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DIR Return to: TECFIDERA (dimethyl fumarate, BG-12, Fumaderm)
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#Post#: 993--------------------------------------------------
(ECTRIMS) Tecfidera better than placebo on composite disability
measure
By: agate Date: November 4, 2015, 8:40 pm
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From DGNews (DocGuide), November 3, 2015:
[quote]Dimethyl Fumarate Is Superior to Placebo on Composite
Disability Measure
: Presented at ECTRIMS
By Jill Stein
BARCELONA -- October 8, 2015 -- Delayed-release dimethyl
fumarate (DMF) provides significant clinical benefits over
placebo on composite measures of clinical disability progression
in patients with multiple sclerosis, according to results of an
analysis of 2 phase 3 studies presented at the 2015 Annual
Meeting of the European Committee for Treatment and Research in
Multiple Sclerosis (ECTRIMS).
Amit Bar-Or, MD, Montreal Neurological Institute, McGill
University, Montreal, Quebec, Canada, and colleagues assessed
the effect of DMF twice daily on composite measures of sustained
clinical disability progression in an integrated analysis of the
phase 3 DEFINE and CONFIRM studies of relapsing-remitting MS.
While delayed-release DMF significantly reduced the risk of
sustained disability progression as assessed by the Expanded
Disability Status Scale (EDSS) compared with placebo, EDSS
progression alone may not capture all aspects of disability, the
authors pointed out in their poster presentation here on October
8.
In fact, EDSS progression is inherently subjective, as it is
based on the standard neurological examination, and does not
differentiate between different contributors to motor
disabilities. In addition, it inadequately captures
non-ambulation-related contributors to patient disability such
as vision and cognition, particularly in those patients with an
EDSS in the range of 4.0 to 4.5, who are fully ambulatory
without aid.
In the present study, the researchers tested the use of a
functional composite outcome measure that allows for the capture
of potentially clinically relevant sustained worsening across
multiple neuro-performance components.
The integrated intent-to-treat population included 771 and 769
subjects receiving placebo or DMF twice daily, respectively.
At 2 years, DMF twice daily significantly reduced the risk of
12- or 24-week sustained disability progression on the composite
measure, including EDSS or disability as measured by the timed
25-foot walk or 9-hole peg test compared with placebo.
DMF twice daily significantly reduced the risk of disability
progression on the full composite, measured by any of the
disability outcomes, for 12-week (hazard ratio [HR] = 0.85; P =
.0489) or 24-week (HR = 0.79); P = .0231) sustained disability
progression compared with placebo.
.
The researchers observed significant reductions with DMF twice
daily compared with placebo in an analysis of 12- or 24-week
sustained disability progression including EDSS or the worsening
of 1 of the following: timed 25-foot walk; 9-hole peg test for
12-week sustained disability progression only; paced auditory
serial addition test; or a visual function test.
________________________
Funding for this study was provided by Biogen, Boston,
Massachusetts.
[Presentation title: Efficacy of Delayed-Release Dimethyl
Fumarate for Relapsing-Remitting Multiple Sclerosis Using a
Composite Measure of Disability: Integrated Analysis of the
Phase 3 DEFINE and CONFIRM studies Abstract P628][/quote]
The article can be seen here
HTML http://www.docguide.com/dimethyl-fumarate-superior-placebo-composite-disability-measure.
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