José Meca-Lallana1,2, Teresa Ayuso3, Sergio Martínez-Yelamos4, Carmen Durán5, Yessica Contreras Martín6, Nicolás Herrera Navarro7, Angel Pérez Sempere8, Jose C Álvarez-Cermeño9, Jorge Millán Pascual10, Virginia Meca-Lallana11, Raúl Romero Sevilla12, Javier Ricart12. 1. Unidad de Esclerosis Múltiple, Servicio de Neurología, Hospital Clínico Universitario "Virgen de la Arrixaca" (IMIB-ARRIXACA), Murcia, Spain, pmecal@gmail.com. 2. Cátedra de Neuroinmunología Clínica y Esclerosis Múltiple, UCAM, Universidad Católica San Antonio, Murcia, Spain, pmecal@gmail.com. 3. Hospital de Navarra, Pamplona, Spain. 4. Hospital de Bellvitge, Hospitalet de Llobregat, Spain. 5. Hospital Universitario Infanta Cristina, Badajoz, Spain. 6. Hospital Universitario Nuestra Señora de Candelaria, Santa Cruz de Tenerife, Spain. 7. Hospital de Burgos, Burgos, Spain. 8. Hospital General de Alicante, Alicante, Spain. 9. Hospital Universitario Ramón y Cajal, IRYCIS, Madrid, Spain. 10. Complejo Hospitalario La Mancha Centro, Alcázar de San Juan, Spain. 11. Unidad de Enfermedades Desmielinizantes, Hospital Universitario de la Princesa, Madrid, Spain. 12. Novartis Farmacéutica S.A., Barcelona, Spain.
Abstract
BACKGROUND: There is a lack of head-to-head studies comparing the efficacy of fingolimod (FIN) and natalizumab (NTZ) as second-line therapy for relapsing-remitting multiple sclerosis (RRMS). METHODS: Multicenter, observational study, in which, information of 388 patients randomly selected and treated with FIN or NTZ in routine clinical practice was retrospectively collected with the main objective of comparing the annualized relapse rate (ARR) over the first year, after FIN or NTZ treatment initiation. RESULTS: Mean ARR during the first year of treatment was 0.28 in FIN group and 0.12 in NTZ group (p = 0.0064); nevertheless, the difference between groups lost statistical significance when the propensity score analysis was performed. Time to disability -progression was similar in both treatment groups (12.3 ± 6.7 months in FIN, and 12.8 ± 0.1 months in NTZ; p = 0.4654). Treatment persistence after the first year of treatment was higher in patients treated with FIN (95%) than in those treated with NTZ (84%; p = 0.0014). CONCLUSIONS: After 12 months of treatment, both FIN and NTZ reduced the ARR, but ARR percent reduction was significantly higher with NTZ. Treatment persistence was higher in patients receiving FIN. The Author(s). Published by S. Karger AG, Basel.
BACKGROUND: There is a lack of head-to-head studies comparing the efficacy of fingolimod (FIN) and natalizumab (NTZ) as second-line therapy for relapsing-remitting multiple sclerosis (RRMS). METHODS: Multicenter, observational study, in which, information of 388 patients randomly selected and treated with FIN or NTZ in routine clinical practice was retrospectively collected with the main objective of comparing the annualized relapse rate (ARR) over the first year, after FIN or NTZ treatment initiation. RESULTS: Mean ARR during the first year of treatment was 0.28 in FIN group and 0.12 in NTZ group (p = 0.0064); nevertheless, the difference between groups lost statistical significance when the propensity score analysis was performed. Time to disability -progression was similar in both treatment groups (12.3 ± 6.7 months in FIN, and 12.8 ± 0.1 months in NTZ; p = 0.4654). Treatment persistence after the first year of treatment was higher in patients treated with FIN (95%) than in those treated with NTZ (84%; p = 0.0014). CONCLUSIONS: After 12 months of treatment, both FIN and NTZ reduced the ARR, but ARR percent reduction was significantly higher with NTZ. Treatment persistence was higher in patients receiving FIN. The Author(s). Published by S. Karger AG, Basel.
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