• PML Risk
    Stratification
  • Anti-JCV
    Antibody Test
PML RISK STRATIFICATION

NOW IS THE TIME:
DETECT ANTI-JCV ANTIBODIES AND ASSESS PML RISK

Testing for anti-JC virus (JCV) antibodies is recommended in patients considering or receiving TYSABRI1

Anti-JCV antibody negative status indicates that exposure to JCV has not been detected1

IT IS RECOMMENDED THAT ANTI-JCV ANTIBODY NEGATIVE PATIENTS BE RETESTED EVERY 6 MONTHS.1

Anti-JCV antibody positive status is 1 of 3 known risk factors that increase the risk of PML1

a
The estimated incidence of PML related to TYSABRI is based on postmarketing PML data as of September 5, 2012 and TYSABRI use data as of August 31, 2012. Data beyond 4 years of treatment are limited. Risk in anti-JCV antibody positive patients was estimated based on the assumptions that 18% of TYSABRI-treated MS patients have a history of prior immunosuppressant treatment and that 55% of TYSABRI-treated MS patients are anti-JCV antibody positive.1
b
Immunosuppressants may include mitoxantrone, azathioprine, methotrexate, cyclophosphamide, and mycophenolate mofetil.1

THE RISKS AND BENEFITS OF CONTINUING TYSABRI SHOULD BE CAREFULLY CONSIDERED IN PATIENTS WHO ARE ANTI-JCV POSITIVE AND HAVE ONE OR MORE ADDITIONAL RISK FACTORS.1

References

  1. TYSABRI Prescribing Information. Cambridge, MA: Biogen Idec.
  2. Sunyaev SR, Lugovskoy A, Simon K, Gorelik L. Adaptive mutations in the JC virus protein capsid are associated with progressive multifocal leukoencephalopathy (PML). PLoS Genet. 2009;5(2):e1000368. Epub 2009 Feb 6.
  3. Gorelik L, Lerner M, Bixler S, et al. Anti-JC virus antibodies: implications for PML risk stratification. Ann Neurol. 2010;68(3):295-303.
  4. Data on file, Biogen Idec.
Indication
TYSABRI is indicated as monotherapy for the treatment
of patients with relapsing
forms of multiple sclerosis to delay the accumulation of physical disability and reduce
the frequency of clinical exacerbations. The efficacy of TYSABRI beyond 2 years is unknown. Because TYSABRI increases the risk of progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection of the brain that usually leads to death or severe disability, TYSABRI is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, an alternate multiple sclerosis therapy. Safety and efficacy in patients with chronic progressive multiple sclerosis have not been studied.

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