Hostname: page-component-77c89778f8-cnmwb Total loading time: 0 Render date: 2024-07-17T16:07:11.988Z Has data issue: false hasContentIssue false

Natalizumab Risk Stratification: Role of a Two- Step Anti-JCV Antibody Assay

Published online by Cambridge University Press:  02 December 2014

Paul W. O'Connor*
Affiliation:
Department of Neurology, St. Michael's Hospital, Toronto, Ontario, Canada
*
Department of Neurology, St. Michael's Hospital, 30 bond Street, Toronto, Ontario, M5b 1W8, Canada. Email: oconnorp@smh.toronto.on.ca
Rights & Permissions [Opens in a new window]

Abstract

Image of the first page of this content. For PDF version, please use the ‘Save PDF’ preceeding this image.'
Type
Commentary
Copyright
Copyright © The Canadian Journal of Neurological 2012

References

1.Biogen Idec Canada Inc. Tysabri (natalizumab) Product Monograph. November 1, 2010.Google Scholar
2.Polman, CH, O’Connor, PW, Havrdova, E, et al.A randomized placebo-controlled trial of natalizumab for relapsing multiple sclerosis. N engl J Med. 2006;354:899910.Google Scholar
3.Havrdova, E, Galetta, S, Hutchinson, M, et al.Effect of natalizumab on clinical and radiological disease activity in multiple sclerosis: a retrospective analysis of the Natalizumab Safety and efficacy in Relapsing-Remitting Multiple Sclerosis (aFFiRM) study. lancet Neurol. 2009;8:25460.Google Scholar
4.Balcer, L, Galetta, Sl, Calabresi, PA, et al.Natalizumab reduces visual loss in patients with relapsing multiple sclerosis. Neurology. 2007;68:1299304.CrossRefGoogle ScholarPubMed
5.Rudick, RA, Miller, D, Hass, S, et al; AFFIRM and SENTINEL Investigators. Health-related quality of life in multiple sclerosis: effects of natalizumab. Ann Neurol. 2007;62:33546.CrossRefGoogle ScholarPubMed
6.Agostini, HT, Ryschkewitsch, CF, Singer, EF, Stoner, GL.Coinfection with two JC virus genotypes in brain, cerebrospinal fluid or urinary tract detected by direct cycle sequencing of PCR products. J Neurovirol. 1996;2:25967.Google Scholar
7.Hellwig, K, Gold, R.Progressive multifocal leukoencephalopathy and natalizumab. J Neurol. 2011;258:19208.Google Scholar
8.Sunyaev, SR, Lugovskoy, A, Simon, K, Gorelik, L.adaptive mutation in the JC virus protein capsid are associated with progressive multifocal leukoencephalopathy (PMl). PloS genet. 2009;5:e1000368.Google Scholar
9.Tan, CS, Koralnik, IJ.Progressive multifocal leukoencephalopathy and other disorders caused by JC virus: clinical features and pathogenesis. lancet Neurol. 2010;9:42537.CrossRefGoogle ScholarPubMed
10.Major, EO.Progressive multifocal leukoencephalopathy in patients on immunomodulatory therapies. annu Rev Med. 2010;61:3547.CrossRefGoogle ScholarPubMed
11.Langer-Gould, A, Atlast, SW, Green, AJ, Bollen, AW, Pelletier, D.Progressive multifocal leukoencephalopathy in a patient treated with natalizumab. N engl J Med. 2005;353:37581.CrossRefGoogle Scholar
12.Kleinschmidt-DeMasters, BK, Tyler, KL.Progressive multifocal leukoencephalopathy complicating treatment with natalizumab and interferon-beta-1a for multiple sclerosis. N engl J Med. 2005;353:36974.CrossRefGoogle ScholarPubMed
13.Van Assche, G, Van Ranst, M, Sciot, R, et al.Progressive multifocal leukoencephalopathy after natalizumab therapy for Crohn’s disease. N engl J Med. 2005;353:3628.Google Scholar
14.Biogen, Idec. Data on file as of February 29, 2012.Google Scholar
15.Foley, J, Vermersch, P, Gold, R, et al.Natalizumab-associated progressive multifocal leukoencephalopathy outcomes. int J MS Care. 2011;13(Suppl 3):7.Google Scholar
16.Clifford, DB, De Luca, A, Simpson, DW, Arendt, G, Giovannoni, G, Nath, A.Natalizumab-associated progressive multifocal leukoencephalopathy in patients with multiple sclerosis: lessons learned from 28 cases. lancet Neurol. 2010;9:43846.CrossRefGoogle Scholar
17.Khatri, BO, Man, S, Giovannoni, G, et al.effect of plasma exchange in accelerating natalizumab clearance and restoring leukocyte function. Neurology. 2009;72:4029.Google Scholar
18.Vermersch, P, Kappos, L, Gold, R, et al.Clinical outcomes of natalizumab-associated progressive multifocal leukoencephalopathy. Neurology. 2001;76:1697704.Google Scholar
19.Gorelik, L, Lerner, M, Bixler, S, et al.Anti-JCV virus antibodies: implications for PMl risk stratification. Ann Neurol. 2010;68:295303.CrossRefGoogle ScholarPubMed
20.Sørensen, PS, Bbertolotto, A, Edan, G, et al.Risk stratification for progressive multifocal leukoencephalopathy in patients treated with natalizumab. Mult Scler. 2012;18:14352.CrossRefGoogle ScholarPubMed
21.Rudick, RA, O’Connor, PW, Polman, CH, et al.Assessment of JC virus DNa in blood and urine from natalizumab-treated patients. Ann Neurol. 2010;68:30410.CrossRefGoogle ScholarPubMed
22.Bozic, C, Richman, S, Plavina, T, et al.Anti-John Cunningham virus antibody prevalence in multiple sclerosis patients: baseline results of STRATIFY-1. Ann Neurol. 2011;70:74250.CrossRefGoogle Scholar
23.Moiola, L, Sangalli, F, Martinelli, V, et al.Prevalence of anti-JCV antibodies in a cohort of natalizumab-treated multiople sclerosis patients from italy. Neurology. 2011;76(Suppl 4):S30.007, S31.Google Scholar
24.Bloomgren, G, Richman, S, Hotermans, C, et al.Contribution of natalizumab treatment duration, prior immunosuppressant use, and anti-JCv virus antibody status to the risk of progressive multifocal leukoencephalopathy in natalizumab-treated multiple sclerosis patients. Mult Scler J. 2011;17(Suppl 10):S451.Google Scholar
25.O’Connor, PW.Use of natalizumab in multiple sclerosis patients. Can J Neurol Sci. 2010;37:98104.Google Scholar
26.O’Connor, PW, Goodman, A, Kappos, L, et al.Disease activity return during natalizumab treatment interruption in patients with multiple sclerosis. Neurology. 2011;76:185865.CrossRefGoogle ScholarPubMed
27.Kappos, L, Foley, J, Gold, R, et al.Overview of survival outcome and functional status in postmarketing cases of natalizumab-associated progressive multifocal leukoencephalopathy. Mult Scler J. 2011;17(10 Suppl):S131.Google Scholar
28.Phan-Ba, R, Lommers, E, Tshibanda, L, et al.MRI preclinical detection and asymptomatic course of a progressive multifocal leucoencephalopathy (PMl) under natalizumab therapy. J Neurol Neurosurg Psychiatry. 2012;83:2246.Google Scholar