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| |  Sustained Use Of Copaxone (Glatiramer Acetate) Reduces Relapse Rate In Multiple Sclerosis BALTIMORE, MD -- August 22, 2000 -- Sustained use of Copaxone® (glatiramer acetate for injection) significantly reduces the relapse rate and delays disability in people with the relapsing-remitting form of multiple sclerosis (MS), according to a six-year study published in the August issue of Multiple Sclerosis. No other licensed MS therapy has been evaluated this thoroughly for this long. The study is scheduled to continue until mid-2002, when patients will have completed 10 years of organized evaluation. Of the 101 patients receiving daily injections of Copaxone during the study, 77 had three or fewer relapses, and 26 had no relapses during the six years. Participants also experienced a steady decline in the relapse rate, so that on average, they were having one relapse every four to five years, compared to two medically documented relapses in the two years prior to taking the medication. That represents a 72-percent reduction in the annual relapse rate for patients receiving Copaxone compared with the documented experience before entering the trial (P equals 0.0001). "The findings of this study suggest that not only is Copaxone well- tolerated, but that the longer a patient takes Copaxone the better it works," said Kenneth Johnson, M.D., professor and chairman of neurology at the University of Maryland School of Medicine in Baltimore and principal investigator of the multi-center trial. "This is good news because managing relapsing-remitting multiple sclerosis requires long-term drug therapy. Patients' willingness to make Copaxone injections a part of their daily routines is an important measure of the tolerability, safety, and personal benefit of this treatment." Eighty-two percent of the 251 individuals who participated in the initial placebo-controlled study of two years enrolled immediately in the open-label extension of this study. Upon entering the open-label study, the 107 individuals who had been receiving placebo began taking Copaxone. This study focuses on the 101 patients receiving Copaxone throughout both phases of the study. The number of observed relapses was measured in both the 30-plus month double-blind and 36-plus month open-label studies. A relapse was defined as the appearance or reappearance of one or more MS symptoms persisting for at least 48 hours, before which the patient was stable or improving for at least 30 days. Patients were required to have experienced at least two medically documented relapses in the two years prior to entering the study. The annual relapse rate was calculated by dividing the total number of relapses by years of therapy with Copaxone. During the study, patients were evaluated within seven days of first noting symptoms of an impending new relapse. During the six-year study, the mean relapse rate was 2.23 (95 percent Confidence Interval equals 1.78-2.68). This equated to an overall mean annual relapse rate of 0.42 (95 percent Confidence Interval equals 0.34-0.51; P equals 0.0001) per year for the 101 patients receiving Copaxone for six years. The relapse rate has continued to fall and during the last two years, patients are, on average, at risk of having a relapse every four-plus years. Furthermore, the majority of patients experienced no confirmed disease progression. Seventy-five percent of patients receiving Copaxone remained stable or improved over the six years in terms of disease progression. Disease progression is measured using the Expanded Disability Status Scale (EDSS) that is based on sustained disability over 90 days. The categorical analysis revealed that 69 percent of patients receiving Copaxone throughout the six- year study were identified as neurologically unchanged (EDSS change of +1/-0.5 step) or improved (EDSS score decreased by one or more steps). According to the Kaplan-Meier survival analysis, patients' time to worsening by 1.5 or more EDSS steps is further delayed the longer they remain on Copaxone. "Over time, people with relapsing-remitting MS who are not on any treatment experience fewer relapses, but are known to display increasing fixed disability. This study showed that the beneficial effect of treatment with Copaxone on neurological disability has continued over six years when patients were regularly evaluated by their examining neurologist," noted Dr. Johnson. MS affects approximately 350,000 Americans. About 60 percent of all MS patients have the relapsing-remitting form of the disease. Relapsing-remitting MS is characterized by attacks followed by periods of remission. In the remission periods, the person can be free of symptoms. During the relapses or attacks, a person can develop substantial physical disability that may or may not be temporary. Numbness, blurred vision, difficulty walking, fatigue, and pain are all common symptoms of relapsing-remitting MS. Related link: Copaxone.
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