Longest MS drug study shows copaxone benefits continue long term
The 6-year preliminary results from a 10-year study shows that sustained use of the drug Copaxone (glatiramer acetate) significantly reduces the relapse rate and also delays disability in persons with relapsing-remitting MS. The study, published in the August issue of Multiple Sclerosis, is the longest evaluation to date of a licensed MS therapy.
The study is scheduled to continue until mid-2002, when participants will have been evaluated for 10 years. Of the 101 MS patients receiving daily injections of Copaxone throughout the past 6 years, 77 have had three or fewer relapses, while 26 have not had any relapses. On average, study participants experienced a 72% reduction in the annual relapse rate.
“The findings suggest that not only is Copaxone well tolerated, but that the longer a patient takes the drug, the better it works,” said Kenneth Johnson, MD, professor and chairman of neurology at the University of Maryland School of Medicine in Baltimore and principal investigator of the multicenter trial. An important finding in the study was that Copaxone could be taken daily for years and be well tolerated–good news because managing relapsing-remitting MS requires long-term drug therapy. Dr. Johnson said patients’ willingness to make injections of Copaxone a part of their daily routines is an important measure of the tolerability, safety, and personal benefit of this treatment.
An international, multicenter study to evaluate the oral use of Copaxone has just begun and will last for 13 months. The goal is to assess the effectiveness of an oral form of the drug compared with placebo.
Source: National Multiple Sclerosis Society
Advisory Board note: The results of this study nust be interpreted with caution.This group of patients represents a selected sample of all patients originally entered into the randomized, double-blind, placebo-controlled trial of Copaxone. Some patients who may not have responded as well to Copaxone may have dropped out of the study at an earlier point. In addition, patients in the long-term study, as well as their physicians, were aware that they were taking Copaxone, which creates potential bias. Nonetheless, the results of this study are encouraging.
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