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Comparative efficacyof fingolimod versus natalizumab in multiple sclerosis: a prospective multicenter observational study
Author(s): ,
D.A. Laplaud
Affiliations:
Neurology, CHU Nantes; Inserm U1064; CIC Inserm 0015
,
L. Barbin
Affiliations:
Neurology, CHU Nantes; CIC Inserm 0015
,
C. Rousseau
Affiliations:
CIC Inserm 0015; Clinical Research and Subjective Measures in Health Sciences, Nantes University, EA 4275 Biostatistics, Nantes
,
N. Jousset
Affiliations:
CIC Inserm 0015
,
R. Casey
Affiliations:
Université de Lyon, Observatoire Français de la Sclérose en Plaques, OFSEP, Lyon
,
M. Debouverie
Affiliations:
CHU, Department of Neurology, Nancy
,
S. Vukusic
Affiliations:
CHU-Hospices Civils, Department of Neurology, Lyon
,
J. De Sèze
Affiliations:
CHU, Department of Neurology, Strasbourg
,
D. Brassat
Affiliations:
CHU, Department of Neurology, Toulouse
,
S. Wiertlewski
Affiliations:
Neurology, CHU Nantes
,
B. Brochet
Affiliations:
CHU, Department of Neurology, Bordeaux
,
J. Pelletier
Affiliations:
CHU, Department of Neurology, Marseille
,
P. Vermersch
Affiliations:
CHU, Department of Neurology, Lille
,
G. Edan
Affiliations:
CHU, Department of Neurology, Rennes
,
C. Lebrun-Frenay
Affiliations:
CHU, Department of Neurology, Nice
,
P. Clavelou
Affiliations:
CHU, Department of Neurology, Clermont-Ferrand
,
E. Thouvenot
Affiliations:
CHU, Department of Neurology, Nîmes
,
J.-P. Camdessanché
Affiliations:
CHU, Department of Neurology, Saint-Etienne
,
A. Tourbah
Affiliations:
CHU, Department of Neurology, Reims
,
B. Stankoff
Affiliations:
CHU Saint-Antoine, Department of Neurology, Paris
,
A. Al Khedr
Affiliations:
CHU, Department of Neurology, Amiens
,
P. Cabre
Affiliations:
CHU, Department of Neurology, Fort de France
,
C. Papeix
Affiliations:
CHU Salpétrière, Department of Neurology, Paris
,
E. Berger
Affiliations:
CHU, Department of Neurology, Besançon
,
O. Heinzlef
Affiliations:
CH, Department of Neurology, Poissy-Saint-Germain
,
T. Debroucker
Affiliations:
CH, Department of Neurology, Saint-Denis
,
T. Moreau
Affiliations:
CHU, Department of Neurology, Dijon
,
O. Gout
Affiliations:
Fondation Rotschild, Department of Neurology, Paris
,
B. Bourre
Affiliations:
CHU, Department of Neurology, Rouen
,
A. Créange
Affiliations:
CHU, Department of Neurology, Créteil
,
P. Labauge
Affiliations:
CHU, Department of Neurology, Montpellier
,
L. Magy
Affiliations:
CHU, Department of Neurology, Limoges
,
G. Defer
Affiliations:
CHU, Department of Neurology, Caen, France
,
Y. Foucher
Affiliations:
Clinical Research and Subjective Measures in Health Sciences, Nantes University, EA 4275 Biostatistics, Nantes
OFSEP and SFSEP
OFSEP and SFSEP
Affiliations:
(Abstract release date: Sep 23, 2015) ECTRIMS Online Library. Laplaud D. Oct 9, 2015; 116627
David Laplaud
David Laplaud
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Abstract: 191

Type: Oral

Abstract Category: Immunomodulation / Immunosuppression

Background: Both Fingolimod and Natalizumab have been approved in European countries as second line treatments for patients with active relapsing-remitting multiple sclerosis (RRMS) non-responding to first line treatment or in patients with rapidly evolving disease. However, to date, no randomized controlled study has compared their relative efficacy and results from observational studies are scarce.

Objective: The aim of the study is to compare natalizumab and fingolimod on both clinical and MRI outcomes in RRMS patients from 27 MS centers participating to the French follow-up cohort entitled OFSEP.

Methods: RRMS Patients included in the study were aged from 18 to 65 with an EDSS score of 0 to 5.5 and an available brain MRI performed within the year before treatment initiation. The data were collected prospectively for 326 patients treated with natalizumab and 303 with fingolimod. The statistical analysis was performed using two different methods: logistic regressions and propensity scores (Inverse Probability Treatment Weighting).

Results: The confounder-adjusted proportion of patients with at least one relapse within the first year of treatment was lower in natalizumab-treated patients compared to fingolimod group (21.1% versus30.4%, p=0.0092). Such statistically significant associations were also observed for Gd-enhancing lesions (9.3% versus 29.8%, p< 0.0001) and new T2-lesions at one year of treatment initiation (10.6% versus 29.6%, p< 0.0001).

Interpretation: This observational study provides class III evidence in favour of natalizumab as compared to fingolimod, to decrease disease activity as assessed by relapses or new MRI lesions within the first year after treatment onset.

Disclosure: All authors have nothing to disclose concerning this work.
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