Zusammenfassung
Die JC-Virus (JCV)-assoziierte progressive multifokale Leukenzephalopathie (PML) ist eine schwerwiegende unerwünschte Arzneimittelwirkung, die unter der Behandlung einer Multiplen Sklerose (MS) mit Natalizumab (Tysabri®) in seltenen Fällen auftreten kann. Neben den bekannten Risikofaktoren – Behandlungsdauer über 24 Monate hinaus sowie eine vorangegangene immunsuppressive Therapie – wurde nun auch eine serologische Untersuchung zum Nachweis sog. Anti-JCV-Antikörper zur Risikostratifizierung in den Zulassungstext der Substanz mit aufgenommen. Unzweifelhaft stellt die JCV-Serologie ein Werkzeug zur PML-Risiko-Stratifzierung von MS-Patienten unter Natalizumab-Therapie dar. Die bisherige Datenlage und die wissenschaftlichen Entwicklungen zur Validität des Assays wurden bisher aber nicht unabhängig bestätigt.
Der vorliegende Artikel erläutert daher Möglichkeiten und Grenzen einer solchen Untersuchung und gibt auf der Basis des zur Verfügung stehenden Wissens konkrete Empfehlungen für die klinische Anwendung dieser neuen Untersuchung.
Summary
JC virus (JCV)-associated progressive multifocal leukoencephalopathy (PML) represents a rare but serious side effect of natalizumab (Tysabri®) in the treatment of patients with relapsing forms of multiple sclerosis (MS). Two factors that may increase the risk of PML have been identified: treatment duration beyond 24 months and prior immunosuppressive therapy. Recently determination of anti-JCV antibodies mirroring JCV infection has allowed a third factor to be added to this list, and a positive serological test has been included as a risk factor on the label of natalizumab. Clearly, JCV serology represents a tool for PML risk stratification in MS patients treated with natalizumab. However, current data as well as the experimental development of the underlying assay have not been validated by an independent laboratory.
The present article discusses possibilities and challenges of this assay and, based on our present knowledge, provides recommendations for the clinical implementation in daily practice.
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Warnke, C., Adams, O., Hartung, H. et al. Risikostratifizierung einer progressiven multifokalen Leukenzephalopathie unter Natalizumab. Nervenarzt 82, 1314–1319 (2011). https://doi.org/10.1007/s00115-011-3319-2
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DOI: https://doi.org/10.1007/s00115-011-3319-2