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| |  Early Use of Glatiramer Acetate May Mitigate Course of Disease in Multiple Sclerosis: Presented at ENS By Paula Moyer VIENNA, AUSTRIA -- June 24, 2005 -- Patients with relapsing-remitting multiple sclerosis (MS) appear to have less disability and a slower disease progression if they are treated earlier in their disease with glatiramer acetate (Copaxone), according to findings presented here on June 21st at the 15th meeting of the European Neurological Society (ENS). Among patients in a multinational study who were followed for an average of 5.8 years, "the proportion of patients who did not reach relevant locomotor disability...was significantly greater in patients treated with glatiramer acetate during the first 9 months of the trial," according to principal investigator Marco Rovaris, MD, Consultant Neurologist, Scientific Institute and University Hospital, San Raffaele, Milan, Italy. To determine whether long-term treatment with glatiramer acetate affected disease course, the investigators conducted the study to track the course of clinical and magnetic resonance imaging (MRI) findings in patients with relapsing-remitting MS who had participated in an earlier study. The original trial consisted of two consecutive phases, each lasting 9 months. The first was a randomised, double-blind, placebo-controlled phase, and the second was an extension phase in which all patients received the study drug. The treatment consisted of daily subcutaneous injections of 20 mg of glatiramer acetate. Brain MRI at the initial screening helped determine whether patients met the criteria of one or more gadolinium-enhancing lesions. Subsequent MRIs were performed at baseline, monthly during the double-blind phase, and every 3 months during the extension phase. Patients also underwent neurological exams using the Expanded Disability Status Scale (EDSS) score rating. For patients who went on to participate in the long-term follow-up study, the researchers obtained dual echo, pre- and post-gadolinium T1-weighted brain MRI scans that had the same acquisition scheme as the original trial. Patients also underwent a neurological assessment, as well as measurement of total T2-hyperintense and T1-hypointense lesion volumes, normalised brain volumes and percentage changes in brain volume. Of the 224 patients who completed the original two-phase study, 142 (63.4%) participated in long-term follow-up for an average of 5.8 years. Among these patients, 73 had been treated with glatiramer acetate since the beginning of the two-phase study. At baseline in that study, there were no significant differences between patients who subsequently participated in the follow-up study and those who did not. At the time of the long-term follow-up assessment, baseline MRI measures of disease burden and activity, as well as brain volume changes, did not significantly differ between patients originally assigned to placebo and those who were treated with glatiramer acetate throughout the two phases. However, significantly fewer of the patients who were treated with glatiramer acetate from the beginning of the study reached locomotor disability or an EDSS of 6.0 or greater (P = .03). The findings suggest that earlier initiation of glatiramer acetate treatment in patients with active relapsing-remitting MS could favourably influence disease progression, the investigators concluded.
[Presentation title: Long-Term Follow-up of Patients Treated With Glatiramer Acetate: a Multi-Centre, Multi-National Extension of the European/Canadian Double-Blind, Placebo-Controlled, MRI-Monitored Trial. Abstract O139]
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