Abstract
Progressive multifocal leukoencephalopathy (PML) has been associated with the use of a number of multiple sclerosis (MS) immunomodulatory therapies and has assumed a critical place in the evaluation of their benefit/risk. In this review, we discuss the European Union regulatory approach to drug-induced PML in MS, highlight a number of key issues related to the current knowledge on PML, and outline possible paths to help progress the risk management of patients with MS at risk of PML.
© 2016 American Society for Clinical Pharmacology and Therapeutics.
MeSH terms
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Antibodies, Monoclonal, Humanized / adverse effects
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Europe / epidemiology
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European Union*
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Humans
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Immunologic Factors / adverse effects*
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Leukoencephalopathy, Progressive Multifocal / chemically induced*
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Leukoencephalopathy, Progressive Multifocal / epidemiology
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Leukoencephalopathy, Progressive Multifocal / immunology
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Multiple Sclerosis / drug therapy*
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Multiple Sclerosis / epidemiology
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Multiple Sclerosis / immunology
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Natalizumab / adverse effects
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Risk Assessment / legislation & jurisprudence
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Risk Factors
Substances
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Antibodies, Monoclonal, Humanized
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Immunologic Factors
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Natalizumab