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Article Dans Une Revue CNS Drugs Année : 2021

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)
1 University of Melbourne
2 REPERES - Recherche en Pharmaco-épidémiologie et Recours aux Soins
3 Centre Hospitalier Universitaire de Rennes [CHU Rennes] = Rennes University Hospital [Ponchaillou]
4 CIC - Centre d'Investigation Clinique [Rennes]
5 UCPH - University of Copenhagen = Københavns Universitet
6 EHESP - École des Hautes Études en Santé Publique [EHESP]
7 UK - Univerzita Karlova [Praha, Česká republika] = Charles University [Prague, Czech Republic]
8 Amiri hospital
9 Hospital Virgen Macarena
10 DEÜ - Dokuz Eylül Üniversitesi = Dokuz Eylül University [Izmir]
11 Unict - Università degli studi di Catania = University of Catania
12 G.F. Ingrassia Hospital
13 Ud'A - Università degli studi "G. d'Annunzio" Chieti-Pescara [Chieti-Pescara]
14 UNIBO - Alma Mater Studiorum Università di Bologna = University of Bologna
15 IRCCS - Institute of Neurological Science of Bologna
16 OMU - Ondokuz Mayis University
17 AUB - American University of Beirut Faculty of Medicine and Medical Center
18 CHUM - Centre Hospitalier de l'Université de Montréal
19 KTU - Karadeniz Technical University
20 UNIBA - Università degli studi di Bari Aldo Moro = University of Bari Aldo Moro
21 UQ [All campuses : Brisbane, Dutton Park Gatton, Herston, St Lucia and other locations] - The University of Queensland
22 RBWH - Royal Brisbane & Women's Hospital [Brisbane, Australia]
23 Flinders University [Adelaide, Australia]
24 UoN - University of Newcastle [Callaghan, Australia]
25 Azienda Ospedaleria Universitaria di Modena
26 UNIPR - Università degli studi di Parma = University of Parma
27 Azienda Ospedaliero-Universitaria di Parma = Maggiore Hospital in Parma
28 Monash University [Melbourne]
29 The Alfred Hospital
30 UHasselt - Hasselt University
31 University of Debrecen Egyetem [Debrecen]
32 San Giuseppe Moscati Hospital [Avellino, Italie]
33 Westmead Hospital [Sydney]
34 UCBL - Université Claude Bernard Lyon 1
35 HCL - Hospices Civils de Lyon
36 CRNL - Centre de recherche en neurosciences de Lyon - Lyon Neuroscience Research Center
37 Fondation Eugène Devic EDMUS
38 APEMAC - Adaptation, mesure et évaluation en santé. Approches interdisciplinaires
39 Service de neurologie [CHRU Nancy]
40 CHU Toulouse - Centre Hospitalier Universitaire de Toulouse
41 U1215 Inserm - UB - Neurocentre Magendie : Physiopathologie de la Plasticité Neuronale
42 CIC Bordeaux
43 Centre d’Investigation Clinique Plurithématique (CIC - P) - CIC Strasbourg
44 CHU Pitié-Salpêtrière [AP-HP]
45 CHRU Lille - Centre Hospitalier Régional Universitaire [CHU Lille]
46 CHRU Montpellier - Centre Hospitalier Régional Universitaire [Montpellier]
47 CHU Caen
48 CHU - Hôpital Pasteur [Nice]
49 Service de Neurologie générale, vasculaire et dégénérative (CHU de Dijon)
50 CHU Clermont-Ferrand
51 Neuro-Dol - Neuro-Dol
52 TIMONE - Hôpital de la Timone [CHU - APHM]
53 ICM - Institut du Cerveau = Paris Brain Institute
54 Fondation Ophtalmologique Adolphe de Rothschild [Paris]
55 IGF - Institut de Génomique Fonctionnelle
56 CHI Poissy-Saint-Germain
57 Service de neurologie [Amiens]
58 Service de neurologie [Rouen]
59 CHUGA - Centre Hospitalier Universitaire [CHU Grenoble]
60 CHU de la Martinique [Fort de France]
61 Service de Neurologie [CHU Limoges]
62 CHU Henri Mondor [Créteil]
63 CHU ST-E - Centre Hospitalier Universitaire de Saint-Etienne [CHU Saint-Etienne]
64 Service de Neurologie [Tours]
65 Hôpital Sud Francilien Corbeil Essonne
66 Centre Hospitalier de Saint-Denis [Ile-de-France]
67 Centre Hospitalier René Dubos [Pontoise]
68 Hôpital de la Milétrie
69 AP-HP Hôpital Bicêtre (Le Kremlin-Bicêtre)
70 CHV - Centre Hospitalier de Versailles André Mignot
71 CIC Nantes - Centre d’Investigation Clinique de Nantes
72 U1064 Inserm - CRTI - Centre de Recherche en Transplantation et Immunologie
73 Aarhus University Hospital
74 AAU - Aalborg University [Denmark]
75 University Hospital of Northern Sealand
76 Rigshospitalet [Copenhagen]
77 The Royal Melbourne Hospital
Raed Alroughani
  • Fonction : Auteur
Pierre Grammond
  • Fonction : Auteur
Francois Grand’maison
  • Fonction : Auteur
Recai Turkoglu
  • Fonction : Auteur
Julie Prevost
  • Fonction : Auteur
Davide Maimone
  • Fonction : Auteur
Jérôme de Sèze
  • Fonction : Auteur
Gilles Defer
  • Fonction : Auteur
Eric Berger
  • Fonction : Auteur
Pierre Clavelou
  • Fonction : Auteur
Jean Pelletier
Bruno Stankoff
Eric Thouvenot
  • Fonction : Auteur
  • PersonId : 1037455
Tomas Kalincik
  • Fonction : Auteur correspondant
  • PersonId : 1098429

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Résumé

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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Dates et versions

hal-03367246 , version 1 (06-10-2021)

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Citer

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, 2021, 35 (11), pp.1217-1232. ⟨10.1007/s40263-021-00860-7⟩. ⟨hal-03367246⟩
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