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   DIR Return to: TYSABRI (natalizumab)
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       #Post#: 1745--------------------------------------------------
       (Abst.) Role of Tysabri in MS treatment: benefits and risks
   DIR By: agate
       Date: July 7, 2017, 9:20 pm
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       From Therapeutic Advances in Neurological Disorders, June 23,
       2017:
       --- Quote ---
       > The role of natalizumab in the treatment of multiple
       sclerosis: benefits and risks
       >
       > Barry A. Singer
       >
       > Natalizumab, a monoclonal antibody that blocks lymphocyte
       infiltration in the central nervous system, is a valuable tool
       in the treatment of relapsing forms of multiple sclerosis (MS).
       In a phase III clinical trial comparing natalizumab with placebo
       over 2 years, natalizumab reduced annualized relapse rate by
       68%, 12-week confirmed disability progression by 42%, and
       reduced contrast-enhancing lesions by 92%. In post hoc analyses,
       natalizumab treatment was associated with 37% of patients
       achieving no evidence of disease activity (versus 7% on placebo)
       and 30% achieving sustained disability improvement (versus 19%
       on placebo).
       >
       > Natalizumab did not achieve a statistically significant
       primary composite disability outcome in a trial of 887 patients
       with secondary progressive MS, but it did demonstrate a benefit
       on a prespecified component of the 9-Hole Peg Test.
       >
       > The greatest risk of natalizumab treatment is progressive
       multifocal leukoencephalopathy (PML), with a 23% mortality rate.
       Risk stratification on the basis of immunosuppressant exposure,
       natalizumab treatment duration and anti-John Cunningham virus
       (JCV) antibody status and index has greatly improved clinical
       decision making. Other potential serious natalizumab-associated
       risks reported in clinical trials and postmarketing settings
       include infusion reactions, hepatotoxicity and rare, serious
       opportunistic infections.
       >
       > With more than a decade of continuous postmarketing
       experience, natalizumab remains a very effective option for
       patients with relapsing forms of MS. To optimize appropriate
       selection of natalizumab for patients with relapsing MS,
       however, a thorough understanding of individual patient risk
       factors for PML or other adverse events is also required.
       --- End Quote ---
  HTML http://journals.sagepub.com/doi/abs/10.1177/1756285617716002
  HTML http://journals.sagepub.com/doi/abs/10.1177/1756285617716002
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