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Drug Safety
Published in: Drug Safety 11/2010

01-11-2010 | Review Article

Progressive Multif ocal Leukoencephalopathy and Newer Biological Agents

Author: Joseph R. Berger, MD

Published in: Drug Safety | Issue 11/2010

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Abstract

Progressive multifocal leukoencephalopathy (PML) is a rare demyelinating disease of the brain due to a polyoma virus, JC virus. Despite the ubiquity of this virus, PML is rare and almost always seen in association with an underlying immunosuppressive condition. In the last 30 years, AIDS has been the most common predisposing factor. The observation of PML attending the use of certain monoclonal antibody therapies and other pharmacological agents has raised concerns about the safety profile of these agents, but has also provided a window into the pathogenesis of PML. Certain agents, such as the monoclonal antibodies natalizumab, an α4b1 and α4β7 integrin inhibitor, and efalizumab, an antibody directed against CD11a, appear to uniquely predispose to PML. Prior to their introduction for multiple sclerosis and Crohn’s disease with respect to natalizumab, and psoriasis with respect to efalizumab, PML had never been observed with these disorders. PML occurring with other agents that currently carry US FDA-mandated ‘black-box’ warnings, such as rituximab, an antibody directed to CD20, or mycophenolate mofetil, a drug that inhibits T- and B-cell proliferation, typically occur in the background of underlying disorders that have already been identified as risks for PML. This review will focus on the available data regarding the risk for PML with monoclonal antibodies and other drugs. A biologically plausible explanation for the increased risk of PML will be proposed, as well as potential strategies for mitigating disease risk.
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Metadata
Title
Progressive Multif ocal Leukoencephalopathy and Newer Biological Agents
Author
Joseph R. Berger, MD
Publication date
01-11-2010
Publisher
Springer International Publishing
Published in
Drug Safety / Issue 11/2010
Print ISSN: 0114-5916
Electronic ISSN: 1179-1942
DOI
https://doi.org/10.2165/11537510-000000000-00000

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