Journal
REVIEWS IN MEDICAL VIROLOGY
Volume 29, Issue 6, Pages -Publisher
WILEY
DOI: 10.1002/rmv.2077
Keywords
CD20; JC virus; obinutuzumab; ofatumumab; progressive multifocal leukoencephalopathy; rituximab
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In 1997, rituximab was the first monoclonal antibody clinically approved for the treatment of cancer. Ten years later, progressive multifocal leukoencephalopathy (PML), until that time a rare opportunistic infection mostly seen in AIDS patients, was added as a black box warning after retrospective case-control studies showed an increased incidence in both B-cell lymphoproliferative disorders and autoimmune diseases. Despite more than 5 million worldwide exposures to date (and about 500 000 new exposures per year), insufficient data collection has hampered identification of risk minimization strategies, and concerns have been raised about a class effect extending to the newer anti-CD20 monoclonal antibodies (ofatumumab, obinutuzumab, and ocrelizumab). Here, we report current PML case counts registered in the FAERS and EudraVigilance databases and comment on severe CD4(+) T lymphopenia as a plausible common mechanism of action for anti-CD20 antibodies in causation of PML.
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