Glatiramer Acetate Shows Positive Impact on Average Relapse Rate and Disease Progression in Multiple Sclerosis For Up to 5 Years: Presented at ECTRIMS
By Bruce Sylvester
MADRID, SPAIN -- October 1, 2006 -- Treatment of relapsing-remitting multiple sclerosis (MS) with glatiramer-acetate (glatiramer, Copaxone) is safe and effective, and it has a positive impact on average relapse rate and disease progression scores.
The findings were presented here on September 28th at the 22nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).
"Glatiramer treatment not only has a positive impact on relapse rate and disease progression but we found that the effect increases over time, out to 5 years," said lead presenter Paul Hradilek, MD, neurologist, University Hospital, Ostrova, Czech Republic. "The drug is very effective on both fronts in relapsing-remitting MS patients."
The study cohort consisted of 96 women and 12 men diagnosed with relapsing-remitting multiple sclerosis who began glatiramer treatment in1999. For 95 patients glatiramer was their first disease-modifying drug. Thirteen had been treated previously with interferons.
For study entry, participants were required to have at least 2 relapses per year or 3 relapses every 2 years and magnetic resonance imaging finding confirming an MS diagnosis.
Average time from diagnosis to initiation of treatment with glatiramer was 6.75 years (1-30).
Investigators evaluated relapse rate and Expanded Disability Status Scale (EDSS) change in subgroups treated at least 1, 3 or 5 years.
Average relapse rate before treatment was 1.5. After 1 year of glatiramer treatment the rate decreased to 0.68. With glatiramer treatment, it continued to decrease after 3 years to 0.51. In the subgroup treated for at least 5 years the relapse rate was 0.31.
A majority of subjects showed stable EDSS scores, with an average change in EDSS of 0.1 point after 5 years.
The authors noted that 5 patients discontinued treatment. There were 2 skin allergic reactions leading to discontinuation, but no other major side effects.
Eleven patients became pregnant during glatiramer treatment, "which was interrupted the day the subjects knew about their pregnancy," Dr. Hradilek said. There were 3 spontaneous abortions and 8 normal deliveries. The researcher did not observe any foetal abnormalities.
Copaxone is approved in much of the world for relapsing-remitting MS. It acts as both immunomodulatory and neuroprotective agent.