If this is not your name, click here.
| | If this is not your name, click here. | | |
| | Contact Us | Order Now | Journals | Bookstore | Register a colleague | | |
| |  Long-Term Glatiramer Acetate Injection Study Showed 92% of Multiple Sclerosis Patients Were Walking Unaided After a Mean of 10 Years on Treatment 10-Year Data from the Longest Continuous Prospective Study of Any MS Drug KANSAS CITY, M.O. -- May 8, 2006 -- Data from a 10-year long-term study showed that 92% of relapsing-remitting multiple sclerosis (RRMS) patients in the study who remained on Copaxone® (glatiramer acetate injection) were still walking without assistance despite an average disease duration of more than 15 years. These results were published in the June 2006 issue of the journal Multiple Sclerosis, which was mailed today. This study represents the only prospective, open-label follow-up of more than 10 years' duration designed to evaluate continuous immunomodulatory therapy in RRMS patients. The study has been extended to 15 years. "Copaxone provides RRMS patients with a treatment option that has demonstrated long-term efficacy and safety," said Corey Ford, MD, PhD, Associate Professor of Neurology, Director of the Multiple Sclerosis Specialty Clinic and Medical Director of Pharmacy at the University of New Mexico Health Sciences Center and an investigator in the study. "Results of the study are consistent with the presumed mechanism of action of Copaxone, which appear to treat inflammation and neurodegeneration, the underlying pathologies of multiple sclerosis." Patients who remained in the study and were on Copaxone had a relapse rate reduction of more than 80% over a mean of 10 years in the trial. On average, patients experienced only one relapse every five years compared to an average of 1.18 attacks a year before entering the study. A favorable safety profile was maintained over the course of the study. The most common adverse events associated with Copaxone were local injection-site reactions and immediate post- injection reactions. No other immune- mediated disorders, infections, or malignancies were reported. This study of Copaxone (glatiramer acetate injection) in 251 RRMS patients began in 1991 as a double-blind, placebo-controlled trial in which patients were randomized to receive either Copaxone 20 mg or placebo by subcutaneous injection daily for a mean of 30 months. A total of 232 patients (125 Copaxone and 107 placebo, the modified intent-to-treat cohort, or mITT) were evaluated in this analysis. After double-blind treatment, all patients were offered Copaxone as part of an ongoing, prospective, open- label study. All of the original 11 U.S. study sites participated, and these patients were evaluated every six months. Patients were also examined, usually within seven days, if they experienced symptoms suggestive of a relapse. After 10 years, 108 patients of the 232 remained in the study on Copaxone. Investigators looked at the percentage of patients who progressed to Kurtzke Expanded Disability Status Scale (EDSS) 4 -- a stage at which they were still ambulatory despite moderately severe disability; EDSS 6 -- a level at which a cane, crutch or brace is required for mobility; and EDSS 8 -- a state in which the patient is wheelchair-bound. At the start of Copaxone treatment, patients had an average EDSS score of 2.79. At 10 years, the ongoing patient group on Copaxone showed significantly decreased accumulation of disability, with 24% of patients reaching EDSS 4, eight% reaching EDSS 6 and only one% reaching EDSS 8 compared with 68%, 50% and 10% respectively in the withdrawn with long-term follow-up visit (LTFU) cohort. The 50 patients who withdrew from the trial and returned for the 10-year LTFU showed significantly increased disability compared with ongoing patients treated with Copaxone. The mean increase in EDSS score was 2.24 points in those patients who withdrew compared with a 0.50 point increase in patients remaining on Copaxone (P <.0001). Similarly, 62% of the ongoing Copaxone patients had stable or improved EDSS scores. "The results from this trial and the fact that patient safety was maintained over time make these data clinically useful for the MS community," said Ford. "No other immunomodulatory agents used to treat multiple sclerosis have been followed continuously for as long as Copaxone." After a mean of 10 years, patients who continued Copaxone treatment showed significantly less disability than those who withdrew from the study and returned for the long-term follow-up visit. This was evaluated using the EDSS. "Copaxone was shown to maintain efficacy over the long term. As a group, the patients who remained in the study had no significant changes in EDSS -- even after 10 years of treatment," said Ford. About Copaxone The most common side effects of Copaxone are redness, pain, swelling, itching, or a lump at the site of injection, weakness, infection, pain, nausea, joint pain, anxiety, and muscle stiffness. Copaxone is now approved in 44 countries worldwide, including the United States, Canada, Mexico, Australia, Israel, and all European countries. In Europe, Copaxone is marketed by Teva Pharmaceutical Industries Ltd. and sanofi-aventis. In North America, Copaxone is marketed by Teva Neuroscience, Inc.
SOURCE: Teva Neuroscience
|
