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Three-Year Study Shows Good Efficacy and Safety for Copaxone in MS: Presented at ECTRIMS By Bruce Sylvester THESSALONIKI, GREECE -- October 5, 2005 -- A 3-year study of patients with relapsing-remitting multiple sclerosis (RRMS) in Russia using Copaxone showed efficacy in disease stabilisation, a significant decrease in relapse rate, no disability progression, and good tolerability. The findings were reported here on September 29th at the 21st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). Lead investigator Natalia Kchachanova, MD, assistant professor, Russian State Medical University, Moscow, Russia, and colleagues enrolled 104 subjects diagnosed with RRMS for the 36-month open-label study at the Moscow MS Center. Mean age of patients at baseline was 37.5 years, mean MS duration was 8.1 years, and mean EDSS score was 2.54. Subjects underwent a neurological examination every 3 months during the study. All subjects had experienced at least 1 relapse in the year before initiating Copaxone therapy. During the study, 42 subjects (40.4%) remained relapse-free and 83 (79.8%) did not have Expanded Disability Status Scale (EDSS) progression. The relapse rate decreased significantly in the first 12 months of treatment, with 29 relapses (P < .001). The relapse rate remained stable during the second year, with 27 relapses. In year 3 there were 28 relapses. The authors noted that, in the 3 years of the study, the 104 subjects had 84 relapses and that this was nearly half the number seen during the year prior to beginning Copaxone treatment. There was an increase in EDSS scores in 6 subjects (5.8%) during the first year, 7 subjects (6.7%) during the second year, and 12 subjects (11.5%) in the third year. Mean EDSS score increased nonsignificantly from 2.54 at baseline to 2.61 at 36 months. In 9 subjects (8.7%), the disease transformed to secondary progressive MS with relapses, and Copaxone treatment was terminated. Local adverse effects occurred in 24 subjects (26%), and systemic reactions occurred in 9 subjects. "Thus, in this group of patients, Copaxone during the whole 3-year period showed stable positive influence on RRMS course -- significant decrease of relapse rate, no EDSS progression in up to 80% of patients, and good tolerability," the researchers concluded. The study was independently supported by the Moscow MS Centre. [Presentation title: Clinical Results of 3 Year Experience of Copaxone(R) in Relapsing-Remitting Multiple Sclerosis Patients From a Moscow MS Centre. Poster 324] E-mail this page to a friend or colleague! To print, use this version