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Title: | Natalizumab Versus Fingolimod in Patients with Relapsing-Remitting Multiple Sclerosis: A Subgroup Analysis From Three International Cohorts | Authors: | Sharmin, Sifat Lefort, Mathilde Andersen, Johanna Balslev Leray, Emmanuelle Horakova, Dana Havrdova, Eva Kubala Alroughani, Raed Izquierdo, Guillermo Ozakbas, Serkan Patti, Francesco Onofrj, Marco Lugaresi, Alessandra Terzi, Murat Grammond, Pierre Grand'Maison, Francois Yamout, Bassem Prat, Alexandre Girard, Marc Duquette, Pierre Boz, Cavit Trojano, Maria McCombe, Pamela Slee, Mark Lechner-Scott, Jeannette Turkoglu, Recai Sola, Patrizia Ferraro, Diana Granella, Franco Prevost, Julie Maimone, Davide Skibina, Olga Buzzard, Katherine Van der Walt, Anneke VAN WIJMEERSCH, Bart Csepany, Tunde Spitaleri, Daniele Vucic, Steve Casey, Romain Debouverie, Marc Edan, Gilles Ciron, Jonathan Ruet, Aurelie De Seze, Jerome Maillart, Elisabeth Zephir, Helene Labauge, Pierre Defer, Gilles Lebrun-Frenay, Christine Moreau, Thibault Berger, Eric Clavelou, Pierre Pelletier, Jean Stankoff, Bruno Gout, Olivier Thouvenot, Eric Heinzlef, Olivier Al-Khedr, Abullatif Bourre, Bertrand Casez, Olivier Cabre, Philippe Montcuquet, Alexis Wahab, Abir Camdessanche, Jean-Philippe Maurousset, Aude Patry, Ivania Hankiewicz, Karolina Pottier, Corinne Maubeuge, Nicolas Labeyrie, Celine Nifle, Chantal Laplaud, David Koch-Henriksen, Niels Sellebjerg, Finn Thorup Soerensen, Per Soelberg Pfleger, Claudia Christina Rasmussen, Peter Vestergaard Jensen, Michael Broksgaard Frederiksen, Jette Lautrup Bramow, Stephan Mathiesen, Henrik Kahr Schreiber, Karen Ingrid Magyari, Melinda Vukusic, Sandra Butzkueven, Helmut Kalincik, Tomas |
Issue Date: | 2021 | Publisher: | ADIS INT LTD | Source: | CNS DRUGS, 35 (11) , p. 1217 -1232 | 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. | Notes: | Kalincik, T (corresponding author), Univ Melbourne, Dept Med, CORE, L4 East,Grattan St, Melbourne, Vic 3050, Australia.; Kalincik, T (corresponding author), Royal Melbourne Hosp, Dept Med, MS Ctr, Melbourne, Vic, Australia. tomas.kalincik@unimelb.edu.au |
Document URI: | http://hdl.handle.net/1942/36025 | ISSN: | 1172-7047 | e-ISSN: | 1179-1934 | DOI: | 10.1007/s40263-021-00860-7 | ISI #: | WOS:000697081200001 | Category: | A1 | Type: | Journal Contribution | Validations: | ecoom 2022 |
Appears in Collections: | Research publications |
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