Further Analysis Suggests Greater Benefit for Patients With More Brain Lesions
Wednesday June 26, 10:46 am Eastern Time
SOURCE: Buffalo General Hospital
BERLIN, June 26 /PRNewswire/ -- Early treatment with the multiple sclerosis therapy Avonex® (interferon beta-1a) can significantly reduce the rate at which individuals at particularly high risk for the disease actually develop clinically definite multiple sclerosis (CDMS). This new data analysis on a clinical trial subgroup of patients was presented this week at the 12th annual meeting of the European Neurological Society being held in Berlin, Germany. The subgroup analysis results suggest that there is a greater benefit of treatment with Avonex for patients with more disease activity as measured by MRI.
The subgroup analyzed was from a larger trial known as the Controlled High Risk Subjects AVONEX® Multiple Sclerosis Prevention Study or CHAMPS. The principal investigator for the CHAMPS study, a pioneer in interferon treatment for multiple sclerosis, was the late Lawrence Jacobs, MD, former Head of the Department of Neurology at the Buffalo General Hospital - Kaleida Health and former Interim Chairman of The Department of Neurology at the State University of New York at Buffalo. The CHAMPS trial sought to determine the effect of treatment with Avonex, already proven beneficial to patients diagnosed with MS, in individuals who had experienced a single multiple sclerosis exacerbation (also known as an attack or flare-up) and whose magnetic resonance imaging (MRI) scans showed brain abnormalities indicating that they were at high risk of developing CDMS.
"We now have compelling data from the sub-analysis of the CHAMPS trial that use of Avonex in a high risk patient population significantly reduces the rate of progression to clinically definite MS," said Frederick Munschauer, MD, Professor of Neurology and Interim Chair at the State University of New York (SUNY) at Buffalo School of Medicine and Biomedical Sciences, Buffalo General Hospital. "Importantly, Avonex provided even greater benefit to patients who had more abnormal disease activity as measured by MRI."
The CHAMPS trial followed 383 randomized, double-blinded patients receiving once-weekly intramuscular injections of either 30 mcg of Avonex or placebo. After two years, the risk of progression to CDMS was reduced 44% by Avonex compared to placebo.
The subgroup of CHAMPS patients was comprised of 91 individuals who had high MRI lesion burden with evidence of inflammation, defined as the presence of at least nine T2-hyperintense lesions and at least one gadolinium-enhanced lesion on the initial MRI scan. In this subgroup analysis, the risk of progression to CDMS was decreased by 66% in the Avonex group compared with the placebo group.
The multiple sclerosis symptoms presented by the analyzed subgroup ranged from inflammation of the optic nerve, inflammation of the brain stem, or inflammation of the spinal cord. "Whatever the initial symptom was, Avonex was effective in a significant way in reducing the progression to multiple sclerosis," concluded Dr. Munschauer.
Multiple sclerosis (MS) is a chronic disease of the central nervous system that affects approximately 400,000 Americans and about one million individuals worldwide. It is a disease of young adults, mostly women, with onset typically between 20 and 40 years of age. Symptoms of MS may include vision problems, loss of balance, numbness, difficulty walking and paralysis.
The disease is believed to be caused by the destruction of myelin by
the immune system. Myelin is the fatty tissue that surrounds and protects
central nervous system nerve fibers and facilitates the flow of nerve impulses
to and from the brain. The loss of myelin disrupts the conduction of nerve
impulses, producing the symptoms of MS.
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