Treatment of Multiple Sclerosis With Teriflunomide. Multicenter Study of Real Clinical Practice in the Valencian Community-Spain

Introduction: We have different treatment alternatives for relapsing-remitting multiple sclerosis–RRMS–within the so-called platform drugs. It would be desirable to know the ideal drug for each patient. Real clinical practice studies provide us with data on drug efficacy in the medium and long term,...

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Autores principales:	Lamberto Landete, Francisco Pérez-Miralles, Sara García, Antonio Belenguer, Francisco Gascón, Jose Andres Domínguez, María Carcelén-Gadea, Carlos Quintanilla-Bordás, Laura Navarro, Laura Gabaldón, Bonaventura Casanova
Formato:	article
Lenguaje:	EN
Publicado:	Frontiers Media S.A. 2021
Materias:	teriflunomide MS therapy real world evidence (RWE) cohort analysis multicentric study Neurology. Diseases of the nervous system RC346-429
Acceso en línea:	https://doaj.org/article/e4c47455c9fb40f4b29c944df0dadf9c
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spelling	oai:doaj.org-article:e4c47455c9fb40f4b29c944df0dadf9c2021-11-05T15:36:28ZTreatment of Multiple Sclerosis With Teriflunomide. Multicenter Study of Real Clinical Practice in the Valencian Community-Spain1664-229510.3389/fneur.2021.727586https://doaj.org/article/e4c47455c9fb40f4b29c944df0dadf9c2021-10-01T00:00:00Zhttps://www.frontiersin.org/articles/10.3389/fneur.2021.727586/fullhttps://doaj.org/toc/1664-2295Introduction: We have different treatment alternatives for relapsing-remitting multiple sclerosis–RRMS–within the so-called platform drugs. It would be desirable to know the ideal drug for each patient. Real clinical practice studies provide us with data on drug efficacy in the medium and long term, safety beyond clinical trials, and can help us to know the patient profile appropriate for each therapy.Material and Methods: An observational multicenter study of real clinical practice in patients with RRMS who were treated with teriflunomide in the Valencian Community, since teriflunomide was authorized in Spain. The database created for this study collects retrospectively patients followed prospectively in the MS clinics.Objectives: To analyze the efficacy and safety of teriflunomide treatment in patients with RRMS under the conditions of real clinical practice, and to identify a patient profile responding to the treatment.Results: We obtained data from 340 patients who received at least one dose of 14 mg teriflunomide. The patients were 69.4% female to 30.6% male, had a mean age of 46.4 years, and a mean time of progression of MS of 11.5 years. The mean pre-teriflunomide relapse rate was 0.4 years, the mean EDSS scorewas 1.98, IgG Oligoclonal bands were present in the CSF of 66.2% of the patients, IgM Oligoclonal bands were present in 46.9%, and the mean number of gadolinium-enhancing lesions was 1.07 lesions per patient at the beginning of treatment. The average number of treatments previously received was 1.04, and 28.53% were naïve. After a follow-up of up to 4 years, a reduction in the annualized and cumulative annualized relapse rate was observed in the first year, in the second year, and in the third year, compared to the pre-treatment year. The EDSS scores were stabilized throughout the follow-up. Likewise, there was a reduction in gadolinium-enhancing lesions in the 1st and 2nd years compared to the pre-treatment period. Applying different generalized multiple linear regression models, we identified a profile of a responding patient to teriflunomide as a male without IgM oligoclonal bands in the CSF, a previous EDSS score of <3, and more than 5 years duration of MS.Lamberto LandeteFrancisco Pérez-MirallesSara GarcíaAntonio BelenguerFrancisco GascónJose Andres DomínguezMaría Carcelén-GadeaCarlos Quintanilla-BordásLaura NavarroLaura GabaldónBonaventura CasanovaFrontiers Media S.A.articleteriflunomideMS therapyreal world evidence (RWE)cohort analysismulticentric studyNeurology. Diseases of the nervous systemRC346-429ENFrontiers in Neurology, Vol 12 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	teriflunomide MS therapy real world evidence (RWE) cohort analysis multicentric study Neurology. Diseases of the nervous system RC346-429
spellingShingle	teriflunomide MS therapy real world evidence (RWE) cohort analysis multicentric study Neurology. Diseases of the nervous system RC346-429 Lamberto Landete Francisco Pérez-Miralles Sara García Antonio Belenguer Francisco Gascón Jose Andres Domínguez María Carcelén-Gadea Carlos Quintanilla-Bordás Laura Navarro Laura Gabaldón Bonaventura Casanova Treatment of Multiple Sclerosis With Teriflunomide. Multicenter Study of Real Clinical Practice in the Valencian Community-Spain
description	Introduction: We have different treatment alternatives for relapsing-remitting multiple sclerosis–RRMS–within the so-called platform drugs. It would be desirable to know the ideal drug for each patient. Real clinical practice studies provide us with data on drug efficacy in the medium and long term, safety beyond clinical trials, and can help us to know the patient profile appropriate for each therapy.Material and Methods: An observational multicenter study of real clinical practice in patients with RRMS who were treated with teriflunomide in the Valencian Community, since teriflunomide was authorized in Spain. The database created for this study collects retrospectively patients followed prospectively in the MS clinics.Objectives: To analyze the efficacy and safety of teriflunomide treatment in patients with RRMS under the conditions of real clinical practice, and to identify a patient profile responding to the treatment.Results: We obtained data from 340 patients who received at least one dose of 14 mg teriflunomide. The patients were 69.4% female to 30.6% male, had a mean age of 46.4 years, and a mean time of progression of MS of 11.5 years. The mean pre-teriflunomide relapse rate was 0.4 years, the mean EDSS scorewas 1.98, IgG Oligoclonal bands were present in the CSF of 66.2% of the patients, IgM Oligoclonal bands were present in 46.9%, and the mean number of gadolinium-enhancing lesions was 1.07 lesions per patient at the beginning of treatment. The average number of treatments previously received was 1.04, and 28.53% were naïve. After a follow-up of up to 4 years, a reduction in the annualized and cumulative annualized relapse rate was observed in the first year, in the second year, and in the third year, compared to the pre-treatment year. The EDSS scores were stabilized throughout the follow-up. Likewise, there was a reduction in gadolinium-enhancing lesions in the 1st and 2nd years compared to the pre-treatment period. Applying different generalized multiple linear regression models, we identified a profile of a responding patient to teriflunomide as a male without IgM oligoclonal bands in the CSF, a previous EDSS score of <3, and more than 5 years duration of MS.
format	article
author	Lamberto Landete Francisco Pérez-Miralles Sara García Antonio Belenguer Francisco Gascón Jose Andres Domínguez María Carcelén-Gadea Carlos Quintanilla-Bordás Laura Navarro Laura Gabaldón Bonaventura Casanova
author_facet	Lamberto Landete Francisco Pérez-Miralles Sara García Antonio Belenguer Francisco Gascón Jose Andres Domínguez María Carcelén-Gadea Carlos Quintanilla-Bordás Laura Navarro Laura Gabaldón Bonaventura Casanova
author_sort	Lamberto Landete
title	Treatment of Multiple Sclerosis With Teriflunomide. Multicenter Study of Real Clinical Practice in the Valencian Community-Spain
title_short	Treatment of Multiple Sclerosis With Teriflunomide. Multicenter Study of Real Clinical Practice in the Valencian Community-Spain
title_full	Treatment of Multiple Sclerosis With Teriflunomide. Multicenter Study of Real Clinical Practice in the Valencian Community-Spain
title_fullStr	Treatment of Multiple Sclerosis With Teriflunomide. Multicenter Study of Real Clinical Practice in the Valencian Community-Spain
title_full_unstemmed	Treatment of Multiple Sclerosis With Teriflunomide. Multicenter Study of Real Clinical Practice in the Valencian Community-Spain
title_sort	treatment of multiple sclerosis with teriflunomide. multicenter study of real clinical practice in the valencian community-spain
publisher	Frontiers Media S.A.
publishDate	2021
url	https://doaj.org/article/e4c47455c9fb40f4b29c944df0dadf9c
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Treatment of Multiple Sclerosis With Teriflunomide. Multicenter Study of Real Clinical Practice in the Valencian Community-Spain

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