Pulse monthly steroids during an elective interruption of natalizumab: a post-marketing study.
Eur J Neurol
; 19(5): 783-7, 2012 May.
Article
em En
| MEDLINE
| ID: mdl-22054236
BACKGROUND AND PURPOSE: Temporary discontinuation of natalizumab is sometimes considered as the observed risk of progressive multifocal leukoencephalopathy (PML) in patients with multiple sclerosis (MS). However, interruption of natalizumab may result in a re-start of disease activity. METHODS: In this prospective post-marketing study, 23 patients with MS treated with natalizumab elected a trial of treatment interruption (90-150 days) because of safety concerns on the risk of developing PML. To reduce the risk of disease activity return, patients received monthly intravenous (i.v.) steroid pulses before natalizumab re-start. RESULTS: Despite the steroid coverage, seven patients (30.4%) had an active scan during the natalizumab interruption period; of these, four also had a concomitant clinical exacerbation. CONCLUSIONS: Our findings suggest that i.v. steroids are not currently recommendable as drug coverage during a scheduled treatment interruption period.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Vigilância de Produtos Comercializados
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Anticorpos Monoclonais Humanizados
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Fatores Imunológicos
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Esclerose Múltipla
Tipo de estudo:
Observational_studies
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Risk_factors_studies
Limite:
Adult
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Revista:
Eur J Neurol
Assunto da revista:
NEUROLOGIA
Ano de publicação:
2012
Tipo de documento:
Article
País de afiliação:
Itália