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New drug may
help fight Multiple Sclerosis, Crohn's
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An experimental drug shows promise as an effective new
approach for treating multiple sclerosis and the intestinal
ailment Crohn's disease.
In preliminary tests, the new drug Antegren dramatically
reduced the number of new brain lesions in patients with MS
and cut the number of relapses in half. In Crohn's patients,
it increased the rate of remission and improved the patients'
quality of life.
Both were early studies, and researchers stressed that more
definitive results will come from larger, longer studies now
under way.
"At this stage, these are very promising results," said one of
the MS researchers, Dr. David H. Miller of the Institute of
Neurology in London. "One hopes that these will be confirmed .
. . and then one will have an additional effective treatment
for people with MS."
The findings were reported in Thursday's New England Journal
of Medicine. The studies were funded by the two companies
developing the drug, Elan Corp. and Biogen Inc. Some of the
researchers have received grants from the companies or worked
as consultants for them.
There is no cure for MS or Crohn's and the causes are unknown.
In both, the immune system goes awry, resulting in
inflammation and damage to brain tissue in MS and to the
intestinal wall in Crohn's disease.
MS patients can have loss of balance and coordination, blurry
vision and fatigue. Crohn's causes chronic diarrhea, abdominal
pain, fever and weight loss.
Current treatments include injections of interferon, which
slows down the immune system, or anti-inflammatory drugs,
including steroids, which ease the swelling. Some of the drugs
have serious side effects and they don't work for all
patients, researchers said.
Antegren, also called natalizumab, is the first in a new class
of medicines that uses a novel approach to prevent
inflammation. It attaches to the immune cells and stops them
from leaving the bloodstream and reaching inflammation areas
in MS and Crohn's.
Dr. Lars Ekman, president of research and development at Elan,
said the companies expect to seek approval for the drug at the
end of 2003 in the United States and Europe. Depending on the
regulatory process, the drug could be available as early as
the end of 2004, he said.
In the MS study, 213 patients in the United States, Canada and
the United Kingdom were given six monthly infusions of one of
two Antegren doses or a dummy drug. Patients who received the
dummy drug had about 10 new brain lesions, compared to about
one new lesion in those getting Antegren, a reduction of about
90 percent.
The frequency of relapses was cut in half in the Antegren
groups, to 19 percent from 38 percent in the comparison group.
The 248 patients in the Crohn's study in Europe received two
infusions a month apart of either of two Antegren doses, a
dummy drug or a combination of Antegren and the dummy drug. A
scoring system measured their response over 12 weeks.
Overall, the patients who received only Antegren had higher
remission rates and response rates. The highest remission rate
was 44 percent at six weeks in the low dose Antegren group,
compared with 27 percent in the dummy drug group.
In both studies, there were few serious side effects and there
was no difference in side effects between the treatment
groups.
"It's promising new results for a new approach to treating
people with MS, but we're not at the end of the story yet,'
said Patricia O'Looney, director of biomedical research
programs for the National Multiple Sclerosis Society.
Web sites:
New England Journal:
www.nejm.org
National Institutes of Health:
www.niddk.nih.gov/health/digest/pubs/crohns/crohns.htm
www.nmss.org
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