MONTREAL, QC -- March 28, 2001 -- Research published this month in The Annals of Neurology confirms that relapsing-remitting multiple sclerosis (RRMS) patients treated with the immunomodulator Copaxone (glatiramer acetate for injection) have a significant reduction in number of MS lesions as measured by magnetic resonance imaging (MRI).
The study also confirmed that the drug sustains its efficacy over time. There were 29 centres involved in the trial, with Canadian trial sites located in Montreal, London and Calgary. In this study, MRI was used to evaluate the number of active lesions seen in the brains of MS patients. The total area of lesions was used to indicate disease burden and severity.
"Copaxone significantly reduced the number of relapses in RRMS patients by 33 percent over placebo (p equals 0.012) during the nine months of the study," Dr. Douglas Arnold, Director, Clinical Research Unit, Montreal Neurological Institute and Hospital (MNI/H), explains. "Researchers noted a significant correlation between the cumulative number of enhancing lesions and the total number of relapses over the study period in both placebo (p equals 0.0001) and Copaxone-treated patients (p equals 0.01)."
"This study is significant because these MRI trial results support the presumed mode of action of Copaxone and its ability to affect lesions and relapses in a timely and correlated manner," comments Dr. Yves Lapierre, Director of the Multiple Sclerosis Clinic at the MNI/H. "This is also the first study to show a clear correlation between MRI and clinical effects. This study is important because it shows how Copaxone works on the brain."
The results shed light on how Copaxone works, and why its benefits increase over time. In patients with MS, the body's own T cells become activated, migrate across breakdowns in the blood brain barrier and release harmful byproducts which cause inflammation and break down myelin, the insulation that protects the central nervous system. Copaxone appears to work by modifying the T cell response to produce anti-inflammatory byproducts that act at the site of the lesion where the damage is taking place, reducing inflammation and damage. In addition, Copaxone may inhibit harmful T cell production.
The result of this action plus a sustained drug benefit, as shown in published studies (Johnson, et al), is the inhibition of harmful immune processes that are currently held responsible for the cause of MS.
Almost 50,000 Canadians live with MS, a chronic, progressive, sometimes devastating disease for which there is, as yet, no cure. There are several treatments available to manage the disease, including nonsteroidal non- interferons, interferons, and steroids. Copaxone is the first nonsteroidal non- interferon, a specific immunomodulator indicated for the treatment of relapsing-remitting MS and was launched in 1997 for the treatment of relapsing- remitting MS.
The Montreal Neurological
Institute and Hospital is a teaching and research institute of McGill University.
It is one of the largest institutions of its kind in the world committed
to understanding how the brain functions, and to alleviating neurological
SOURCE Montreal Neurological Institute