Comparative efficacy of fingolimod vs natalizumab: A French multicenter observational study

Laetitia Barbin 1 Chloé Rousseau 2, 1, 3 Natacha Jousset 1 Romain Casey 4 Marc Debouverie 5 Sandra Vukusic 6 Jerome de Sèze 7 David Brassat 8 Sandrine Wiertlewski 9 Bruno Brochet 10, 11 Jean Pelletier 12 Patrick Vermersch 13, 14, 15 Gilles Edan 16, 3 Christine Lebrun-Frenay 17 Pierre Clavelou 18 Eric Thouvenot 18 Jean-Philippe Camdessanché 19 Ayman Tourbah 20 Bruno Stankoff 21, 22, 23 Abdullatif Al Khedr 24 Philippe Cabre 25 Caroline Papeix 26 Eric Berger 27 Olivier Heinzlef 28 Thomas Debroucker 29 Thibault Moreau 30 Olivier Gout 31 Bertrand Bourre 31 Alain Créange 32 Pierre Labauge 33 Laurent Magy 34 Gilles Defer 35 Yohann Foucher 36 David A. Laplaud 37, *
* Corresponding author
1 CIC Nantes - Centre d’Investigation Clinique de Nantes
2 Biostatistique, Pharmacoépidémiologie et Mesures Subjectives en Santé
3 CIC - Centre d'Investigation Clinique [Rennes]
4 CarMeN - Cardiovasculaire, métabolisme, diabétologie et nutrition
5 ReLSEP
6 Department of Neurology
7 Service de Neurologie [Lyon]
8 CPTP - Centre de Physiopathologie de Toulouse Purpan
9 Service de Neurologie
10 Service de neurologie [Bordeaux]
11 UB - Université de Bordeaux
12 Pôle de Neurosciences Cliniques, Department of Neurology
13 Inflammation: mécanismes et régulation et interactions avec la nutrition et les candidoses
14 EA 2686 - Laboratoire d'Immunologie
15 Service de neurologie D
16 VisAGeS - Vision, Action et Gestion d'informations en Santé
INSERM - Institut National de la Santé et de la Recherche Médicale : U746, Inria Rennes – Bretagne Atlantique , IRISA-D5 - SIGNAUX ET IMAGES NUMÉRIQUES, ROBOTIQUE
17 Department of Neurology
18 Department of Neurology
19 Service de Neurologie
20 Hôpital Maison Blanche
21 ICM - Institut du Cerveau et de la Moëlle Epinière = Brain and Spine Institute
22 SHFJ - Service Hospitalier Frédéric Joliot
23 CHU Saint-Antoine [APHP]
24 Service de Neurologie [CHU Saint-Antoine]
25 Department of Neurology
26 CHU Pitié-Salpêtrière [APHP]
27 Department of Neurology
28 Service de Neurologie [CHU Besançon]
29 Service de Neurologie [CHU de Poissy]
30 Service de Neurologie générale, vasculaire et dégénérative (CHU de Dijon)
31 Service de Neurologie
32 ENT - Excitabilité nerveuse et thérapeutique
33 CRMBM - Centre de résonance magnétique biologique et médicale
34 CHU Limoges
35 Department of Neurology
36 Biostatistique, Recherche Clinique et Mesures Subjectives en Santé
37 U1064 Inserm - CRTI - Centre de Recherche en Transplantation et Immunologie
Abstract : OBJECTIVE: To compare natalizumab and fingolimod on both clinical and MRI outcomes in patients with relapsing-remitting multiple sclerosis (RRMS) from 27 multiple sclerosis centers participating in the French follow-up cohort Observatoire of Multiple Sclerosis. METHODS: Patients with RRMS included in the study were aged from 18 to 65 years with an Expanded Disability Status Scale score of 0-5.5 and an available brain MRI performed within the year before treatment initiation. The data were collected for 326 patients treated with natalizumab and 303 with fingolimod. The statistical analysis was performed using 2 different methods: logistic regression and propensity scores (inverse probability treatment weighting). RESULTS: The confounder-adjusted proportion of patients with at least one relapse within the first and second year of treatment was lower in natalizumab-treated patients compared to the fingolimod group (21.1% vs 30.4% at first year, p = 0.0092; and 30.9% vs 41.7% at second year, p = 0.0059) and supported the trend observed in nonadjusted analysis (21.2% vs 27.1% at 1 year, p = 0.0775). Such statistically significant associations were also observed for gadolinium (Gd)-enhancing lesions and new T2 lesions at both 1 year (Gd-enhancing lesions: 9.3% vs 29.8%, p \textless 0.0001; new T2 lesions: 10.6% vs 29.6%, p \textless 0.0001) and 2 years (Gd-enhancing lesions: 9.1% vs 22.1%, p = 0.0025; new T2 lesions: 16.9% vs 34.1%, p = 0.0010) post treatment initiation. CONCLUSION: Taken together, these results suggest the superiority of natalizumab over fingolimod to prevent relapses and new T2 and Gd-enhancing lesions at 1 and 2 years. CLASSIFICATION OF EVIDENCE: This study provides Class IV evidence that for patients with RRMS, natalizumab decreases the proportion of patients with at least one relapse within the first year of treatment compared to fingolimod
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Laetitia Barbin, Chloé Rousseau, Natacha Jousset, Romain Casey, Marc Debouverie, et al.. Comparative efficacy of fingolimod vs natalizumab: A French multicenter observational study. Neurology, American Academy of Neurology, 2016, 86 (8), pp.771-778. ⟨10.1212/WNL.0000000000002395⟩. ⟨hal-01299977⟩

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