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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

2022; Adis, Springer Healthcare; Volume: 11; Issue: 2 Linguagem: Inglês

10.1007/s40120-022-00334-y

2193-8253

Caroline Papeix, Giovanni Castelnovo, Emmanuelle Leray, Marc Coustans, Pierre Lévy, Jean-Marc Visy, Gisela Kobelt, Fabienne Lamy, Bashar Allaf, François Heintzmann, Isabelle Chouette, Éric Raponi, Barbara Durand, Emmanuelle Grevat, Driss Kamar, Marc Debouverie, Christine Lebrun‐Frénay, Abdelhakim Abdelmoumni, Mouhmmad Jamal Al Aloucy, Abdullatif Al Khedr, Amer Al Najjar Carpentier, Bernard Alonzo, Tony Altarcha, Amévi Ananivi, G. Androdias, Gilles Angibaud, Marie-Sylvie Artaud-Uriot, Dominique Audry-Chaboud, Marie Barré, P Barres, R. Benrabah, Éric 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 Camdessanché, William Camu, Christophe Carel, Bertrand Carlander, Olivier Casez, Giovanni Castelnovo, Marie-Pierre Chanel-Soulier, Stéphane Chapuis, Mirella Cimpoesu, Jonathan Ciron, Pierre Clavelou, Christine Clerc, R. Colamarino, C. Couratier, Sylvie Courtois, Marc Coustans, Alain Créange, Antoine Danielli, T. de Broucker, de Sèze, Marc Debouverie, Gilles Defer, J. Delorme, Béatrice Denis, Fayçal Derouiche, Philippe Devos, Anne-Marie Deyrolle, Michel Dib, Joseph E. Dib, E. Diot, Emmanuelle Doury, Sophie Dufourd-Delalande, Corinne Dupel-Pottier, Patrick Dussaux, Gilles Edan, Thibault Edouard, Jean-Pierre Escaillas, D. Ferriby, Nicolas Fouillet, Guillaume Fromager, Tsouria Gaida-Rostane, Philippe Gaida, Guillaume Gal, Guillaume Garrigues, Annick Gayou-Joyeux, Arnaud Gentil, Philippe Gérard, Julien Gere, Laurence Gignoux, Philippe Girard, P. Giraud, Michel Gouttard, Pierre Gras, Anne Marie Guennoc, Michel Gugenheim, L. Guilloton, Karim Hadjout, Patrick Hautecœur, Yawo Hegbe, Olivier Heinzlef, Patrice Henry, Yann Herve, Jihad Hijazi, Pascale Homeyer, Bernard Huttin, Olivier Ille, Alain Jager, Laurentiu Jomir, Nabil Kardous, A. Kerouanton, Comlan Kpade, Christophe Kubler, Pierre Labauge, F. Lallement, N. Landragin, David Laplaud, Henda Laribi, Gilles Lavernhe, Pierre-Éric Le Biez, Françoise Le Bras, P. Le Coz, Christine Lebrun‐Frénay, Josette Leche, Sara Julia Leder, Alain Legout, M Levasseur, Alberta Lorenzi-Pernot, Pierre Louchart, Fabien Louillet, Laurent Magy, Sophie Maillard, Élisabeth Maillart, Marcel Maillet-Vioud, Catherine Mallecourt-Emberger, Éric Manchon, Alexandre Mania, L. Martinez-Almoyna, Mikel Martínez, Serge Massengo, D. Maugin, S Medjbeur, Gayané Meliksetyan, Michael Menassa, Dalia Meshaka-Dimitri-Boulos, Gérard Mick, Thibault Moreau, Antoine Moulignier, Isabelle Mourand, Jean-Philippe Muller, Philippe Neuschwander, A 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 Rémy, Christophe Robin, G. Rodier, J.Rallo Romero, B Roualdès, F Rouhart, Irene Ruggieri, Feras Abdul Samad, Irina Sarafiant, S. Schaeffer, Nicolás Schmidt, P Schuermans, Nicolas Seiller, T. Soisson, Annie Sortais, Bruno Stankoff, Sabrina Stefanizzi-Debuc, Laurent Suchet, Jean Tardy, Grégory Taurin, Florent Thabuy, Marie Théaudin, Caroline Tilikete-Froment, Ayman Tourbah, Patricia Tourniaire, Sylvie Tréfouret, Michel Vastene, Pierre Verdure, Patrick Vermersch, Frédérique Viala, Dorothée Videt-Gibou, Elisabeth Vidry, Jean-Marc Visy, Sandra Vukusic, M. Wagner, Valery Wattier, C. Zaenker, F. Ziegler, Jean-Médard Zola,

Peripheral Neuropathies and Disorders

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. 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. 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). 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.