The efficacy and safety of natalizumab for the treatment of multiple sclerosis in Portugal: a retrospective study

Detalhes bibliográficos
Autor(a) principal: Sousa, L.
Data de Publicação: 2014
Outros Autores: de Sa, J., Sa, M., Cerqueira, J., Martins-Silva, A.
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
Texto Completo: http://hdl.handle.net/10400.16/1876
Resumo: INTRODUCTION: Studies have shown that natalizumab is an effective treatment for relapsing-remitting multiple sclerosis (RRMS). To date, no data are available in Portuguese patients. AIM: To determine the efficacy and safety of natalizumab in patients with RRMS in routine clinical practice in Portugal. PATIENTS AND METHODS: Clinical data for adult patients with RRMS treated with natalizumab at specialist neurology centres in Portugal were entered retrospectively into a database for analysis between October 2010 and February 2012. Changes in annualized relapse rates (ARR), Expanded Disability Status Scale (EDSS) scores and disability status were analysed. RESULTS: A total of 383 patients from 20 centres were included. Prior to starting natalizumab, the baseline median EDSS score was 4 and the mean ARR was 1.64. Most patients had previously received multiple sclerosis treatment (93.0%). Median natalizumab treatment duration was 12 months. Natalizumab treatment was associated with significant (p < 0.001) reductions from baseline in the mean ARR and EDSS scores in patients treated with natalizumab for >= 12 months (n = 288) and for >= 24 months (n = 160). Natalizumab was more effective in patients with less disability (EDSS < 3) and in those who had not previously received disease-modifying treatments. Two cases of progressive multifocal leukoencephalopathy were reported. No new unexpected adverse events occurred. CONCLUSION: Natalizumab is well tolerated, and is effective in reducing relapse rate and stabilising disease in patients with RRMS in the clinical practice setting in Portugal. Its efficacy persists with continued treatment, and it may be particularly effective in patients with less disability and without prior disease modifying therapy.
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spelling The efficacy and safety of natalizumab for the treatment of multiple sclerosis in Portugal: a retrospective studyEstudio retrospectivo de la eficacia y seguridad del natalizumab en el tratamiento de la esclerosis múltiple en PortugalDemyelinating autoimmune diseasesMultiple sclerosisNatalizumabProgressive multifocal leukoencephalopathyRelapse rateRetrospective studyEnfermedades autoinmunitarias desmielinizantesEsclerosis múltipleEstudio retrospectivoLeucoencefalopatía multifocal progresivaNatalizumabTasa de brotesINTRODUCTION: Studies have shown that natalizumab is an effective treatment for relapsing-remitting multiple sclerosis (RRMS). To date, no data are available in Portuguese patients. AIM: To determine the efficacy and safety of natalizumab in patients with RRMS in routine clinical practice in Portugal. PATIENTS AND METHODS: Clinical data for adult patients with RRMS treated with natalizumab at specialist neurology centres in Portugal were entered retrospectively into a database for analysis between October 2010 and February 2012. Changes in annualized relapse rates (ARR), Expanded Disability Status Scale (EDSS) scores and disability status were analysed. RESULTS: A total of 383 patients from 20 centres were included. Prior to starting natalizumab, the baseline median EDSS score was 4 and the mean ARR was 1.64. Most patients had previously received multiple sclerosis treatment (93.0%). Median natalizumab treatment duration was 12 months. Natalizumab treatment was associated with significant (p < 0.001) reductions from baseline in the mean ARR and EDSS scores in patients treated with natalizumab for >= 12 months (n = 288) and for >= 24 months (n = 160). Natalizumab was more effective in patients with less disability (EDSS < 3) and in those who had not previously received disease-modifying treatments. Two cases of progressive multifocal leukoencephalopathy were reported. No new unexpected adverse events occurred. CONCLUSION: Natalizumab is well tolerated, and is effective in reducing relapse rate and stabilising disease in patients with RRMS in the clinical practice setting in Portugal. Its efficacy persists with continued treatment, and it may be particularly effective in patients with less disability and without prior disease modifying therapy.Introduccion. Los estudios han demostrado que el natalizumab constituye un tratamiento eficaz contra la esclerosis multiple remitente recurrente (EMRR). Hasta la fecha, no habia datos de pacientes portugueses. Objetivo. Determinar la eficacia y la seguridad del natalizumab en pacientes con EMRR atendidos en la practica clinica ordinaria en Portugal. Pacientes y metodos. Los datos clinicos de adultos con EMRR tratados con natalizumab en centros especializados de neurologia en Portugal se introdujeron de forma retrospectiva en una base de datos para llevar a cabo un analisis entre octubre de 2010 y febrero de 2012. Se analizo el cambio en la tasa anualizada de brotes (TAB), en las puntuaciones de la escala ampliada de discapacidad (EDSS) y en el estado de discapacidad. Resultados. Se admitio un total de 383 pacientes atendidos en 20 centros. Antes de iniciar el tratamiento con natalizumab, la mediana inicial de la EDSS era de 4,0 y la TAB media, de 1,64. La mayor parte de los pacientes ya habia recibido tratamiento contra la esclerosis multiple (93,0%). La duracion media del tratamiento con natalizumab era de 12 meses. El tratamiento propicio reducciones significativas (p < 0,001) de los valores iniciales de la TAB media y de las puntuaciones EDSS en los tratados con el anticuerpo durante >= 12 meses (n = 288) y durante >= 24 meses (n = 160). El natalizumab resulto mas eficaz en los pacientes que presentaban un menor grado de discapacidad (EDSS < 3,0) y en los que no habian recibido ningun tratamiento modificador de la enfermedad. Se notificaron dos casos de leucoencefalopatia multifocal progresiva. No hubo efectos adversos inesperados. Conclusion. El natalizumab presenta una tolerabilidad satisfactoria y se muestra eficaz en la reduccion de las recidivas y la estabilizacion de la EMRR en el marco de la practica clinica ordinaria en Portugal. Conserva su eficacia con el tratamiento continuado y podria ser eficaz especialmente en los pacientes con menos discapacidad y en aquellos que no han recibido ningun tratamiento modificador de la enfermedad hasta el momento.Cesar VigueraRepositório Científico do Centro Hospitalar Universitário de Santo AntónioSousa, L.de Sa, J.Sa, M.Cerqueira, J.Martins-Silva, A.2015-11-02T13:54:14Z2014-11-012014-11-01T00:00:00Zinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleapplication/pdfapplication/pdfhttp://hdl.handle.net/10400.16/1876engRev Neurol 2014; 59 (9): 399-4060210-0010info:eu-repo/semantics/openAccessreponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãoinstacron:RCAAP2023-10-20T10:57:56Zoai:repositorio.chporto.pt:10400.16/1876Portal AgregadorONGhttps://www.rcaap.pt/oai/openaireopendoar:71602024-03-19T20:38:11.989289Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãofalse
dc.title.none.fl_str_mv The efficacy and safety of natalizumab for the treatment of multiple sclerosis in Portugal: a retrospective study
Estudio retrospectivo de la eficacia y seguridad del natalizumab en el tratamiento de la esclerosis múltiple en Portugal
title The efficacy and safety of natalizumab for the treatment of multiple sclerosis in Portugal: a retrospective study
spellingShingle The efficacy and safety of natalizumab for the treatment of multiple sclerosis in Portugal: a retrospective study
Sousa, L.
Demyelinating autoimmune diseases
Multiple sclerosis
Natalizumab
Progressive multifocal leukoencephalopathy
Relapse rate
Retrospective study
Enfermedades autoinmunitarias desmielinizantes
Esclerosis múltiple
Estudio retrospectivo
Leucoencefalopatía multifocal progresiva
Natalizumab
Tasa de brotes
title_short The efficacy and safety of natalizumab for the treatment of multiple sclerosis in Portugal: a retrospective study
title_full The efficacy and safety of natalizumab for the treatment of multiple sclerosis in Portugal: a retrospective study
title_fullStr The efficacy and safety of natalizumab for the treatment of multiple sclerosis in Portugal: a retrospective study
title_full_unstemmed The efficacy and safety of natalizumab for the treatment of multiple sclerosis in Portugal: a retrospective study
title_sort The efficacy and safety of natalizumab for the treatment of multiple sclerosis in Portugal: a retrospective study
author Sousa, L.
author_facet Sousa, L.
de Sa, J.
Sa, M.
Cerqueira, J.
Martins-Silva, A.
author_role author
author2 de Sa, J.
Sa, M.
Cerqueira, J.
Martins-Silva, A.
author2_role author
author
author
author
dc.contributor.none.fl_str_mv Repositório Científico do Centro Hospitalar Universitário de Santo António
dc.contributor.author.fl_str_mv Sousa, L.
de Sa, J.
Sa, M.
Cerqueira, J.
Martins-Silva, A.
dc.subject.por.fl_str_mv Demyelinating autoimmune diseases
Multiple sclerosis
Natalizumab
Progressive multifocal leukoencephalopathy
Relapse rate
Retrospective study
Enfermedades autoinmunitarias desmielinizantes
Esclerosis múltiple
Estudio retrospectivo
Leucoencefalopatía multifocal progresiva
Natalizumab
Tasa de brotes
topic Demyelinating autoimmune diseases
Multiple sclerosis
Natalizumab
Progressive multifocal leukoencephalopathy
Relapse rate
Retrospective study
Enfermedades autoinmunitarias desmielinizantes
Esclerosis múltiple
Estudio retrospectivo
Leucoencefalopatía multifocal progresiva
Natalizumab
Tasa de brotes
description INTRODUCTION: Studies have shown that natalizumab is an effective treatment for relapsing-remitting multiple sclerosis (RRMS). To date, no data are available in Portuguese patients. AIM: To determine the efficacy and safety of natalizumab in patients with RRMS in routine clinical practice in Portugal. PATIENTS AND METHODS: Clinical data for adult patients with RRMS treated with natalizumab at specialist neurology centres in Portugal were entered retrospectively into a database for analysis between October 2010 and February 2012. Changes in annualized relapse rates (ARR), Expanded Disability Status Scale (EDSS) scores and disability status were analysed. RESULTS: A total of 383 patients from 20 centres were included. Prior to starting natalizumab, the baseline median EDSS score was 4 and the mean ARR was 1.64. Most patients had previously received multiple sclerosis treatment (93.0%). Median natalizumab treatment duration was 12 months. Natalizumab treatment was associated with significant (p < 0.001) reductions from baseline in the mean ARR and EDSS scores in patients treated with natalizumab for >= 12 months (n = 288) and for >= 24 months (n = 160). Natalizumab was more effective in patients with less disability (EDSS < 3) and in those who had not previously received disease-modifying treatments. Two cases of progressive multifocal leukoencephalopathy were reported. No new unexpected adverse events occurred. CONCLUSION: Natalizumab is well tolerated, and is effective in reducing relapse rate and stabilising disease in patients with RRMS in the clinical practice setting in Portugal. Its efficacy persists with continued treatment, and it may be particularly effective in patients with less disability and without prior disease modifying therapy.
publishDate 2014
dc.date.none.fl_str_mv 2014-11-01
2014-11-01T00:00:00Z
2015-11-02T13:54:14Z
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
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dc.identifier.uri.fl_str_mv http://hdl.handle.net/10400.16/1876
url http://hdl.handle.net/10400.16/1876
dc.language.iso.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv Rev Neurol 2014; 59 (9): 399-406
0210-0010
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dc.publisher.none.fl_str_mv Cesar Viguera
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dc.source.none.fl_str_mv reponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
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