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Long-Term Use of Glatiramer Acetate (Copaxone) for Multiple Sclerosis Appears Safe and Efficacious: Presented at ECTRIMS
By Bruce Sylvester
THESSALONIKI, GREECE -- September 30, 2005 -- Patients with relapsing-remitting multiple sclerosis who used glatiramer acetate (Copaxone) for up to 26 years show sustained efficacy and safety of treatment, researchers reported here.
"These were patients in the 'compassionate use' program for this drug before any multiple sclerosis drugs were approved," said investigator Rivka Riven Kreitman, MD, vice-president for research and development, Teva Pharmaceutical Industries, Netanya, Israel.
Dr. Kreitman presented the findings here on September 30th at the 21st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).
"These patients have been very stable on Copaxone [GA] for the long term, and have had very few relapses," he explained. "We saw very few safety issues and very good efficacy."
Patients in the study all had a diagnosis of relapsing-remitting multiple sclerosis (RRMS). They self-injected Copaxone at a subcutaneous dose of 20 mg daily. A neurologist ascertained Expanded Disability Status Scale (EDSS) scores every 6 months and reported relapses at the time of occurrence. Subjects self reported adverse events monthly.
The 46 subjects were treated for 1 to 26 years (mean 10.5 +/= 7.1 years)
At entry, mean disease duration was 7.2 +/= 5.7 years (range: 0-20 years), mean EDSS was 3.0 +/= 1.8 (range: 0-6.5), and mean annual relapse rate was 2.9 +/= 1.4 (range: 1-7).
The investigators reported that long-term therapy was associated with a mean EDSS increase from baseline of 0.9 +/= 1.9 to 3.9 +/= 2.5 (P = .0755). Ten of 28 (35.7%) patients with baseline EDSS below 4 had a last observed EDSS value 4 or greater, and 8 of 34 (23.5%) patients with entry EDSS below 6 had a last observed EDSS value of 6 or greater.
Of the 46 subjects, 28 (61%) achieved improved or unchanged EDSS scores. Annual relapse rates decreased versus baseline by 97% to 0.1 +/= 0.2 (P < .0001).
The investigators reported that up to 26 years of daily injections had been generally well tolerated, with adverse events for long-term therapy being similar to those observed in short-term clinical trials.
Eighteen patients remain active in the study. "Patient decision" was the most common reason for withdrawal.
The study was supported by Teva Pharmaceutical Industries.
[Presentation title: Long-Term (Up to 26 Years), Open-Label, Compassionate Use Study of Glatiramer Acetate in Relapsing-Remitting Multiple Sclerosis. Abstract 329]
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