April 18, 2002
The majority of patients treated with Copaxone® (glatiramer acetate for injection) remained either unchanged or improved in their neurologic status during an eight-year period in the longest prospective multiple sclerosis drug trial ever.
These results were released today at the American Academy of Neurology (AAN) annual conference in Denver, Colorado.
"People in this study have had relapsing-remitting multiple sclerosis (RRMS) for an average of 15 years. Based on studies on the natural course of MS, half of those would be expected to use walking aids, such as a cane or a wheelchair, if left untreated. This study found that patients who received drug therapy had a mean EDSS of 3.17, which means most of them are still walking without assistance," said Kenneth P. Johnson, MD, professor of neurology, director of the Maryland Center for MS at the University of Maryland, Baltimore.
This trial was originated in 1991, and 251 patients with RRMS were randomised into a double-blind, placebo-controlled trial of Copaxone. The placebo-controlled phase lasted for approximately 30 months. Patients were then invited to continue in the open-label phase of the trial in which all patients received Copaxone. Of the 251 patients, 208 continued in the open-label phase. At year eight, 68 percent or 142 patients remained in the study. This study presented the results eight years into the 12-year trial.
"One of the key questions was how the group that started on Copaxone compared with the patients who spent 30 months on placebo. We discovered there was a consequence for delaying therapy," said Dr. Johnson.
Patients who received placebo at the beginning of the study were more likely to have worsened by more than one step on the EDSS (Expanded Disability Status Scale) (p=0.0263). The EDSS measures the levels of disability of a person with MS.
In addition, the relapse rate across the entire eight years was significantly better for patients always on Copaxone versus those who began on placebo (p=0.0459). The Copaxone group began the trial with a yearly relapse rate of 1.49 and that rate fell to 0.16 by year eight. For the group that began on placebo, the entry relapse rate was 1.45, falling to 0.23 by year eight.
Copaxone is indicated for the reduction in the frequency of relapses in RRMS. 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 40 countries worldwide, including the U.S., Canada, Australia, Israel and all the European countries. In Europe, Copaxone is marketed by Teva Pharmaceutical Industries Ltd. and Aventis Pharma. In North America, Copaxone is marketed by Teva Neuroscience.
SOURCE: Teva Pharmaceutical Industries Ltd.
Copyright (c) 1995-2002 Doctor's Guide Publishing Limited