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

Johanna B. Andersen, Sifat Sharmin, Mathilde Lefort, Nils Koch-Henriksen, Finn Sellebjerg, Per Soelberg Sørensen, Claudia C. Hilt Christensen, Peter V. Rasmussen, Michael B. Jensen, Jette L. Frederiksen, Stephan Bramow, Henrik K. Mathiesen, Karen I. Schreiber, Dana Horakova, Eva K. Havrdova, Raed Alroughani, Guillermo Izquierdo, Sara Eichau, Serkan Ozakbas, Francesco PattiMarco 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 V. Wijmeersch, Tunde Csepany, Daniele Spitaleri, Steve Vucic, Romain Casey, Marc Debouverie, Gilles Edan, Jonathan Ciron, Aurélie Ruet, Jérôme D. 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 A. Laplaud, Helmut Butzkueven, Tomas Kalincik, Sandra Vukusic, Melinda Magyari

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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.

Original languageEnglish
Article number103012
Number of pages15
JournalMultiple Sclerosis and Related Disorders
Publication statusPublished - Aug 2021


  • Fingolimod
  • Head-to-head comparison
  • Multiple sclerosis
  • Natalizumab
  • Treatment effectiveness


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