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https://hdl.handle.net/1822/51752
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Campo DC | Valor | Idioma |
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dc.contributor.author | Hauser, S .L. | por |
dc.contributor.author | Bar-Or, A. | por |
dc.contributor.author | Comi, G. | por |
dc.contributor.author | Giovannoni, G. | por |
dc.contributor.author | Hartung, H. -P. | por |
dc.contributor.author | Hemmer, B. | por |
dc.contributor.author | Lublin, F. | por |
dc.contributor.author | Cerqueira, João José | por |
dc.contributor.author | et. al. | por |
dc.date.accessioned | 2018-03-07T17:17:34Z | - |
dc.date.available | 2018-03-07T17:17:34Z | - |
dc.date.issued | 2017-01-18 | - |
dc.identifier.citation | Hauser, S. L., Bar-Or, A., Comi, G., Giovannoni, G., Hartung, H. P., Hemmer, B., ... & Traboulsee, A. (2017). Ocrelizumab versus interferon beta-1a in relapsing multiple sclerosis. New England Journal of Medicine, 376(3), 221-234 | por |
dc.identifier.issn | 1533-4406 | - |
dc.identifier.uri | https://hdl.handle.net/1822/51752 | - |
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 mu g 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 T 1 -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.) | por |
dc.language.iso | eng | por |
dc.publisher | Massachusetts Medical Society | por |
dc.rights | openAccess | por |
dc.title | Ocrelizumab versus Interferon Beta-1a in Relapsing Multiple Sclerosis | por |
dc.type | article | por |
dc.peerreviewed | yes | por |
dc.relation.publisherversion | http://www.nejm.org/doi/full/10.1056/NEJMoa1601277 | por |
oaire.citationStartPage | 221 | por |
oaire.citationEndPage | 234 | por |
oaire.citationVolume | 376 | por |
dc.date.updated | 2018-01-30T09:49:14Z | - |
dc.identifier.doi | 10.1056/NEJMoa1601277 | por |
dc.subject.fos | Ciências Médicas::Medicina Clínica | por |
dc.description.publicationversion | info:eu-repo/semantics/publishedVersion | por |
sdum.journal | New England Journal of Medicine | por |
Aparece nas coleções: | ICVS - Artigos em revistas internacionais / Papers in international journals |
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Ficheiro | Descrição | Tamanho | Formato | |
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nejmoa1601277.pdf | 287,24 kB | Adobe PDF | Ver/Abrir |