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Treatment with Glatiramer Acetate Linked to Greater Disease Stability in Early Multiple Sclerosis: Presented at ENS By Paula Moyer VIENNA, AUSTRIA -- June 23, 2005 -- Patients with early-onset multiple sclerosis have increased disease stability and fewer rates of disease progression when they are treated with glatiramer acetate (Copaxone), according to findings presented here June 20th at the 15th meeting of the European Neurological Society (ENS). "The results confirm the benefit seen in the first analysis in 2003, which involved fewer patients and shorter time of treatment," according to investigator Eva M. Maida, MD, Consultant Neurologist, Neurological University Clinic, Vienna, Austria. "Treatment was highly accepted, probably because of the low rate of side effects and a feeling of well-being during the treatment," Dr. Maida added. She attributed the long-term benefits seen in this study to increasing stability of the disease with time of GLA treatment. The investigators were interested in a long-term therapy that could be used in patients with early-onset MS because axonal degeneration that occurs early in the disease. They were interested in glatiramer because of its benefits and tolerability profile, she said. Their open prospective trial began at the end of 1998 and recruited patients who had experienced the first relapse, whose magnetic resonance imaging (MRI) studies showed changes typical of MS. The investigators planned to observe 100 patients for 5 years. Patients were 45 years or younger and had a relapse less than 12 months before enrolling in the study. They had been in stable remission for more than 3 weeks, and had an Expanded Disability Status Scale (EDSS) score of at least 2.0. They had at least five lesions in the brain or the cervical spinal cord that were consistent with MS. The investigators recruited 77 women and 23 men, mean age of 29. 9 years. They had had relapses an average of 65 days before beginning treatment with glatiramer. The baseline mean EDSS score was 2.3. In the first year of treatment, 82.0% of patients were free of relapse and the average EDSS score was 1.4, with two patients worsening from baseline. Improvement was seen in 39.4% of brain MRIs and in 26.3% of cervical spinal cord MRIs. There was no change in 43.4% of the brain and 66.7 % of the cervical spinal cord MRIs. The investigators saw worsening in 17.2% of the brain and 7.1 % of the cervical spinal cord MRIs. There were gadolinium-positive lesions in 7.1% of the brain and 2.0 % of the cervical spinal cord MRIs. Among the 75 patients with complete data in the second year of the study, 84.0% were relapse free, with a mean EDSS score of 1.3 and worsening in two patients. The MRIs showed improvement in 16.7% of the brain and 19.4% of the cervical spinal cord images; no change in 77.8% of the brain and 72.2% of the cervical spinal cord findings, and worsening in 5.6% of the brain and 1.4% of the cervical spinal cord readings. Gadolinium-positive lesions were detected in 6.9% of the patients brain MRIs and 1.4% of their cervical spinal cord lesions. The investigators reported on 3-year data for 35 patients, of whom 80% were relapse free at this time point and in whom the EDSS average score was 1.1, with two patients worsening. MRIs were conducted in 30 patients, which showed improvement in 13.3% of brains and 20% of cervical spinal cords, no change in 70.0% of brains and 73.3% of spinal cords, and worsening in 16.7% of brains and 6.% of spinal cords. The lesions were gadolinium-positive in 16.7% of brains and in none of the spinal cords. In the original cohort, 18 discontinued treatment early. Of these, six dropped out of the study because they had either become pregnant or were planning to do so; three had relapses; and one withdrew due to an increase in the EDSS score. Five had local reactions, and one patient had a systemic reaction. One patient developed an exacerbation of a previously diagnosed neurodermatitis, and one developed psychosis. The investigators speculated that glatiramer's long-lasting benefit might be due to its known stimulating effect on production of neurotrophic factors. They concluded that the results of this study suggest that physicians should consider glatiramer as a first-line treatment for patients with MS. Copaxone is manufactured by Teva. [Presentation title: Early Treatment of MS With Glatiramer-Acetate: Second Interim Analysis of Clinical and MRI Observations. Abstract P337] E-mail this page to a friend or colleague! To print, use this version