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Journal Articles Multiple Sclerosis and Related Disorders Year : 2021

The effectiveness of natalizumab vs fingolimod–A comparison of international registry studies

Johanna Andersen (1) , Sifat Sharmin (2) , Mathilde Lefort (3, 4, 5) , Nils Koch-Henriksen (6) , Finn Sellebjerg (7) , Per Soelberg Sørensen (1) , Claudia C. Pfleger , Peter Rasmussen , Michael Jensen , Jette Frederiksen , Stephan Bramow , Henrik Mathiesen , Karen Schreiber , Dana Horakova , Eva Havrdova , Raed Alroughani , Guillermo Izquierdo , Sara Eichau , Serkan Ozakbas , 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 , Vahid Shaygannejad , Julie Prevost , Olga Skibina , Claudio Solaro , Rana Karabudak , Bart Wijmeersch , Tunde Csepany , Daniele Spitaleri , Steve Vucic , Romain Casey (8) , Marc Debouverie (9) , Gilles Edan (5) , Jonathan Ciron (10) , Aurélie Ruet (11) , Jérôme Sèze (12) , Elisabeth Maillart (13) , Hélène Zephir (14) , Pierre Labauge (15, 16) , Gilles Defer (17) , Christine Lebrun (18) , Thibault Moreau (19) , Eric Berger (20) , Pierre Clavelou (21) , Jean Pelletier (22) , Bruno Stankoff (23) , Olivier Gout (24) , Eric Thouvenot (25, 26) , Olivier Heinzlef (27) , Abdullatif Al-Khedr (28) , Bertrand Bourre (29) , Olivier Casez (30) , Philippe Cabre (31) , Alexis Montcuquet (32) , Abir Wahab (33) , Jean-Philippe Camdessanché (34) , Aude Marousset (35) , Ivania Patry , Karolina Hankiewicz (36) , Corinne Pottier , Nicolas Maubeuge (37) , Céline Labeyrie (38) , Chantal Nifle (39) , Emmanuelle Leray (4, 3, 5) , David Laplaud (40, 41) , Helmut Butzkueven (2) , Tomas Kalincik (2) , Sandra Vukusic (1) , Melinda Magyari (1, 42)
1 UCPH - University of Copenhagen = Københavns Universitet
2 University of Melbourne
3 REPERES - Recherche en Pharmaco-épidémiologie et Recours aux Soins
4 CIC - Centre d'Investigation Clinique [Rennes]
5 Centre Hospitalier Universitaire de Rennes [CHU Rennes] = Rennes University Hospital
6 Aarhus University Hospital
7 Rigshospitalet [Copenhagen]
8 CRNL - Centre de recherche en neurosciences de Lyon - Lyon Neuroscience Research Center
9 CHRU Nancy - Centre Hospitalier Régional Universitaire de Nancy
10 CHU Toulouse - Centre Hospitalier Universitaire de Toulouse
11 CHU Bordeaux [Bordeaux]
12 CHU Strasbourg
13 CHU Pitié-Salpêtrière [AP-HP]
14 CHRU Lille - Centre Hospitalier Régional Universitaire [Lille]
15 CHRU Montpellier - Centre Hospitalier Régional Universitaire [Montpellier]
16 UM - Université de Montpellier
17 CHU Caen
18 CHU Nice - Centre Hospitalier Universitaire de Nice
19 CHU Dijon - Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand
20 CHRU Besançon - Centre Hospitalier Régional Universitaire de Besançon
21 CHU Clermont-Ferrand
22 TIMONE - Hôpital de la Timone [CHU - APHM]
23 AP-HP - Assistance publique - Hôpitaux de Paris (AP-HP)
24 Hôpital de la Fondation Ophtalmologique Adolphe de Rothschild [AP-HP]
25 CHU Nîmes - Centre Hospitalier Universitaire de Nîmes
26 IGF - Institut de Génomique Fonctionnelle
27 Centre hospitalier intercommunal de Poissy/Saint-Germain-en-Laye - CHIPS [Poissy]
28 CHU Amiens-Picardie
29 CHU Rouen
30 CHU - Centre Hospitalier Universitaire [Grenoble]
31 CHU de la Martinique [Fort de France]
32 CHU Limoges
33 Hôpital Henri Mondor
34 CHU ST-E - Centre Hospitalier Universitaire de Saint-Etienne [CHU Saint-Etienne]
35 CHU Trousseau [Tours]
36 Centre Hospitalier de Saint-Denis [Ile-de-France]
37 CHU Poitiers - Centre hospitalier universitaire de Poitiers
38 AP-HP Hôpital Bicêtre (Le Kremlin-Bicêtre)
39 CHV - Centre Hospitalier de Versailles André Mignot
40 CIC Nantes - Centre d’Investigation Clinique de Nantes
41 CHU Nantes - Centre hospitalier universitaire de Nantes
42 Copenhagen University Hospital
Claudia C. Pfleger
  • Function : Author
Peter Rasmussen
  • Function : Author
Michael Jensen
  • Function : Author
Jette Frederiksen
  • Function : Author
Stephan Bramow
  • Function : Author
Henrik Mathiesen
  • Function : Author
Karen Schreiber
  • Function : Author
Dana Horakova
  • Function : Author
Eva Havrdova
  • Function : Author
Raed Alroughani
  • Function : Author
Guillermo Izquierdo
  • Function : Author
Sara Eichau
  • Function : Author
Serkan Ozakbas
  • Function : Author
Francesco Patti
  • Function : Author
Marco Onofrj
  • Function : Author
Alessandra Lugaresi
  • Function : Author
Murat Terzi
  • Function : Author
Pierre Grammond
  • Function : Author
Francois Grand Maison
  • Function : Author
Bassem Yamout
  • Function : Author
Alexandre Prat
  • Function : Author
Marc Girard
  • Function : Author
Pierre Duquette
  • Function : Author
Cavit Boz
  • Function : Author
Maria Trojano
  • Function : Author
Pamela Mccombe
  • Function : Author
Mark Slee
  • Function : Author
Jeannette Lechner-Scott
  • Function : Author
Recai Turkoglu
  • Function : Author
Patrizia Sola
  • Function : Author
Diana Ferraro
  • Function : Author
Franco Granella
  • Function : Author
Vahid Shaygannejad
  • Function : Author
Julie Prevost
  • Function : Author
Olga Skibina
  • Function : Author
Claudio Solaro
  • Function : Author
Rana Karabudak
  • Function : Author
Bart Wijmeersch
  • Function : Author
Tunde Csepany
  • Function : Author
Daniele Spitaleri
  • Function : Author
Steve Vucic
  • Function : Author
Jérôme Sèze
  • Function : Author
Elisabeth Maillart
Gilles Defer
  • Function : Author
Jean Pelletier
Bertrand Bourre
  • Function : Author
Alexis Montcuquet
  • Function : Author
Abir Wahab
  • Function : Author
Ivania Patry
  • Function : Author
Corinne Pottier
  • Function : Author

Abstract

Background: Natalizumab and fingolimod were the first preparations recommended for disease breakthrough in priorly treated relapsing-remitting multiple sclerosis. Of three published head-to-head studies two showed that natalizumab is the more effective to prevent relapses and EDSS worsening.Methods: By re-analyzing original published results from MSBase, France, and Denmark using uniform methodologies, we aimed at identifying the effects of differences in methodology, in the MS-populations, and at re-evaluating the differences in effectiveness between the two drugs. We gained access to copies of the individual amended databases and pooled all data. We used uniform inclusion/exclusion criteria and statistical methods with Inverse Probability Treatment Weighting.Results: The pooled analyses comprised 968 natalizumab- and 1479 fingolimod treated patients. The on-treatment natalizumab/fingolimod relapse rate ratio was 0.77 (p=0.004). The hazard ratio (HR) for a first relapse was 0.82 (p=0.030), and the HR for sustained EDSS improvement was 1.4 (p=0.009). There were modest differences between each of the original published studies and the replication study, but the conclusions of the three original studies remained unchanged: in two of them natalizumab was more effective, but in the third there was no difference between natalizumab and fingolimod.Conclusion: The results were largely invariant to the epidemiological and statistical methods but differed between the MS populations. Generally, the advantage of natalizumab was confirmed.
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Dates and versions

hal-03268539 , version 1 (01-07-2021)

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Johanna Andersen, Sifat Sharmin, Mathilde Lefort, Nils Koch-Henriksen, Finn Sellebjerg, et al.. The effectiveness of natalizumab vs fingolimod–A comparison of international registry studies. Multiple Sclerosis and Related Disorders, 2021, 53, pp.103012. ⟨10.1016/j.msard.2021.103012⟩. ⟨hal-03268539⟩
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