التفاصيل البيبلوغرافية
| العنوان: |
Long-Term Effectiveness, Safety and Tolerability of Fingolimod in Patients with Multiple Sclerosis in Real-World Treatment Settings in France: The VIRGILE Study |
| المؤلفون: |
Papeix, Caroline, Castelnovo, Giovanni, Leray, Emmanuelle, Coustans, Marc, Levy, Pierre, Visy, Jean-Marc, Kobelt, Gisela, Lamy, Fabienne, Allaf, Bashar, Heintzmann, François, Chouette, Isabelle, Raponi, Eric, Durand, Barbara, Grevat, Emmanuelle, Kamar, Driss, Debouverie, Marc, Lebrun-Frenay, Christine, Abdelmoumni, Abdelhakim, Al Aloucy, Mouhmmad Jamal, Al Khedr, Abdullatif, Al Najjar Carpentier, Amer, Alonzo, Bernard, Altarcha, Tony, Ananivi, Amevi, Androdias, Géraldine, Angibaud, Gilles, Artaud-Uriot, Marie-Sylvie, Audry-Chaboud, Dominique, Barre, Marie, Barres, Philippe, Benrabah, Rabah, Berger, Eric, Bergouignan, François-Xavier, Bernady, Patricia, Billy, Christophe, Blanchard, Christian, Bonnan, Mickaël, Borsotti, Jean-Paul, Bossu-van Nieuwenhuyse, Catherine, Bouffeteau, Jean-Claude, Bouillaguet, Sophie, Boukriche, Yassine, Boulesteix, Jean-Marc, Bourre, Bertrand, Brassat, David, Bredin, Alain, Brochet, Bruno, Brugeilles Baguelin, Helene, Camara, Ousmane, Camdessanche, Jean-Philippe, Camu, William, Carel, Christophe, Carlander, Bertrand, Casez, Olivier, Chanel-Soulier, Marie-Pierre, Chapuis, Stéphane, Cimpoesu, Mirella, Ciron, Jonathan, Clavelou, Pierre, Clerc, Christine, Colamarino, Renato, Couratier, Christophe, Courtois, Sylvie, Creange, Alain, Danielli, Antoine, de Broucker, Thomas, de Seze, Jérôme, Defer, Gilles, Delorme, Jérôme, Denis, Béatrice, Derouiche, Fayçal, Devos, Philippe, Deyrolle, Anne-Marie, Dib, Michel, Dib, Joseph, Diot, Eric, Doury, Emmanuelle, Dufourd-Delalande, Sophie, Dupel-Pottier, Corinne, Dussaux, Patrick, Edan, Gilles, Edouard, Thibault, Escaillas, Jean-Pierre, Ferriby, Didier, Fouillet, Nicolas, Fromager, Guillaume, Gaida-Rostane, Tsouria, Gaida, Philippe, Gal, Guillaume, Garrigues, Guillaume, Gayou-Joyeux, Annick, Gentil, Arnaud, Gerard, Philippe, Gere, Julien, Gignoux, Laurence, Girard, Philippe, Giraud, Pierric, Gouttard, Michel, Gras, Pierre, Guennoc, Anne Marie, Gugenheim, Michel, Guilloton, Laurent, Hadjout, Karim, Hautecoeur, Patrick, Hegbe, Yawo, Heinzlef, Olivier, Henry, Patrice, Herve, Yann, Hijazi, Jihad, Homeyer, Pascale, Huttin, Bernard, Ille, Olivier, Jager, Alain, Jomir, Laurentiu, Kardous, Nabil, Kerouanton, Agnès, Kpade, Comlan Paul, Kubler, Christophe, Labauge, Pierre, Lallement, François, Landragin, Nicolas, Laplaud, David Axel, Laribi, Henda, Lavernhe, Gilles, Le Biez, Pierre-Éric, Le Bras, Françoise, Le Coz, Patrick, Leche, Josette, Leder, Sara Julia, Legout, Alain, Levasseur, Michele, Lorenzi-Pernot, Alberta, Louchart, Pierre, Louillet, Fabien, Magy, Laurent, Maillard, Sophie, Maillart, Elisabeth, Maillet-Vioud, Marcel, Mallecourt-Emberger, Catherine, Manchon, Éric, Mania, Alexandre, Martinez-Almoyna, Laurent, Martinez, Mikel, Massengo, Serge, Maugin, Dominique, Medjbeur, Souraya, Meliksetyan, Gayané, Menassa, Michael, Meshaka-Dimitri-Boulos, Dalia, Mick, Gérard, Moreau, Thibault, Moulignier, Antoine, Mourand, Isabelle, Muller, Jean-Philippe, Neuschwander, Philippe, Nibbio, Argentino, Nifle, Chantal, Nkendjuo, Jean-Bertin, Nokam Talom, Ghislain, Ory, Sophie, Patry, Ivania, Pedespan, Bernard, Pelletier, Jean, Pencu, Delia-Gianina, Perrouty, Bruno, Peysson, Stéphane, Popa-Coman, Irène, Pouliquen, André, Prat, Christophe, Prundean, Adriana, Radji, Fataï, Rakotoharinandrasana, Haja Tiana, Razlog, Lilia, Remy, Philippe, Robin, Christophe, Rodier, Gilles, Romero, Jérôme, Roualdes, Brigitte, Rouhart, François, Ruggieri, Irene, Samad, Feras Abdul, Sarafiant, Irina, Schaeffer, Stephane, Schmidt, Nicolas, Schuermans, Philippe, Seiller, Nicolas, Soisson, Thierry, Sortais, Annie, Stankoff, Bruno, Stefanizzi-Debuc, Sabrina, Suchet, Laurent, Tardy, Jean, Taurin, Gregory, Thabuy, Florent, Theaudin, Marie, Tilikete-Froment, Caroline, Tourbah, Ayman, Tourniaire, Patricia, Trefouret, Sylvie, Vastene, Michel, Verdure, Pierre, Vermersch, Patrick, Viala, Frédérique, Videt-Gibou, Dorothée, Vidry, Elisabeth, Vukusic, Sandra, Wagner, Marc, Wattier, Valery, Zaenker, Christophe, Ziegler, François, Zola, Jean-Médard |
| المساهمون: |
Arènes: politique, santé publique, environnement, médias (ARENES), Université de Rennes (UR)-Institut d'Études Politiques IEP - Rennes-École des Hautes Études en Santé Publique EHESP (EHESP)-Université de Rennes 2 (UR2)-Centre National de la Recherche Scientifique (CNRS), École des Hautes Études en Santé Publique EHESP (EHESP), Département Méthodes quantitatives en santé publique (METIS), Collectif de recherche handicap, autonomie et société inclusive (CoRHASI) |
| المصدر: |
ISSN: 2193-8253. |
| بيانات النشر: |
HAL CCSD
Springer Healthcare |
| سنة النشر: |
2022 |
| المجموعة: |
EHESP - Productions scientifiques de l'Ecole des hautes études en santé publique |
| مصطلحات موضوعية: |
Disability, Disease-modifying treatment, Effectiveness, Quality of life, Radiological markers, Relapsing–remitting multiple sclerosis, Tolerability, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie |
| الوصف: |
Online ahead of print ; International audience ; 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 ... |
| نوع الوثيقة: |
article in journal/newspaper |
| اللغة: |
English |
| العلاقة: |
info:eu-repo/semantics/altIdentifier/pmid/35147904; hal-03608016; https://ehesp.hal.science/hal-03608016Test; https://ehesp.hal.science/hal-03608016/documentTest; https://ehesp.hal.science/hal-03608016/file/Papeix2022_Article_Long-TermEffectivenessSafetyAn.pdfTest; PUBMED: 35147904 |
| DOI: |
10.1007/s40120-022-00334-y |
| الإتاحة: |
https://doi.org/10.1007/s40120-022-00334-yTest
https://ehesp.hal.science/hal-03608016Test
https://ehesp.hal.science/hal-03608016/documentTest
https://ehesp.hal.science/hal-03608016/file/Papeix2022_Article_Long-TermEffectivenessSafetyAn.pdfTest |
| حقوق: |
info:eu-repo/semantics/OpenAccess |
| رقم الانضمام: |
edsbas.155FD5C0 |
| قاعدة البيانات: |
BASE |
