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Effects of glatiramer acetate on relapse rate and accumulated disability in multiple sclerosis: meta-analysis of three double-blind, randomized, placebo-controlled clinical trialsDepartment of Neuroscience, Scientific Institute and University H San Raffaele, Milan, Italy
Department of Neuroscience, Scientific Institute and University H San Raffaele, Milan, Italy
Department of Neurology, University of Maryland School of Medicine, Baltimore, USA
Department of Neurology, Maimonides Medical Center, Brooklyn, New York, USA
The University of Texas, Houston Health Science Center, Houston, Texas, USA
TEVA Pharmaceutical Industries, Petah Tiqva, Israel
TEVA Pharmaceutical Industries, Petah Tiqva, Israel
Department of Neuroscience, Scientific Institute and University H San Raffaele, Milan, Italy
Department of Neuroscience, Scientific Institute and University H San Raffaele, Milan, Italy, filippi.massimo{at}hsr.it Three randomized, double-blind, placebo-controlled trials have shown that glatiramer acetate (GA) is effective in reducing relapse rate in patients with relapsing-remitting (RR) multiple sclerosis (MS). Using raw data pooled from 540 patients, we performed a meta-analysis of these three trials, to investigate whether the extent of G A efficacy varies according to disease-related variables at study entry. Three regression models were developed to assess the efficacy of G A on the annualized relapse rate (primary outcome measure), on the total number of on-trial relapses and on the time to first relapse. We also explored the efficacy of G A on accumulated disability and the potential role of baseline clinical variables as predicto rs of relapse-rate variables and treatment efficacy. The mean adjusted annualized relapse rate on study was 1.14 in the pooled placebo -treated subjects and 0.82 in the pooled GA group (P =0.004), indicating an average reductio n in annualized relapse rate of 28%. A bout a one third reductio n of the total number of on-trial relapses was also observed in patients receiving GA (P B-0.0001), who had a median time to the first relapse of 322 days versus a median time to the first relapse of 219 days seen in those receiving placebo (P =0.01). A beneficial effect on accumulated disability was also found (risk ratio of 0.6; 95%; C I =0.4-0.9; P =0.02). The drug assignment (P =0.004), baseline EDSS score (P =0.02) and number of relapses during the two years prior to study entry (P =0.002) were significant predicto rs of on-trial annualized relapse rate. No other demographic or clinical variable at baseline significantly influenced the treatment effect. This meta-analysis reaffirms the effectiveness of G A in reducing relapse rate and disability accumulatio n in RRMS, at a magnitude comparable to that of other available immunomodulating treatments. It also suggests that G A efficacy is not significantly influenced by the patients’ clinical characteristics at the time of treatment initiation.
Key Words: clinical trial • glatiramer acetate • interferon beta • multiple sclerosis • relapse rate
Multiple Sclerosis, Vol. 9, No. 4,
349-355 (2003) This article has been cited by other articles:
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