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Ofatumumab versus Teriflunomide in Multiple Sclerosis

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dc.contributor.author Hauser, Stephen L.
dc.contributor.author Bar-Or, Amit
dc.contributor.author Comi, Giancarlo
dc.contributor.author Correale, Jorge
dc.contributor.author Coyle, Patricia K.
dc.contributor.author Cross, Anne H.
dc.contributor.author de Seze, Jerome
dc.contributor.author Leppert, David
dc.contributor.author Montalban, Xavier
dc.contributor.author Selmaj, Krzysztof
dc.contributor.author Wiendl, Heinz
dc.contributor.author Kerloeguen, Cecile
dc.contributor.author Willi, Roman
dc.contributor.author Li, Bingbing
dc.contributor.author Kakarieka, Algirdas
dc.contributor.author Tomic, Davorka
dc.contributor.author Goodyear, Alexandra
dc.contributor.author Pingili, Ratnakar
dc.contributor.author ASCLEPIOS I and ASCLEPIOS II Trial Groups
dc.date.accessioned 2021-04-21T14:47:18Z
dc.date.available 2021-04-21T14:47:18Z
dc.date.issued 2020-08-06
dc.identifier.citation Hauser, S.L., Bar-Or, A., Cohen, J.A., Comi, G., Correale, J., Coyle, P.K., Cross, A.H., de Seze, J., Leppert, D., Montalban, X., Selmaj, K., Wiendl, H., Kerloeguen, C., Willi, R., Li, B., Kakarieka, A., Tomic, D., Goodyear, A., Pingili, R., Häring, D.A., Ramanathan, K., Merschhemke, M., Kappos, L., ASCLEPIOS I and ASCLEPIOS II Trial Groups, 2020. Ofatumumab versus Teriflunomide in Multiple Sclerosis. N. Engl. J. Med. 383, 546-557. https://doi.org/10.1056/NEJMoa1917246 es_ES
dc.identifier.uri https://repositorio.fleni.org.ar/xmlui/handle/123456789/421
dc.identifier.uri https://www.nejm.org/doi/full/10.1056/NEJMoa1917246
dc.description.abstract Background: Ofatumumab, a subcutaneous anti-CD20 monoclonal antibody, selectively depletes B cells. Teriflunomide, an oral inhibitor of pyrimidine synthesis, reduces T-cell and B-cell activation. The relative effects of these two drugs in patients with multiple sclerosis are not known. Methods: In two double-blind, double-dummy, phase 3 trials, we randomly assigned patients with relapsing multiple sclerosis to receive subcutaneous ofatumumab (20 mg every 4 weeks after 20-mg loading doses at days 1, 7, and 14) or oral teriflunomide (14 mg daily) for up to 30 months. The primary end point was the annualized relapse rate. Secondary end points included disability worsening confirmed at 3 months or 6 months, disability improvement confirmed at 6 months, the number of gadolinium-enhancing lesions per T1-weighted magnetic resonance imaging (MRI) scan, the annualized rate of new or enlarging lesions on T2-weighted MRI, serum neurofilament light chain levels at month 3, and change in brain volume. Results: Overall, 946 patients were assigned to receive ofatumumab and 936 to receive teriflunomide; the median follow-up was 1.6 years. The annualized relapse rates in the ofatumumab and teriflunomide groups were 0.11 and 0.22, respectively, in trial 1 (difference, -0.11; 95% confidence interval [CI], -0.16 to -0.06; P<0.001) and 0.10 and 0.25 in trial 2 (difference, -0.15; 95% CI, -0.20 to -0.09; P<0.001). In the pooled trials, the percentage of patients with disability worsening confirmed at 3 months was 10.9% with ofatumumab and 15.0% with teriflunomide (hazard ratio, 0.66; P = 0.002); the percentage with disability worsening confirmed at 6 months was 8.1% and 12.0%, respectively (hazard ratio, 0.68; P = 0.01); and the percentage with disability improvement confirmed at 6 months was 11.0% and 8.1% (hazard ratio, 1.35; P = 0.09). The number of gadolinium-enhancing lesions per T1-weighted MRI scan, the annualized rate of lesions on T2-weighted MRI, and serum neurofilament light chain levels, but not the change in brain volume, were in the same direction as the primary end point. Injection-related reactions occurred in 20.2% in the ofatumumab group and in 15.0% in the teriflunomide group (placebo injections). Serious infections occurred in 2.5% and 1.8% of the patients in the respective groups. Conclusions: Among patients with multiple sclerosis, ofatumumab was associated with lower annualized relapse rates than teriflunomide. (Funded by Novartis; ASCLEPIOS I and II ClinicalTrials.gov numbers, NCT02792218 and NCT02792231.). es_ES
dc.language.iso eng es_ES
dc.publisher Massachusetts Medical Society es_ES
dc.rights info:eu-repo/semantics/openAccess
dc.rights.uri https://creativecommons.org/licenses/by/2.5/ar/
dc.subject Multiple Sclerosis es_ES
dc.subject Esclerosis Múltiple es_ES
dc.title Ofatumumab versus Teriflunomide in Multiple Sclerosis es_ES
dc.type info:eu-repo/semantics/article es_ES
dc.type info:eu-repo/semantics/publishedVersion
dc.description.fil Fil: Hauser, Stephen L. University of California. Department of Neurology. UCSF Weill Institute for Neurosciences; Estados Unidos.
dc.description.fil Fil: Correale, Jorge. Fleni. Departamento de Neurología. Servicio de Neuroinmunología y Enfermedades Desmielinizantes; Argentina.
dc.description.fil Fil: Bar-Or, Amit. University of Pennsylvania. Perelman School of Medicine. Center for Neuroinflammation and Experimental Therapeutics and Department of Neurology; Estados Unidos.
dc.relation.ispartofVOLUME 383
dc.relation.ispartofNUMBER 6
dc.relation.ispartofPAGINATION 546-557.
dc.relation.ispartofCOUNTRY Estados Unidos
dc.relation.ispartofCITY Boston
dc.relation.ispartofTITLE The New England journal of medicine
dc.relation.ispartofTITLE Fil: Correale, Jorge. Fleni. Departamento de Neurología. Servicio de Neuroinmunología y Enfermedades Desmielinizantes; Argentina.
dc.relation.ispartofISSN 1533-4406
dc.type.snrd info:ar-repo/semantics/artículo es_ES


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