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MS disease activity in RESTORE: a randomized 24-week natalizumab treatment interruption study
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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.
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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. MS disease activity in RESTORE: a randomized 24-week natalizumab treatment interruption study. _Neurology_. 2014. Vol. 82, núm. 17, pàgs. 1491-1498. [consulta: 15 de gener de 2026]. ISSN: 0028-3878. [Disponible a: https://hdl.handle.net/2445/178215]