Long-term safety and efficacy of ozanimod in relapsing multiple sclerosis

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 tri...

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Detalles Bibliográficos
Autores: Cree, Bruce A. C.|||0000-0001-7689-2533, Selmaj, Krzysztof W.|||0000-0003-1213-7218, Steinman, Lawrence|||0000-0002-2437-2250, Comi, Giancarlo|||0000-0002-6989-1054, Bar-Or, Amit|||0000-0001-7179-0335, Arnold, Douglas Lorne|||0000-0003-4266-0106, Hartung, Hans-Peter|||0000-0002-0614-6989, Montalban, Xavier|||0000-0002-0098-9918, Kubala Havrdova, Eva|||0000-0002-9543-4359, Sheffield, James K., Minton, Neil, Cheng, Chun Yen, Silva, Diego, Kappos, Ludwig|||0000-0003-4175-5509, Cohen, Jeffrey A.|||0000-0001-9245-9772
Tipo de recurso: artículo
Fecha de publicación:2022
País:España
Institución:Universitat Autònoma de Barcelona
Repositorio:Dipòsit Digital de Documents de la UAB
Idioma:inglés
OAI Identifier:oai:ddd.uab.cat:275796
Acceso en línea:https://ddd.uab.cat/record/275796
https://dx.doi.org/urn:doi:10.1177/13524585221102584
Access Level:acceso abierto
Palabra clave:Adverse events
Clinical efficacy
Extension study
Multiple sclerosis
Ozanimod
Sphingosine 1-phosphate receptor modulators
Descripción
Sumario: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.

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