Defining reliable disability outcomes in multiple sclerosis

T Kalincik; G Cutter; T Spelman; V Jokubaitis; E Havrdova; D Horakova; M Trojano; G Izquierdo; M Girard; P Duquette; A Prat; A Lugaresi; F Grand'Maison; P Grammond; R Hupperts; C Oreja-Guevara; C Boz; E Pucci; R Bergamaschi; J Lechner-Scott; R Alroughani; V Van Pesch; G Iuliano; R Fernandez-Bolaños; C Ramo; M Terzi; M Slee; D Spitaleri; F Verheul; E Cristiano; JL Sánchez-Menoyo; M Fiol; O Gray; JA Cabrera-Gomez; M Barnett; H Butzkueven

Journal article

Defining reliable disability outcomes in multiple sclerosis

T Kalincik, G Cutter, T Spelman, V Jokubaitis, E Havrdova, D Horakova, M Trojano, G Izquierdo, M Girard, P Duquette, A Prat, A Lugaresi, F Grand'Maison, P Grammond, R Hupperts, C Oreja-Guevara, C Boz, E Pucci, R Bergamaschi, J Lechner-Scott Show all

Brain | OXFORD UNIV PRESS | Published : 2015

DOI: 10.1093/brain/awv258

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Abstract

Prevention of irreversible disability is currently the most important goal of disease modifying therapy for multiple sclerosis. The disability outcomes used in most clinical trials rely on progression of Expanded Disability Status Scale score confirmed over 3 or 6 months. However, sensitivity and stability of this metric has not been extensively evaluated. Using the global MSBase cohort study, we evaluated 48 criteria of disability progression, testing three definitions of baseline disability, two definitions of progression magnitude, two definitions of long-term irreversibility and four definitions of event confirmation period. The study outcomes comprised the rates of detected progression ..

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University of Melbourne Researchers

Tomas Kalincik Author

Timothy Spelman Author

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Funding Acknowledgements

The work was supported by the NHMRC Early Career Fellowship (1071124), NHMRC Practitioner Fellowship (1080518), NHMRC Project Grants (1083539 and 1032484), NHMRC Centre for Research Excellence (Grant ID 1001216) and the MSBase Foundation. The MSBase Foundation is a not-for-profit organization that receives support from Merck Serono, Biogen, Novartis Pharma, Bayer-Schering, Sanofi-Aventis and BioCSL. The study was conducted separately and apart from the guidance of the sponsors.