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Published on: November 23, 2013
Monoclonal antibodies and progressive multifocal leukoencephalopathy
Daniel L Keene1, Carole Legare, Elaine Taylor
1Biotechnology and Natural Health Products Bureau, Ottawa, Ontario, Canada.
Summary
Monoclonal antibodies, used for serious conditions, are associated with progressive multifocal leukoencephalopathy (PML). This review found 182 adverse event cases, with natalizumab and rituximab having box warnings for PML.
Area of Science:
- Immunology
- Neurology
- Pharmacovigilance
Background:
- Monoclonal antibodies are crucial therapeutics for various serious diseases.
- Concerns exist regarding their potential link to progressive multifocal leukoencephalopathy (PML).
Purpose of the Study:
- To investigate the association between monoclonal antibody use and progressive multifocal leukoencephalopathy (PML).
- To compile and analyze reported cases of PML following monoclonal antibody administration in Canada.
Main Methods:
- Data sourced from Health Canada's Drug Product Database for authorized monoclonal antibodies.
- Case reports of PML were identified through Canada Vigilance, WHO adverse event databases, and PubMed/Medline searches.
- Adverse event data was systematically collected and categorized by monoclonal antibody type.
Main Results:
- A total of 182 adverse event case reports of PML were identified.
- Rituximab (114 cases) and natalizumab (32 cases) were associated with the highest number of PML reports.
- Canadian Product Monographs for natalizumab and rituximab include box warnings for PML.
- A registry for natalizumab has been established to monitor PML risk.
Conclusions:
- Monoclonal antibody therapies carry a risk of progressive multifocal leukoencephalopathy (PML).
- Specific agents like rituximab and natalizumab require heightened vigilance due to reported PML cases.
- Regulatory warnings and patient monitoring systems are essential for managing PML risk associated with these treatments.
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