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Glatiramer Acetate Treatment Reduces Risk of Early MS Progressing to Clinically Definite Disease
NEW YORK -- October 6, 2009 -- Treatment with glatiramer acetate can reduce by almost half the risk of patients progressing from the very early signs of multiple sclerosis (MS) to clinically definite disease, according to a study published early online and in an upcoming edition of The Lancet.
Giancarlo Comi, MD, Department of Neurology, University Vita-Salute, Milan, Italy, and colleagues conducted a randomised, double-blind trial at 80 sites in 16 countries.
A total of 481 patients presenting with a clinically isolated syndrome were randomly assigned to receive either subcutaneous glatiramer acetate 20 mg per day (n = 243) or placebo (n = 238) for up to 36 months, unless they converted to clinically definite MS.
The primary endpoint was time to clinically definite MS, based on a second clinical attack. A preplanned interim analysis was done for data accumulated from 81% of the 3-year study exposure.
Glatiramer acetate reduced the risk of developing clinically definite MS by 45% compared with placebo. The time for 25% of patients to convert to clinically definite disease was more than doubled, from just under 1 year for placebo to just under 2 years for glatiramer acetate.
The most common adverse events in the glatiramer acetate group were injection-site reactions (56% glatiramer acetate vs 24% placebo) and immediate post-injection reactions (19% vs 5%).
The authors note that the robustness of the positive results was emphasised by the concomitant efficacy of glatiramer acetate in reducing all the magnetic resonance imaging of disease activity, such as evidence of MS-related lesions in the brain.
In a post-hoc analysis based on all patients who completed 2 years of the study without converting to clinically definite multiple sclerosis, they noted a significant reduction of the cumulative number of new T2 lesions in patients receiving glatiramer acetate versus those receiving placebo, both in the 4 and in the 8 scans done during the first year and the entire 2 years, respectively. The results of this study reiterate the key importance of early treatment in MS to contrast the accumulation of irreversible nervous damage.
"This study establishes glatiramer acetate as an option for patients with clinically isolated syndrome who choose to start treatment early to improve control of the underlying disease process," the authors concluded.
SOURCE: The Lancet
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