Assessment of JC virus DNA in blood and urine from natalizumab-treated patients

Objective Analyses were conducted to determine the clinical utility of measuring JC virus (JCV) DNA in blood or urine of natalizumab‐treated multiple sclerosis (MS) patients to predict the risk of progressive multifocal leukoencephalopathy (PML). Methods A total of 12,850 blood and urine samples fro...

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Bibliographic Details
Published in:	Annals of neurology Vol. 68; no. 3; pp. 304 - 310
Main Authors:	Rudick, Richard A., O'Connor, Paul W., Polman, Chris H., Goodman, Andrew D., Ray, Soma S., Griffith, Nancy M., Jurgensen, Stephanie A., Gorelik, Leonid, Forrestal, Fiona, Sandrock, Alfred W., E. Goelz, Susan
Format:	Journal Article
Language:	English
Published:	Hoboken Wiley Subscription Services, Inc., A Wiley Company 01-09-2010 Wiley Subscription Services, Inc
Subjects:	Antibodies, Monoclonal - therapeutic use Antibodies, Monoclonal, Humanized Antibodies, Viral - blood Antibodies, Viral - therapeutic use Antibodies, Viral - urine Confidence Intervals Deoxyribonucleic acid DNA DNA, Viral - blood DNA, Viral - immunology DNA, Viral - urine Enzyme-Linked Immunosorbent Assay - methods Female Follow-Up Studies Humans JC virus JC Virus - immunology Leukoencephalopathy, Progressive Multifocal - blood Leukoencephalopathy, Progressive Multifocal - therapy Leukoencephalopathy, Progressive Multifocal - urine Male Natalizumab Statistics, Nonparametric Urine
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Summary:	Objective Analyses were conducted to determine the clinical utility of measuring JC virus (JCV) DNA in blood or urine of natalizumab‐treated multiple sclerosis (MS) patients to predict the risk of progressive multifocal leukoencephalopathy (PML). Methods A total of 12,850 blood and urine samples from nearly 1,400 patients participating in natalizumab clinical trials were tested for JCV DNA using a commercially available quantitative polymerase chain reaction (qPCR) assay. A subset of these samples was also tested using a more sensitive qPCR assay developed at the National Institutes of Health (NIH). Results At the time natalizumab dosing was suspended, JCV DNA was detected in plasma by the commercial assay in 4 of 1,397 (0.3%) patients; the NIH assay confirmed these positive samples and detected JCV DNA in an additional 2 of 205 (1%) patients who tested negative with the commercial assay. None of these 6 JCV DNA positive patients developed PML. In a 48‐week study testing the safety of natalizumab redosing, JCV DNA was detected in plasma of 6 of 1,094 (0.3%) patients, none of whom developed PML. Urine at baseline and week 48 was assessed in 224 patients; 58 (26%) were positive at baseline, and 55 (25%) were positive after 48 weeks of natalizumab, treatment. JCV DNA was not detected in peripheral blood mononuclear cells from any of these 1,094 patients before or after natalizumab treatment. In 5 patients who developed PML, JCV DNA was not detected in blood at any time point before symptoms first occurred. Interpretation Measuring JCV DNA in blood or urine with currently available methods is unlikely to be useful for predicting PML risk in natalizumab‐treated MS patients. Ann Neurol 2010
Bibliography:	istex:BB3E3E01312456C82B59C8B03C5E055E422B9CEC ark:/67375/WNG-43HRL82X-W ArticleID:ANA22107 ObjectType-Article-2 SourceType-Scholarly Journals-1 ObjectType-Feature-1 content type line 23
ISSN:	0364-5134 1531-8249
DOI:	10.1002/ana.22107