Please use this identifier to cite or link to this item: http://hdl.handle.net/2445/178215
Title: MS disease activity in RESTORE: a randomized 24-week natalizumab treatment interruption study
Author: Fox, Robert J.
Cree, Bruce A.C.
Sèze, Jerome De
Gold, Ralf
Hartung, Hans-Peter
Jeffery, Douglas
Kappos, Ludwig
Kaufman, Michael
Montalbán Gairín, Xavier
Weinstock-Guttman, Bianca
Anderson, Britt
Natarajan, Amy
Ticho, Barry
Duda, Petra
Martínez Yélamos, Sergio
RESTORE
Keywords: Anticossos monoclonals
Immunologia
Esclerosi múltiple
Ús terapèutic
Monoclonal antibodies
Immunology
Multiple sclerosis
Therapeutic use
Issue Date: 29-Apr-2014
Publisher: Lippincott, Williams & Wilkins. Wolters Kluwer Health
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.
Note: Reproducció del document publicat a: https://doi.org/10.1212/WNL.0000000000000355
It is part of: Neurology, 2014, vol. 82, num. 17, p. 1491-1498
URI: http://hdl.handle.net/2445/178215
Related resource: https://doi.org/10.1212/WNL.0000000000000355
ISSN: 0028-3878
Appears in Collections:Articles publicats en revistes (Biologia Cel·lular, Fisiologia i Immunologia)
Articles publicats en revistes (Ciències Clíniques)

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