Relapsing-remitting multiple sclerosis (MS) patients who received early treatment with Copaxone (glatiramer acetate for injection) showed fewer enhancing lesions (which reflect recent lesions) on subsequent magnetic resonance imaging (MRI) scans. These findings, from an 18-month joint Canadian-European study, were reported in the October 22, 2002 issue of Neurology.
The accumulation of brain lesions in patients with MS is indicative of disease activity. The total volume of lesions indicates how the disease is progressing. “This study is significant because it showed that patients who started Copaxone had 35 per cent fewer enhancing lesions over the study period of 18 months,” said Dr Douglas Arnold, Director, Clinical Research Unit, Montreal Neurological Institute and Hospital (MNI/H). “Relapse rates for these same patients were 23 per cent lower than for patients who started on Copaxone nine months later and it appeared that delaying treatment with Copaxone resulted in a poorer clinical outcome.”
MRI was used to evaluate brain lesions for patients who were on Copaxone for the entire 18-month period, compared to those who switched from placebo to active drug after nine months. Canadian trial sites were located in Montreal, London and Calgary. The trial involved 239 people with relapsing-remitting MS having MRI scans of the brain. MRI is used to evaluate the number and size of lesions seen in the brains of MS patients.
The study showed that the benefits gained in the first nine months were sustained throughout the entire 18 months, indicating a benefit from continuous drug therapy started soon after diagnosis. The delay in starting therapy resulted in six new enhancing lesions per patient during the first nine study months that could have been prevented, according to the study.
“Over the extension of the trial, there was a 54-per cent reduction in the mean number of enhanced lesions for those converted from placebo to Copaxone and an additional 24.6 per cent reduction for those always on Copaxone,” said Giancarlo Comi, M.D., of the Scientific Institute and University Ospedale San Raffaele, Milan, Italy, and lead European investigator. “Over the entire study, the accumulated disease burden was less for those always on Copaxone.”
Dr. Jean Godin, Medical Director, Teva Neuroscience, notes, “This research is important because it shows that active MRI disease and relapses are strongly correlated, and that COPAXONE has an impact on both. It’s also important to prevent MRI-appearing lesions, since many new lesions could develop into chronic black holes. These are a radiological sign of permanent, destructive damage.”
Early treatment of MS has been advocated since 1999 by a group of respected neurologists located across Canada. In a consensus statement, the Canadian MS Clinics Network and the Multiple Sclerosis Society of Canada recommended that all eligible patients be treated as early as possible in the course of their disease.
Copaxone is indicated for the reduction of the frequency of relapses in relapsing-remitting MS.