BUFFALO, N.Y., Nov. 9 /PRNewswire/ -- A new study shows that individuals with relapsing-remitting forms of multiple sclerosis experience a progressive loss of brain volume -- or atrophy -- early in the course of the disease, perhaps before the patient exhibits any MS symptoms.
According to the study, published today in the journal Neurology, drug treatment can slow the progression of this brain tissue loss.
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Brain shrinkage is irreversible and is associated with the advance of other common symptoms of MS, such as loss of memory, slurred speech, and reduced muscular control.
"This study is important because we now know that long before the symptoms and signs of MS appear, the disease is active in the brain, and it will continue during the early stages of diagnosis unless adequately treated, as soon as possible, to slow the progression of brain shrinkage and to preserve brain substance," said investigator Lawrence Jacobs, M.D. Dr. Jacobs is Head of the Department of Neurology at the Buffalo General Hospital, Chief of the Baird Multiple Sclerosis Research Center at Millard Fillmore Hospital, and Professor of Neurology at the State University of New York at Buffalo. Using a new technique developed to measure brain atrophy, researchers analyzed MRIs (magnetic resonance images) from patients with relapsing MS enrolled in the Phase III trial of interferon beta-1a (Avonex(R)). The data from 70 patients treated with Avonex and 70 placebo-treated patients were compared to MRIs from healthy controls.
"This new measurement tool showed that brain atrophy occurs much earlier in MS patients than previously thought, even in the early stages of the disease, when symptoms are still very mild," said Dr. Jacobs. "In addition, the study showed that patients who received Avonex had a preservation of their brain tissue -- it wasn't subjected to the same loss that the patients who received placebo underwent and the discrepancy between the two was about 50 percent. Thus, a very significant amount of brain substance was preserved by active treatment."
According to Dr. Jacobs, the study provided the following conclusions:
* MS patients indeed experience measurable amounts of brain atrophy that progresses yearly.
* Aside from its other proven therapeutic value for MS patients, Avonex significantly reduces the rate of brain atrophy during the second year of treatment.
* This new method of measuring brain atrophy, called the brain parenchymal fraction, may be a promising method of determining the severity of the disease and a valuable tool for quantifying outcomes in future clinical trials for MS therapies.
"These data suggest an important new way to monitor MS disease activity over time and could have a substantial impact on future MS clinical trials and treatment protocols," Dr. Jacobs said. "It also emphasizes the importance of early diagnosis and treatment with an MS therapy. Early treatment may actually preserve MS patients' brain tissue."
Last year, the National Multiple Sclerosis Society issued a recommendation that all people with relapsing-remitting MS should begin treatment with one of the three FDA-approved MS medications as soon as possible after they are diagnosed as these agents have a clear impact on disease course and may help to forestall future relapses and disability in many individuals with MS.
"This research further confirms our strong belief that drug treatment early in the course of the disease can provide significant benefits to patients with relapsing MS," said Stephen Reingold, Ph.D., Vice President Research, of the National Multiple Sclerosis Society.
About 350,000 Americans have been diagnosed with multiple sclerosis. MS can strike at almost any age but is most common among people in their 20s and 30s. In fact, it is the leading cause of nontraumatic neurological disability among young adults in North America. The great majority of MS patients -- approximately two-thirds -- are women.
The study was supported by grants from the National Institutes of Health, the National Multiple Sclerosis Society, the Potiker Foundation, and Biogen, Inc. Avonex, approved by the FDA in 1996, was developed by Biogen, Inc., which is providing communications support in conjunction with publication of these new study findings.
STUDY PROFILE: Use of the brain parenchymal fraction to measure whole brain atrophy in relapsing remitting MS. Neurology 1999; 53:1698-1704.
Co-Authors: Richard Rudick, M.D., Mellen Center, Department of Neurology, Cleveland Clinic Foundation, Cleveland, OH; Elizabeth Fisher, Ph.D., Biomedical Engineering, Cleveland Clinic Foundation, Cleveland, OH; Jar-Chi Lee, M.S., Biostatistics and Epidemiology, Cleveland Clinic Foundation, Cleveland, OH; Jack Simon, M.D., Radiology-MRI, University of Colorado Health Sciences Center, Denver, CO; Lawrence Jacobs, M.D., Neurology, State University of New York at Buffalo, Buffalo, NY; and the Multiple Sclerosis Collaborative Research Group.
Method: In the double-blind, placebo-controlled study, the magnetic resonance image (MRI) scans of 140 MS patients who participated in the two- year Avonex Phase III study were reevaluated to determine the amount of brain atrophy that had occurred, calculated as the loss of brain tissue volume relative to the cranial volume. The MRI scans were analyzed using a new special image analysis method called brain parenchymal fraction (BPF). BPF calculates the amount of brain tissue in the skull as a ratio of skull volume. Upon study entry, the baseline MRIs showed a significantly reduced BPF in the MS patients when compared to 16 healthy controls, indicating significant brain atrophy at entry into the study.
The placebo-controlled group showed a significant reduction in BPF -- or increased loss of brain tissue -- during the first year (-0.75%) and second year (-0.53%) of observation. Avonex treatment (30 mcg injected intramuscularly once a week) had no effect on brain atrophy during the first year of observation; however, there was a statistically significant 55 percent reduction in the rate of atrophy compared with placebo recipients during the second year.
Avonex(R) (interferon beta-1a) is a registered trademark of Biogen, Inc.
SOURCE Buffalo General Hospital
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