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Title: Treatment effectiveness of alemtuzumab compared with natalizumab, fingolimod, and interferon beta in relapsing-remitting multiple sclerosis: a cohort study.
Authors: Kalincik, Tomas
Brown, J William L
Robertson, Neil
Willis, Mark
Scolding, Neil
Rice, Claire M
Wilkins, Alastair
Pearson, Owen
Ziemssen, Tjalf
Hutchinson, Michael
McGuigan, Christopher
Jokubaitis, Vilija
Spelman, Tim
Horakova, Dana
Havrdova, Eva
Trojano, Maria
Izquierdo, Guillermo
Lugaresi, Alessandra
Prat, Alexandre
Girard, Marc
Duquette, Pierre
Grammond, Pierre
Alroughani, Raed
Pucci, Eugenio
Sola, Patrizia
Hupperts, Raymond
Lechner-Scott, Jeannette
Terzi, Murat
Van Pesch, Vincent
Rozsa, Csilla
Grand'Maison, François
Boz, Cavit
Granella, Franco
Slee, Mark
Spitaleri, Daniele
Olascoaga, Javier
Bergamaschi, Roberto
Verheul, Freek
Vucic, Steve
McCombe, Pamela
Hodgkinson, Suzanne
Sanchez-Menoyo, Jose Luis
Ampapa, Radek
Simo, Magdolna
Csepany, Tunde
Ramo, Cristina
Cristiano, Edgardo
Barnett, Michael
Butzkueven, Helmut
Coles, Alasdair
MSBase Study Group
metadata.dc.subject.mesh: Adult
Antibodies, Monoclonal, Humanized
Cohort Studies
Databases, Bibliographic
Disability Evaluation
Fingolimod Hydrochloride
Immunologic Factors
Multiple Sclerosis, Relapsing-Remitting
Treatment Outcome
Young Adult
Issue Date: 11-Feb-2017
Abstract: Alemtuzumab, an anti-CD52 antibody, is proven to be more efficacious than interferon beta-1a in the treatment of relapsing-remitting multiple sclerosis, but its efficacy relative to more potent immunotherapies is unknown. We compared the effectiveness of alemtuzumab with natalizumab, fingolimod, and interferon beta in patients with relapsing-remitting multiple sclerosis treated for up to 5 years. In this international cohort study, we used data from propensity-matched patients with relapsing-remitting multiple sclerosis from the MSBase and six other cohorts. Longitudinal clinical data were obtained from 71 MSBase centres in 21 countries and from six non-MSBase centres in the UK and Germany between Nov 1, 2015, and June 30, 2016. Key inclusion criteria were a diagnosis of definite relapsing-remitting multiple sclerosis, exposure to one of the study therapies (alemtuzumab, interferon beta, fingolimod, or natalizumab), age 65 years or younger, Expanded Disability Status Scale (EDSS) score 6·5 or lower, and no more than 10 years since the first multiple sclerosis symptom. The primary endpoint was annualised relapse rate. The secondary endpoints were cumulative hazards of relapses, disability accumulation, and disability improvement events. We compared relapse rates with negative binomial models, and estimated cumulative hazards with conditional proportional hazards models. Patients were treated between Aug 1, 1994, and June 30, 2016. The cohorts consisted of 189 patients given alemtuzumab, 2155 patients given interferon beta, 828 patients given fingolimod, and 1160 patients given natalizumab. Alemtuzumab was associated with a lower annualised relapse rate than interferon beta (0·19 [95% CI 0·14-0·23] vs 0·53 [0·46-0·61], p Alemtuzumab and natalizumab seem to have similar effects on annualised relapse rates in relapsing-remitting multiple sclerosis. Alemtuzumab seems superior to fingolimod and interferon beta in mitigating relapse activity. Natalizumab seems superior to alemtuzumab in enabling recovery from disability. Both natalizumab and alemtuzumab seem highly effective and viable immunotherapies for multiple sclerosis. Treatment decisions between alemtuzumab and natalizumab should be primarily governed by their safety profiles. National Health and Medical Research Council, and the University of Melbourne.
metadata.dc.identifier.doi: 10.1016/S1474-4422(17)30007-8
Appears in Collections:Producción 2020

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