Impact of methodological choices in comparative effectiveness studies: application in natalizumab versus fingolimod comparison among patients with multiple sclerosis

M Lefort; S Sharmin; JB Andersen; S Vukusic; R Casey; M Debouverie; G Edan; J Ciron; A Ruet; J De Sèze; E Maillart; H Zephir; P Labauge; G Defer; C Lebrun-Frenay; T Moreau; E Berger; P Clavelou; J Pelletier; B Stankoff; O Gout; E Thouvenot; O Heinzlef; A Al-Khedr; B Bourre; O Casez; P Cabre; A Montcuquet; A Wahab; JP Camdessanché; A Maurousset; H Ben Nasr; K Hankiewicz; C Pottier; N Maubeuge; D Dimitri-Boulos; C Nifle; DA Laplaud; D Horakova; EK Havrdova; R Alroughani; G Izquierdo; S Eichau; S Ozakbas; F Patti; M Onofrj; A Lugaresi; M Terzi; P Grammond; F Grand’Maison; B Yamout; A Prat; M Girard; P Duquette; C Boz; M Trojano; P McCombe; M Slee; J Lechner-Scott; R Turkoglu; P Sola; D Ferraro; F Granella; V Shaygannejad; J Prevost; D Maimone; O Skibina; K Buzzard; A Van der Walt; R Karabudak; B Van Wijmeersch; T Csepany; D Spitaleri; S Vucic; N Koch-Henriksen; F Sellebjerg; PS Soerensen; CC Hilt Christensen; PV Rasmussen; MB Jensen; JL Frederiksen; S Bramow; HK Mathiesen; KI Schreiber; H Butzkueven; M Magyari; T Kalincik; E Leray

Journal article

Impact of methodological choices in comparative effectiveness studies: application in natalizumab versus fingolimod comparison among patients with multiple sclerosis

M Lefort, S Sharmin, JB Andersen, S Vukusic, R Casey, M Debouverie, G Edan, J Ciron, A Ruet, J De Sèze, E Maillart, H Zephir, P Labauge, G Defer, C Lebrun-Frenay, T Moreau, E Berger, P Clavelou, J Pelletier, B Stankoff Show all

BMC Medical Research Methodology | BMC | Published : 2022

DOI: 10.1186/s12874-022-01623-8

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Abstract

Background: Natalizumab and fingolimod are used as high-efficacy treatments in relapsing–remitting multiple sclerosis. Several observational studies comparing these two drugs have shown variable results, using different methods to control treatment indication bias and manage censoring. The objective of this empirical study was to elucidate the impact of methods of causal inference on the results of comparative effectiveness studies. Methods: Data from three observational multiple sclerosis registries (MSBase, the Danish MS Registry and French OFSEP registry) were combined. Four clinical outcomes were studied. Propensity scores were used to match or weigh the compared groups, allowing for est..

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University of Melbourne Researchers

Sifat Sharmin Author

Tomas Kalincik Author

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Awarded by Instituto de Salud Carlos III

Funding Acknowledgements

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 Eugene Devic EDMUS Foundation against multiple sclerosis and by the ARSEP Foundation. ML has recieved travel grant from ARSEP foundation for this project. The Clinical Outcomes Research unit at the University of Melbourne received funding from NHMRC (grant number 1140766, 1129789, and 1157717) to support this study. The MSBase Foundation is a not-for-profit organization that receives support from Biogen, Novartis, Merck, Roche, Teva Pharmaeutical Industries and Sanofi Genzyme. The Danish Multiple Sclerosis Registry did not receive any funding to collaborate in this study.