RT Journal Article
T1 Four-year safety and effectiveness data from patients with multiple sclerosis treated with fingolimod: The Spanish GILENYA registry
A1 Meca-Lallana, J. E.
A1 Oreja-Guevara, C.
A1 Munoz, D.
A1 Olascoaga, J.
A1 Pato, A.
A1 Ramio-Torrenta, L.
A1 Meca-Lallana, V.
A1 Hernandez, M. A.
A1 Marzo, M. E.
A1 Alvarez- Cermeno, J. C.
A1 Rodriguez-Antigueedad, A.
A1 Montalban, X.
A1 Fernandez, O.
A1 Spanish Gilenya Registry Investi, 
K1 Real-world evidence
K1 Clinical-practice
K1 Oral fingolimod
K1 Efficacy
K1 Persistence
K1 Experience
K1 Therapy
K1 Trial
K1 Rwe
AB 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. 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 naïve. 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<0.001). This significant reduction in the ARR continued to be observed in all subgroups. After 4 years, the EDSS showed a minimal deterioration, with the EDSS scores from year 1 to year 4 remaining mostly stable. The percentage of patients without T1 Gd+ lesions progressively increased from 45.6% during the year prior to fingolimod initiation to 88.2% at year 4. The proportion of patients free from new/enlarged T2 lesions after 4 years of fingolimod treatment was 80.3%. This trend in both radiological measures was also observed in the subgroups. Adverse events (AEs) were experienced by up to 41.6% of patients (most commonly: lymphopenia [12.5%] and urinary tract infection [3.7%]). Most AEs were mild in severity, 3.6% of patients had serious AEs. The patient profile was similar to other observational studies. The results obtained from the long-term use of fingolimod showed that it was effective, regardless of prior DMT, and it had adequate safety results, with a positive benefit-risk balance.
PB Public library science
SN 1932-6203
YR 2021
FD 2021-10-13
LK https://hdl.handle.net/10668/28225
UL https://hdl.handle.net/10668/28225
LA en
NO Meca-Lallana JE, Oreja-Guevara C, Muñoz D, Olascoaga J, Pato A, Ramió-Torrentà L, et al. Four-year safety and effectiveness data from patients with multiple sclerosis treated with fingolimod: The Spanish GILENYA registry. PLoS One. 2021 Oct 13;16(10):e0258437.
DS RISalud
RD Sep 19, 2025