Please use this identifier to cite or link to this item:
http://hdl.handle.net/2445/178507
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DC Field | Value | Language |
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dc.contributor.author | Hauser, Stephen L. | - |
dc.contributor.author | Bar-Or, Amit | - |
dc.contributor.author | Comi, Giancarlo | - |
dc.contributor.author | Giovannoni, Gavin | - |
dc.contributor.author | Hartung, Hans-Peter | - |
dc.contributor.author | Hemmer, Bernhard | - |
dc.contributor.author | Lublin, Fred | - |
dc.contributor.author | Montalbán Gairín, Xavier | - |
dc.contributor.author | Rammohan, Kottil W. | - |
dc.contributor.author | Selmaj, Krzysztof | - |
dc.contributor.author | Traboulsee, Anthony | - |
dc.contributor.author | Wolinsky, Jerry S. | - |
dc.contributor.author | Arnold, Douglas L. | - |
dc.contributor.author | Klingelschmitt, Gaelle | - |
dc.contributor.author | Masterman, Donna | - |
dc.contributor.author | Fontoura, Paulo | - |
dc.contributor.author | Belachew, Shibeshih | - |
dc.contributor.author | Chin, Peter | - |
dc.contributor.author | Mairon, Nicole | - |
dc.contributor.author | Garren, Hideki | - |
dc.contributor.author | Kappos, Ludwig | - |
dc.contributor.author | Martínez Yélamos, Sergio | - |
dc.contributor.author | OPERA I | - |
dc.contributor.author | OPERA II Clinical Investigators | - |
dc.date.accessioned | 2021-06-17T14:58:59Z | - |
dc.date.available | 2021-06-17T14:58:59Z | - |
dc.date.issued | 2017-01-19 | - |
dc.identifier.issn | 0028-4793 | - |
dc.identifier.uri | http://hdl.handle.net/2445/178507 | - |
dc.description.abstract | 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). | - |
dc.format.extent | 14 p. | - |
dc.format.mimetype | application/pdf | - |
dc.language.iso | eng | - |
dc.publisher | Massachusetts Medical Society | - |
dc.relation.isformatof | Reproducció del document publicat a: https://doi.org/10.1056/NEJMoa1601277 | - |
dc.relation.ispartof | New England Journal of Medicine, 2017, vol. 376, num. 3, p. 221-234 | - |
dc.relation.uri | https://doi.org/10.1056/NEJMoa1601277 | - |
dc.rights | (c) Massachusetts Medical Society, 2017 | - |
dc.source | Articles publicats en revistes (Ciències Clíniques) | - |
dc.subject.classification | Anticossos monoclonals | - |
dc.subject.classification | Immunologia | - |
dc.subject.classification | Esclerosi múltiple | - |
dc.subject.other | Monoclonal antibodies | - |
dc.subject.other | Immunology | - |
dc.subject.other | Multiple sclerosis | - |
dc.title | Ocrelizumab versus Interferon Beta-1a in Relapsing Multiple Sclerosis | - |
dc.type | info:eu-repo/semantics/article | - |
dc.type | info:eu-repo/semantics/publishedVersion | - |
dc.identifier.idgrec | 677313 | - |
dc.date.updated | 2021-06-17T14:59:00Z | - |
dc.rights.accessRights | info:eu-repo/semantics/openAccess | - |
dc.identifier.pmid | 28002679 | - |
Appears in Collections: | Articles publicats en revistes (Ciències Clíniques) Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL)) |
Files in This Item:
File | Description | Size | Format | |
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677313.pdf | 287 kB | Adobe PDF | View/Open |
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