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Title: | The effectiveness of natalizumab vs fingolimod–A comparison of international registry studies | Authors: | Andersen, Johanna B. Lefort, Mathilde Koch-Henriksen, Nils Sellebjerg, Finn Sorensen, Per Soelberg Christensen, Claudia C. Hilt Rasmussen, Peter, V Jensen, Michael B. Frederiksen, Jette L. Bramow, Stephan Mathiesen, Henrik K. Schreiber, Karen, I Horakova, Dana Havrdova, Eva K. Alroughani, Raed Izquierdo, Guillermo Eichau, Sara Ozakbas, Serkan Patti, Francesco Onofrj, Marco Lugaresi, Alessandra Terzi, Murat Grammond, Pierre Maison, Francois Grand Yamout, Bassem Prat, Alexandre Girard, Marc Duquette, Pierre Boz, Cavit Trojano, Maria McCombe, Pamela Slee, Mark Lechner-Scott, Jeannette Turkoglu, Recai Sola, Patrizia Ferraro, Diana Granella, Franco Shaygannejad, Vahid Prevost, Julie Skibina, Olga Solaro, Claudio Karabudak, Rana VAN WIJMEERSCH, Bart Csepany, Tunde Spitaleri, Daniele Vucic, Steve Casey, Romain Debouverie, Marc Edan, Gilles Ciron, Jonathan Ruet, Aurelie Seze, Jerome D. Maillart, Elisabeth Zephir, Helene Labauge, Pierre Defer, Gilles Lebrun, Christine Moreau, Thibault Clavelou, Pierre Pelletier, Jean Stankoff, Bruno Gout, Olivier Thouvenot, Eric Heinzlef, Olivier Al-Khedr, Abdullatif Bourre, Bertrand Casez, Olivier Cabre, Philippe Montcuquet, Alexis Wahab, Abir Camdessanche, Jean-Philippe Marousset, Aude Patry, Ivania Hankiewicz, Karolina Pottier, Corinne Maubeuge, Nicolas Labeyrie, Celine Nifle, Chantal Leray, Emmanuelle Laplaud, David A. Butzkueven, Helmut Kalincik, Tomas Vukusic, Sandra Magyari, Melinda Berger, Eric Sharmin, Sifat |
Issue Date: | 2021 | Publisher: | ELSEVIER SCI LTD | Source: | MULTIPLE SCLEROSIS AND RELATED DISORDERS, 53 (Art N° 103012) | 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 meth-odologies, 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. | Notes: | Andersen, JB (corresponding author), Blegdamsvej 9, DK-2100 Copenhagen, Denmark. | Keywords: | Multiple sclerosis; Natalizumab; Fingolimod; Treatment effectiveness;;Head-to-head comparison | Document URI: | http://hdl.handle.net/1942/34842 | ISSN: | 2211-0348 | e-ISSN: | 2211-0356 | DOI: | 10.1016/j.msard.2021.103012 | ISI #: | WOS:000687405300017 | Category: | A1 | Type: | Journal Contribution | Validations: | ecoom 2022 |
Appears in Collections: | Research publications |
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1-s2.0-S2211034821002790-main.pdf | Published version | 1.67 MB | Adobe PDF | View/Open |
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