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Calculated risk of natalizumab-related PML according to currently known risk factors

Calculated risk of natalizumab-related PML according to currently known risk factors
  Prior immunosuppressant use? Risk up to 24 months of natalizumab exposure Risk after 24 months of natalizumab exposure  
JC virus antibody negative No ∼0.02/1000 ∼0.2/1000  
Yes ∼0.06/1000 ∼0.9/1000  
    Risk up to 24 months of natalizumab exposure Risk during 25 to 48 months of natalizumab exposure Risk during 49 to 72 months of natalizumab exposure
JC virus antibody positive No, anti-JCV antibody index not available ∼1/1000 ∼3/1000 ∼6/1000
No; anti-JCV antibody index ≤1.5 ∼0.2/1000 ∼1.1/1000 ∼1.4/1000
No; anti-JCV antibody index >1.5 ∼1.2/1000 ∼8.8/1000 ∼10.1/1000
Yes ∼6/1000 ∼12/1000 ∼13/1000
JCV: JC virus; PML: progressive multifocal leukoencephalopathy.
Data from:
  1. Berger JR, Fox RJ. Reassessing the risk of natalizumab-associated PML. J Neurovirol 2016.
  2. Kuesters G, Plavina T, Lee S, et al. Anti-JC virus (JCV) antibody index differentiates risk of progressive multifocal leukoencephalopathy (PML) in natalizumab-treated multiple sclerosis (MS) patients with no prior immunosuppressant (IS) use: An updated analysis. Poster presentation, 67th American Academy of Neurology Annual Meeting, April 22, 2015 Washington DC, USA. www.abstracts2view.com/aan/view.php?nu=AAN15L1_P4.031 (Accessed on February 04, 2016).
  3. Plavina T, Subramanyam M, Bloomgren G, et al. Anti-JC virus antibody levels in serum or plasma further define risk of natalizumab-associated progressive multifocal leukoencephalopathy. Ann Neurol 2014; 76:802.
  4. Fox RJ, Rudick RA. Risk stratification and patient counseling for natalizumab in multiple sclerosis. Neurology 2012; 78:436.
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