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http://hdl.handle.net/2445/178215
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DC Field | Value | Language |
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dc.contributor.author | Fox, Robert J. | - |
dc.contributor.author | Cree, Bruce A.C. | - |
dc.contributor.author | Sèze, Jerome De | - |
dc.contributor.author | Gold, Ralf | - |
dc.contributor.author | Hartung, Hans-Peter | - |
dc.contributor.author | Jeffery, Douglas | - |
dc.contributor.author | Kappos, Ludwig | - |
dc.contributor.author | Kaufman, Michael | - |
dc.contributor.author | Montalbán Gairín, Xavier | - |
dc.contributor.author | Weinstock-Guttman, Bianca | - |
dc.contributor.author | Anderson, Britt | - |
dc.contributor.author | Natarajan, Amy | - |
dc.contributor.author | Ticho, Barry | - |
dc.contributor.author | Duda, Petra | - |
dc.contributor.author | Martínez Yélamos, Sergio | - |
dc.contributor.author | RESTORE | - |
dc.date.accessioned | 2021-06-09T16:34:23Z | - |
dc.date.available | 2021-06-09T16:34:23Z | - |
dc.date.issued | 2014-04-29 | - |
dc.identifier.issn | 0028-3878 | - |
dc.identifier.uri | http://hdl.handle.net/2445/178215 | - |
dc.description.abstract | Objective: RESTORE was a randomized, partially placebo-controlled exploratory study evaluating multiple sclerosis (MS) disease activity during a 24-week interruption of natalizumab. Methods: eligible patients were relapse-free through the prior year on natalizumab and had no gadolinium-enhancing lesions on screening brain MRI. Patients were randomized 1:1:2 to continue natalizumab, to switch to placebo, or to receive alternative immunomodulatory therapy (other therapies: IM interferon β-1a [IM IFN-β-1a], glatiramer acetate [GA], or methylprednisolone [MP]). During the 24-week randomized treatment period, patients underwent clinical and MRI assessments every 4 weeks. Results: patients (n = 175) were randomized to natalizumab (n = 45), placebo (n = 42), or other therapies (n = 88: IM IFN-β-1a, n = 17; GA, n = 17; MP, n = 54). Of 167 patients evaluable for efficacy, 49 (29%) had MRI disease activity recurrence: 0/45 (0%) natalizumab, 19/41 (46%) placebo, 1/14 (7%) IM IFN-β-1a, 8/15 (53%) GA, and 21/52 (40%) MP. Relapse occurred in 4% of natalizumab patients and in 15%-29% of patients in the other treatment arms. MRI disease activity recurred starting at 12 weeks (n = 3 at week 12) while relapses were reported as early as 4-8 weeks (n = 2 in weeks 4-8) after the last natalizumab dose. Overall, 50/167 patients (30%), all in placebo or other-therapies groups, restarted natalizumab early because of disease activity. Conclusions: MRI and clinical disease activity recurred in some patients during natalizumab interruption, despite use of other therapies. Classification of evidence: this study provides Class II evidence that for patients with MS taking natalizumab who are relapse-free for 1 year, stopping natalizumab increases the risk of MS relapse or MRI disease activity as compared with continuing natalizumab. | - |
dc.format.extent | 8 p. | - |
dc.format.mimetype | application/pdf | - |
dc.language.iso | eng | - |
dc.publisher | Lippincott, Williams & Wilkins. Wolters Kluwer Health | - |
dc.relation.isformatof | Reproducció del document publicat a: https://doi.org/10.1212/WNL.0000000000000355 | - |
dc.relation.ispartof | Neurology, 2014, vol. 82, num. 17, p. 1491-1498 | - |
dc.relation.uri | https://doi.org/10.1212/WNL.0000000000000355 | - |
dc.rights | (c) American Academy of Neurology, 2014 | - |
dc.source | Articles publicats en revistes (Ciències Clíniques) | - |
dc.subject.classification | Anticossos monoclonals | - |
dc.subject.classification | Immunologia | - |
dc.subject.classification | Esclerosi múltiple | - |
dc.subject.classification | Ús terapèutic | - |
dc.subject.other | Monoclonal antibodies | - |
dc.subject.other | Immunology | - |
dc.subject.other | Multiple sclerosis | - |
dc.subject.other | Therapeutic use | - |
dc.title | MS disease activity in RESTORE: a randomized 24-week natalizumab treatment interruption study | - |
dc.type | info:eu-repo/semantics/article | - |
dc.type | info:eu-repo/semantics/publishedVersion | - |
dc.identifier.idgrec | 653785 | - |
dc.date.updated | 2021-06-09T16:34:23Z | - |
dc.rights.accessRights | info:eu-repo/semantics/openAccess | - |
dc.identifier.pmid | 24682966 | - |
dc.identifier.pmid | 25713117 | - |
Appears in Collections: | Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL)) Articles publicats en revistes (Biologia Cel·lular, Fisiologia i Immunologia) Articles publicats en revistes (Ciències Clíniques) |
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File | Description | Size | Format | |
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653785.pdf | 655.96 kB | Adobe PDF | View/Open |
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