Spanish real-world experience with fingolimod in relapsing-remitting multiple sclerosis patients: MS NEXT study
Barrero, F. ; Mallada-Frechin, J. ; Martínez-Ginés, M.L. ; Marzo, M.E. ; Meca-Lallana, V. ; Izquierdo, G. ; Ara, J.R. ; Oreja-Guevara, C. ; Meca-Lallana, J. ; Forero, L. ; Sánchez-Vera, I. ; Moreno, M.J. ; in, representation, of, the, MS, NEXT, study, investigators
Resumen: Purpose
The objective of this study was to characterize the demographic and clinical profile of RRMS patients receiving fingolimod in Spain, and to evaluate drug effectiveness and safety in clinical practice.
Methods
This observational, retrospective, multicentre, nationwide study was performed at 56 Spanish hospitals and involved 804 RRMS patients who received oral fingolimod (0.5 mg) since November 2011, with a minimum follow-up of 12 months.
Results
The mean annualized relapse rate (ARR) in the year before fingolimod was 1.08 and the median EDSS was 3; patients were exposed to fingolimod for 2.2 years as average; regarding magnetic resonance imaging (MRI) activity, more than half of the patients had >20 lesions at baseline. Patients were previously treated with first-line injectable DMTs (60.3%), or natalizumab (31.3%), and 8.3% were naïve patients. Overall, the ARR significantly decreased to 0.28, 0.22 and 0.17 (74.1%, 79.7% and 83.5% of relative reduction, respectively) after 12, 24 and 36 months of treatment, P<0.001. The ARR of patients who switched from natalizumab to fingolimod was stable over the study. Most of the patients (88.7%) were free from confirmed disability and MRI activity (67.3%) after 24 months. The persistence after 12 months on fingolimod was 93.9%.
Conclusions
The subgroups of patients analysed showed differential baseline demographic and clinical characteristics. The analysis of patients who received fingolimod in routine clinical practice confirmed adequate efficacy and safety, even for long-term treatment. The present data also confirmed the positive benefit/risk balance with fingolimod in real-world clinical practice setting.
Idioma: Inglés
DOI: 10.1371/journal.pone.0230846
Año: 2020
Publicado en: PloS one 15, 4 (2020), e0230846 [13 pp]
ISSN: 1932-6203
Factor impacto JCR: 3.24 (2020)
Categ. JCR: MULTIDISCIPLINARY SCIENCES rank: 26 / 73 = 0.356 (2020) - Q2 - T2
Factor impacto SCIMAGO: 0.99 - Multidisciplinary (Q1)
Tipo y forma: Artículo (Versión definitiva)
Debe reconocer adecuadamente la autoría, proporcionar un enlace a la licencia e indicar si se han realizado cambios. Puede hacerlo de cualquier manera razonable, pero no de una manera que sugiera que tiene el apoyo del licenciador o lo recibe por el uso que hace.
Exportado de SIDERAL (2021-09-02-08:52:32)
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The objective of this study was to characterize the demographic and clinical profile of RRMS patients receiving fingolimod in Spain, and to evaluate drug effectiveness and safety in clinical practice.
Methods
This observational, retrospective, multicentre, nationwide study was performed at 56 Spanish hospitals and involved 804 RRMS patients who received oral fingolimod (0.5 mg) since November 2011, with a minimum follow-up of 12 months.
Results
The mean annualized relapse rate (ARR) in the year before fingolimod was 1.08 and the median EDSS was 3; patients were exposed to fingolimod for 2.2 years as average; regarding magnetic resonance imaging (MRI) activity, more than half of the patients had >20 lesions at baseline. Patients were previously treated with first-line injectable DMTs (60.3%), or natalizumab (31.3%), and 8.3% were naïve patients. Overall, the ARR significantly decreased to 0.28, 0.22 and 0.17 (74.1%, 79.7% and 83.5% of relative reduction, respectively) after 12, 24 and 36 months of treatment, P<0.001. The ARR of patients who switched from natalizumab to fingolimod was stable over the study. Most of the patients (88.7%) were free from confirmed disability and MRI activity (67.3%) after 24 months. The persistence after 12 months on fingolimod was 93.9%.
Conclusions
The subgroups of patients analysed showed differential baseline demographic and clinical characteristics. The analysis of patients who received fingolimod in routine clinical practice confirmed adequate efficacy and safety, even for long-term treatment. The present data also confirmed the positive benefit/risk balance with fingolimod in real-world clinical practice setting.
Idioma: Inglés
DOI: 10.1371/journal.pone.0230846
Año: 2020
Publicado en: PloS one 15, 4 (2020), e0230846 [13 pp]
ISSN: 1932-6203
Factor impacto JCR: 3.24 (2020)
Categ. JCR: MULTIDISCIPLINARY SCIENCES rank: 26 / 73 = 0.356 (2020) - Q2 - T2
Factor impacto SCIMAGO: 0.99 - Multidisciplinary (Q1)
Tipo y forma: Artículo (Versión definitiva)
Debe reconocer adecuadamente la autoría, proporcionar un enlace a la licencia e indicar si se han realizado cambios. Puede hacerlo de cualquier manera razonable, pero no de una manera que sugiera que tiene el apoyo del licenciador o lo recibe por el uso que hace. Exportado de SIDERAL (2021-09-02-08:52:32)
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Registro creado el 2020-06-09, última modificación el 2021-09-02