RESUMO
OBJECTIVE: Natalizumab is a new and efficient treatment for multiple sclerosis (MS). The risk of developing progressive multifocal leukoencephalopathy (PML) during the use of this drug has created the need for better comprehension of JC virus (JCV) infection. The objective of the present study was to assess the prevalence of JCV-DNA in Brazilian patients using natalizumab. METHOD: Qualitative detection of the JCV in the serum was performed with real-time polymerase chain reaction (PCR). RESULTS: In a group of 168 patients with MS who were undergoing treatment with natalizumab, JCV-DNA was detectable in 86 (51.2%) patients. DISCUSSION: Data on JCV-DNA in Brazil add to the worldwide assessment of the prevalence of the JCV in MS patients requiring treatment with natalizumab.
Assuntos
Anticorpos Monoclonais Humanizados/efeitos adversos , DNA Viral/análise , Vírus JC/genética , Leucoencefalopatia Multifocal Progressiva/induzido quimicamente , Esclerose Múltipla/tratamento farmacológico , Adulto , Brasil/epidemiologia , Feminino , Humanos , Vírus JC/imunologia , Leucoencefalopatia Multifocal Progressiva/epidemiologia , Masculino , Pessoa de Meia-Idade , Esclerose Múltipla/virologia , Natalizumab , Reação em Cadeia da Polimerase em Tempo Real , Fatores de RiscoRESUMO
OBJECTIVE: To assess the prevalence and the profile of adverse events (AE) of natalizumab in patients with multiple sclerosis (MS). METHODS: Data collection from neurologists attending to patients with MS at specialized units in Brazil. RESULTS: 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. CONCLUSION: 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.
Assuntos
Anticorpos Monoclonais Humanizados/efeitos adversos , Esclerose Múltipla/tratamento farmacológico , Adolescente , Adulto , Brasil , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Natalizumab , Estudos Retrospectivos , Adulto JovemRESUMO
Objective Natalizumab is a new and efficient treatment for multiple sclerosis (MS). The risk of developing progressive multifocal leukoencephalopathy (PML) during the use of this drug has created the need for better comprehension of JC virus (JCV) infection. The objective of the present study was to assess the prevalence of JCV-DNA in Brazilian patients using natalizumab. Method Qualitative detection of the JCV in the serum was performed with real-time polymerase chain reaction (PCR). Results In a group of 168 patients with MS who were undergoing treatment with natalizumab, JCV-DNA was detectable in 86 (51.2%) patients. Discussion Data on JCV-DNA in Brazil add to the worldwide assessment of the prevalence of the JCV in MS patients requiring treatment with natalizumab. .
Objetivo Natalizumabe é um tratamento novo e eficaz para esclerose múltipla (EM). O risco constatado de desenvolver leucoencefalopatia multifocal progressiva (LEMP) durante o uso desta droga criou a necessidade de melhor estudar a infecção pelo vírus JC (JCV). O objetivo do presente estudo foi avaliar a prevalência de DNA-JCV em paciente brasileiros usando natalizumabe. Método Detecção qualitativa de JCV no soro foi realizada através de reação em cadeia por polimerase (PCR) em tempo real. Resultados DNA-JCV foi detectado em 86 pacientes (51,2%) de um grupo de 168 pessoas com EM recebendo tratamento com natalizumabe,). Discussão Dados do DNA-JCV no Brasil complementam as avaliações mundiais sobre a prevalência de JCV em pacientes com EM que necessitam tratamento natalizumabe. .