Comparative efficacy of fingolimod vs natalizumab

Laetitia Barbin, Chloe Rousseau, Natacha Jousset, Romain Casey, Marc Debouverie, Sandra Vukusic, Jerome De Sèze, David Brassat, Sandrine Wiertlewski, Bruno Brochet, Jean Pelletier, Patrick Vermersch, Gilles Edan, Christine Lebrun-Frenay, Pierre Clavelou, Eric Thouvenot, Jean-Philippe Camdessanché, Ayman Tourbah, Bruno Stankoff, Abdullatif Al Khedr, Philippe Cabre, Caroline Papeix, Eric Berger, Olivier Heinzlef, Thomas Debroucker, Thibault Moreau, Olivier Gout, Bertrand Bourre, Alain Créange, Pierre Labauge, Laurent Magy, Gilles Defer, Yohann Foucher, David A. Laplaud, O. Anne, B. Audouin, E. Berger, D. Brassat, B. Brochet, B. Bourre, P. Cabre, J.P. Camdessanché, O. Casez, P. Clavelou, N. Collongues, M. Coustans, A. Créange, M. Debouverie, G. Defer, N. Derache, J. de Seze, D. Dive, A. Fromont, R. Guider, J. Grimaud, O. Heinzlef, A. Kiatkoswki, P. Labauge, D. Laplaud, C. Lebrun, E. Le Page, R. Marignier, T. Moreau, J.C. Ouallet, C. Papeix, J. Pelletier, S. Pittion, L. Rumbach, M. Schluep, P. Seeldrayers, I.S. Sennou, B. Stankoff, F. Thaite, A. Tourbah, E. Thouvenot, P. Vermersch, S. Vukusic, S. Wiertlewski, H. Zephir, Sandra Vukusic, Michel Clanet, Bertrand Fontaine, Bruno Stankoff, Thibault Moreau, Bruno Brochet, Jean Pelletier, Jérôme de Seze, François Cotton, Vincent Dousset, David Laplaud, Jérôme de Seze, Sandra Vukusic, Romain Marignier, Françoise Durand-Dubief, Marc Debouverie, Francis Guillemin, Sophie 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 Creange, Yann Mikaeloff, Kumaran Deiva, Marie Theaudin, Olivier Gout, Caroline Bensa, Olivier Heinzlef, Nicolas Collongues, Patrick Vermersch, Hélène Zephir, Olivier Outteryck, Patrick Hautecoeur, Arnaud Kwiatkowski, Christine Lebrun-Frenay, Mikael Cohen, Thibault Moreau, Agnès Fromont, Pierre Clavelou, Sandrine Wiertlewski, Jean Pelletier, Bertrand Audoin, Audrey Rico-Lamy, Gilles Defer, Nathalie Derache, Eric Berger, Giovanni Castelnovo, Eric Thouvenot, Philippe Cabre, Pierre Labauge, William Camu, Bertrand Bourre, Jean-Philippe CAMDESSANCHE, Laurent Magy, Alexis Montcuquet, Abdelatif Al-Khedr, Ayman Tourbah, Olivier Casez, Anne-Marie Guennnoc, Jonathan Ciron, S. Pittion, R. Marignier, N. Derache, F. Durand-Dubief, N. Collongues, M. Fleury, M. Clanet, L. Michel, J.C. Ouallet, A. Ruet, B. Audouin, A. Rico, H. Zephir, E. Le Page, V. Deburghgraeve, M. Cohen, G. Castelnovo, C. Lubetzki, A. Fromont, C. Bensa, J.M. Vallat

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.