MS disease activity in RESTORE: a randomized 24-week natalizumab treatment interruption study

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 les...

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Autores: 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
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2014
País:España
Institución:Universidad de Barcelona
Repositorio:Dipòsit Digital de la UB
OAI Identifier:oai:diposit.ub.edu:2445/178215
Acceso en línea:https://hdl.handle.net/2445/178215
Access Level:acceso abierto
Palabra clave:Anticossos monoclonals
Immunologia
Esclerosi múltiple
Ús terapèutic
Monoclonal antibodies
Immunology
Multiple sclerosis
Therapeutic use
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spelling MS disease activity in RESTORE: a randomized 24-week natalizumab treatment interruption studyFox, Robert J.Cree, Bruce A.C.Sèze, Jerome DeGold, RalfHartung, Hans-PeterJeffery, DouglasKappos, LudwigKaufman, MichaelMontalbán Gairín, XavierWeinstock-Guttman, BiancaAnderson, BrittNatarajan, AmyTicho, BarryDuda, PetraMartínez Yélamos, SergioRESTOREAnticossos monoclonalsImmunologiaEsclerosi múltipleÚs terapèuticMonoclonal antibodiesImmunologyMultiple sclerosisTherapeutic useObjective: 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.Lippincott, Williams & Wilkins. Wolters Kluwer Health2014info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfhttps://hdl.handle.net/2445/178215Articles publicats en revistes (Ciències Clíniques)reponame:Dipòsit Digital de la UBinstname:Universidad de BarcelonaInglésReproducció del document publicat a: https://doi.org/10.1212/WNL.0000000000000355Neurology, 2014, vol. 82, num. 17, p. 1491-1498https://doi.org/10.1212/WNL.0000000000000355(c) American Academy of Neurology, 2014info:eu-repo/semantics/openAccessoai:diposit.ub.edu:2445/1782152026-05-27T06:46:51Z
dc.title.none.fl_str_mv MS disease activity in RESTORE: a randomized 24-week natalizumab treatment interruption study
title MS disease activity in RESTORE: a randomized 24-week natalizumab treatment interruption study
spellingShingle MS disease activity in RESTORE: a randomized 24-week natalizumab treatment interruption study
Fox, Robert J.
Anticossos monoclonals
Immunologia
Esclerosi múltiple
Ús terapèutic
Monoclonal antibodies
Immunology
Multiple sclerosis
Therapeutic use
title_short MS disease activity in RESTORE: a randomized 24-week natalizumab treatment interruption study
title_full MS disease activity in RESTORE: a randomized 24-week natalizumab treatment interruption study
title_fullStr MS disease activity in RESTORE: a randomized 24-week natalizumab treatment interruption study
title_full_unstemmed MS disease activity in RESTORE: a randomized 24-week natalizumab treatment interruption study
title_sort MS disease activity in RESTORE: a randomized 24-week natalizumab treatment interruption study
dc.creator.none.fl_str_mv 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
author Fox, Robert J.
author_facet 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
author_role author
author2 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
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv Anticossos monoclonals
Immunologia
Esclerosi múltiple
Ús terapèutic
Monoclonal antibodies
Immunology
Multiple sclerosis
Therapeutic use
topic Anticossos monoclonals
Immunologia
Esclerosi múltiple
Ús terapèutic
Monoclonal antibodies
Immunology
Multiple sclerosis
Therapeutic use
description 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.
publishDate 2014
dc.date.none.fl_str_mv 2014
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv https://hdl.handle.net/2445/178215
url https://hdl.handle.net/2445/178215
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv Reproducció del document publicat a: https://doi.org/10.1212/WNL.0000000000000355
Neurology, 2014, vol. 82, num. 17, p. 1491-1498
https://doi.org/10.1212/WNL.0000000000000355
dc.rights.none.fl_str_mv (c) American Academy of Neurology, 2014
info:eu-repo/semantics/openAccess
rights_invalid_str_mv (c) American Academy of Neurology, 2014
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv Lippincott, Williams & Wilkins. Wolters Kluwer Health
publisher.none.fl_str_mv Lippincott, Williams & Wilkins. Wolters Kluwer Health
dc.source.none.fl_str_mv Articles publicats en revistes (Ciències Clíniques)
reponame:Dipòsit Digital de la UB
instname:Universidad de Barcelona
instname_str Universidad de Barcelona
reponame_str Dipòsit Digital de la UB
collection Dipòsit Digital de la UB
repository.name.fl_str_mv
repository.mail.fl_str_mv
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score 15,300724

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