Long-Term Effectiveness, Safety and Tolerability of Fingolimod in Patients with Multiple Sclerosis in Real-World Treatment Settings in France: The VIRGILE Study - Archive ouverte HAL Access content directly
Journal Articles Neurology and Therapy Year : 2022

Long-Term Effectiveness, Safety and Tolerability of Fingolimod in Patients with Multiple Sclerosis in Real-World Treatment Settings in France: The VIRGILE Study

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Caroline Papeix
Giovanni Castelnovo
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Marc Coustans
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Pierre Levy
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Jean-Marc Visy
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Gisela Kobelt
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Fabienne Lamy
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Bashar Allaf
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François Heintzmann
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Isabelle Chouette
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Eric Raponi
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Barbara Durand
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Emmanuelle Grevat
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Driss Kamar
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Marc Debouverie
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Christine Lebrun-Frenay
Abdelhakim Abdelmoumni
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Mouhmmad Jamal Al Aloucy
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Abdullatif Al Khedr
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Amer Al Najjar Carpentier
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Bernard Alonzo
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Tony Altarcha
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Amevi Ananivi
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Géraldine Androdias
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Gilles Angibaud
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Marie-Sylvie Artaud-Uriot
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Dominique Audry-Chaboud
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Marie Barre
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Philippe Barres
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Rabah Benrabah
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Eric Berger
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François-Xavier Bergouignan
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Patricia Bernady
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Christophe Billy
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Christian Blanchard
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Mickaël Bonnan
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Jean-Paul Borsotti
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Jean-Claude Bouffeteau
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Sophie Bouillaguet
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Yassine Boukriche
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Jean-Marc Boulesteix
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Bertrand Bourre
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David Brassat
Alain Bredin
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Bruno Brochet
Helene Brugeilles Baguelin
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Ousmane Camara
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Jean-Philippe Camdessanche
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William Camu
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Christophe Carel
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Bertrand Carlander
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Olivier Casez
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Marie-Pierre Chanel-Soulier
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Stéphane Chapuis
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Mirella Cimpoesu
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Jonathan Ciron
Pierre Clavelou
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Christine Clerc
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Renato Colamarino
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Christophe Couratier
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Sylvie Courtois
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Alain Creange
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Antoine Danielli
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Thomas de Broucker
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Jérôme de Seze
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Gilles Defer
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Jérôme Delorme
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Béatrice Denis
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Fayçal Derouiche
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Philippe Devos
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Anne-Marie Deyrolle
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Michel Dib
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Joseph Dib
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Eric Diot
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Emmanuelle Doury
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Sophie Dufourd-Delalande
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Corinne Dupel-Pottier
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Patrick Dussaux
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Gilles Edan
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Thibault Edouard
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Jean-Pierre Escaillas
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Didier Ferriby
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Nicolas Fouillet
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Guillaume Fromager
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Tsouria Gaida-Rostane
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Philippe Gaida
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Guillaume Gal
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Guillaume Garrigues
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Annick Gayou-Joyeux
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Arnaud Gentil
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Philippe Gerard
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Julien Gere
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Laurence Gignoux
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Philippe Girard
Pierric Giraud
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Michel Gouttard
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Pierre Gras
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Anne Marie Guennoc
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Michel Gugenheim
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Laurent Guilloton
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Karim Hadjout
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Patrick Hautecoeur
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Yawo Hegbe
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Olivier Heinzlef
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Patrice Henry
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Yann Herve
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Jihad Hijazi
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Pascale Homeyer
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Bernard Huttin
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Olivier Ille
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Alain Jager
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Laurentiu Jomir
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Nabil Kardous
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Agnès Kerouanton
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Comlan Paul Kpade
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Christophe Kubler
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Pierre Labauge
François Lallement
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Nicolas Landragin
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David Axel Laplaud
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Henda Laribi
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Gilles Lavernhe
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Pierre-Éric Le Biez
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Françoise Le Bras
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Patrick Le Coz
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Josette Leche
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Sara Julia Leder
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Alain Legout
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Michele Levasseur
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Alberta Lorenzi-Pernot
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Pierre Louchart
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Fabien Louillet
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Laurent Magy
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Sophie Maillard
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Elisabeth Maillart
Marcel Maillet-Vioud
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Catherine Mallecourt-Emberger
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Éric Manchon
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Alexandre Mania
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Laurent Martinez-Almoyna
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Mikel Martinez
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Serge Massengo
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Dominique Maugin
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Souraya Medjbeur
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Gayané Meliksetyan
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Michael Menassa
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Dalia Meshaka-Dimitri-Boulos
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Gérard Mick
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Thibault Moreau
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Antoine Moulignier
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Isabelle Mourand
Jean-Philippe Muller
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Philippe Neuschwander
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Argentino Nibbio
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Chantal Nifle
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Jean-Bertin Nkendjuo
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Ghislain Nokam Talom
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Sophie Ory
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Ivania Patry
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Bernard Pedespan
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Jean Pelletier
Delia-Gianina Pencu
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Bruno Perrouty
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Stéphane Peysson
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Irène Popa-Coman
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André Pouliquen
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Christophe Prat
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Adriana Prundean
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Fataï Radji
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Lilia Razlog
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Philippe Remy
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Christophe Robin
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Gilles Rodier
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Jérôme Romero
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Brigitte Roualdes
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François Rouhart
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Irene Ruggieri
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Feras Abdul Samad
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Irina Sarafiant
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Stephane Schaeffer
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Nicolas Schmidt
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Philippe Schuermans
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Nicolas Seiller
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Thierry Soisson
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Annie Sortais
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Bruno Stankoff
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Sabrina Stefanizzi-Debuc
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Laurent Suchet
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Jean Tardy
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Gregory Taurin
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Florent Thabuy
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Marie Theaudin
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Caroline Tilikete-Froment
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Ayman Tourbah
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Patricia Tourniaire
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Sylvie Trefouret
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Michel Vastene
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Pierre Verdure
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Patrick Vermersch
Frédérique Viala
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Dorothée Videt-Gibou
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Elisabeth Vidry
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Sandra Vukusic
Marc Wagner
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Valery Wattier
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Christophe Zaenker
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François Ziegler
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Jean-Médard Zola
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Abstract

Introduction: It is important to confirm the effectiveness and tolerability of disease-modifying treatments for relapsing-remitting multiple sclerosis (RRMS) in real-world treatment settings. This prospective observational cohort study (VIRGILE) was performed at the request of the French health authorities. The primary objective was to evaluate the effectiveness of fingolimod 0.5 mg in reducing the annualised relapse rate (ARR) in patients with RRMS. Methods: Participating neurologists enrolled all adult patients with RRMS starting fingolimod treatment between 2014 and 2016, who were followed for 3 years. Follow-up consultations took place at the investigator's discretion. The primary outcome measure was the change in ARR at month 24 after fingolimod initiation. Relapses and adverse events were documented at each consultation; disability assessment (EDSS) and magnetic resonance imagery were performed at the investigator's discretion. Results: Of 1055 eligible patients, 633 patients were assessable at month 36; 405 (64.0%) were treated continuously with fingolimod for 3 years. The ARR decreased from 0.92 ± 0.92 at inclusion to 0.31 ± 0.51 at month 24, a significant reduction of 0.58 [95% CI - 0.51 to - 0.65] relapses/year (p < 0.001). Since starting fingolimod, 461 patients (60.9%) remained relapse-free at month 24 and 366 patients (55.5%) at month 36. In multivariate analysis, no previous disease-modifying treatment, number of relapses in the previous year and lower EDSS score at inclusion were associated with a greater on-treatment reduction in ARR. The mean EDSS score remained stable over the course of the study. Sixty-one out of 289 (21.1%) patients presented new radiological signs of disease activity. Treatment-related serious adverse events were lymphopenia (N = 21), bradycardia (N = 19), elevated transaminases (N = 9) and macular oedema (N = 9). Conclusions: The effectiveness and tolerability of fingolimod in everyday clinical practice are consistent with findings of previous phase III studies. Our study highlights the utility of fingolimod for the long-term management of patients with multiple sclerosis.
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Dates and versions

hal-03608016 , version 1 (14-03-2022)

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Caroline Papeix, Giovanni Castelnovo, Emmanuelle Leray, Marc Coustans, Pierre Levy, et al.. Long-Term Effectiveness, Safety and Tolerability of Fingolimod in Patients with Multiple Sclerosis in Real-World Treatment Settings in France: The VIRGILE Study. Neurology and Therapy, 2022, ⟨10.1007/s40120-022-00334-y⟩. ⟨hal-03608016⟩
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