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Combination of validated progressive multifocal leukoencephalopathy (PML) risk factors and resulting risks for natalizumab-associated PML

Combination of validated progressive multifocal leukoencephalopathy (PML) risk factors and resulting risks for natalizumab-associated PML
Integrated datasets: based on the official PML data from December 2014, 2015, and 2016[1]:
  1. PML incidence 4.22/1000 treated patients (2016).
  2. 57.6% of patients are treated for more than two years (2014).
  3. 55% of treated patients are JC virus (JCV+).
  4. 14% of PML cases occur during the first two years of treatment (2015).
  5. 42% of PML cases have been immunosuppressed prior to natalizumab treatment (2014).
  6. Approximately 1% of PML cases were JCV– before developing PML (2016).
  7. 95.6% of (JCV+) non-immunosuppressed PML cases had an index value of >0.9 before PML (2015).
Own data:
  1. Rate of immunosuppression was ≤15% in 2014.
  2. ≤14% of patients are JCV+, but have an index value of <0.9. Shown is the calculated risk tree of 100,000 hypothetical patients under treatment with natalizumab and resulting 422 cases of PML (4.22/1000), grouped according to the risk factors JCV serostatus, treatment duration, prior immunosuppression, and JCV index. Given are the number of patients in the particular population, the number of PML cases in that population, and the resulting PML incidence/risk. This representation is supposed to allow the reader to weigh the effect of different risk parameters and help with decision making. As a thought and calculation exercise solely based on published statistics, this tree is not meant to be a replacement for actual patient numbers and data from clinical studies.
IS: immunosuppression; JCV: JC virus; MS: multiple sclerosis.
Reference:
  1. Biogen Idec. Biogen Idec MedInfo. Available at: medinfo.biogenidec.com (Accessed on June 4, 2016).
From: Schwab N, Schneider-Hohendorf T, Melzer N, et al. Natalizumab-associated PML: Challenges with incidence, resulting risk, and risk stratification. Neurology 2017; 88:1197. DOI: 10.1212/WNL.0000000000003739. Copyright © 2017 American Academy of Neurology. Reproduced with permission from Lippincott Williams & Wilkins. Unauthorized reproduction of this material is prohibited.
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