Researchers analyze data from three published, randomized, placebo-controlled trials
April 8, 2003
COPAXONE(R) (glatiramer acetate injection) nearly doubled the time relapsing-remitting multiple sclerosis (MS) patients took to accumulate disability, according to a poster presented this week at the American Academy of Neurology (AAN).
This analysis reviewed three double-blind, placebo-controlled, randomized clinical trials in relapsing-remitting MS to determine if COPAXONE(R) could slow the accumulation of new neurological disability that persisted for more than 90 days. In their original published data, these clinical trials had shown beneficial effects both in reducing the relapse rate and on MRI measures of brain lesions.
"The meta-analysis gave us the opportunity to look at the three major clinical trials conducted on glatiramer acetate. We found that patients treated with glatiramer acetate consistently did better than the placebo-treated patients in slowing the progression of MS," said Kenneth P. Johnson, M.D., professor of neurology, University of Maryland, Baltimore.
"Each study is individually important, but a meta-analysis can better capture what one can expect from a therapy. The meta-analysis showed glatiramer acetate slowed accumulated disability across the three trials," said Jerry S. Wolinsky, M.D., director of MS research, University of Texas Health Science Center, Houston.
There were 540 patients from the Bornstein et al, Johnson et al pivotal trials and the European-Canadian study analyzed in the meta-analysis. All patients had at least one relapse in the two years prior to enrollment and a baseline EDSS score of 0-6 inclusive. Patients were randomized to either COPAXONE(R) or placebo.
The researchers defined the treatment effect as the odds ratio of the proportion of patients increasing one or more steps for 90 days or more on the expanded disability status scale (EDSS) between the COPAXONE(R)-(glatiramer acetate injection) treated group and the placebo group. The time to accumulating this level of disability was estimated by the Kaplan Meier survival curve analysis.
Based on this odds analysis, it should take 25 percent of the studied population 521 days to reach accumulated sustained disability. The COPAXONE(R)-treated patients did not accumulate disability to reach this milestone (p less than 0.03). However, the placebo patients did, indicating COPAXONE(R)'s ability to slow the accumulation of disability in MS. In fact, COPAXONE(R) nearly doubled the time to confirmed progression when compared to placebo in this population (ratio estimate 1.88, p less than 0.02, Weibull regression).
"Overall, significantly more placebo patients advanced one or more steps on the EDSS for 90 days or more compared to the number of patients treated with glatiramer acetate," said Dr. Wolinsky. "This suggests that glatiramer acetate does limit disability in RRMS."
Relapsing-remitting MS is a chronic disease that affects patients for decades. Therefore, one of the concerns is the ability of immunomodulating drugs to provide sustained benefits.
"In all three clinical trials, we saw that the longer
COPAXONE(R), the better they did in terms of preventing accumulated
disability," said Dr. Johnson.
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