Effectiveness and Safety of Teriflunomide in Relapsing-Remitting Multiple Sclerosis and Improvements in Quality of Life: Results from the Real-World TERICARE Study

被引：1

作者：

Meca-Lallana, Jose E. ^{[1
,2
]}

Gonzalez, Jose M. Prieto ^{[3
]}

Rodriguez, Ana B. Caminero ^{[4
]}

Urtaza, Javier Olascoaga ^{[5
]}

Alonso, Ana M. ^{[6
]}

Ferreras, Eduardo Duran ^{[7
]}

Espinosa, Raul ^{[8
]}

Dotor, Julio ^{[9
]}

Romera, Mercedes ^{[10
]}

Luque, Adrian Ares ^{[11
]}

Ruiz, Domingo Perez ^{[12
]}

Calles, Carmen ^{[13
]}

Hernandez, Miguel A. ^{[14
]}

Garcia, Miguel Hervas ^{[15
]}

Rodriguez, Amelia Mendoza ^{[16
]}

Montero, Yasmina Berdei ^{[17
]}

Tellez, Nieves ^{[18
]}

Varo, Nicolas Herrera ^{[19
]}

Sotoca, Javier ^{[20
]}

Presas-Rodriguez, Silvia ^{[21
]}

Gutierrez, Luis A. Querol ^{[22
]}

Pujol, Mariona Hervas ^{[23
]}

Nadal, Jordi ^{[24
]}

Ozaeta, Gisela Martin ^{[25
]}

Lillo, Laura Gubieras ^{[26
]}

Yelamos, Sergio Martinez ^{[27
]}

Ramio-Torrenta, Lluis ^{[28
]}

Frechin, Javier Mallada ^{[29
]}

Benavides, Antonio Belenguer ^{[30
]}

Gascon-Gimenez, Francisco ^{[31
]}

Casanova, Bonaventura ^{[32
]}

Pascual, Lamberto Landete ^{[33
]}

Berenguer, Leticia ^{[34
]}

Navarro, Laura ^{[35
]}

Gutierrez, Montserrat Gomez ^{[36
]}

Duran, Carmen ^{[37
]}

Regal, Ana Rodriguez ^{[38
]}

Alvarez, Elena ^{[39
]}

Garcia-Estevez, Daniel A. ^{[40
]}

Real, Ana M. Lopez ^{[41
]}

Gonzalez, Miguel A. Llaneza ^{[42
]}

Sola, Maria E. Marzo ^{[43
]}

Sanchez-Menoyo, Jose L. ^{[44
]}

Oterino, Agustin ^{[45
]}

Gonzalez, Ramon Villaverde ^{[46
]}

Castillo-Trivino, Tamara ^{[47
]}

de Arcaya, Amaya ^{[48
]}

Llarena, Cristina ^{[49
]}

机构：

[1] Univ Catolica San Antonio, Hosp Clin Univ Virgen de la Arrixaca IMIB Arrixaca, Neurol Dept, Clin Neuroimmunol Unit,UCAM,Clin Neuroimmunol & Mu, Murcia, Spain

[2] Univ Catolica San Antonio, Hosp Clin Univ Virgen de la Arrixaca IMIB Arrixaca, Neurol Dept, Multiple Sclerosis CSUR,UCAM,Clin Neuroimmunol & M, Murcia, Spain

[3] Complejo Hosp Univ Santiago de Compostela, Neurol Serv, Santiago De Compostela, Spain

[4] Complejo Asistencial Avila, Neurol Serv, Avila, Spain

[5] Hosp Univ Donostia, Multiple Sclerosis Unit, Donostia San Sebastian, Spain

[6] Hosp Reg Univ Malaga, Neurol Serv, Malaga, Spain

[7] Hosp Univ Virgen del Rocio, Neurol Serv, Seville, Spain

[8] Hosp Univ Jerez La Frontera, Neurol Unit, Cadiz, Spain

[9] Hosp Univ Virgen Macarena, Neurol Serv, Multiple Sclerosis Unit, Seville, Spain

[10] Hosp Univ Virgen de Valme, Neurol Serv, Seville, Spain

[11] Hosp Univ Leon, Neurol Serv, E-24008 Leon, Spain

[12] Hosp El Bierzo, Neurol Unit, Ponferrada, Spain

[13] Hosp Univ Son Espases, Neurol Dept, Palma De Mallorca, Spain

[14] Hosp Univ Nuestra Senora de Candelaria, Neurol Serv, Tenerife, Spain

[15] Hosp Insular Univ Gran Canaria, Neurol Serv, Las Palmas Gran Canaria, Spain

[16] Complejo Asistencial Segovia, Neurol Serv, Segovia, Spain

[17] Hosp Univ Salamanca, Neurol Serv, Salamanca, Spain

[18] Hosp Clin Univ Valladolid, Neurol Serv, Valladolid, Spain

[19] Hosp Univ Burgos, Neurol Serv, Burgos, Spain

[20] Hosp Mutua Terrassa, Neurol Dept, Barcelona, Spain

[21] Hosp Germans Trias i Pujol, Dept Neurosci, MS Neuroimmunol Unit, Badalona, Spain

[22] Hosp Santa Creu & Sant Pau, Inst Recerca Biomed St Pau, Autoimmune Neurol Neuromuscular Lab, Neurol Dept,Neuromuscular Dis Unit, Barcelona, Spain

[23] Hosp Parc Tauli, Neurol Serv, Sabadell, Spain

[24] Hosp St Pau & Santa Tecla, Neurol Serv, Tarragona, Spain

[25] Hosp Verge de la Cinta, Neurol Serv, Tortosa, Spain

[26] Hosp St Joan Despi Moises Broggi, Neurol Serv, Barcelona, Spain

[27] Hosp Univ Bellvitge, Inst Catala Salut, Multiple Sclerosis Unit, Barcelona, Spain

[28] Hosp Univ Dr Josep Trueta & Santa Caterina, Neurol Dept, Hosp Univ Dr, Girona, Spain

[29] Hosp Gen Univ Elda, Neurol Serv, Alicante, Spain

[30] Hosp Gen Univ Castello, Neurol Serv, Castellon de La Plana, Spain

[31] Hosp Clin Univ Valencia, Multiple Sclerosis Unit, Valencia, Spain

[32] Hosp Univ & Politecn La Fe, Neuroimmunol Unit, Valencia, Spain

[33] Hosp Univ Dr Peset, Neurol Dept, Hosp Univ Dr, Valencia, Spain

[34] Hosp Marina Baixa, Neurol Serv, Valencia, Spain

[35] Hosp Gen Univ Elche, Neurol Dept, Alicante, Spain

[36] Hosp Univ Caceres, Neurol Serv, Caceres, Spain

[37] Hosp Univ Infanta Cristina, Neurol Serv, Badajoz, Spain

[38] Complejo Hosp Univ Pontevedra, Neurol Serv, Pontevedra, Spain

[39] Hosp Alvaro Cunqueiro, Neurol Serv, Vigo, Pontevedra, Spain

[40] Complejo Hosp Univ Ourense, Neurol Serv, Orense, Spain

[41] Complejo Hosp Univ A Coruna, Neurol Serv, La Coruna, Spain

[42] Hosp Cent Univ Asturias, Neurol Dept, Oviedo, Spain

[43] Hosp San Pedro, Neurol Serv, Logrono, La Rioja, Spain

[44] Hosp Univ Galdakao Usansolo, Neurol Dept, Bizkaia, Spain

[45] Hosp Univ Marques de Valdecilla, Neurol Serv, Santander, Spain

[46] Hosp Univ Jose Maria Morales Meseguer, Neurol Serv, Murcia, Spain

[47] Hosp Univ Donostia, Neurol Serv, Gipuzkoa, Spain

[48] Hosp Univ Araba, Neurol Dept, Vitoria, Spain

[49] Hosp Univ Basurto, Neurol Serv, Bilbao, Spain

来源：

NEUROLOGY AND THERAPY | 2023年 / 12卷 / 06期

关键词：

Annualised relapse rate; Clinical practice; Disability; Health-related quality of life; Multiple sclerosis; Teriflunomide; PATIENT-REPORTED OUTCOMES; ORAL TERIFLUNOMIDE; FOLLOW-UP; IMPACT; EFFICACY; PHASE-2; FORMS;

D O I：

10.1007/s40120-023-00557-7

中图分类号：

R74 [神经病学与精神病学];

学科分类号：

摘要：

IntroductionTeriflunomide 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.MethodsThis 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.ResultsA 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.ConclusionTeriflunomide 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.

引用

页码：2177 / 2193

页数：17

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