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       #Post#: 1687--------------------------------------------------
       (AAN) Selecting first-line MS therapy w/risk-benefit decision
       analysis (Tysabri, Copaxone, Gilenya)
   DIR By: agate
       Date: May 17, 2017, 1:58 pm
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       Presented at the AAN annual meeting in Boston, April 2017:
       --- Quote ---
       > Selection of first-line therapy in multiple sclerosis using
       risk-benefit decision analysis
       >
       > David Bargiela1, Matt Bianchi2, Brandon Westover2, Brian
       Healy1, Philip De Jager3, Zongqi Xia4
       >
       > 1
       > Brigham and Women's Hospital, 2 Massachusetts General
       Hospital, 3 Brigham & Women's Hospital, 4 University of
       Pittsburgh
       >
       > Objective:
       >
       > To integrate long-term measures of disease-modifying drugs
       (DMDs) efficacy and risk to guide selection of first-line
       treatment of multiple sclerosis (MS).
       >
       > Background:
       >
       > With the growing choices of DMDs, there is an increasing need
       for stratified treatment guidance in MS due to variable
       responses and adverse events. However, head-to-head comparison
       of DMDs that includes a broad range of risk profiles and
       long-term outcomes is challenging to perform.
       >
       > Design/Methods:
       >
       > We created a Markov decision model to evaluate disability
       worsening and progressive multifocal leukoencephalopathy (PML)
       risk in patients receiving three representative DMDs across 30
       years: natalizumab (NTZ), fingolimod (FGL) or glatiramer acetate
       (GA).
       >
       > Leveraging publicly available data, we integrated treatment
       > utility, disability worsening and risk of PML into
       quality-adjusted life-years (QALYs). We performed extensive
       sensitivity analyses varying PML risk, mortality and morbidity,
       and relative risk of disease worsening across clinically
       relevant ranges.
       >
       > Results:
       >
       > Over the entire reported range of NTZ-associated PML risk, NTZ
       as first-line therapy is predicted to provide a greater net
       benefit (15.06 QALYs) than FGL (13.99 QALYs) or GA (12.71 QALYs)
       treatment over 30 years, after accounting for loss of QALYs due
       to PML or death (from all causes). NTZ treatment is associated
       with delayed
       > worsening to an Expanded Disability Status Scale score
       ≥6.0 versus FGL or GA (22.7 years, 17.0 years and 12.4
       years, respectively).
       >
       > When compared to untreated patients, NTZ-treated patients have
       greater relative risk of death in the early years of treatment
       that varies according to PML risk profile.
       >
       > Conclusions:
       >
       > NTZ as a first-line treatment is associated with the highest
       net benefit across full ranges of PML risk, mortality and
       morbidity when compared to FGL or GA. Integrated modelling of
       long-term treatment risks and benefits informs
       > stratified clinical decision-making and can support patient
       counselling on selection of first-line treatment options.
       >
       > ___________________
       > Study Supported by:
       >
       > None relevant to this study.
       --- End Quote ---
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