Background and purpose: In relapsing-remitting multiple sclerosis patients (RRMS) disability progressively accumulates over time. To compare the cumulative probability of 6-month confirmed disability-worsening events using a fixed baseline or a roving Expanded Disability Status Scale (EDSS) reference, in a real-world setting. Methods: A cohort of 7964 RRMS patients followed for 2 or more years, with EDSS scores recorded every 6 months, was selected from the Italian Multiple Sclerosis Register. The overall probability of confirmed disability-worsening events and of confirmed disability-worsening events unrelated to relapse was evaluated using as reference a fixed baseline EDSS score or a roving EDSS score in which the increase had to be separated from the last EDSS assessment by at least 6 or 12 months. Results: Using a fixed baseline EDSS reference, the cumulative probability of 6-year overall confirmed disability-worsening events was 33.2%, and that of events unrelated to relapse was 10.9% (33% of overall confirmed disability-worsening events). Using a roving EDSS, the proportions were respectively 35.2% and 21.3% (61% of overall confirmed disability-worsening events). Conclusions: In a real-world setting, roving EDSS reference scores appear to be more sensitive for detecting confirmed disability-worsening events unrelated to relapse in RRMS patients.
Detection of disability worsening in relapsing-remitting multiple sclerosis patients: a real-world roving Expanded Disability Status Scale reference analysis from the Italian Multiple Sclerosis Register / V. Lepore, C. Bosetti, C. Santucci, P. Iaffaldano, M. Trojano, P. Mosconi, R. Totaro, M.G. Coniglio, R.B. Bossio, P. Valentino, M. Gatto, D. Paolicelli, B. Ardito, V. Barcella, L. Capone, P. Nicolao, A. Lugaresi, A. Rini, M. Bianchi, I. Plasmati, E. Cocco, R. Docimo, G. De Luca, F. Mondino, A. Di Sapio, R. Clerici, N. Mascoli, M.T. Ferro, C.G. Chisari, D. Maimone, S. Strumia, M. Pugliatti, D. Cargnelutti, L.M. Caniatti, C. Avolio, P. Crociani, M.P. Amato, L. Massacesi, S. Malagu, G. Ribizzi, M. Inglese, S. Venturi, P. Gazzola, N.R. Pizio, G. Brichetto, K. Plewnia, P. Bellantonio, R. Balgera, F. De Robertis, S. Fermi, F. Fausto, M. Mazzoni, G. Meucci, E. Cartechini, G. Cavaletti, M. Buccafusca, P. Bramanti, M. Romeo, M. Rovaris, M. Ronzoni, P. Confalonieri, L. Chiveri, P. Bertora, S. Tonietti, M. De Riz, A. Protti, P. Sola, C. Maremmani, G. Lus, A. Gallo, G.T. Maniscalco, V.B. Morra, G. Cacchio, R. Iodice, M. Ragno, L. Sinisi, R. Cantello, M.L. Piras, G. Salemi, S. Cottone, L.M.E. Grimaldi, F. Corea, G. Santangelo, P. Immovili, P. Gallo, F. D'Andrea, C. Frittelli, L. Pasquali, M. Falcini, F. Granella, I. Pesci, A.L. Ancona, R. Bergamaschi, A. Giordano, M. Di Napoli, S. Romano, C. Pozzilli, M. Mirabella, A. Conte, S. Galgani, M. Peresson, M.G. Grasso, E. Ferraro, F. Capone, G.A. Marfia, D. de Pascalis, C. Piantadosi, M. Valeriani, V. Busillo, P. Barone, N. De Stefano, M. Ulivelli, G. Santuccio, S. Parodi, S. Bucello, S. Traccis, R. Zarbo, T. Tassinari, F. Bandini, P. Cavalla, M. Clerico, G. De Rosa, A. Bertolotto, D. Imperiale, P. Sarchielli, M.G. Celani, M. Vianello, B. Marini, M. Fortunato, M. Zaffaroni, D. Nasuelli, P. Banfi, A.M. Brioschi, C. Solaro, R. Quatrale, P. Rossi, A. Gajofatto, M. Trojano, M.A. Battaglia, M. Capobianco, M. Ulivelli, P. Mosconi, F. Patti, M.P. Amato, G. Comi. - In: EUROPEAN JOURNAL OF NEUROLOGY. - ISSN 1351-5101. - 28:2(2021), pp. 567-578. [10.1111/ene.14589]
Detection of disability worsening in relapsing-remitting multiple sclerosis patients: a real-world roving Expanded Disability Status Scale reference analysis from the Italian Multiple Sclerosis Register
C. Santucci;P. Bertora;
2021
Abstract
Background and purpose: In relapsing-remitting multiple sclerosis patients (RRMS) disability progressively accumulates over time. To compare the cumulative probability of 6-month confirmed disability-worsening events using a fixed baseline or a roving Expanded Disability Status Scale (EDSS) reference, in a real-world setting. Methods: A cohort of 7964 RRMS patients followed for 2 or more years, with EDSS scores recorded every 6 months, was selected from the Italian Multiple Sclerosis Register. The overall probability of confirmed disability-worsening events and of confirmed disability-worsening events unrelated to relapse was evaluated using as reference a fixed baseline EDSS score or a roving EDSS score in which the increase had to be separated from the last EDSS assessment by at least 6 or 12 months. Results: Using a fixed baseline EDSS reference, the cumulative probability of 6-year overall confirmed disability-worsening events was 33.2%, and that of events unrelated to relapse was 10.9% (33% of overall confirmed disability-worsening events). Using a roving EDSS, the proportions were respectively 35.2% and 21.3% (61% of overall confirmed disability-worsening events). Conclusions: In a real-world setting, roving EDSS reference scores appear to be more sensitive for detecting confirmed disability-worsening events unrelated to relapse in RRMS patients.
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