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BEST-MS: A prospective head-to-head comparative study of natalizumab and fingolimod in active relapsing MS.

Authors:
Mikael Cohen Lydiane Mondot Florence Bucciarelli Béatrice Pignolet David-Axel Laplaud Sandrine Wiertlewski Bruno Brochet Aurélie Ruet Gilles Defer Nathalie Derache Patrick Vermersch Hélène Zephir Marc Debouverie Guillaume Mathey Eric Berger Chrystelle Cappé Pierre Labauge Clarisse Carra Jérôme De Seze Kevin Bigaut David Brassat Christine Lebrun-Frenay

Mult Scler 2020 Oct 30:1352458520969145. Epub 2020 Oct 30.

Service de Neurologie, CRCSEP, Unité de Recherche Clinique Cote d'Azur (UR2CA), Centre Hospitalier Universitaire Pasteur 2, Nice, France.

Background: There are few head-to-head studies to compare highly active treatments in multiple sclerosis (MS).

Objective: The aim of this study was to compare the effectiveness between natalizumab (NTZ) and fingolimod (FTY) in active relapsing-remitting MS.

Method: Best Escalation STrategy in Multiple Sclerosis (BEST-MS) is a multicentric, prospective study with a 12-month follow-up including patients with active MS. Treatment choice was at the discretion of physician. Clinical and magnetic resonance imaging (MRI) data were collected at baseline and at 12 months. The primary outcome was the proportion of patients reaching no evidence of disease activity (NEDA) at 12 months. Secondary outcomes included annualized relapse rate and MRI activity.

Results: A total of 223 patients were included (NTZ: 109 and FTY: 114). Treatment groups were well balanced at baseline. Proportion of NEDA patients was 47.8% in NTZ group versus 30.4% in FTY group ( = 0.015). This superiority was driven by annualized relapse rate and MRI activity. In the multivariate analysis, treatment group was the only factor associated with NEDA at 12 months with a lower probability in FTY group (odds ratio (OR) = 0.49,  = 0.029).

Conclusion: BEST-MS is a prospective study that compared head-to-head the effectiveness of NTZ and FTY in active relapsing-remitting MS. Our results suggest a superiority of NTZ over FTY.

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http://dx.doi.org/10.1177/1352458520969145DOI Listing
October 2020

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