Ocrelizumab versus Interferon Beta-1a in Relapsing Multiple Sclerosis

Hauser, Stephen L.; Bar-Or, Amit; Comi, Giancarlo; Giovannoni, Gavin; Hartung, Hans-Peter; Hemmer, Bernhard; Lublin, Fred; Montalbán Gairín, Xavier; Rammohan, Kottil W.; Selmaj, Krzysztof; Traboulsee, Anthony; Wolinsky, Jerry S.; Arnold, Douglas L.; Klingelschmitt, Gaelle; Masterman, Donna; Fontoura, Paulo; Belachew, Shibeshih; Chin, Peter; Mairon, Nicole; Garren, Hideki; Kappos, Ludwig; Martínez Yélamos, Sergio; OPERA I; OPERA II Clinical Investigators

Ocrelizumab versus Interferon Beta-1a in Relapsing Multiple Sclerosis

Background: B cells influence the pathogenesis of multiple sclerosis. Ocrelizumab is a humanized monoclonal antibody that selectively depletes CD20+ B cells. Methods: In two identical phase 3 trials, we randomly assigned 821 and 835 patients with relapsing multiple sclerosis to receive intravenous o...

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Detalles Bibliográficos
Autores:	Hauser, Stephen L., Bar-Or, Amit, Comi, Giancarlo, Giovannoni, Gavin, Hartung, Hans-Peter, Hemmer, Bernhard, Lublin, Fred, Montalbán Gairín, Xavier, Rammohan, Kottil W., Selmaj, Krzysztof, Traboulsee, Anthony, Wolinsky, Jerry S., Arnold, Douglas L., Klingelschmitt, Gaelle, Masterman, Donna, Fontoura, Paulo, Belachew, Shibeshih, Chin, Peter, Mairon, Nicole, Garren, Hideki, Kappos, Ludwig, Martínez Yélamos, Sergio, OPERA I, OPERA II Clinical Investigators
Tipo de recurso:	artículo
Estado:	Versión publicada
Fecha de publicación:	2017
País:	España
Institución:	Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
Repositorio:	Recercat. Dipósit de la Recerca de Catalunya
OAI Identifier:	oai:recercat.cat:2445/178507
Acceso en línea:	https://hdl.handle.net/2445/178507
Access Level:	acceso abierto
Palabra clave:	Anticossos monoclonals Immunologia Esclerosi múltiple Monoclonal antibodies Immunology Multiple sclerosis

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spelling	Ocrelizumab versus Interferon Beta-1a in Relapsing Multiple SclerosisHauser, Stephen L.Bar-Or, AmitComi, GiancarloGiovannoni, GavinHartung, Hans-PeterHemmer, BernhardLublin, FredMontalbán Gairín, XavierRammohan, Kottil W.Selmaj, KrzysztofTraboulsee, AnthonyWolinsky, Jerry S.Arnold, Douglas L.Klingelschmitt, GaelleMasterman, DonnaFontoura, PauloBelachew, ShibeshihChin, PeterMairon, NicoleGarren, HidekiKappos, LudwigMartínez Yélamos, SergioOPERA IOPERA II Clinical InvestigatorsAnticossos monoclonalsImmunologiaEsclerosi múltipleMonoclonal antibodiesImmunologyMultiple sclerosisBackground: B cells influence the pathogenesis of multiple sclerosis. Ocrelizumab is a humanized monoclonal antibody that selectively depletes CD20+ B cells. Methods: In two identical phase 3 trials, we randomly assigned 821 and 835 patients with relapsing multiple sclerosis to receive intravenous ocrelizumab at a dose of 600 mg every 24 weeks or subcutaneous interferon beta-1a at a dose of 44 μg three times weekly for 96 weeks. The primary end point was the annualized relapse rate. Results: the annualized relapse rate was lower with ocrelizumab than with interferon beta-1a in trial 1 (0.16 vs. 0.29; 46% lower rate with ocrelizumab; P<0.001) and in trial 2 (0.16 vs. 0.29; 47% lower rate; P<0.001). In prespecified pooled analyses, the percentage of patients with disability progression confirmed at 12 weeks was significantly lower with ocrelizumab than with interferon beta-1a (9.1% vs. 13.6%; hazard ratio, 0.60; 95% confidence interval [CI], 0.45 to 0.81; P<0.001), as was the percentage of patients with disability progression confirmed at 24 weeks (6.9% vs. 10.5%; hazard ratio, 0.60; 95% CI, 0.43 to 0.84; P=0.003). The mean number of gadolinium-enhancing lesions per T1-weighted magnetic resonance scan was 0.02 with ocrelizumab versus 0.29 with interferon beta-1a in trial 1 (94% lower number of lesions with ocrelizumab, P<0.001) and 0.02 versus 0.42 in trial 2 (95% lower number of lesions, P<0.001). The change in the Multiple Sclerosis Functional Composite score (a composite measure of walking speed, upper-limb movements, and cognition; for this z score, negative values indicate worsening and positive values indicate improvement) significantly favored ocrelizumab over interferon beta-1a in trial 2 (0.28 vs. 0.17, P=0.004) but not in trial 1 (0.21 vs. 0.17, P=0.33). Infusion-related reactions occurred in 34.3% of the patients treated with ocrelizumab. Serious infection occurred in 1.3% of the patients treated with ocrelizumab and in 2.9% of those treated with interferon beta-1a. Neoplasms occurred in 0.5% of the patients treated with ocrelizumab and in 0.2% of those treated with interferon beta-1a. Conclusions: among patients with relapsing multiple sclerosis, ocrelizumab was associated with lower rates of disease activity and progression than interferon beta-1a over a period of 96 weeks. Larger and longer studies of the safety of ocrelizumab are required. (Funded by F. Hoffmann-La Roche; OPERA I and II ClinicalTrials.gov numbers, NCT01247324 and NCT01412333 , respectively).Massachusetts Medical Society2021202120172021info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersion14 p.application/pdfhttps://hdl.handle.net/2445/178507Articles publicats en revistes (Ciències Clíniques)reponame:Recercat. Dipósit de la Recerca de Catalunyainstname:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)InglésReproducció del document publicat a: https://doi.org/10.1056/NEJMoa1601277New England Journal of Medicine, 2017, vol. 376, num. 3, p. 221-234https://doi.org/10.1056/NEJMoa1601277(c) Massachusetts Medical Society, 2017info:eu-repo/semantics/openAccessoai:recercat.cat:2445/1785072026-05-29T05:05:01Z
dc.title.none.fl_str_mv	Ocrelizumab versus Interferon Beta-1a in Relapsing Multiple Sclerosis
title	Ocrelizumab versus Interferon Beta-1a in Relapsing Multiple Sclerosis
spellingShingle	Ocrelizumab versus Interferon Beta-1a in Relapsing Multiple Sclerosis Hauser, Stephen L. Anticossos monoclonals Immunologia Esclerosi múltiple Monoclonal antibodies Immunology Multiple sclerosis
title_short	Ocrelizumab versus Interferon Beta-1a in Relapsing Multiple Sclerosis
title_full	Ocrelizumab versus Interferon Beta-1a in Relapsing Multiple Sclerosis
title_fullStr	Ocrelizumab versus Interferon Beta-1a in Relapsing Multiple Sclerosis
title_full_unstemmed	Ocrelizumab versus Interferon Beta-1a in Relapsing Multiple Sclerosis
title_sort	Ocrelizumab versus Interferon Beta-1a in Relapsing Multiple Sclerosis
dc.creator.none.fl_str_mv	Hauser, Stephen L. Bar-Or, Amit Comi, Giancarlo Giovannoni, Gavin Hartung, Hans-Peter Hemmer, Bernhard Lublin, Fred Montalbán Gairín, Xavier Rammohan, Kottil W. Selmaj, Krzysztof Traboulsee, Anthony Wolinsky, Jerry S. Arnold, Douglas L. Klingelschmitt, Gaelle Masterman, Donna Fontoura, Paulo Belachew, Shibeshih Chin, Peter Mairon, Nicole Garren, Hideki Kappos, Ludwig Martínez Yélamos, Sergio OPERA I OPERA II Clinical Investigators
author	Hauser, Stephen L.
author_facet	Hauser, Stephen L. Bar-Or, Amit Comi, Giancarlo Giovannoni, Gavin Hartung, Hans-Peter Hemmer, Bernhard Lublin, Fred Montalbán Gairín, Xavier Rammohan, Kottil W. Selmaj, Krzysztof Traboulsee, Anthony Wolinsky, Jerry S. Arnold, Douglas L. Klingelschmitt, Gaelle Masterman, Donna Fontoura, Paulo Belachew, Shibeshih Chin, Peter Mairon, Nicole Garren, Hideki Kappos, Ludwig Martínez Yélamos, Sergio OPERA I OPERA II Clinical Investigators
author_role	author
author2	Bar-Or, Amit Comi, Giancarlo Giovannoni, Gavin Hartung, Hans-Peter Hemmer, Bernhard Lublin, Fred Montalbán Gairín, Xavier Rammohan, Kottil W. Selmaj, Krzysztof Traboulsee, Anthony Wolinsky, Jerry S. Arnold, Douglas L. Klingelschmitt, Gaelle Masterman, Donna Fontoura, Paulo Belachew, Shibeshih Chin, Peter Mairon, Nicole Garren, Hideki Kappos, Ludwig Martínez Yélamos, Sergio OPERA I OPERA II Clinical Investigators
author2_role	author author author author author author author author author author author author author author author author author author author author author author author
dc.subject.none.fl_str_mv	Anticossos monoclonals Immunologia Esclerosi múltiple Monoclonal antibodies Immunology Multiple sclerosis
topic	Anticossos monoclonals Immunologia Esclerosi múltiple Monoclonal antibodies Immunology Multiple sclerosis
description	Background: B cells influence the pathogenesis of multiple sclerosis. Ocrelizumab is a humanized monoclonal antibody that selectively depletes CD20+ B cells. Methods: In two identical phase 3 trials, we randomly assigned 821 and 835 patients with relapsing multiple sclerosis to receive intravenous ocrelizumab at a dose of 600 mg every 24 weeks or subcutaneous interferon beta-1a at a dose of 44 μg three times weekly for 96 weeks. The primary end point was the annualized relapse rate. Results: the annualized relapse rate was lower with ocrelizumab than with interferon beta-1a in trial 1 (0.16 vs. 0.29; 46% lower rate with ocrelizumab; P<0.001) and in trial 2 (0.16 vs. 0.29; 47% lower rate; P<0.001). In prespecified pooled analyses, the percentage of patients with disability progression confirmed at 12 weeks was significantly lower with ocrelizumab than with interferon beta-1a (9.1% vs. 13.6%; hazard ratio, 0.60; 95% confidence interval [CI], 0.45 to 0.81; P<0.001), as was the percentage of patients with disability progression confirmed at 24 weeks (6.9% vs. 10.5%; hazard ratio, 0.60; 95% CI, 0.43 to 0.84; P=0.003). The mean number of gadolinium-enhancing lesions per T1-weighted magnetic resonance scan was 0.02 with ocrelizumab versus 0.29 with interferon beta-1a in trial 1 (94% lower number of lesions with ocrelizumab, P<0.001) and 0.02 versus 0.42 in trial 2 (95% lower number of lesions, P<0.001). The change in the Multiple Sclerosis Functional Composite score (a composite measure of walking speed, upper-limb movements, and cognition; for this z score, negative values indicate worsening and positive values indicate improvement) significantly favored ocrelizumab over interferon beta-1a in trial 2 (0.28 vs. 0.17, P=0.004) but not in trial 1 (0.21 vs. 0.17, P=0.33). Infusion-related reactions occurred in 34.3% of the patients treated with ocrelizumab. Serious infection occurred in 1.3% of the patients treated with ocrelizumab and in 2.9% of those treated with interferon beta-1a. Neoplasms occurred in 0.5% of the patients treated with ocrelizumab and in 0.2% of those treated with interferon beta-1a. Conclusions: among patients with relapsing multiple sclerosis, ocrelizumab was associated with lower rates of disease activity and progression than interferon beta-1a over a period of 96 weeks. Larger and longer studies of the safety of ocrelizumab are required. (Funded by F. Hoffmann-La Roche; OPERA I and II ClinicalTrials.gov numbers, NCT01247324 and NCT01412333 , respectively).
publishDate	2017
dc.date.none.fl_str_mv	2017 2021 2021 2021
dc.type.none.fl_str_mv	info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion
format	article
status_str	publishedVersion
dc.identifier.none.fl_str_mv	https://hdl.handle.net/2445/178507
url	https://hdl.handle.net/2445/178507
dc.language.none.fl_str_mv	Inglés
language_invalid_str_mv	Inglés
dc.relation.none.fl_str_mv	Reproducció del document publicat a: https://doi.org/10.1056/NEJMoa1601277 New England Journal of Medicine, 2017, vol. 376, num. 3, p. 221-234 https://doi.org/10.1056/NEJMoa1601277
dc.rights.none.fl_str_mv	(c) Massachusetts Medical Society, 2017 info:eu-repo/semantics/openAccess
rights_invalid_str_mv	(c) Massachusetts Medical Society, 2017
eu_rights_str_mv	openAccess
dc.format.none.fl_str_mv	14 p. application/pdf
dc.publisher.none.fl_str_mv	Massachusetts Medical Society
publisher.none.fl_str_mv	Massachusetts Medical Society
dc.source.none.fl_str_mv	Articles publicats en revistes (Ciències Clíniques) reponame:Recercat. Dipósit de la Recerca de Catalunya instname:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
instname_str	Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
reponame_str	Recercat. Dipósit de la Recerca de Catalunya
collection	Recercat. Dipósit de la Recerca de Catalunya
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repository.mail.fl_str_mv
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Ocrelizumab versus Interferon Beta-1a in Relapsing Multiple Sclerosis

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