Effectiveness and Safety of Teriflunomide in Relapsing-Remitting Multiple Sclerosis and Improvements in Quality of Life : Results from the Real-World TERICARE Study
Meca-Lallana, Jose Eustasio (Universidad Católica San Antonio de Murcia)
Prieto, Jose Maria (Complejo Hospitalario Universitario de Santiago de Compostela)
Caminero, Ana B (Complejo Asistencial de Ávila)
Olascoaga, Javier Sebastián (Hospital Universitario de Donostia (Sant Sebastià, País Basc))
Alonso Torres, Ana Maria (Hospital Regional Universitario de Málaga)
Durán-Ferreras, Eduardo (Hospital Universitario Virgen del Rocío (Sevilla, Andalusia))
Espinosa Rosso, Raul (Hospital Universitario Jerez de La Frontera (Andalusia))
Dotor García-Soto, Julio (Hospital Universitario Virgen Macarena (Sevilla, Andalusia))
Romera, Mercedes (Hospital Universitario Virgen de Valme (Sevilla, Andalusia))
Ares-Luque, Adrian (Hospital Universitario de León)
Pérez-Ruiz, Domingo (Hospital El Bierzo (Ponferrada, Castella i Lleó))
Calles, Carmen (Hospital Universitario Son Espases (Palma, Mallorca))
Hernández-Pérez, Miguel Ángel (Hospital Universitario Nuestra Señora de Candelaria (Santa Cruz de Tenerife))
Hervás García, Miguel (Hospital Insular Universitario de Gran Canaria (Las Palmas de Gran Canaria))
Mendoza-Rodríguez, Amelia (Complejo Asistencial de Segovia (Segòvia, Castella i Lleó))
Berdei-Montero, Yasmina El (Hospital Universitario de Salamanca (Castella i Lleó))
Téllez Lara, Nieves Lara (Hospital Clínico Universitario de Valladolid)
Herrera Varo, Nicolás (Neurology Service Hospital Universitario de Burgos (Castella i LLeó))
Sotoca Fernández, Javier (Hospital Mútua de Terrassa)
Presas Rodríguez, Sílvia (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
Querol, Luis (Institut d'Investigació Biomèdica Sant Pau)
Hervás, Mariona (Parc Taulí Hospital Universitari. Institut d'Investigació i Innovació Parc Taulí (I3PT))
Batlle Nadal, Jordi (Hospital Sant Pau i Santa Tecla (Tarragona))
Martín Ozaeta, Gisela (Hospital Verge de la Cinta (Tortosa))
Gubieras Lillo, Laura (Hospital Sant Joan Despí Moisès Broggi (Barcelona))
Martínez Yélamos, Sergio (Hospital Universitari de Bellvitge)
Ramió-Torrentà, Lluís (Hospital Universitari de Girona Doctor Josep Trueta)
Mallada-Frechín, Javier J. (Hospital General Universitario de Elda (País Valencià))
Belenguer Benavides, Antonio (Hospital General Universitari de Castelló (País Valencià))
Gascon Gimenez, Francisco (Hospital Clínic Universitari (València))
Casanova, Bonaventura (Hospital Universitari i Politècnic La Fe (València))
Landete Pascual, Lamberto (Hospital Universitari Doctor Peset (València))
Berenguer, Leticia (Hospital Marina Baixa (La Vila Joiosa, Alacant))
Navarro Canto, Laura (Hospital General Universitario de Elche (País Valencià))
Gómez-Gutiérrez, Montserrat (Hospital Universitario de Cáceres)
Durán Barquero, Carmen (Hospital Universitario Infanta Cristina)
Rodríguez Regal, Ana (Complejo Hospitalario Universitario de Pontevedra)
Álvarez, Elena (Hospital Álvaro Cunqueiro (Vigo))
García-Estévez, Daniel Apolinar (Complejo Hospitalario Universitario de Ourense (Galícia))
López Real, Ana María (Complejo Hospitalario Universitario de A Coruña)
Llaneza González, Miguel Ángel (Hospital Central Universitario de Asturias (Oviedo, Asturies))
Marzo-Sola, María Eugenia (Hospital San Pedro (Logroño, La Rioja))
Sánchez Menoyo, José Luis (Hospital Universitario Galdakao-Usansolo (Biscaia))
Oterino, Agustín (Hospital Universitario Marqués de Valdecilla (Santander, Cantabria))
Villaverde-González, Ramón (Hospital General Universitario Morales Meseguer (Múrcia))
Castillo-Triviño, Tamara (Hospital Universitario de Donostia (Sant Sebastià, País Basc))
Álvarez de Arcaya, Amaya (Hospital Universitario Araba (Vitoria-Gasteiz))
Llarena, Cristina (Hospital Universitario de Basurto (Bilbao, Biscaia))
Universitat Autònoma de Barcelona

Date:	2023
Abstract:	Teriflunomide is a once-daily oral immunomodulator approved for relapsing forms of multiple sclerosis (MS) or relapsing-remitting multiple sclerosis (RRMS; depending on the local label), based on extensive evidence from clinical trials and a real-world setting on efficacy, tolerability and patient-reported benefits. The TERICARE study assessed the impact of teriflunomide treatment over 2 years on health-related quality of life (HRQoL) and some of the most common and disabling symptoms of MS, such as fatigue and depression. This prospective observational study in Spain included RRMS patients treated with teriflunomide for ≤ 4 weeks. The following patient-reported outcomes (PROs) were collected at baseline and every 6 months for 2 years: the 29-item Multiple Sclerosis Impact Scale version 2 (MSIS-29), the 21-item Modified Fatigue Impact Scale (MFIS-21), the Beck Depression Inventory (BDI-II), the Short Form (SF)-Qualiveen and the Treatment Satisfaction Questionnaire for Medication v1. 4 (TSQM). Annualised relapse rate (ARR), disability progression according to the Expanded Disability Status Scale (EDSS), and no evidence of disease activity (NEDA-3) were also assessed. A total of 325 patients were analysed. Patients had a mean (SD) age of 43. 2 years (10. 4), a mean baseline EDSS score of 1. 75 (1. 5), a mean number of relapses in the past 2 years of 1. 5 (0. 7), and 64% had received prior disease-modifying therapy (DMT). Patients showed significant improvements in the psychological domain of MSIS-29 from 35. 9 (26. 6) at baseline to 29. 4 (25. 5) at 18 months (p = 0. 004) and 29. 0 (24. 6) at 24 months (p = 0. 002). Levels of fatigue and depression were also reduced. After 2 years of treatment with teriflunomide, ARR was reduced to 0. 17 (95% CI 0. 14-0. 21) from the baseline of 0. 42 (95% CI 0. 38-0. 48), representing a 60. 1% reduction. Mean EDSS scores remained stable during the study, and 79. 9% of patients showed no disability progression. 54. 7% of patients achieved NEDA-3 in the first 12 months, which increased to 61. 4% during months 12-24. Patients reported increased satisfaction with treatment over the course of the study, regardless of whether they were DMT naive or not. Teriflunomide improves psychological aspects of HRQoL and maintains low levels of fatigue and depression. Treatment with teriflunomide over 2 years is effective in reducing ARR and disability progression.
Rights:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original.
Language:	Anglès
Document:	Article ; recerca ; Versió publicada
Subject:	Annualised relapse rate ; Clinical practice ; Disability ; Health-related quality of life ; Multiple sclerosis ; Teriflunomide
Published in:	Neurology and Therapy, Vol. 12 Núm. 6 (december 2023) , p. 2177-2193, ISSN 2193-6536

DOI: 10.1007/s40120-023-00557-7
PMID: 37861931

17 p, 765.0 KB

The record appears in these collections:
Research literature > UAB research groups literature > Research Centres and Groups (research output) > Health sciences and biosciences > Institut d'Investigació en Ciencies de la Salut Germans Trias i Pujol (IGTP)
Research literature > UAB research groups literature > Research Centres and Groups (research output) > Health sciences and biosciences > Parc Taulí Research and Innovation Institute (I3PT
Research literature > UAB research groups literature > Research Centres and Groups (research output) > Health sciences and biosciences > Institut de Recerca Sant Pau
Articles > Research articles
Articles > Published articles