Tysabri Risk Stratification
Jack H. Florin, MD
MS Center at Fullerton Neurology
45% of PML patients were previously treated with an immunosuppressive (IS), 20% not and the remainder unknown. Treatment before use of Tysabri with any IS confers a 4-fold higher risk of PML.
Risk is greatest between 24-30 months of therapy and may fall thereafter. No patient has developed PML at less than 12 months.
Risks are as follows:
if JCV-
- 2 yrs: 0.1/1000 = 1 in 10000 or less
- 2 yrs: same as <2 yrs
if JCV+ and no IS
- 2 yrs: 0.35/1000 = 1 in 2850
- 2 yrs: 2.8/1000 = 1 in 357
if JCV+ and IS
- 2 yrs: 1.2/1000 = 1 in 833
- 2 yrs: 8.1/100 = 1 in 123
A commercial JCV antibody assay is not yet available. STRATIFY sites will test any MS patient (whether or not on Tysabri) and forward results to the patient’s neurologist.
Look for the Stratify study at www.clinicaltrials.gov , then " search for trials", and type in JCV antibody assay and the study comes up.
Ref. Poster 0.3248, Sandrock et al, AAN, 2011.
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