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Multiple Sclerosis
Multiple sclerosis
(ms) is the most common, disabling, neurological condition, to
affect young adults in the world today.
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Multiple
Sclerosis News
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Copaxone Reduces Brain Atrophy
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Copaxone Reduces Brain Atrophy in Multiple
Sclerosis
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According to new data published in the April 27 edition of
Neurology, Copaxone® (glatiramer acetate injection) significantly
reduces brain atrophy in patients living with relapsing-remitting
multiple sclerosis (RRMS). As brain atrophy is a sensitive measure
of the neurodegenerative component of MS, there is an increasing
interest in measuring this phenomenon on more accurate and sensitive
MRI techniques.
The study utilized a post-hoc analysis of a fully automated,
normalized technique for analyzing MRI scans. The technique, known
as SIENA (structural image evaluation of normalized atrophy),
reduces measurement error and increases the power to detect small
but significant changes in brain volume by more than twofold
compared to older techniques. There is continued interest in
developing measurements, such as SIENA, to further assess brain
atrophy.
The study included 207 RRMS patients randomized to Copaxone (n=102)
or placebo (n=105) for a period of nine months, followed by a second
open-label period of an additional nine months where all patients
took Copaxone (n=194). In 13 patients, data loss was due to
inadequate image quality for a reliable application of SIENA.
The reduction in brain volume expressed as percent brain volume
change (PBVC) throughout the 18-month study was observed when
comparing patients originally randomized to Copaxone and those
originally randomized to placebo. During the initial double-blind
phase, PBVC was slightly, but not significantly less in patients
treated with Copaxone.
In the second period, between nine and 18 months, PBVC was
significantly lower in Copaxone (glatiramer acetate injection)
patients compared to those originally randomized to placebo (-0.6%
vs. -1.0%, p=0.015). Moreover, for the whole 18 month period, PBVC
was significantly less in patients originally randomized to Copaxone
(- 1.5% vs. -2.0%, p= 0.037).
The results of this study reaffirm two previous studies. In the
first study, a subcohort from the United States pivotal study with
Copaxone, placebo patients (n=13) exhibited a nearly threefold
greater annual decline (p=0.0078) in brain volume after 24 months
than the Copaxone treated patients (n=14) (1). The second study was
the open label, long-term follow up to the placebo-controlled
pivotal US trial of Copaxone. Those patients originally randomized
to Copaxone (n=69) had 6.7 years of exposure to therapy and showed
less brain atrophy than those originally randomized to placebo
(n=66) (p=0.041) and only on active treatment for 4.0 years (2).
Thus, Copaxone has shown an effect on brain atrophy in both short
term trials and long term follow up.
Dr. Jerry S. Wolinsky, Bartels Family Professor of Neurology, The
University of Texas Health Science Center at Houston, commented on
the study findings. "Results from this study support an effect of
glatiramer acetate on limiting brain atrophy. Evolving MRI analytic
techniques are improving our ability to reliably detect brain volume
change and the neurodegenerative components of the pathology of MS
and to study an impact of treatment on this process." In the current
study, both SIENA and an older semi-automated, non- normalized
technique were used to assess brain volume from MRI images in study
patients. Mean values for PBVC were similar using both techniques,
but statistically significant reduction in brain atrophy with
Copaxone was observed with the more sensitive and accurate SIENA
method, but not with the old technique. "Using a technique with less
measurement error and improved statistical power not only increases
our confidence in study outcomes, but decreases the number of
patients required in future studies," said Dr Wolinsky. "We also
need to be aware of variances between measurement techniques in
previous studies when comparing the effects of different MS
therapies on slowing neurodegeneration."
Copaxone (glatiramer acetate injection) is indicated for the
reduction of the frequency of relapses in relapsing-remitting MS.
The most common side effects of Copaxone are redness, pain,
swelling, itching, or a lump at the site of injection, weakness,
infection, pain, nausea, joint pain, anxiety, and muscle stiffness.
Copaxone is now approved in 42 countries worldwide, including the
United States, Canada, Australia, Israel, and all European
countries. In Europe, Copaxone is marketed by Teva Pharmaceutical
Industries Ltd. and Aventis Pharma. In North America, Copaxone is
marketed by Teva Neuroscience Inc.
Copaxone is a registered trademark of Teva Pharmaceutical Industries
Ltd.
References: (1) Ge, Y. et. al. Glatiramer Acetate (Copaxone)
Treatment in Relapsing-Remitting Multiple Sclerosis. Neurology,
2000, 54:813-817.
(2) Wolinsky, JS. et. al. United States Open-Label Glatiramer
Acetate Extension Trial for Relapsing Multiple Sclerosis: MRI and
Clinical Correlates. Multiple Sclerosis, 2001, 7:33-41 [JSW1].
SOURCE: Teva Neuroscience, Inc. |
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