title: Comparative efficacy of fingolimod vs natalizumab: A French multicenter observational study.
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 < 0.0001; new T2 lesions: 10.6% vs 29.6%, p < 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.
  
  
  CONCLUSIONS
  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.
  
  
  METHODS
  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.
authors.affiliation: Authors' affiliations are listed at the end of the article.
authors.forename: Laetitia
authors.initials: L
authors.lastname: Barbin
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authors.forename: Chloe
authors.initials: C
authors.lastname: Rousseau
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authors.forename: Natacha
authors.initials: N
authors.lastname: Jousset
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authors.forename: Romain
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authors.lastname: Casey
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authors.forename: Marc
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authors.lastname: Debouverie
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authors.forename: Sandra
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authors.lastname: Vukusic
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authors.forename: David
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authors.forename: Sandrine
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authors.forename: Jean
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authors.forename: Patrick
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authors.forename: Gilles
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authors.lastname: Edan
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authors.forename: Christine
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authors.lastname: Lebrun-Frenay
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authors.forename: Pierre
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authors.lastname: Clavelou
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authors.forename: Eric
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authors.lastname: Thouvenot
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authors.forename: Jean-Philippe
authors.initials: JP
authors.lastname: Camdessanché
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authors.forename: Ayman
authors.initials: A
authors.lastname: Tourbah
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authors.forename: Bruno
authors.initials: B
authors.lastname: Stankoff
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authors.forename: Abdullatif
authors.initials: A
authors.lastname: Al Khedr
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authors.forename: Philippe
authors.initials: P
authors.lastname: Cabre
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authors.forename: Caroline
authors.initials: C
authors.lastname: Papeix
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authors.forename: Eric
authors.initials: E
authors.lastname: Berger
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authors.forename: Olivier
authors.initials: O
authors.lastname: Heinzlef
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authors.forename: Thomas
authors.initials: T
authors.lastname: Debroucker
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authors.forename: Thibault
authors.initials: T
authors.lastname: Moreau
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authors.forename: Olivier
authors.initials: O
authors.lastname: Gout
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authors.forename: Bertrand
authors.initials: B
authors.lastname: Bourre
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authors.forename: Alain
authors.initials: A
authors.lastname: Créange
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authors.forename: Pierre
authors.initials: P
authors.lastname: Labauge
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authors.forename: Laurent
authors.initials: L
authors.lastname: Magy
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authors.forename: Gilles
authors.initials: G
authors.lastname: Defer
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authors.forename: Yohann
authors.initials: Y
authors.lastname: Foucher
authors.affiliation: Authors' affiliations are listed at the end of the article. david.laplaud@univ-nantes.fr.
authors.forename: David A
authors.initials: DA
authors.lastname: Laplaud
mesh_terms: D000328:Adult; D015331:Cohort Studies; D005260:Female; D000068876:Fingolimod Hydrochloride / Q000627:therapeutic use*; D005500:Follow-Up Studies; D005602:France / Q000453:epidemiology; D006801:Humans; D007155:Immunologic Factors / Q000627:therapeutic use; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D008297:Male; D009103:Multiple Sclerosis / Q000175:diagnosis* / Q000188:drug therapy* / Q000453:epidemiology; D000069442:Natalizumab / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D007155:Immunologic Factors; D007166:Immunosuppressive Agents; D000069442:Natalizumab; D000068876:Fingolimod Hydrochloride
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