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

Johanna Andersen; Sifat Sharmin; Mathilde Lefort; Nils Koch-Henriksen; Finn Sellebjerg; Per Soelberg Sørensen; 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; Marc Debouverie; Gilles Edan; Jonathan Ciron; Aurélie Ruet; Jérôme Sèze; Elisabeth Maillart; Hélène Zephir; Pierre Labauge; Gilles Defer; Christine Lebrun; Thibault Moreau; Eric Berger; Pierre Clavelou; Jean Pelletier; Bruno Stankoff; Olivier Gout; Eric Thouvenot; Olivier Heinzlef; Abdullatif Al-Khedr; Bertrand Bourre; Olivier Casez; Philippe Cabre; Alexis Montcuquet; Abir Wahab; Jean-Philippe Camdessanché; Aude Marousset; Ivania Patry; Karolina Hankiewicz; Corinne Pottier; Nicolas Maubeuge; Céline Labeyrie; Chantal Nifle; Emmanuelle Leray; David Laplaud; Helmut Butzkueven; Tomas Kalincik; Sandra Vukusic; Melinda Magyari

doi:10.1016/j.msard.2021.103012

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

Journal article

Open access

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

Johanna Andersen, Sifat Sharmin, Mathilde Lefort, Nils Koch-Henriksen, Finn Sellebjerg, Per Soelberg Sørensen, Claudia C. Pfleger, Peter Rasmussen, Michael Jensen, Jette Frederiksen, …

Multiple Sclerosis and Related Disorders, Vol.53

08/2021

DOI: https://doi.org/10.1016/j.msard.2021.103012

PMID: 34116480

Abstract

Fingolimod

Head-to-head comparison

Multiple sclerosis

Natalizumab

Treatment effectiveness

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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Title: The effectiveness of natalizumab vs fingolimod–A comparison of international registry studies
Creators - without role: Johanna Andersen - University of Copenhagen
Sifat Sharmin - University of Melbourne
Mathilde Lefort - Inserm
Nils Koch-Henriksen - Aarhus University Hospital
Finn Sellebjerg - Danish Multiple Sclerosis Center
Per Soelberg Sørensen - Danish Multiple Sclerosis Center
Claudia C. Pfleger
Peter Rasmussen - Aarhus University Hospital
Michael Jensen - Northern Hospital
Jette Frederiksen - Rigshospitalet
Stephan Bramow - Danish Multiple Sclerosis Center
Henrik Mathiesen - University of Copenhagen
Karen Schreiber - Danish Multiple Sclerosis Center
Dana Horakova - Charles University
Eva Havrdova - Charles University
Raed Alroughani - Amiri Hospital
Guillermo Izquierdo - Hospital Universitario Virgen Macarena
Sara Eichau - Hospital Universitario Virgen Macarena
Serkan Ozakbas - Dokuz Eylül University
Francesco Patti - University of Catania
Marco Onofrj - University of Chieti-Pescara
Alessandra Lugaresi - Istituto delle Scienze Neurologiche di Bologna
Murat Terzi - Ondokuz Mayıs University
Pierre Grammond - Centre intégré de santé et de services sociaux de Chaudière-Appalaches
Francois Grand Maison
Bassem Yamout - American University of Beirut Medical Center
Alexandre Prat - Hôpital Notre-Dame
Marc Girard - Hôpital Notre-Dame
Pierre Duquette - Université de Montréal
Cavit Boz - Farabi Hastanesi
Maria Trojano - University of Bari Aldo Moro
Pamela Mccombe - Royal Brisbane and Women's Hospital
Mark Slee - Flinders University
Jeannette Lechner-Scott - John Hunter Hospital
Recai Turkoglu - Haydarpaşa Numune Eğitim ve Araştırma Hastanesi
Patrizia Sola - Policlinico di Modena
Diana Ferraro - Policlinico di Modena
Franco Granella - University of Parma
Vahid Shaygannejad - Isfahan University of Medical Sciences
Julie Prevost - Cegep de Saint Jerome
Olga Skibina - Monash University
Claudio Solaro
Rana Karabudak - Hacettepe University
Bart Wijmeersch
Tunde Csepany - University of Debrecen
Daniele Spitaleri - Azienda Ospedaliera S.Giuseppe Moscati
Steve Vucic - Westmead Hospital
Romain Casey - Observatoire Français de la Sclérose en Plaques
Marc Debouverie - Centre Hospitalier Régional et Universitaire de Nancy
Gilles Edan - Centre Hospitalier Universitaire de Rennes
Jonathan Ciron - Centre Hospitalier Universitaire de Toulouse
Aurélie Ruet - Hôpital Pellegrin
Jérôme Sèze - Centre Hospitalier Universitaire [Strasbourg]
Elisabeth Maillart - Pitié-Salpêtrière Hospital
Hélène Zephir - Hôpital Roger Salengro
Pierre Labauge - Hôpital Gui de Chauliac
Gilles Defer - Centre Hospitalier Universitaire de Caen
Christine Lebrun - Centre Hospitalier Universitaire de Nice
Thibault Moreau - Centre Hospitalier Universitaire Dijon Bourgogne
Eric Berger - Centre Hospitalier Universitaire de Besançon
Pierre Clavelou - Centre Hospitalier Universitaire de Clermont-Ferrand
Jean Pelletier - Hôpital de la Timone
Bruno Stankoff - Hôpital Saint-Antoine
Olivier Gout - Fondation Ophtalmologique Adolphe de Rothschild
Eric Thouvenot - Centre Hospitalier Universitaire de Nîmes
Olivier Heinzlef - Centre Hospitalier Intercommunal de Poissy
Abdullatif Al-Khedr - Centre Hospitalier Universitaire Amiens-Picardie
Bertrand Bourre - Université de Rouen Normandie
Olivier Casez - Centre Hospitalier Universitaire de Grenoble
Philippe Cabre - Centre Hospitalier Universitaire de Martinique
Alexis Montcuquet - Hôpital Universitaire Dupuytren
Abir Wahab - Hôpital Henri Mondor
Jean-Philippe Camdessanché - Centre Hospitalier Universitaire de Saint-Étienne
Aude Marousset - Université de Tours
Ivania Patry - Centre Hospitalier Sud Francilien
Karolina Hankiewicz - Centre Hospitalier Saint-Denis
Corinne Pottier
Nicolas Maubeuge - Centre Hospitalier Universitaire de Poitiers
Céline Labeyrie - Bicêtre Hospital
Chantal Nifle - Hôpital André Mignot
Emmanuelle Leray - Inserm
David Laplaud - Inserm
Helmut Butzkueven - Monash University
Tomas Kalincik - University of Melbourne
Sandra Vukusic - Danish Multiple Sclerosis Center
Melinda Magyari - University of Copenhagen
Publication Details: Multiple Sclerosis and Related Disorders, Vol.53
Grant note: The MSBase Foundation is a not-for-profit organization that receives support from Biogen, Novartis, Merck, Roche, Teva and Sanofi Genzyme. The study was conducted separately and apart from the guidance of the sponsors. CORe received funding from NHMRC [1140766, 1129789, 1157717] to support studies of comparative effectiveness of MS therapies.OFSEP was supported by a grant provided by the French State and handled by the "Agence Nationale de la Recherche," within the framework of the "Investments for the Future" program, under the reference ANR-10-COHO-002, by the Eugène Devic EDMUS Foundation against multiple sclerosis and by the ARSEP Foundation.DMSR did not receive any funding to collaborate in this study.
Identifiers: 9938781509311
Academic Unit: Institut de Génomique Fonctionnelle - IGF
Language: English
Resource Type: Journal article
Local Fields: hal-03268539