Natalizumab adverse events are rare in patients with multiple sclerosis.

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.

Natalizumab adverse events are rare in patients with multiple sclerosis / Eventos adversos por natalizumabe são raros em pacientes com esclerose múltipla

To assess the prevalence and the profile of adverse events (AE) of natalizumab in patients with multiple sclerosis (MS). Data collection from neurologists attending to patients with MS at specialized units in Brazil. 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. 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. .

Avaliar a prevalência e o perfil dos eventos adversos (EA) por natalizumabe em pacientes com esclerose múltipla (EM). Coleta de dados fornecidos por neurologistas de unidades especializadas em EM no Brasil. No estudo, foram incluídos dados de 103 pacientes em tratamento em centros de infusão de 16 unidades de EM em 9 estados brasileiros. O número total de infusões foi 1.042. Setenta e nove pacientes (76,7%) não apresentaram nenhum EA. Vinte e quatro pacientes (23,3%) apresentaram apenas EA leves. Foram relatados três importantes EA, incluindo duas mortes. Embora não necessariamente ligadas à droga, estas EA devem ser levadas em consideração. O perfil de EA para natalizumabe mostrou que em 97% dos pacientes não houve EA ou houve apenas EA leves. No entanto, dadas as preocupações com segurança da droga, o uso deste medicamento deve continuar restrito às unidades de EM sob os cuidados de neurologistas especializados. .

The effects of long-term exposure to disease-modifying drugs during pregnancy in multiple sclerosis.

BACKGROUND AND OBJECTIVE: Women with multiple sclerosis (MS) who intend to get pregnant are often advised to discontinue disease modifying therapy (DMT) prior to conception. This recommendation is not based on medical evidence and may interfere with disease control by immunomodulatory drugs. The present study was designed to help discuss the effect of DMT for MS on pregnancy and on disease course. PATIENTS AND METHODS: Retrospective data from 152 pregnancies of 132 women with MS were collected by the physician in charge of the case. All data were entered into a specific file for qualitative and quantitative statistical analysis. RESULTS: From the total group of patients, 89 pregnancies occurred without any exposure to MS drugs, while 61 pregnancies occurred with at least eight weeks of exposure to MS immunomodulatory drugs. The rate of obstetric and neonatal complications was similar in both groups, except for the newborn weight and height which was smaller for mothers receiving medications. Mothers' post-delivery relapse rate and EDSS scores in the follow-up period were significantly higher in the absence of treatment. CONCLUSION: It is possible that, with further such supportive data, international guidelines on MS treatment in young women who intend to get pregnant may need to be revised.

Metástases cerebrais / Brain metastasis

Os autores apresentam o estudo de 94 casos de metástases tumorais para o cérebro. Procuraram analisar a freqüência, a incidência das metástases em relaçäo aos tumores primários e a etiologia dos mesmos. Os dados relativos ao sexo mostraram que 64 dos pacientes (68 por cento) eram do sexo masculino e 30 eram do sexo feminino (32 por cento). Com relaçäo a cor, observou-se que os pacientes do sexo masculino apresentaram uma incidência proporcional de 4:1 e os do sexo feminino, uma proporçäo de 1,5:1 para os de cor branca. A idade média dos pacientes estudados foi de 43 anos. Quanto a localizaçäo dos tumores primários, foi observado que os originários do pulmäo, pÚlvis e trato digestivo eram os mais freqüentes. Cerca de 25 por cento dos casos tinham origem no que classificamos como OUTROS FOCOS. Com relaçäo ao número de mestástases cerebrais, o maior número de metástases cerebrais isoladas encontrado, foi dos tumores originários da mama (91 por cento deles). As metástases múltiplas para o Sistema Nervoso Central tiveram sua maior incidência nos tumores originários do trato digestivo (68 por cento). A distribuiçäo topográfica das metástases cerebrais de localizaçäo supratentorial, näo mostrou predomínio evidente entre os hemisférios cerebrais direito e esquerdo, havendo contudo, grande predominância das metástases de localizaçäo supratentoriais (93,5 por cento) em relaçäo as infratentoriais (6,65 por cento). Os resultados obtidos com relaçäo ao tipo de tratamento instituido, em especial o tratamento cirúrgico (46 casos - 49 por cento), säo analisados e comparados.