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

Caroline Papeix Giovanni Castelnovo Emmanuelle Leray 1, 2, 3, 4 Marc Coustans Pierre Levy Jean-Marc Visy Gisela Kobelt Fabienne Lamy Bashar Allaf François Heintzmann Isabelle Chouette Eric Raponi Barbara Durand Emmanuelle Grevat Driss Kamar Marc Debouverie Christine Lebrun-Frenay Abdelhakim Abdelmoumni Mouhmmad Jamal Al Aloucy Abdullatif Al Khedr Amer Al Najjar Carpentier Bernard Alonzo Tony Altarcha Amevi Ananivi Géraldine Androdias Gilles Angibaud Marie-Sylvie Artaud-Uriot Dominique Audry-Chaboud Marie Barre Philippe Barres Rabah Benrabah Eric Berger François-Xavier Bergouignan Patricia Bernady Christophe Billy Christian Blanchard Mickaël Bonnan Jean-Paul Borsotti Catherine Bossu-van Nieuwenhuyse Jean-Claude Bouffeteau Sophie Bouillaguet Yassine Boukriche Jean-Marc Boulesteix Bertrand Bourre David Brassat Alain Bredin Bruno Brochet Helene Brugeilles Baguelin Ousmane Camara Jean-Philippe Camdessanche William Camu Christophe Carel Bertrand Carlander Olivier Casez Marie-Pierre Chanel-Soulier Stéphane Chapuis Mirella Cimpoesu Jonathan Ciron Pierre Clavelou Christine Clerc Renato Colamarino Christophe Couratier Sylvie Courtois Alain Creange Antoine Danielli Thomas de Broucker Jérôme de Seze Gilles Defer Jérôme Delorme Béatrice Denis Fayçal Derouiche Philippe Devos Anne-Marie Deyrolle Michel Dib Joseph Dib Eric Diot Emmanuelle Doury Sophie Dufourd-Delalande Corinne Dupel-Pottier Patrick Dussaux Gilles Edan Thibault Edouard Jean-Pierre Escaillas Didier Ferriby Nicolas Fouillet Guillaume Fromager Tsouria Gaida-Rostane Philippe Gaida Guillaume Gal Guillaume Garrigues Annick Gayou-Joyeux Arnaud Gentil Philippe Gerard Julien Gere Laurence Gignoux Philippe Girard Pierric Giraud Michel Gouttard Pierre Gras Anne Marie Guennoc Michel Gugenheim Laurent Guilloton Karim Hadjout Patrick Hautecoeur Yawo Hegbe Olivier Heinzlef Patrice Henry Yann Herve Jihad Hijazi Pascale Homeyer Bernard Huttin Olivier Ille Alain Jager Laurentiu Jomir Nabil Kardous Agnès Kerouanton Comlan Paul Kpade Christophe Kubler Pierre Labauge François Lallement Nicolas Landragin David Axel Laplaud Henda Laribi Gilles Lavernhe Pierre-Éric Le Biez Françoise Le Bras Patrick Le Coz Josette Leche Sara Julia Leder Alain Legout Michele Levasseur Alberta Lorenzi-Pernot Pierre Louchart Fabien Louillet Laurent Magy Sophie Maillard Elisabeth Maillart Marcel Maillet-Vioud Catherine Mallecourt-Emberger Éric Manchon Alexandre Mania Laurent Martinez-Almoyna Mikel Martinez Serge Massengo Dominique Maugin Souraya Medjbeur Gayané Meliksetyan Michael Menassa Dalia Meshaka-Dimitri-Boulos Gérard Mick Thibault Moreau Antoine Moulignier Isabelle Mourand Jean-Philippe Muller Philippe Neuschwander Argentino Nibbio Chantal Nifle Jean-Bertin Nkendjuo Ghislain Nokam Talom Sophie Ory Ivania Patry Bernard Pedespan Jean Pelletier Delia-Gianina Pencu Bruno Perrouty Stéphane Peysson Irène Popa-Coman André Pouliquen Christophe Prat Adriana Prundean Fataï Radji Haja Tiana Rakotoharinandrasana Lilia Razlog Philippe Remy Christophe Robin Gilles Rodier Jérôme Romero Brigitte Roualdes François Rouhart Irene Ruggieri Feras Abdul Samad Irina Sarafiant Stephane Schaeffer Nicolas Schmidt Philippe Schuermans Nicolas Seiller Thierry Soisson Annie Sortais Bruno Stankoff Sabrina Stefanizzi-Debuc Laurent Suchet Jean Tardy Gregory Taurin Florent Thabuy Marie Theaudin Caroline Tilikete-Froment Ayman Tourbah Patricia Tourniaire Sylvie Trefouret Michel Vastene Pierre Verdure Patrick Vermersch Frédérique Viala Dorothée Videt-Gibou Elisabeth Vidry Sandra Vukusic Marc Wagner Valery Wattier Christophe Zaenker François Ziegler Jean-Médard Zola
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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Submitted on : Monday, March 14, 2022 - 2:28:37 PM
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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, Springer Healthcare, 2022, ⟨10.1007/s40120-022-00334-y⟩. ⟨hal-03608016⟩

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