Spanish real-world experience with fingolimod in relapsing-remitting multiple sclerosis patients: MS NEXT study
Por:
Barrero F, Mallada-Frechin J, Martínez-Ginés ML, Marzo ME, Meca-Lallana V, Izquierdo G, Ara JR, Oreja-Guevara C, Meca-Lallana J, Forero L, Sánchez-Vera I and Moreno MJ
Publicada:
2 abr 2020
Ahead of Print:
2 abr 2020
Categoría:
Multidisciplinary
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 naive 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.
Filiaciones:
Barrero F:
Neurology Department, Hospital Uniersitario San Cecilio de Granada, Granada, Spain
:
Neurology Department, Hospital General Universitario de Elda, Alicante, Spain
Martínez-Ginés ML:
Neurology Department, Hospital General Universitario Gregorio Marañón, Madrid, Spain
Marzo ME:
Neurology Department, Hospital San Pedro, Logroño, Spain
Meca-Lallana V:
Demyelinating Disorders Unit, Hospital Universitario de La Princesa, Madrid, Spain
Izquierdo G:
Neurology Department, Hospital Universitario Virgen Macarena, Sevilla, Spain
Ara JR:
Neurology Department, Hospital Universitario Miguel Servet, Zaragoza, Spain
Oreja-Guevara C:
Neurology Department, Hospital Universitario Clínico San Carlos, Madrid, Spain
Meca-Lallana J:
Hospital Virgen de la Arrixaca (IMIB-Arrixaca), Murcia, Spain
Forero L:
Neurology Department, Hospital Universitario Puerta del Mar, Cádiz, Spain
Sánchez-Vera I:
Novartis Farmacéutica S.A., Barcelona, Spain
Moreno MJ:
Novartis Farmacéutica S.A., Barcelona, Spain
Green Published, gold
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