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       #Post#: 446--------------------------------------------------
       (Abst.) Does risk stratification decrease PML risk? Where is evi
       dence?
       By: agate Date: August 26, 2014, 6:13 pm
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       From Multiple Sclerosis Journal, August 26, 2014:
       [quote]Does risk stratification decrease the risk of
       natalizumab-associated PML? Where is the evidence?
       Gary R Cutter
       Section on Research Methods and Clinical Trials, University of
       Alabama at Birmingham, Birmingham, USA
       Olaf Stüve
       VA North Texas Health Care System, Medical Service Dallas, VA
       Medical Center/University of Texas Southwestern Medical Center
       at Dallas, Dallas, TX, USA/Klinikum rechts der Isar, Technische
       Universität München, Germany
       Neurology Section, VA North Texas Health Care System, Medical
       Service, 4500 South Lancaster Rd., Dallas, TX 75216, USA.
       olaf.stuve@utsouthwestern.edu
       The use of natalizumab has likely been limited by its
       association with progressive multifocal leukoencephalopathy
       (PML), an infection caused by the human polyomavirus John
       Cunningham (JC). Three factors were recently identified that
       contribute to the overall risk of natalizumab-associated PML:
       (1) Positive serostatus for anti-JCV antibodies, (2) prior use
       of immunosuppressants, and (3) duration of natalizumab therapy.
       This risk stratification algorithm has not led to a reduction in
       the incidence of PML in natalizumab-treated patients with
       multiple sclerosis between April 2010 and February 2014. This
       observation may appear perplexing, as treatment duration and JCV
       serostatus are modifiable risk factors. Potential reasons for
       the lack of success of companion diagnostics that determine the
       overall risk of natalizumab-associated PML are
       discussed.[/quote]
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