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

Laetitia Barbin; Chloé Rousseau; Natacha Jousset; Romain Casey; Marc Debouverie; Sandra Vukusic; Jerome de Sèze; David Brassat; Sandrine Wiertlewski; Bruno Brochet; Jean Pelletier; Patrick Vermersch; Gilles Edan; Christine Lebrun-Frenay; Pierre Clavelou; Eric Thouvenot; Jean-Philippe Camdessanché; Ayman Tourbah; Bruno Stankoff; Abdullatif Al Khedr; Philippe Cabre; Caroline Papeix; Eric Berger; Olivier Heinzlef; Thomas Debroucker; Thibault Moreau; Olivier Gout; Bertrand Bourre; Alain Créange; Pierre Labauge; Laurent Magy; Gilles Defer; Yohann Foucher; David A. Laplaud

doi:10.1212/WNL.0000000000002395

Journal articles

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 Toulouse Purpan ex IFR 30 et IFR 150

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

IRISA-D5 - SIGNAUX ET IMAGES NUMÉRIQUES, ROBOTIQUE, INSERM - Institut National de la Santé et de la Recherche Médicale : U746, Inria Rennes – Bretagne Atlantique

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 Service de Neurologie [CHU Caen]

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

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

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