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| |  Glatiramer Acetate Reduces Disease Severity for Patients Treated Early for Mild Relapsing-Remitting MS: Presented at ECTRIMS By Chris Berrie DÜSSELDORF, Germany -- September 12, 2009 -- Glatiramer acetate demonstrates a significant reduction in disease severity for patients with relapsing-remitting multiple sclerosis (RRMS), according to research presented here on September 10 at the 25th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). The US Pivotal Glatiramer Acetate Study Group reported the results of an open-label extension trial that followed a randomised, double-blind, placebo-controlled trial of glatiramer acetate 20 mg/day subcutaneously compared with placebo in patients with RRMS. In the original 35-month study, a significant reduction was shown in the relapse rate of those in the treatment group (P = .0019). The current study examines “the progression of disability in those patients who stayed on the drug compared [with] those who entered the extension study but withdrew [from glatiramer acetate treatment],” explained lead author Joseph Herbert, MD, Department of Neurology and Multiple Sclerosis Centre, New York University Hospital for Joint Disease, New York, New York. RRMS was determined through the use of the Multiple Sclerosis Severity Score (MSSS). Each patient with RRMS was defined based on 1 of the 6 percentile severity grades into which they fell, with each grade representing approximately 17% of the RRMS reference population. As Dr. Herbert noted, “This is actually more of a measure of rate of change of disability than disability per se.” At the start of the open-label treatment with glatiramer acetate, these 2 patient groups showed similar characteristics across age (approximately 35 years), gender (70% female), prior relapse rate (approximately 1.2 years), and disease duration (around 8.4 years). For ongoing patients at both 10 years (n = 108) and 15 years (n = 100), there was a dramatic reduction in mean baseline MSSS (from 3.89 and 3.78 to 2.53 and 2.34, respectively), while the total patients who withdrew (n = 132) showed a slight worsening of mean MSSS (4.60 to 4.70). “So there is a remarkable divergence of these 2 groups,” added Dr. Herbert. Both the Expanded Disability Status Scale (EDSS) score and the MSSS were greater in the total withdrawn patients versus the ongoing 10/15-year patients (mean EDSS score, 3.00 vs 2.56/2.50; mean MSSS, 4.60 vs 3.89/3.78). For the patients in the 15-year ongoing group versus total patients who withdrew, a significant reduction in disease severity was seen, with a shift to a lower MSSS disease severity group (56% vs 28%, respectively; P < .0001). “When we go back and see who are those patients who withdrew, they all started with a more severe EDSS score and MSSS,” noted Dr. Herbert. Glatiramer acetate, therefore, appears to be more useful for the more mildly affected patient when treated early -- with these patients actually improving their MSSS. Funding for this study was provided by Teva Pharmaceutical Industries Ltd and Teva Neuroscience. [Presentation title: Improvement on the Multiple Sclerosis Severity Scale Score After 10 and 15 Years of Glatiramer Acetate Treatment. Abstract P415]
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