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Natalizumab Versus Fingolimod in Patients with Relapsing-Remitting Multiple Sclerosis: A Subgroup Analysis From Three International Cohorts

Sifat Sharmin 1 Mathilde Lefort 2, 3, 4 Johanna Balslev Andersen Emmanuelle Leray 5, 2, 3, 4 Dana Horakova 6 Eva Kubala Havrdova 6 Raed Alroughani Guillermo Izquierdo Serkan Ozakbas 7 Francesco Patti Marco Onofrj Alessandra Lugaresi Murat Terzi Pierre Grammond Francois Grand’maison Bassem Yamout Alexandre Prat Marc Girard Pierre Duquette Cavit Boz Maria Trojano Pamela Mccombe Mark Slee Jeannette Lechner-Scott Recai Turkoglu Patrizia Sola Diana Ferraro Franco Granella Julie Prevost Davide Maimone Olga Skibina Katherine Buzzard Anneke van der Walt Bart van Wijmeersch Tunde Csepany Daniele Spitaleri Steve Vucic Romain Casey 8, 9, 10, 11 Marc Debouverie 12, 13 Gilles Edan 3, 4 Jonathan Ciron 14 Aurélie Ruet 15, 16 Jérôme de Sèze 17 Elisabeth Maillart 18 Hélène Zephir 19 Pierre Labauge 20 Gilles Defer 21 Christine Lebrun-Frénay Thibault Moreau Eric Berger Pierre Clavelou 22 Jean Pelletier 23 Bruno Stankoff 24 Olivier Gout Eric Thouvenot 25 Olivier Heinzlef Abullatif Al-Khedr Bertrand Bourre Olivier Casez Philippe Cabre Alexis Montcuquet Abir Wahab Jean-Philippe Camdessanché Aude Maurousset Ivania Patry Karolina Hankiewicz Corinne Pottier Nicolas Maubeuge Céline Labeyrie Chantal Nifle David Laplaud 26, 27 Niels Koch-Henriksen Finn Thorup Sellebjerg Per Soelberg Soerensen Claudia Christina Pfleger Peter Vestergaard Rasmussen Michael Broksgaard Jensen Jette Lautrup Frederiksen Stephan Bramow Henrik Kahr Mathiesen Karen Ingrid Schreiber Melinda Magyari Sandra Vukusic 9, 10 Helmut Butzkueven 28 Tomas Kalincik 29, *
Abstract : Introduction: Natalizumab has proved to be more effective than fingolimod in reducing disease activity in relapsing-remitting multiple sclerosis (RRMS). Whether this association is universal for all patient groups remains to be determined.Objective: The aim of this study was to compare the relative effectiveness of natalizumab and fingolimod in RRMS subgroups defined by the baseline demographic and clinical characteristics of interest.Methods: Patients with RRMS who were given natalizumab or fingolimod were identified in a merged cohort from three international registries. Efficacy outcomes were compared across subgroups based on patients' sex, age, disease duration, Expanded Disability Status Scale (EDSS) score, and disease and magnetic resonance imaging (MRI) activity 12 months prior to treatment initiation. Study endpoints were number of relapses (analyzed with weighted negative binomial generalized linear model) and 6-month confirmed disability worsening and improvement events (weighted Cox proportional hazards model), recorded during study therapy. Each patient was weighted using inverse probability of treatment weighting based on propensity score.Results: A total of 5148 patients (natalizumab 1989; fingolimod 3159) were included, with a mean ± standard deviation age at baseline of 38 ± 10 years, and the majority (72%) were women. The median on-treatment follow-up was 25 (quartiles 15-41) months. Natalizumab was associated with fewer relapses than fingolimod (incidence rate ratio [IRR]; 95% confidence interval [CI]) in women (0.76; 0.65-0.88); in those aged ≤ 38 years (0.64; 0.54-0.76); in those with disease duration ≤ 7 years (0.63; 0.53-0.76); in those with EDSS score < 4 (0.75; 0.64-0.88), < 6 (0.80; 0.70-0.91), and ≥ 6 (0.52; 0.31-0.86); and in patients with pre-baseline relapses (0.74; 0.64-0.86). A higher probability of confirmed disability improvement on natalizumab versus fingolimod (hazard ratio [HR]; 95% CI) was observed among women (1.36; 1.10-1.66); those aged > 38 years (1.34; 1.04-1.73); those with disease duration > 7 years (1.33; 1.01-1.74); those with EDSS score < 6 (1.21; 1.01-1.46) and ≥ 6 (1.93; 1.11-3.34); and patients with no new MRI lesion (1.73; 1.19-2.51).Conclusions: Overall, in women, younger patients, those with shorter disease durations, and patients with pre-treatment relapses, natalizumab was associated with a lower frequency of multiple sclerosis relapses than fingolimod. It was also associated with an increased chance of recovery from disability among most patients, particularly women and those with no recent MRI activity.
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Submitted on : Wednesday, October 6, 2021 - 10:17:56 AM
Last modification on : Friday, October 22, 2021 - 2:48:10 PM

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Sifat Sharmin, Mathilde Lefort, Johanna Balslev Andersen, Emmanuelle Leray, Dana Horakova, et al.. Natalizumab Versus Fingolimod in Patients with Relapsing-Remitting Multiple Sclerosis: A Subgroup Analysis From Three International Cohorts. CNS Drugs, Springer Verlag, 2021, ⟨10.1007/s40263-021-00860-7⟩. ⟨hal-03367246⟩

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