Multiple Sclerosis Treatment with Natalizumab: Analysis of a Hospital-Based Cohort

Detalhes bibliográficos
Autor(a) principal: Carvalho, Ana Teresa
Data de Publicação: 2014
Outros Autores: Abreu, Pedro, José Sá, Maria
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
Texto Completo: https://www.actamedicaportuguesa.com/revista/index.php/amp/article/view/5032
Resumo: Introduction: Natalizumab is licensed as monotherapy for relapsing–remitting multiple sclerosis. Since pivotal studies showing natalizumab efficacy, several subsequent studies confirmed the reduction in annualized relapse rate and the slowing of disability progression. Nevertheless, ‘real-world’ data, namely in Portugal, are still scarce. We intend to report demographic and clinical data of the cohort of patients treated with natalizumab in the multiple sclerosis Clinic of Centro Hospitalar São João, based on daily practice.Material and Methods: We have conducted a retrospective study of multiple sclerosis patients who had been treated with natalizumab (at least one dose) from January 2007 to May 2013 in our Center. We have gathered information about demography, baseline disease, natalizumab treatment, and outcome.Results: We have found 66 patients treated with natalizumab since 2007 in our center. The majority (65.2%) were female, with a mean age of 35 years, and mean disease duration of 9.5 years. Almost all patients (93.9%) had received a prior multiple sclerosis immunomodulatory therapy. Patients have been treated with natalizumab on an average time of 24 months, with a statistically significant reduction in Annualized Relapse Ratio (- 1.9, p < 0.001) and Expanded Disability Status Scale score (- 0.8, p < 0.001). One patient has developed progressive multifocal leukoencephalopathy; other adverse effects have been uncommon.Discussion: In general, our results fit those earlier reported in other post-marketing studies. Lack of MRI data and retrospective design are the most important limitations of our study.Conclusion: Our study confirms natalizumab efficacy and safety in the treatment of relapsing-remitting multiple sclerosis in a ‘realworld’ practice.Keywords: Multiple Sclerosis; Natalizumab; Treatment Outcome; Antibodies, Monoclonal, Humanized/ adverse effects; Leukoencephalopathy, Progressive Multifocal/chemically induced.
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spelling Multiple Sclerosis Treatment with Natalizumab: Analysis of a Hospital-Based CohortTratamento da Esclerose Múltipla com Natalizumab: Análise de Uma Coorte HospitalarIntroduction: Natalizumab is licensed as monotherapy for relapsing–remitting multiple sclerosis. Since pivotal studies showing natalizumab efficacy, several subsequent studies confirmed the reduction in annualized relapse rate and the slowing of disability progression. Nevertheless, ‘real-world’ data, namely in Portugal, are still scarce. We intend to report demographic and clinical data of the cohort of patients treated with natalizumab in the multiple sclerosis Clinic of Centro Hospitalar São João, based on daily practice.Material and Methods: We have conducted a retrospective study of multiple sclerosis patients who had been treated with natalizumab (at least one dose) from January 2007 to May 2013 in our Center. We have gathered information about demography, baseline disease, natalizumab treatment, and outcome.Results: We have found 66 patients treated with natalizumab since 2007 in our center. The majority (65.2%) were female, with a mean age of 35 years, and mean disease duration of 9.5 years. Almost all patients (93.9%) had received a prior multiple sclerosis immunomodulatory therapy. Patients have been treated with natalizumab on an average time of 24 months, with a statistically significant reduction in Annualized Relapse Ratio (- 1.9, p < 0.001) and Expanded Disability Status Scale score (- 0.8, p < 0.001). One patient has developed progressive multifocal leukoencephalopathy; other adverse effects have been uncommon.Discussion: In general, our results fit those earlier reported in other post-marketing studies. Lack of MRI data and retrospective design are the most important limitations of our study.Conclusion: Our study confirms natalizumab efficacy and safety in the treatment of relapsing-remitting multiple sclerosis in a ‘realworld’ practice.Keywords: Multiple Sclerosis; Natalizumab; Treatment Outcome; Antibodies, Monoclonal, Humanized/ adverse effects; Leukoencephalopathy, Progressive Multifocal/chemically induced.Introdução: O natalizumab está aprovado no tratamento da Esclerose Múltipla forma surto-remissão em monoterapia. Desde os ensaios pivot que demostraram a sua eficácia, vários estudos confirmaram a redução da Taxa Anualizada de Surtos e o atraso na progressão da incapacidade. No entanto, dados do ‘mundo real’, nomeadamente em Portugal, são escassos. Com este trabalho pretendemos descrever os dados demográficos e clínicos dos doentes tratados com natalizumab na Clínica de Esclerose Múltipla do Centro Hospitalar São João, na prática clínica diária.Material e Métodos: Realizámos um estudo retrospetivo incluindo todos os doentes com esclerose múltipla tratados no nosso Centro com natalizumab (expostos ≥ 1 dose) desde janeiro de 2007 até maio de 2013. Apurámos dados demográficos, das caraterísticas da doença e do tratamento com natalizumab.Resultados: No nosso Centro, foram tratados 66 doentes com natalizumab desde 2007. A maioria (65,2%) era do sexo feminino, com idade média de 35 anos e duração média da doença de 9,5 anos. Quase todos (93,9%) haviam sido expostos a outro imunomodulador para a esclerose múltipla. O tratamento durou em média 24 meses, com redução estatisticamente significativa da Taxa Anualizada de Surtos (-1,9, p < 0,001) e EDSS (-0,8, p < 0,001). Um doente desenvolveu leucoencefalopatia multifocal progressiva; outros efeitos adversos foram raros.Discussão: Em geral, os nossos resultados são sobreponíveis aos descritos noutros estudos pós-comercialização. As limitações mais importantes são a ausência de dados imagiológicos e o desenho retrospetivo.Conclusão: O nosso estudo confirma a eficácia e segurança do natalizumab no tratamento da esclerose múltipla forma surto- remissão na prática clínica.Palavras-chave: Esclerose Múltipla; Natalizumab; Anticorpos Monoclonais Humanizados/efeitos adversos; Leucoencefalopatia Multifocal Progressiva/induzida quimicamente.Ordem dos Médicos2014-08-25info:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleapplication/pdfimage/pngimage/pngimage/pngimage/pngapplication/pdfhttps://www.actamedicaportuguesa.com/revista/index.php/amp/article/view/5032oai:ojs.www.actamedicaportuguesa.com:article/5032Acta Médica Portuguesa; Vol. 27 No. 4 (2014): July-August; 437-443Acta Médica Portuguesa; Vol. 27 N.º 4 (2014): Julho-Agosto; 437-4431646-07580870-399Xreponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãoinstacron:RCAAPenghttps://www.actamedicaportuguesa.com/revista/index.php/amp/article/view/5032https://www.actamedicaportuguesa.com/revista/index.php/amp/article/view/5032/4018https://www.actamedicaportuguesa.com/revista/index.php/amp/article/view/5032/7062https://www.actamedicaportuguesa.com/revista/index.php/amp/article/view/5032/7063https://www.actamedicaportuguesa.com/revista/index.php/amp/article/view/5032/7320https://www.actamedicaportuguesa.com/revista/index.php/amp/article/view/5032/7321https://www.actamedicaportuguesa.com/revista/index.php/amp/article/view/5032/7337Carvalho, Ana TeresaAbreu, PedroJosé Sá, Mariainfo:eu-repo/semantics/openAccess2022-12-20T11:04:10Zoai:ojs.www.actamedicaportuguesa.com:article/5032Portal AgregadorONGhttps://www.rcaap.pt/oai/openaireopendoar:71602024-03-19T16:19:01.350455Repositório 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 Multiple Sclerosis Treatment with Natalizumab: Analysis of a Hospital-Based Cohort
Tratamento da Esclerose Múltipla com Natalizumab: Análise de Uma Coorte Hospitalar
title Multiple Sclerosis Treatment with Natalizumab: Analysis of a Hospital-Based Cohort
spellingShingle Multiple Sclerosis Treatment with Natalizumab: Analysis of a Hospital-Based Cohort
Carvalho, Ana Teresa
title_short Multiple Sclerosis Treatment with Natalizumab: Analysis of a Hospital-Based Cohort
title_full Multiple Sclerosis Treatment with Natalizumab: Analysis of a Hospital-Based Cohort
title_fullStr Multiple Sclerosis Treatment with Natalizumab: Analysis of a Hospital-Based Cohort
title_full_unstemmed Multiple Sclerosis Treatment with Natalizumab: Analysis of a Hospital-Based Cohort
title_sort Multiple Sclerosis Treatment with Natalizumab: Analysis of a Hospital-Based Cohort
author Carvalho, Ana Teresa
author_facet Carvalho, Ana Teresa
Abreu, Pedro
José Sá, Maria
author_role author
author2 Abreu, Pedro
José Sá, Maria
author2_role author
author
dc.contributor.author.fl_str_mv Carvalho, Ana Teresa
Abreu, Pedro
José Sá, Maria
description Introduction: Natalizumab is licensed as monotherapy for relapsing–remitting multiple sclerosis. Since pivotal studies showing natalizumab efficacy, several subsequent studies confirmed the reduction in annualized relapse rate and the slowing of disability progression. Nevertheless, ‘real-world’ data, namely in Portugal, are still scarce. We intend to report demographic and clinical data of the cohort of patients treated with natalizumab in the multiple sclerosis Clinic of Centro Hospitalar São João, based on daily practice.Material and Methods: We have conducted a retrospective study of multiple sclerosis patients who had been treated with natalizumab (at least one dose) from January 2007 to May 2013 in our Center. We have gathered information about demography, baseline disease, natalizumab treatment, and outcome.Results: We have found 66 patients treated with natalizumab since 2007 in our center. The majority (65.2%) were female, with a mean age of 35 years, and mean disease duration of 9.5 years. Almost all patients (93.9%) had received a prior multiple sclerosis immunomodulatory therapy. Patients have been treated with natalizumab on an average time of 24 months, with a statistically significant reduction in Annualized Relapse Ratio (- 1.9, p < 0.001) and Expanded Disability Status Scale score (- 0.8, p < 0.001). One patient has developed progressive multifocal leukoencephalopathy; other adverse effects have been uncommon.Discussion: In general, our results fit those earlier reported in other post-marketing studies. Lack of MRI data and retrospective design are the most important limitations of our study.Conclusion: Our study confirms natalizumab efficacy and safety in the treatment of relapsing-remitting multiple sclerosis in a ‘realworld’ practice.Keywords: Multiple Sclerosis; Natalizumab; Treatment Outcome; Antibodies, Monoclonal, Humanized/ adverse effects; Leukoencephalopathy, Progressive Multifocal/chemically induced.
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dc.publisher.none.fl_str_mv Ordem dos Médicos
publisher.none.fl_str_mv Ordem dos Médicos
dc.source.none.fl_str_mv Acta Médica Portuguesa; Vol. 27 No. 4 (2014): July-August; 437-443
Acta Médica Portuguesa; Vol. 27 N.º 4 (2014): Julho-Agosto; 437-443
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