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Confirmed disabilityprogression as amarker of permanentdisability inmultiple sclerosis Sifat SharminFrancesca BovisCharles B. Malpas2022 год

Confirmed disability progression as a marker of permanent disability in multiple sclerosis
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Аннотация: Background and purpose The prevention of disability over the long term is the main treatment goal in multiple sclerosis (MS); however, randomized clinical trials evaluate only short-term treatment effects on disability. This study aimed to define criteria for 6-month confirmed disability progression events of MS with a high probability of resulting in sustained long-term disability worsening. Methods In total, 14,802 6-month confirmed disability progression events were identified in 8741 patients from the global MSBase registry. For each 6-month confirmed progression event (13,321 in the development and 1481 in the validation cohort), a sustained progression score was calculated based on the demographic and clinical characteristics at the time of progression that were predictive of long-term disability worsening. The score was externally validated in the Cladribine Tablets Treating Multiple Sclerosis Orally (CLARITY) trial. Results The score was based on age, sex, MS phenotype, relapse activity, disability score and its change from baseline, number of affected functional system domains and worsening in six of the domains. In the internal validation cohort, a 61% lower chance of improvement was estimated with each unit increase in the score (hazard ratio 0.39, 95% confidence interval 0.29–0.52; discriminatory index 0.89). The proportions of progression events sustained at 5 years stratified by the score were 1: 72%; 2: 88%; 3: 94%; 4: 100%. The results of the CLARITY trial were confirmed for reduction of disability progression that was >88% likely to be sustained (events with score ˃1.5). Conclusions Clinicodemographic characteristics of 6-month confirmed disability progression events identify those at high risk of sustained long-term disability. This knowledge will allow future trials to better assess the effect of therapy on long-term disability accrual.
Год издания: 2022
Авторы: Sifat Sharmin, Francesca Bovis, Charles B. Malpas, Dana Horáková, Eva Havrdová, Guillermo Izquierdo, Sara Eichau, Maria Trojano, Alexandre Prat, Marc Girard, Pierre Duquette, Marco Onofrj, Alessandra Lugaresi, François Grand’Maison, Pierre Grammond, Patrizia Sola, Diana Ferraro, Murat Terzi, Oliver Gerlach, Raed Alroughani, Cavit Boz, Vahid Shaygannejad, Vincent Van Pesch, Elisabetta Cartechini, Ludwig Kappos, Jeannette Lechner‐Scott, Roberto Bergamaschi, Recai Türkoğlu, Claudio Solaro, Gerardo Iuliano, Franco Granella, Bart Van Wijmeersch, Daniele Spitaleri, Mark Slee, Pamela McCombe, Julie Prévost, Radek Ampapa, Serkan Özakbaş, José Luis Sánchez-Menoyo, Aysun Soysal, Steve Vucic, Thor Petersen, Koen de Gans, Ernest Butler, Suzanne Hodgkinson, Youssef Sidhom, Riadh Gouider, Edgardo Cristiano, Tamara Castillo‐Triviño, Maria Luisa Saladino, Michael Barnett, Fraser Moore, Csilla Rózsa, Bassem Yamout, Olga Skibina, Anneke van der Walt, Katherine Buzzard, Orla Gray, Stella Hughes, Ángel Pérez Sempere, Bhim Singhal, Yára Dadalti Fragoso, Cameron Shaw, Allan G. Kermode, Bruce Taylor, Magdolna Simó, Neil Shuey, Talal Al‐Harbi, Richard Macdonell, José Andrés Domínguez, Tünde Csépány, Carmen Adella Sîrbu, Maria Pia Sormani, Helmut Butzkueven, Tomáš Kalinčík
Издательство: Wiley
Источник: European Journal of Neurology
Ключевые слова: Multiple Sclerosis Research Studies, Rheumatoid Arthritis Research and Therapies, Polyomavirus and related diseases
Другие ссылки: European Journal of Neurology (PDF)
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Scopus (Elsevier) (PDF)
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RISalud Institutional Health Repository of Andalucía (PDF)
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Archivio istituzionale della ricerca (Alma Mater Studiorum Università di Bologna) (PDF)
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PubMed Central (HTML)
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