Originally Released: March, 1998
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A study published today in the March issue of the journal Neurology provides more evidence that the medication Copaxone, the only non-interferon treatment for multiple sclerosis, reduces the number of relapses and slows the progression of disability. The study is a one-year extension of research at 11 medical centers in the United States.
"We find that the longer patients take Copaxone, the better the results, compared to a placebo," says Kenneth Johnson, M.D., professor and chairman of Neurology at the University of Maryland Medical Center in Baltimore, and principal investigator of the multicenter study.
"With a follow-up of up to 35 months, we found that patients who took Copaxone had 32 percent fewer relapses compared to those taking a placebo," Dr. Johnson says. "After the first 24 months of the study, patients in the Copaxone group had 29 percent fewer relapses.
"Each relapse can damage the nervous system and increase the likelihood of disability. Using a scientific measure of disability, we found that patients in the placebo group were 50 percent more likely to have increased disability than those taking Copaxone," Dr. Johnson adds.
The study included 251 patients with relapsing-remitting multiple sclerosis. After approximately 33 months, all of the patients, including those taking the placebo, were offered Copaxone, 190 chose to take it and 170 patients are still on medication. Many have taken it for more than six years.
"Multiple sclerosis therapy is a long-term, possibly life-long proposition, so the medication needs to be well-tolerated with few side effects," says Dr. Johnson.
Copaxone, which was approved by the FDA in December 1996, is taken as a daily injection under the skin. Its generic name is glatiramer acetate for injection. The most common side effects are redness, pain, inflammation, itching or a lump at the site of the injection. Rare side effects are temporary episodes of flushing, chest pain, anxiety and shortness of breath, all of which disappear without any permanent damage.
The new results, showing that the longer people were on Copaxone, the better they did in terms of relapses and disability, were good news to Melissa Hawkins-Holt.
Hawkins-Holt always dreamed of being a doctor. Five years ago, during college, she suffered several mysterious attacks of numbness and blurred vision. It finally became so bad that she went to the hospital. A diagnosis of multiple sclerosis followed, leaving her wondering if her dream was out of reach.
Today she is completing her first year of residency at the University of Maryland Medical Center. She joined the original trial of Copaxone to halt the progression of the disease, and she has now been on the drug for three years.
"I haven't had a significant relapse since I have been taking Copaxone. It makes me feel like I am doing something to give myself the best chance of remaining relapse-free as long as possible," said Dr. Hawkins-Holt.
Hawkins-Holt says taking Copaxone has become part of her life along with eating a healthy diet, exercising daily and trying to fit rest into her busy schedule. One day, she and her husband would like to have a family. She is able to sometimes even forget that she has multiple sclerosis as she focuses on reaching her goals.
"The additional data gathered in this study reinforces that Copaxone is a first-line therapy for relapsing-remitting multiple sclerosis because it is well-tolerated, reduces the number of relapses and slows the progression of disability." said Dr. Johnson. "Unlike the interferon therapies, Copaxone does not produce flu-like side effects, occasional severe skin reactions or fatigue."
The studies showed no evidence of neutralizing antibodies that may reduce the effectiveness of other multiple sclerosis therapies.
"People with multiple sclerosis don't want their disease to run their lives. They want the same things you and I do," said Dr. Johnson. "This study shows increasing evidence that people with relapsing-remitting multiple sclerosis can lead lives with reduced relapses and slowed progression of disability."
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