October 2, 2001
A study published in the August issue
of Neurology showed that Copaxone® (glatiramer acetate for injection)
reduced by 50 percent the number of permanent "black holes" that developed
in the brains of patients with relapsing-remitting multiple sclerosis (MS).
Black holes are lesions MS can cause
in the brain, and these lesions, if permanent, represent areas where the
most severe and irreversible brain tissue damage has occurred.
"This study was designed to determine
if glatiramer acetate could modify the severity of tissue damage in the
lesions of MS patients. We know that permanent black holes represent areas
with most severe brain damage. The study showed that the drug has the potential
to prevent some of the delayed tissue destruction that can follow newly
enhanced lesions," said Jerry S. Wolinsky, M.D., director of the MS Research
Group at the University of Texas-Health Science Center.
The study evaluated 1,722 new lesions
from 239 (119 glatiramer acetate, 120 placebo) MS patients enrolled in
the placebo-controlled medical resonance imaging (MRI) trial with Copaxerone.
Investigators monitored these patients with monthly cerebral MRI scans.
These scans measured the numbers and sizes of several types of lesions
in the brain.
On subsequent monthly scans, researchers
evaluated serial changes in tissues that follow the formation of new enhanced
lesions. "The percentage of black holes on the follow-up scans was lower
in Copaxone-treated patients than in placebo after seven months of follow
up", concluded Massimo Filippi, M.D., Head of the Neuroimaging Research
Unit, Department of Neuroscience, Scientific Institute and the University
Ospedale San Raffaele, in Milan, Italy.
At month seven, the percentage of
lesions that persisted as black holes was 18.9 percent for patients treated
with Copaxone (glatiramer acetate for injection) and 26.3 percent for placebo,
p=0.04. At month eight, the percentage was 15.6 percent for Copaxone-treated
patients and 31.4 percent for placebo, p=0.002.
Copaxone is indicated for the reduction
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, flushing, chest pain, weakness, infection, pain, nausea, joint
pain, anxiety, and muscle stiffness.
These reactions are usually mild
and seldom require professional treatment. Patients should tell their doctor
about any side effects.
Some patients report a short-term
reaction right after injecting Copaxone. This reaction can involve flushing
(feeling of warmth and/or redness), chest tightness or pain with heart
palpitations, anxiety, and trouble breathing. These symptoms generally
appear within minutes of an injection, last about 15 minutes, and go away
by themselves without further problems.
SOURCE: Teva Pharmaceutical Industries
Ltd.
KANSAS CITY, MO