TY - JOUR
T1 - Transition to secondary progression in relapsing-onset multiple sclerosis
T2 - Definitions and risk factors
AU - Iaffaldano, Pietro
AU - Lucisano, Giuseppe
AU - Patti, Francesco
AU - Brescia Morra, Vincenzo
AU - De Luca, Giovanna
AU - Lugaresi, Alessandra
AU - Zaffaroni, Mauro
AU - Inglese, Matilde
AU - Salemi, Giuseppe
AU - Cocco, Eleonora
AU - Conte, Antonella
AU - Ferraro, Diana
AU - Galgani, Simonetta
AU - Bergamaschi, Roberto
AU - Pozzilli, Carlo
AU - Salvetti, Marco
AU - Lus, Giacomo
AU - Rovaris, Marco
AU - Maniscalco, Giorgia Teresa
AU - Logullo, Francesco Ottavio
AU - Paolicelli, Damiano
AU - Achille, Mariaclara
AU - Marrazzo, Giuseppina
AU - Lovato, Valeria
AU - Comi, Giancarlo
AU - Filippi, Massimo
AU - Amato, Maria Pia
AU - Trojano, Maria
N1 - Funding Information:
The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This project was supported by Roche SpA, Monza, Italy, on the basis of a Sponsored Research Agreement in place with the University of Bari Aldo Moro.
Publisher Copyright:
© The Author(s), 2020.
Copyright:
Copyright 2020 Elsevier B.V., All rights reserved.
PY - 2021/3/1
Y1 - 2021/3/1
N2 - Background: No uniform criteria for a sensitive identification of the transition from relapsing–remitting multiple sclerosis (MS) to secondary-progressive multiple sclerosis (SPMS) are available. Objective: To compare risk factors of SPMS using two definitions: one based on the neurologist judgment (ND) and an objective data-driven algorithm (DDA). Methods: Relapsing-onset MS patients (n = 19,318) were extracted from the Italian MS Registry. Risk factors for SPMS and for reaching irreversible Expanded Disability Status Scale (EDSS) 6.0, after SP transition, were estimated using multivariable Cox regression models. Results: SPMS identified by the DDA (n = 2343, 12.1%) were older, more disabled and with a faster progression to severe disability (p < 0.0001), than those identified by the ND (n = 3868, 20.0%). In both groups, the most consistent risk factors (p < 0.05) for SPMS were a multifocal onset, an age at onset >40 years, higher baseline EDSS score and a higher number of relapses; the most consistent protective factor was the disease-modifying therapy (DMT) exposure. DMT exposure during SP did not impact the risk of reaching irreversible EDSS 6.0. Conclusion: A DDA definition of SPMS identifies more aggressive progressive patients. DMT exposure reduces the risk of SPMS conversion, but it does not prevent the disability accumulation after the SP transition.
AB - Background: No uniform criteria for a sensitive identification of the transition from relapsing–remitting multiple sclerosis (MS) to secondary-progressive multiple sclerosis (SPMS) are available. Objective: To compare risk factors of SPMS using two definitions: one based on the neurologist judgment (ND) and an objective data-driven algorithm (DDA). Methods: Relapsing-onset MS patients (n = 19,318) were extracted from the Italian MS Registry. Risk factors for SPMS and for reaching irreversible Expanded Disability Status Scale (EDSS) 6.0, after SP transition, were estimated using multivariable Cox regression models. Results: SPMS identified by the DDA (n = 2343, 12.1%) were older, more disabled and with a faster progression to severe disability (p < 0.0001), than those identified by the ND (n = 3868, 20.0%). In both groups, the most consistent risk factors (p < 0.05) for SPMS were a multifocal onset, an age at onset >40 years, higher baseline EDSS score and a higher number of relapses; the most consistent protective factor was the disease-modifying therapy (DMT) exposure. DMT exposure during SP did not impact the risk of reaching irreversible EDSS 6.0. Conclusion: A DDA definition of SPMS identifies more aggressive progressive patients. DMT exposure reduces the risk of SPMS conversion, but it does not prevent the disability accumulation after the SP transition.
KW - big data
KW - data-driven algorithm
KW - disease registry
KW - Multiple sclerosis
KW - prognosis
KW - secondary progressive
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U2 - 10.1177/1352458520974366
DO - 10.1177/1352458520974366
M3 - Article
AN - SCOPUS:85096338861
VL - 27
SP - 430
EP - 438
JO - Multiple Sclerosis
JF - Multiple Sclerosis
SN - 1352-4585
IS - 3
ER -