1. Fingolimod Use for the Treatment of Multiple Sclerosis in a Clinical Practice Setting in Madrid
- Author
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Marta Garcia-Montojo, Mónica Sánchez-Jiménez, Ignacio Casanova-Peño, Rafael Arroyo-González, Roberto Alvarez-Lafuente, Ana Maria Arias-Leal, Angel Garcia-Martinez, Victoria Galán Sánchez-Seco, and Maria Inmaculada Dominguez-Mozo
- Subjects
Adult ,Male ,medicine.medical_specialty ,Multiple Sclerosis ,Time Factors ,Clinical effectiveness ,03 medical and health sciences ,Disability Evaluation ,0302 clinical medicine ,Natalizumab ,Recurrence ,Internal medicine ,Medicine ,Humans ,Pharmacology (medical) ,030212 general & internal medicine ,Retrospective Studies ,Pharmacology ,Prior treatment ,business.industry ,Fingolimod Hydrochloride ,Multiple sclerosis ,Retrospective cohort study ,Middle Aged ,medicine.disease ,Fingolimod ,Clinical Practice ,Treatment Outcome ,Tolerability ,Spain ,Female ,Neurology (clinical) ,business ,030217 neurology & neurosurgery ,Immunosuppressive Agents ,medicine.drug - Abstract
OBJECTIVE To assess the effectiveness and safety of fingolimod use in a Spanish clinical practice setting. METHODS Retrospective study with multiple sclerosis patients who received at least 1 fingolimod dose between January 2004 and January 2015. Effectiveness and safety data were collected during the entire treatment of each patient. Analysis was performed for the total population and stratified according to prior treatment, sex, and age at treatment initiation. RESULTS A total of 167 patients were included, 50.9% had prior immunomodulator use, 33.5% natalizumab use, and 15.6% were naive patients. The annual relapse rate (ARR) decreased for the total population at month 12 (62%) and month 24 (84%) (P < 0.0001, in both cases); for naive patients (P < 0.05) and patients with prior immunomodulator use (P < 0.0001); for patients with prior natalizumab use, the ARR kept low after treatment initiation (0.23). After 24 months, the proportion of relapse-free patients was 70% or greater and disability progression-free patients was 80% or greater. No significant differences were observed when the results were compared by prior treatment, sex, or age. Thirty-two patients (19.2%) reported adverse drug reactions and 9.6% discontinued: 4.8% due to adverse drug reactions and 4.8% for lack of effectiveness. CONCLUSIONS The results support fingolimod use due to clinical effectiveness, tolerability, and ease of administration.
- Published
- 2016