期刊
LANCET HAEMATOLOGY
卷 8, 期 8, 页码 E593-E604出版社
ELSEVIER SCI LTD
DOI: 10.1016/S2352-3026(21)00167-8
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资金
- National Cancer Institute [1R01 CA125077-01A1]
- National Cancer Institute
Progressive multifocal leukoencephalopathy (PML) is a serious CNS infection caused by the John Cunningham virus, with CD4+ and CD8+ T-cell lymphopenia being primary risk factors. The use of the immunomodulatory anti-CD20 monoclonal antibody, rituximab, has been associated with an increased risk of PML infection. Reassuringly, pharmacovigilance efforts have shown rituximab-associated PML to be a rare clinical event with specific causal factors after 20 years of monitoring.
Progressive multifocal leukoencephalopathy (PML) is a serious and usually fatal CNS infection caused by the John Cunningham virus. CD4+ and CD8+ T-cell lymphopenia, resulting from HIV infection, chemotherapy, or immunosuppressive therapy, are primary risk factors for PML. Following its introduction in 1997, the immunomodulatory anti-CD20 monoclonal antibody, rituximab, has received regulatory approval worldwide for treatment of non-Hodgkin lymphoma, rheumatoid arthritis, chronic lymphocytic leukaemia, granulomatosis with polyangiitis, microscopic polyangiitis, and pemphigus vulagris. Rituximab leads to prolonged B-lymphocyte depletion, potentially allowing John Cunningham viral infection to occur. Six unexpected cases of PML infection developing in rituximab-treated patients were first reported in 2002. We review 20 years of information on clinical findings, pathology, epidemiology, proposed pathogenesis, and risk-management issues associated with PML infection developing after rituximab treatment. Since the first case series report of 52 cases of rituximab-associated PML among patients with non-Hodgkin lymphoma or chronic lymphocytic leukaemia in 2009, updated and diligent pharmacovigilance efforts have provided reassurance that this fatal toxicity is a rare clinical event with concurring causal factors. International harmonisation of safety warnings around rituximab-associated PML should be considered, with these notifications listing rituximab-associated PML under a section titled warnings and precautions as is the case in most countries, rather than a boxed warning as is the case in the USA.
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