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| |  AAN: Early Copaxone (Glatiramer Acetate) Could Decrease Permanent Multiple Sclerosis Disability JERUSALEM, ISRAEL -- May 11, 2001 -- Teva Pharmaceutical Industries Ltd. announced today that results from the longest ever multiple sclerosis (MS) treatment trial were presented at the American Academy of Neurology this month. The six-year, open label study showed that early treatment with Copaxone® (glatiramer acetate for injection) could decrease the likelihood of permanent disability. "Delayed therapy was associated with greater risk of disability as shown in all measures of the expanded disability status scale (EDSS)," said Kenneth Johnson, M.D., University of Maryland, Baltimore. "Also, the relapse rate progressively fell, reinforcing the rationale for using Copaxone as a first line drug early in the course of relapsing-remitting MS." Of patients always on Copaxone the whole six years, 69 percent showed neurological improvement of at least one EDSS step or remained stable, compared with 57 percent if Copaxone treatment was delayed by approximately 30 months (p=0.066). The proportion of patients getting worse was smaller in the group always on Copaxone: 31 percent vs. 43 percent. Moreover, of patients always on Copaxone who were relapse-free over six years, three out of 26 (11 percent) were worse by at least one EDSS step, whereas nine out of 21 (43 percent) of those relapse-free in the placebo/active group were worse (p<0.03). This suggests the patients whose therapy was delayed were probably entering a secondary progressive stage of MS, whereas those always on Copaxone were neurologically stable due to treatment. The open label trial was an extension of the multi-center, placebo-controlled pivotal clinical trial on Copaxone. After approximately 30 months of being randomized to either Copaxone or placebo, 208 patients chose to continue in an open-label study in which all received Copaxone; 101 were always on Copaxone, while 107 received placebo for the first 30 months and then switched to Copaxone. The patients who received uninterrupted Copaxone therapy showed a steady decline in relapse rate, from a mean of 1.5 at study entry to a mean of 0.42 over the six years (95 percent confidence interval = 0.34-0.51), a 72 percent reduction (p=0.0001). These patients, after six years of study, are now experiencing, on average, only one relapse every four and a half years (annualized rate 0.23 in year six) and 26 out of 101 remain completely relapse-free. Patients did not do as well on placebo but they also experienced a decline in relapses, which by year six was similar to those always on Copaxone. A fifth remained relapse-free. "Copaxone showed that for patients receiving Copaxone from the onset, neurological deterioration became progressively less likely the longer they remained on treatment," said Dr. Johnson. Copaxone is indicated for the reduction of relapses in relapsing-remitting multiple sclerosis. It reduced relapse rates by a mean of 29 percent in a 24-month study (1.19 vs. 1.68 for placebo, p=0.055). The most common side effects of Copaxone are redness, pain, swelling, itching, or a lump at the site of injection, flushing, chest pain, weakness, infection, pain, nausea, joint pain, anxiety, and muscle stiffness. These reactions are usually mild and seldom require professional treatment. Some patients report a short-term reaction right after injecting Copaxone. This reaction can involve flushing (feeling of warmth and/or redness), chest tightness or pain with heart palpitations, anxiety, and trouble breathing. These symptoms generally appear within minutes of an injection, last about 15 minutes, and go away by themselves without further problems.
SOURCE: Teva Pharmaceutical Industries, Ltd. Related Links: Copaxone (glatiramer acetate) and Teva Pharmaceutical Industries, Ltd.
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