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#Post#: 1687--------------------------------------------------
(AAN) Selecting first-line MS therapy w/risk-benefit decision an
alysis (Tysabri, Copaxone, Gilenya)
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. [/quote]
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