Four-year safety and effectiveness data from patients with multiple sclerosis treated with fingolimod: The Spanish GILENYA registry
No Thumbnail Available
Identifiers
Date
2021-10-13
Authors
Meca-Lallana, J. E.
Oreja-Guevara, C.
Munoz, D.
Olascoaga, J.
Pato, A.
Ramio-Torrenta, L.
Meca-Lallana, V.
Hernandez, M. A.
Marzo, M. E.
Alvarez- Cermeno, J. C.
Advisors
Journal Title
Journal ISSN
Volume Title
Publisher
Public library science
Metrics
Export
Abstract
Objective To describe the profile of patients with multiple sclerosis (MS) treated with fingolimod in Spain and to assess the effectiveness and safety of fingolimod after 4 years of inclusion in the Spanish Gilenya Registry.Methods An observational, retrospective/prospective, multicenter case registry, including all patients with relapsing-remitting MS (RRMS) starting treatment with fingolimod in 43 centers in Spain. Analyses were performed in the overall population and in subgroups according to prior disease-modifying therapy (DMT): glatiramer acetate/interferon beta-1 (BRACE), natalizumab, other treatment, or naive.Results Six hundred and sixty-six evaluable patients were included (91.1% previously treated with at least one DMT). The mean annualized relapse rate (ARR) prior to fingolimod was 1.12, and the mean EDSS at fingolimod initiation was 3.03. Fingolimod reduced the ARR by 71.4%, 75%, 75.5%, and 80.3%, after 1, 2, 3 and 4 years, respectively (p
Description
MeSH Terms
DeCS Terms
CIE Terms
Keywords
Real-world evidence, Clinical-practice, Oral fingolimod, Efficacy, Persistence, Experience, Therapy, Trial, Rwe