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Comparative effectiveness of dimethyl fumarate in Multiple Sclerosis
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  • Pauline Bosco-Lévy,
  • Marc Debouverie,
  • Bruno Brochet,
  • Francis Guillemin,
  • Céline Louapre,
  • Elisabeth Maillart,
  • Olivier Heinzlef,
  • Severine Lignot,
  • Pauline Diez,
  • Abdelilah Abouelfath,
  • Regis Lassalle,
  • Patrick Blin,
  • cecile Droz
Pauline Bosco-Lévy
University of Bordeaux
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Marc Debouverie
CHU Nancy Pôle Médico-chirurgical Central
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Bruno Brochet
CHU Bordeaux GH Pellegrin
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Francis Guillemin
CHU Nancy Pôle Médico-chirurgical Central
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Céline Louapre
Institut du Cerveau et de la Moelle Epiniere
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Elisabeth Maillart
University Hospital Pitié Salpêtrière
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Olivier Heinzlef
Intermunicipal Hospital Centre Poissy-Saint-Germain-en-Laye Poissy Site
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Severine Lignot
University of Bordeaux
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Pauline Diez
University of Bordeaux
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Abdelilah Abouelfath
University of Bordeaux
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Regis Lassalle
University of Bordeaux
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Patrick Blin
University of Bordeaux
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cecile Droz
University of Bordeaux
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Abstract

Objectives: To assess the effectiveness of dimethyl fumarate (DMF) on annual rate of relapse (ARR) and disability progression in multiple sclerosis (MS) compared to injectable immunomodulators (IMM), teriflunomide (TERI) and fingolimob (FTY), in real life setting. Methods: A population-based cohort study was conducted using data of the French nationwide claims database, SNDS. All patients initiating IMM, TERI, FTY or DMF between July 1, 2015 and December 12, 2017, with 4.5 years of database history and 1 to 3.5 years of follow-up were included in this study. DMF patients were 1:1 matched to IMM, TERI or FTY using a high dimensional Propensity Score. Negative binomial regression and a logistic regression models were used to estimate the relative risk (RR ± [95% CI]) of ARR and the Odds Ratio (OR ± [95% CI]) of disability progression, respectively. Results: Overall, 9 304 subjects were identified: 29.0% initiated DMF, 33.2% TERI, 5.6% FTY and 32.2% an IMM. The matched cohorts consisted of 1779 DMF- IMM, patients, 1679 DMF-TERI patients, and 376 DMF-FTY patients. DMF significantly reduced ARR compared to IMM (RR 0.72 [0.61 - 0.86]) and TERI (0.81 [0.68 - 0.96]) and did not show any significant difference when compared with FTY The risk of the progression of MS specific disability was not significantly different for any matched cohorts. Interpretation: DMF is associated with lower risk of relapse for patients with RRMS than other first-line RRMS agents (TERI and IIM).

Peer review status:IN REVISION

18 Mar 2021Submitted to British Journal of Clinical Pharmacology
19 Mar 2021Assigned to Editor
19 Mar 2021Submission Checks Completed
21 Mar 2021Reviewer(s) Assigned
10 Apr 2021Review(s) Completed, Editorial Evaluation Pending
11 May 2021Editorial Decision: Revise Major