Four-year safety and effectiveness data from patients with multiple sclerosis treated with fingolimod : The Spanish GILENYA registry
Meca-Lallana, Jose Eustasio (Hospital Universitario Virgen de la Arrixaca (Múrcia))
Oreja-Guevara, Celia (Hospital Clínico San Carlos (Madrid))
Muñoz, D. (Hospital Xeral de Vigo)
Olascoaga, J. (Hospital Universitario Donosti)
Pato, A. (Hospital POVISA)
Ramió-Torrentà, Lluís (Universitat de Girona)
Meca-Lallana, Virginia (Hospital Universitario de la Princesa (Madrid))
Hernández, M. A. (Hospital Universitario Nuestra Señora de Candelaria (Santa Cruz de Tenerife))
Marzo, M. E. (Hospital San Pedro, Logroño)
Alvarez-Cermeño, José C (Hospital Universitario Ramón y Cajal (Madrid))
Rodríguez-Antigüedad, A. (Hospital Universitario de Cruces (Barakaldo, País Basc))
Montalban, Xavier (Hospital Universitari Vall d'Hebron)
Fernández, O. (Universidad de Málaga)
Universitat Autònoma de Barcelona. Departament de Medicina

Date:	2021
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 naïve. 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<0. 001). This significant reduction in the ARR continuedto 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. Conclusions 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.
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Language:	Anglès
Document:	Article ; recerca ; Versió publicada
Published in:	PloS one, Vol. 16 Núm. 10 October (2021) , p. e0258437, ISSN 1932-6203

DOI: 10.1371/journal.pone.0258437
PMID: 34644366

16 p, 1.8 MB

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