 35765217

19 p, 537.2 KB

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