• 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: Academia Brasileira de Neurologia (ABNEURO) 2013-03-01
• Series: Arquivos de Neuro-Psiquiatria
• Subjects: esclerose múltipla; natalizumabe; eventos adversos; anticorpos monoclonais; multiple sclerosis; natalizumab; adverse events; antibodies; monoclonal
• Online Access: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0004-282X2013000300137

<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>