<sec><title>Objective</title>To assess the prevalence and the profile of adverse events (AE) of natalizumab in patients with multiple sclerosis (MS).</sec><sec><title>Methods</title>Data collection from neurologists attending to patients with MS at specializ...

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Main Authors: Yára Dadalti Fragoso, Soniza Vieira Alves-Leon, Walter Oleschko Arruda, Margarete de Jesus Carvalho, Elizabeth Regina Comini-Frota, Éber Castro Corrêa, Maria Lucia Brito Ferreira, Paulo Diniz da Gama, Sidney Gomes, Marcus Vinicius Magno Gonçalves, Damacio Ramón Kaimen-Maciel, Maria Fernanda Mendes, Rogerio Rizo Morales, Andre Muniz, Pedro Rippel Salgado, Heloisa Helena Ruocco, Livia Brito Bezerra de Albuquerque, Joseph Bruno Bidin Brooks, Letícia Fêzer, Sergio Georgetto, Josiane Lopes, Fabíola Rachid Malfetano, Isabella D'Andrea Meira, Celso Luis Silva Oliveira, Francisco Tomaz Meneses de Oliveira, Fabiana Safanelli, Massaco Satomi
Format: Article
Language:English
Published: Thieme Revinter Publicações 2013-03-01
Series:Arquivos de Neuro-Psiquiatria
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Online Access:http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0004-282X2013000300137
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author Yára Dadalti Fragoso
Soniza Vieira Alves-Leon
Walter Oleschko Arruda
Margarete de Jesus Carvalho
Elizabeth Regina Comini-Frota
Éber Castro Corrêa
Maria Lucia Brito Ferreira
Paulo Diniz da Gama
Sidney Gomes
Marcus Vinicius Magno Gonçalves
Damacio Ramón Kaimen-Maciel
Maria Fernanda Mendes
Rogerio Rizo Morales
Andre Muniz
Pedro Rippel Salgado
Heloisa Helena Ruocco
Livia Brito Bezerra de Albuquerque
Joseph Bruno Bidin Brooks
Letícia Fêzer
Sergio Georgetto
Josiane Lopes
Fabíola Rachid Malfetano
Isabella D'Andrea Meira
Celso Luis Silva Oliveira
Francisco Tomaz Meneses de Oliveira
Fabiana Safanelli
Massaco Satomi
author_facet Yára Dadalti Fragoso
Soniza Vieira Alves-Leon
Walter Oleschko Arruda
Margarete de Jesus Carvalho
Elizabeth Regina Comini-Frota
Éber Castro Corrêa
Maria Lucia Brito Ferreira
Paulo Diniz da Gama
Sidney Gomes
Marcus Vinicius Magno Gonçalves
Damacio Ramón Kaimen-Maciel
Maria Fernanda Mendes
Rogerio Rizo Morales
Andre Muniz
Pedro Rippel Salgado
Heloisa Helena Ruocco
Livia Brito Bezerra de Albuquerque
Joseph Bruno Bidin Brooks
Letícia Fêzer
Sergio Georgetto
Josiane Lopes
Fabíola Rachid Malfetano
Isabella D'Andrea Meira
Celso Luis Silva Oliveira
Francisco Tomaz Meneses de Oliveira
Fabiana Safanelli
Massaco Satomi
author_sort Yára Dadalti Fragoso
collection DOAJ
description <sec><title>Objective</title>To assess the prevalence and the profile of adverse events (AE) of natalizumab in patients with multiple sclerosis (MS).</sec><sec><title>Methods</title>Data collection from neurologists attending to patients with MS at specialized units in Brazil.</sec><sec><title>Results</title>Data from 103 patients attending the infusion centers of 16 MS units in 9 Brazilian states were included in the study. The total number of infusions was 1,042. Seventy-nine patients (76.7%) did not present any AE. Twenty-four patients (23.3%) presented only mild AE. There were three major AE, including two deaths. These three occurrences, although not necessarily being drug-related, must be taken into consideration.</sec><sec><title>Conclusion</title>The profile of AEs for natalizumab shows that 97% of patients have none or only mild AE. However, still due to safety worries, the use of this medication should be restricted to MS units under the care of specialized neurologists.</sec><br><sec><title>Objetivo</title>Avaliar a preval&#234;ncia e o perfil dos eventos adversos (EA) por natalizumabe em pacientes com esclerose m&#250;ltipla (EM).</sec><sec><title>M&#233;todos</title>Coleta de dados fornecidos por neurologistas de unidades especializadas em EM no Brasil.</sec><sec><title>Resultados</title>No estudo, foram inclu&#237;dos dados de 103 pacientes em tratamento em centros de infus&#227;o de 16 unidades de EM em 9 estados brasileiros. O n&#250;mero total de infus&#245;es foi 1.042. Setenta e nove pacientes (76,7%) n&#227;o apresentaram nenhum EA. Vinte e quatro pacientes (23,3%) apresentaram apenas EA leves. Foram relatados tr&#234;s importantes EA, incluindo duas mortes. Embora n&#227;o necessariamente ligadas &#224; droga, estas EA devem ser levadas em considera&#231;&#227;o.</sec><sec><title>Conclus&#227;o</title>O perfil de EA para natalizumabe mostrou que em 97% dos pacientes n&#227;o houve EA ou houve apenas EA leves. No entanto, dadas as preocupa&#231;&#245;es com seguran&#231;a da droga, o uso deste medicamento deve continuar restrito &#224;s unidades de EM sob os cuidados de neurologistas especializados.</sec>
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series Arquivos de Neuro-Psiquiatria
spelling doaj-art-a42a458cc8204080a074ecd93481301e2025-08-20T03:18:59ZengThieme Revinter PublicaçõesArquivos de Neuro-Psiquiatria0004-282X1678-42272013-03-01713137141Yára Dadalti FragosoSoniza Vieira Alves-LeonWalter Oleschko ArrudaMargarete de Jesus CarvalhoElizabeth Regina Comini-FrotaÉber Castro CorrêaMaria Lucia Brito FerreiraPaulo Diniz da GamaSidney GomesMarcus Vinicius Magno GonçalvesDamacio Ramón Kaimen-MacielMaria Fernanda MendesRogerio Rizo MoralesAndre MunizPedro Rippel SalgadoHeloisa Helena RuoccoLivia Brito Bezerra de AlbuquerqueJoseph Bruno Bidin BrooksLetícia FêzerSergio GeorgettoJosiane LopesFabíola Rachid MalfetanoIsabella D'Andrea MeiraCelso Luis Silva OliveiraFrancisco Tomaz Meneses de OliveiraFabiana SafanelliMassaco Satomi<sec><title>Objective</title>To assess the prevalence and the profile of adverse events (AE) of natalizumab in patients with multiple sclerosis (MS).</sec><sec><title>Methods</title>Data collection from neurologists attending to patients with MS at specialized units in Brazil.</sec><sec><title>Results</title>Data from 103 patients attending the infusion centers of 16 MS units in 9 Brazilian states were included in the study. The total number of infusions was 1,042. Seventy-nine patients (76.7%) did not present any AE. Twenty-four patients (23.3%) presented only mild AE. There were three major AE, including two deaths. These three occurrences, although not necessarily being drug-related, must be taken into consideration.</sec><sec><title>Conclusion</title>The profile of AEs for natalizumab shows that 97% of patients have none or only mild AE. However, still due to safety worries, the use of this medication should be restricted to MS units under the care of specialized neurologists.</sec><br><sec><title>Objetivo</title>Avaliar a preval&#234;ncia e o perfil dos eventos adversos (EA) por natalizumabe em pacientes com esclerose m&#250;ltipla (EM).</sec><sec><title>M&#233;todos</title>Coleta de dados fornecidos por neurologistas de unidades especializadas em EM no Brasil.</sec><sec><title>Resultados</title>No estudo, foram inclu&#237;dos dados de 103 pacientes em tratamento em centros de infus&#227;o de 16 unidades de EM em 9 estados brasileiros. O n&#250;mero total de infus&#245;es foi 1.042. Setenta e nove pacientes (76,7%) n&#227;o apresentaram nenhum EA. Vinte e quatro pacientes (23,3%) apresentaram apenas EA leves. Foram relatados tr&#234;s importantes EA, incluindo duas mortes. Embora n&#227;o necessariamente ligadas &#224; droga, estas EA devem ser levadas em considera&#231;&#227;o.</sec><sec><title>Conclus&#227;o</title>O perfil de EA para natalizumabe mostrou que em 97% dos pacientes n&#227;o houve EA ou houve apenas EA leves. No entanto, dadas as preocupa&#231;&#245;es com seguran&#231;a da droga, o uso deste medicamento deve continuar restrito &#224;s unidades de EM sob os cuidados de neurologistas especializados.</sec>http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0004-282X2013000300137esclerose múltiplanatalizumabeeventos adversosanticorpos monoclonaismultiple sclerosisnatalizumabadverse eventsantibodiesmonoclonal
spellingShingle Yára Dadalti Fragoso
Soniza Vieira Alves-Leon
Walter Oleschko Arruda
Margarete de Jesus Carvalho
Elizabeth Regina Comini-Frota
Éber Castro Corrêa
Maria Lucia Brito Ferreira
Paulo Diniz da Gama
Sidney Gomes
Marcus Vinicius Magno Gonçalves
Damacio Ramón Kaimen-Maciel
Maria Fernanda Mendes
Rogerio Rizo Morales
Andre Muniz
Pedro Rippel Salgado
Heloisa Helena Ruocco
Livia Brito Bezerra de Albuquerque
Joseph Bruno Bidin Brooks
Letícia Fêzer
Sergio Georgetto
Josiane Lopes
Fabíola Rachid Malfetano
Isabella D'Andrea Meira
Celso Luis Silva Oliveira
Francisco Tomaz Meneses de Oliveira
Fabiana Safanelli
Massaco Satomi
Arquivos de Neuro-Psiquiatria
esclerose múltipla
natalizumabe
eventos adversos
anticorpos monoclonais
multiple sclerosis
natalizumab
adverse events
antibodies
monoclonal
topic esclerose múltipla
natalizumabe
eventos adversos
anticorpos monoclonais
multiple sclerosis
natalizumab
adverse events
antibodies
monoclonal
url http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0004-282X2013000300137