Skip to Main content Skip to Navigation
Journal articles

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 5 Emmanuelle Leray 6, 2, 3, 4 Dana Horakova 7 Eva Kubala Havrdova 7 Raed Alroughani 8 Guillermo Izquierdo 9 Serkan Ozakbas 10 Francesco Patti 11, 12 Marco Onofrj 13 Alessandra Lugaresi 14, 15 Murat Terzi 16 Pierre Grammond Francois Grand’maison Bassem Yamout 17 Alexandre Prat 18 Marc Girard 18 Pierre Duquette 18 Cavit Boz 19 Maria Trojano 20 Pamela Mccombe 21, 22 Mark Slee 23 Jeannette Lechner-Scott 24 Recai Turkoglu Patrizia Sola 25 Diana Ferraro 25 Franco Granella 26, 27 Julie Prevost Davide Maimone Olga Skibina 28, 29 Katherine Buzzard 29, 28 Anneke van Der Walt 29, 28 Bart van Wijmeersch 30 Tunde Csepany 31 Daniele Spitaleri 32 Steve Vucic 33 Romain Casey 34, 35, 36, 37 Marc Debouverie 38, 39 Gilles Edan 3, 4 Jonathan Ciron 40 Aurélie Ruet 41, 42 Jérôme de Sèze 43 Elisabeth Maillart 44 Hélène Zephir 45 Pierre Labauge 46 Gilles Defer 47 Christine Lebrun-Frénay 48 Thibault Moreau 49 Eric Berger 50 Pierre Clavelou 51 Jean Pelletier 52 Bruno Stankoff 53 Olivier Gout 54 Eric Thouvenot 55 Olivier Heinzlef 56 Abullatif Al-Khedr 57 Bertrand Bourre 58 Olivier Casez 59 Philippe Cabre 60 Alexis Montcuquet 61 Abir Wahab 62 Jean-Philippe Camdessanché 63 Aude Maurousset 64 Ivania Patry 65 Karolina Hankiewicz 66 Corinne Pottier 67 Nicolas Maubeuge 68 Céline Labeyrie 69 Chantal Nifle 70 David Laplaud 71, 72 Niels Koch-Henriksen 73 Finn Thorup Sellebjerg 5 Per Soelberg Soerensen 5 Claudia Christina Pfleger 74 Peter Vestergaard Rasmussen 73 Michael Broksgaard Jensen 75 Jette Lautrup Frederiksen 76, 5 Stephan Bramow 5 Henrik Kahr Mathiesen 5 Karen Ingrid Schreiber 5 Melinda Magyari 5 Sandra Vukusic 35, 36 Helmut Butzkueven 28 Tomas Kalincik 77, * 
* Corresponding author
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.
Document type :
Journal articles
Complete list of metadata

https://hal-univ-rennes1.archives-ouvertes.fr/hal-03367246
Contributor : Laurent Jonchère Connect in order to contact the contributor
Submitted on : Wednesday, October 6, 2021 - 10:17:56 AM
Last modification on : Friday, August 5, 2022 - 2:30:05 PM

Identifiers

Citation

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, 35 (11), pp.1217-1232. ⟨10.1007/s40263-021-00860-7⟩. ⟨hal-03367246⟩

Share

Metrics

Record views

70