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Journal of NeuroVirology
Published in: Journal of NeuroVirology 6/2016

Open Access 01-12-2016 | Letter to the Editor

Statistical analysis of PML incidences of natalizumab-treated patients from 2009 to 2016: outcomes after introduction of the Stratify JCV® DxSelect™ antibody assay

Authors: Denise Campagnolo, Qunming Dong, Lily Lee, Pei-Ran Ho, Diogo Amarante, Harold Koendgen

Published in: Journal of NeuroVirology | Issue 6/2016

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Excerpt

In January 2012, the presence of John Cunningham virus (JCV) antibodies was incorporated into the US prescribing information for Tysabri® (natalizumab) as a third independent risk factor for progressive multifocal leukoencephalopathy (PML) development in natalizumab-treated patients (Tysabri 2016). The assay used to detect the presence of JCV antibodies, Stratify JCV® DxSelect™ (Focus Diagnostics, Cypress, CA, USA), reports a binary output of positive or negative. Additional research described in 2013 (Plavina et al. 2013) and published in 2014 (Plavina et al. 2014) demonstrated that JCV index values could further stratify PML risk in natalizumab-treated anti-JCV antibody positive patients without prior exposure to immunosuppressants. …
Literature
Plavina T, Subramanyam M, Bloomgren S, Pace A, Lee S, Schlain B, Capagnolo D, Belachew S, Ticho B (2013) Anti-JCV antibody index further defines PML risk in natalizumab-tested MS patients. Poster presented at the 27th Annual Meeting of the Consortium of Multiple Sclerosis Centers, May 29–June 1, Orlando, FL
Plavina T, Subramanyam M, Bloomgren G, Richman S, Pace A, Lee S, Schlain B, Campagnolo D, Belachew S, Ticho B (2014) Anti-JC virus antibody levels in serum or plasma further define risk of natalizumab-associated progressive multifocal leukoencephalopathy. Ann Neurol 76:802–812CrossRefPubMed
Tysabri (natalizumab) [prescribing information] (2016) Biogen, Cambridge, MA
Werner MH, Huang D (2016) Natalizumab-treated patients at high risk for PML persistently excrete JC polyomavirus. J Neurovirol May 19
Metadata
Title
Statistical analysis of PML incidences of natalizumab-treated patients from 2009 to 2016: outcomes after introduction of the Stratify JCV® DxSelect™ antibody assay
Authors
Denise Campagnolo
Qunming Dong
Lily Lee
Pei-Ran Ho
Diogo Amarante
Harold Koendgen
Publication date
01-12-2016
Publisher
Springer International Publishing
Published in
Journal of NeuroVirology / Issue 6/2016
Print ISSN: 1355-0284
Electronic ISSN: 1538-2443
DOI
https://doi.org/10.1007/s13365-016-0482-z

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