RT Journal Article
T1 Spanish real-world experience with fingolimod in relapsing-remitting multiple sclerosis patients: MS NEXT study.
A1 Barrero, Francisco
A1 Mallada-Frechin, Javier
A1 Martínez-Ginés, María Luisa
A1 Marzo, María Eugenia
A1 Meca-Lallana, Virginia
A1 Izquierdo, Guillermo
A1 Ara, José Ramón
A1 Oreja-Guevara, Celia
A1 Meca-Lallana, José
A1 Forero, Lucía
A1 Sánchez-Vera, Irene
A1 Moreno, María José
A1 in representation of the MS NEXT study investigators, 
AB 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. 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. 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, P20 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 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.
YR 2020
FD 2020-04-02
LK http://hdl.handle.net/10668/15312
UL http://hdl.handle.net/10668/15312
LA en
DS RISalud
RD Apr 6, 2025