دورية أكاديمية
Four-year safety and effectiveness data from patients with multiple sclerosis treated with fingolimod: The Spanish GILENYA registry
| العنوان: | Four-year safety and effectiveness data from patients with multiple sclerosis treated with fingolimod: The Spanish GILENYA registry |
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| المؤلفون: | Meca-Lallana, Jose Eustasio, Oreja-Guevara, C., Muñoz, D., Olascoaga, J., Pato, A., Ramió-Torrentà, Lluís, Montalban Gairín, Xavier |
| المساهمون: | Institut Català de la Salut, Meca-Lallana JE Neurology Department, Hospital Clínico Universitario Virgen de la Arrixaca, Murcia, Spain. Oreja-Guevara C Neurology Department, Hospital Clínico San Carlos, Madrid, Spain. Muñoz D Neurology Department, Hospital Xeral de Vigo, Vigo, Spain. Olascoaga J Neurology Department, Hospital Universitario Donostia, San Sebastián, Spain. Pato A Neurology Department, Hospital Povisa, Vigo, Spain. Ramió-Torrentà L Neurology Department, Hospital Universitari de Girona Dr. Josep Trueta, IDIBGI, Medical Sciences Department, University of Girona, Girona, Spain. Montalbán X Servei de Neurologia, Vall d’Hebron Hospital Universitari, Barcelona, Spain, Vall d'Hebron Barcelona Hospital Campus |
| المصدر: | Scientia |
| بيانات النشر: | Public Library of Science |
| سنة النشر: | 2021 |
| مصطلحات موضوعية: | Esclerosi múltiple - Tractament, Medicaments immunosupressors - Ús terapèutic - Efectes secundaris, Avaluació de resultats (Assistència sanitària), DISEASES::Nervous System Diseases::Autoimmune Diseases of the Nervous System::Demyelinating Autoimmune Diseases, CNS::Multiple Sclerosis, Other subheadings::Other subheadings::Other subheadings::/drug therapy, CHEMICALS AND DRUGS::Chemical Actions and Uses::Pharmacologic Actions::Physiological Effects of Drugs::Immunologic Factors::Immunosuppressive Agents, Treatment Outcome, ENFERMEDADES::enfermedades del sistema nervioso::enfermedades autoinmunitarias del sistema nervioso::enfermedades autoinmunes desmielinizantes del SNC::esclerosis múltiple, Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia, COMPUESTOS QUÍMICOS Y DROGAS::acciones y usos químicos::acciones farmacológicas::efectos fisiológicos de los fármacos::factores inmunitarios::inmunosupresores, TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::diagnóstico::pronóstico::resultado del tratamiento |
| الوصف: | Esclerosis múltiple; Reacciones adversas; Infecciones respiratorias ; Esclerosi múltiple; Reaccions adverses; Infeccions respiratòries ; Multiple sclerosis; Adverse reactions; Respiratory infections ; 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 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. Conclusions The patient profile was similar to other observational studies. The results obtained from the long-term ... |
| نوع الوثيقة: | article in journal/newspaper |
| وصف الملف: | application/pdf |
| اللغة: | English |
| تدمد: | 1932-6203 |
| العلاقة: | PLOS ONE;16(10); https://doi.org/10.1371/journal.pone.0258437Test; 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.; https://hdl.handle.net/11351/7453Test; 000732519500044 |
| DOI: | 10.1371/journal.pone.0258437 |
| الإتاحة: | https://doi.org/10.1371/journal.pone.0258437Test https://hdl.handle.net/11351/7453Test |
| حقوق: | Attribution 4.0 International ; http://creativecommons.org/licenses/by/4.0Test/ ; info:eu-repo/semantics/openAccess |
| رقم الانضمام: | edsbas.11AC8EF6 |
| قاعدة البيانات: | BASE |
Full Text Finder | تدمد: | 19326203 |
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| DOI: | 10.1371/journal.pone.0258437 |