Early treatment slowed progression of MS.
Patients with clinically isolated syndrome who receive early treatment with glatiramer acetate have more than a 40% reduction in the risk of developing multiple sclerosis, compared with those whose treatment is delayed, according to findings from a prospectively planned 5-year follow-up of patient in the phase III PreCISe study.
After a 2-year extension phase of the 3-year double-blind, placebo-controlled study, 33% of 80 patients who had received early treatment with glatiramer acetate (GA) developed clinically definite multiple sclerosis (CDMS), compared with 50% of 118 patients who began treatment at the end of the initial 3-year double-blind phase. Each patient received 20 mg of GA daily.
GA, marketed as Copaxone by Teva Pharmaceutical, is indicated for reducing the frequency of relapses in relapsing-remitting MS, including those who have experienced a first clinical episode and who have MS features on MRI.
In the Teva-sponsored study, disability progression, as measured by the Expanded Disability Status Scale, occurred in only 21% of patients over 5 years. No differences in disability progression were noted between early and delayed treatment, according to the principal investigator, Dr. Giancarlo Comi of the University Vite Salute, San Raffaele, Italy.
"The long-term study results support the benefit of early GA treatment in delaying conversion to CDMS and in reducing MRI burden, including less accumulation of irreversible brain damage," Dr. Comi said in an interview.
Patients in this 2-year extension phase were initially enrolled in the double-blind phase of PreCISe, and were randomized to receive active early treatment with GA or placebo. Findings from a planned interim analysis showed that treatment reduced the risk of CDMS by 44% versus placebo and delayed disease progression by 722 days vs. 336 days. Patients then were offered the opportunity to enter the open-label extension phase, during which all received treatment.
In the open-label extension phase, early treatment was associated with a delay of nearly 3 years in the time to conversion to CDMS when compared with delayed treatment.
MRI findings from the PreCISe study, which were presented in a separate session at the meeting, also confirmed the importance of early treatment, according to the principal investigator for that portion of the study, Dr. Massimo Filippi of University Ospedale San Raffaele, Milan, and his colleagues.
Early initiation of treatment with GA reduced disease activity and slowed the accumulation of brain atrophy over 5 years as demonstrated by MRI. The early treatment group had significantly fewer new T2 lesions--an indicator of disease activity--and lower T2 lesion volume--a predictor of disease progression--than did the delayed treatment group, the investigators found.
Brain volume change was also significantly lower over the entire study in patients who received early treatment with GA (-0.99% vs. -1.27%), they said.
Major Finding: CDMS occurred in significantly fewer patients who underwent early treatment with glatiramer acetate (33%) than in those who delayed treatment until 3 years later with the drug (40%).
Data Source: A 2-year extension of the 3-year double-blind, placebo-controlled PreCISe study.
Disclosures: Teva Pharmaceutical Industries Ltd. funded the trial. Dr. Comi has received personal compensation for advisory board and consulting activities from Teva Pharmaceuticals, Novartis, Sanofi-Aventis, Merck-Serono, and Bayer Schering. He has also received honoraria for speaking activities from these companies, as well as from Biogen-Dompe. Dr. Filippi also reported financial relationships with many of these companies, including Teva.
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|Publication:||Internal Medicine News|
|Article Type:||Clinical report|
|Date:||Nov 15, 2010|
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