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
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
Johanna Andersen
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- Function : Correspondent author
- PersonId : 1103039
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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
Marc Debouverie
- Function : Author
- PersonId : 762777
- IdRef : 068986629
Jonathan Ciron
- Function : Author
- PersonId : 795646
- ORCID : 0000-0002-3386-6308
- IdRef : 137599021
Elisabeth Maillart
- Function : Author
- PersonId : 768189
- ORCID : 0000-0003-0108-4720
Pierre Labauge
- Function : Author
- PersonId : 759958
- ORCID : 0000-0001-7759-8555
- IdRef : 059860367
Jean Pelletier
- Function : Author
- PersonId : 756935
- ORCID : 0000-0001-9730-7567
- IdRef : 078804868
Bruno Stankoff
- Function : Author
- PersonId : 1146488
- ORCID : 0000-0002-9631-4674
- IdRef : 070067988
Olivier Gout
- Function : Author
- PersonId : 946000
- IdRef : 052535118
Eric Thouvenot
- Function : Author
- PersonId : 758070
- ORCID : 0000-0001-8671-7747
- IdRef : 094970920
Jean-Philippe Camdessanché
- Function : Author
- PersonId : 775005
- ORCID : 0000-0002-5282-6707
Ivania Patry
- Function : Author
Corinne Pottier
- Function : Author
Emmanuelle Leray
- Function : Author
- PersonId : 18386
- IdHAL : emmanuelle-leray
- ORCID : 0000-0001-8424-4499
- IdRef : 099858185
Sandra Vukusic
- Function : Author
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- IdHAL : adil-maarouf
- ORCID : 0000-0002-6755-496X
- IdRef : 164833250
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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