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Injectable Versus Oral First-Line Disease-Modifying Therapies: Results from the Italian MS Register

The current study aims to compare injectable and oral first-line disease-modifying therapies (DMTs) for time to first relapse, time to confirmed disability progression (CDP), and time to discontinuation using a cohort of relapsing remitting multiple sclerosis (RRMS) patients, with data extracted fro...

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Autores principales: D’Amico, Emanuele, Zanghì, Aurora, Romeo, Marzia, Cocco, Eleonora, Maniscalco, Giorgia Teresa, Brescia Morra, Vincenzo, Paolicelli, Damiano, De Luca, Giovanna, Galgani, Simonetta, Amato, Maria Pia, Salemi, Giuseppe, Inglese, Matilde, Confalonieri, Paolo Agostino, Lus, Giacomo, Avolio, Carlo, Gallo, Antonio, Vianello, Marika, Onofrj, Marco, Filippi, Massimo, Trojano, Maria, Patti, Francesco
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8423935/
https://www.ncbi.nlm.nih.gov/pubmed/33528815
http://dx.doi.org/10.1007/s13311-020-01001-6
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author D’Amico, Emanuele
Zanghì, Aurora
Romeo, Marzia
Cocco, Eleonora
Maniscalco, Giorgia Teresa
Brescia Morra, Vincenzo
Paolicelli, Damiano
De Luca, Giovanna
Galgani, Simonetta
Amato, Maria Pia
Salemi, Giuseppe
Inglese, Matilde
Confalonieri, Paolo Agostino
Lus, Giacomo
Avolio, Carlo
Gallo, Antonio
Vianello, Marika
Onofrj, Marco
Filippi, Massimo
Trojano, Maria
Patti, Francesco
author_facet D’Amico, Emanuele
Zanghì, Aurora
Romeo, Marzia
Cocco, Eleonora
Maniscalco, Giorgia Teresa
Brescia Morra, Vincenzo
Paolicelli, Damiano
De Luca, Giovanna
Galgani, Simonetta
Amato, Maria Pia
Salemi, Giuseppe
Inglese, Matilde
Confalonieri, Paolo Agostino
Lus, Giacomo
Avolio, Carlo
Gallo, Antonio
Vianello, Marika
Onofrj, Marco
Filippi, Massimo
Trojano, Maria
Patti, Francesco
author_sort D’Amico, Emanuele
collection PubMed
description The current study aims to compare injectable and oral first-line disease-modifying therapies (DMTs) for time to first relapse, time to confirmed disability progression (CDP), and time to discontinuation using a cohort of relapsing remitting multiple sclerosis (RRMS) patients, with data extracted from the Italian MS Register. This multicenter, observational, retrospectively acquired, and propensity-adjusted cohort study utilized RRMS-naïve patients from the Italian MS Register who started either injectable or oral first-line DMTs between January 1, 2010, and December 31, 2017, to evaluate the impact on disability outcomes in patients. Enrolled patients were divided into two groups, namely the injectable group (IG) and the oral group (OG). Of a cohort of 11,416 patients, 4602 were enrolled (3919 in the IG and 683 in the OG). The IG had a higher rate of women (67.3% vs 63.4%, p < 0.05) and a lower mean age (36.1 ± 10.9 vs 38.9 ± 11.8, p < 0.001). The event time to first relapse demonstrated a lower risk in the OG (HR = 0.58; CI 95% 0.48–0.72, p < 0.001). However, no differences were found between the two groups with respect to the risk of CDP (HR = 0.94; CI 95% 0.76–1.29, p = 0.941), while a lower risk of DMT was found in the OG (HR = 0.72; CI 95% 0.58–0.88, p = 0.002) for the event time to discontinuation. Real-world data from the Italian MS Register suggests that first-line oral DMTs are associated with a lower risk of experiencing a new relapse and of therapy discontinuation compared to injectable DMTs. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s13311-020-01001-6.
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spelling pubmed-84239352021-09-29 Injectable Versus Oral First-Line Disease-Modifying Therapies: Results from the Italian MS Register D’Amico, Emanuele Zanghì, Aurora Romeo, Marzia Cocco, Eleonora Maniscalco, Giorgia Teresa Brescia Morra, Vincenzo Paolicelli, Damiano De Luca, Giovanna Galgani, Simonetta Amato, Maria Pia Salemi, Giuseppe Inglese, Matilde Confalonieri, Paolo Agostino Lus, Giacomo Avolio, Carlo Gallo, Antonio Vianello, Marika Onofrj, Marco Filippi, Massimo Trojano, Maria Patti, Francesco Neurotherapeutics Original Article The current study aims to compare injectable and oral first-line disease-modifying therapies (DMTs) for time to first relapse, time to confirmed disability progression (CDP), and time to discontinuation using a cohort of relapsing remitting multiple sclerosis (RRMS) patients, with data extracted from the Italian MS Register. This multicenter, observational, retrospectively acquired, and propensity-adjusted cohort study utilized RRMS-naïve patients from the Italian MS Register who started either injectable or oral first-line DMTs between January 1, 2010, and December 31, 2017, to evaluate the impact on disability outcomes in patients. Enrolled patients were divided into two groups, namely the injectable group (IG) and the oral group (OG). Of a cohort of 11,416 patients, 4602 were enrolled (3919 in the IG and 683 in the OG). The IG had a higher rate of women (67.3% vs 63.4%, p < 0.05) and a lower mean age (36.1 ± 10.9 vs 38.9 ± 11.8, p < 0.001). The event time to first relapse demonstrated a lower risk in the OG (HR = 0.58; CI 95% 0.48–0.72, p < 0.001). However, no differences were found between the two groups with respect to the risk of CDP (HR = 0.94; CI 95% 0.76–1.29, p = 0.941), while a lower risk of DMT was found in the OG (HR = 0.72; CI 95% 0.58–0.88, p = 0.002) for the event time to discontinuation. Real-world data from the Italian MS Register suggests that first-line oral DMTs are associated with a lower risk of experiencing a new relapse and of therapy discontinuation compared to injectable DMTs. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s13311-020-01001-6. Springer International Publishing 2021-02-02 2021-04 /pmc/articles/PMC8423935/ /pubmed/33528815 http://dx.doi.org/10.1007/s13311-020-01001-6 Text en © The Author(s) 2021 https://creativecommons.org/licenses/by/4.0/Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) .
spellingShingle Original Article
D’Amico, Emanuele
Zanghì, Aurora
Romeo, Marzia
Cocco, Eleonora
Maniscalco, Giorgia Teresa
Brescia Morra, Vincenzo
Paolicelli, Damiano
De Luca, Giovanna
Galgani, Simonetta
Amato, Maria Pia
Salemi, Giuseppe
Inglese, Matilde
Confalonieri, Paolo Agostino
Lus, Giacomo
Avolio, Carlo
Gallo, Antonio
Vianello, Marika
Onofrj, Marco
Filippi, Massimo
Trojano, Maria
Patti, Francesco
Injectable Versus Oral First-Line Disease-Modifying Therapies: Results from the Italian MS Register
title Injectable Versus Oral First-Line Disease-Modifying Therapies: Results from the Italian MS Register
title_full Injectable Versus Oral First-Line Disease-Modifying Therapies: Results from the Italian MS Register
title_fullStr Injectable Versus Oral First-Line Disease-Modifying Therapies: Results from the Italian MS Register
title_full_unstemmed Injectable Versus Oral First-Line Disease-Modifying Therapies: Results from the Italian MS Register
title_short Injectable Versus Oral First-Line Disease-Modifying Therapies: Results from the Italian MS Register
title_sort injectable versus oral first-line disease-modifying therapies: results from the italian ms register
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8423935/
https://www.ncbi.nlm.nih.gov/pubmed/33528815
http://dx.doi.org/10.1007/s13311-020-01001-6
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