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Comparative efficacy of fingolimod vs natalizumab

2016; Lippincott Williams & Wilkins; Volume: 86; Issue: 8 Linguagem: Inglês

10.1212/wnl.0000000000002395

1526-632X

Laëtitia Barbin, Chloé Rousseau, Natacha Jousset, Romain Casey, Marc Debouverie, Sandra Vukusic, de Sèze, David Brassat, Sandrine Wiertlewski, Bruno Brochet, Jean Pelletier, Patrick Vermersch, Gilles Edan, Christine Lebrun‐Frénay, Pierre Clavelou, Éric Thouvenot, Jean‐Philippe Camdessanché, Ayman Tourbah, Bruno Stankoff, Abdullatif Al Khedr, Philippe Cabre, Caroline Papeix, Éric Berger, Olivier Heinzlef, Thomas Debroucker, Thibault Moreau, Olivier Gout, Bertrand Bourre, Alain Créange, Pierre Labauge, Laurent Magy, Gilles Defer, Yohann Foucher, David Laplaud, O. Anne, Bertrand Audouin, Éric Berger, David Brassat, Bruno Brochet, Bertrand Bourre, P. Cabré, Jean‐Philippe Camdessanché, O. Casez, Pierre Clavelou, Nicolas Collongues, Marc Coustans, Alain Créange, Marc Debouverie, G. Defer, Nathalie Derache, de Sèze, Dominique Dive, Agnès Fromont, R. Guider, J Grimaud, O. Heinzlef, Arnaud Kiatkoswki, Pierre Labauge, David Laplaud, Christine Lebrun‐Frénay, Emmanuelle Le Page, Romain Marignier, T. Moreau, Jean‐Christophe Ouallet, Caroline Papeix, Jean Pelletier, Sophie Pittion, L. Rumbach, Myriam Schluep, Pierrette Seeldrayers, I. Slassi Sennou, B. Stankoff, Frederic Thaite, Ayman Tourbah, Éric Thouvenot, Patrick Vermersch, Sandra Vukusic, Sandrine Wiertlewski, Hélène Zéphir, Sandra Vukusic, Michel Clanet, Bertrand Fontaine, Bruno Stankoff, Thibault Moreau, Bruno Brochet, Jean Pelletier, de Sèze, François Cotton, Vincent Dousset, David Laplaud, de Sèze, Sandra Vukusic, Romain Marignier, Françoise Durand‐Dubief, Marc Debouverie, Francis Guillemin, S. Pittion‐Vouyovitch, Gilles Edan, Emmanuelle Leray, Emmanuelle Le Page, Michel Clanet, David Brassat, Bruno Brochet, Jean‐Christophe Ouallet, Catherine Lubetzki, Bertrand Fontaine, Caroline Papeix, Bruno Stankoff, Alain Créange, Yann Mikaeloff, Kumaran Deiva, Marie Théaudin, Olivier Gout, Caroline Bensa, Olivier Heinzlef, Nicolas Collongues, Patrick Vermersch, Hélène Zéphir, Olivier Outteryck, Patrick Hautecœur, Arnaud Kwiatkowski, Christine Lebrun‐Frénay, Mikaël Cohen, Thibault Moreau, Agnès Fromont, Pierre Clavelou, Sandrine Wiertlewski, Jean Pelletier, Bertrand Audoin, Audrey Rico-Lamy, G. Defer, Nathalie Derache, Éric Berger, Giovanni Castelnovo, Éric Thouvenot, Philippe Cabre, Pierre Labauge, William Camu, Bertrand Bourre, Jean‐Philippe Camdessanché, Laurent Magy, Alexis Montcuquet, Abdelatif Al-Khedr, Ayman Tourbah, Olivier Casez, Anne-Marie Guennnoc, Jonathan Ciron, Sophie Pittion, Romain Marignier, Nathalie Derache, Françoise Durand‐Dubief, Nicolas Collongues, Marie‐Céline Fleury, Michel Clanet, Laure Michel, Jean‐Christophe Ouallet, Aurélie Ruet, Bertrand Audouin, Audrey Rico, Hélène Zéphir, Emmanuelle Le Page, V. Deburghgraeve, Mikaël Cohen, Giovanni Castelnovo, Catherine Lubetzki, Agnès Fromont, Caroline Bensa, Jean‐Michel Vallat,

Polyomavirus and related diseases

To compare natalizumab and fingolimod on both clinical and MRI outcomes in patients with relapsing-remitting multiple sclerosis (RRMS) from 27 multiple sclerosis centers participating in the French follow-up cohort Observatoire of Multiple Sclerosis.Patients with RRMS included in the study were aged from 18 to 65 years with an Expanded Disability Status Scale score of 0-5.5 and an available brain MRI performed within the year before treatment initiation. The data were collected for 326 patients treated with natalizumab and 303 with fingolimod. The statistical analysis was performed using 2 different methods: logistic regression and propensity scores (inverse probability treatment weighting).The confounder-adjusted proportion of patients with at least one relapse within the first and second year of treatment was lower in natalizumab-treated patients compared to the fingolimod group (21.1% vs 30.4% at first year, p = 0.0092; and 30.9% vs 41.7% at second year, p = 0.0059) and supported the trend observed in nonadjusted analysis (21.2% vs 27.1% at 1 year, p = 0.0775). Such statistically significant associations were also observed for gadolinium (Gd)-enhancing lesions and new T2 lesions at both 1 year (Gd-enhancing lesions: 9.3% vs 29.8%, p < 0.0001; new T2 lesions: 10.6% vs 29.6%, p < 0.0001) and 2 years (Gd-enhancing lesions: 9.1% vs 22.1%, p = 0.0025; new T2 lesions: 16.9% vs 34.1%, p = 0.0010) post treatment initiation.Taken together, these results suggest the superiority of natalizumab over fingolimod to prevent relapses and new T2 and Gd-enhancing lesions at 1 and 2 years.This study provides Class IV evidence that for patients with RRMS, natalizumab decreases the proportion of patients with at least one relapse within the first year of treatment compared to fingolimod.