| アブストラクト | 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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| ジャーナル名 | Reviews in medical virology |
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| 投稿日 | 2019/8/2 |
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| 投稿者 | Focosi, Daniele; Tuccori, Marco; Maggi, Fabrizio |
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| 組織名 | North-Western Tuscany Blood Bank, Pisa University Hospital, Pisa, Italy.;Unit of Pharmacology and Pharmacovigilance, Department of Clinical and;Experimental Medicine, University of Pisa, Pisa, Italy.;Unit of Adverse Drug Reaction Monitoring, Pisa University Hospital, Pisa, Italy.;Department of Translational Research, University of Pisa, Pisa, Italy. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/31369199/ |
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