Research News from The Cochrane Library
May 27, 2004
Source: Dr Luca M. Munari, M.D.
One of the currently most widely prescribed treatments for multiple sclerosis (MS), glatiramer acetate (Copaxone(R), Teva / Aventis), may provide no significant benefit on the main outcomes measures in the disease, namely either slowing the progression of MS or substantially affecting the risk of clinical relapses over time. "At present there is insufficient evidence to support future routine use of glatiramer acetate in clinical practice and more data from randomised clinical trials are needed," said Dr Munari, neurologist and member of the Cochrane MS Review Group.
The review, carried out by members of the Cochrane MS Group, incorporated the results of 646 patients with MS who participated in four randomized, placebo-controlled clinical trials. The review included both patients with relapsing-remitting MS and chronic progressive MS (CPMS).
Glatiramer acetate is a random mixture of polypeptides derived from the synthesis of four amino acids. It has structural properties similar to myelin, the basic protein within the sheaths surrounding nerves. Its mechanism of action is actually unknown, as it is for beta-interferons. It is prescribed as a secondary alternative to beta interferon, which is well established in the treatment of MS, a chronic disease of the nervous system that affects young and middle-aged adults and can lead to permanent disability.
Currently available data do not provide definite evidence that glatiramer acetate shows any significant effect on disease progression, measured as a sustained worsening in the Expanded Disability Status Scale (EDSS). No benefit was shown in CPMS patients (progression at two years: RR=0.69, 95% CI [0.33 to 1.46]).
The most common systemic adverse events of glatiramer acetate were a transient and self-limiting patterned reaction of flushing, chest tightness, sweating, palpitations, and anxiety (relative risk = 3.40 (95% CI [2.22 to 5.21], p <0.00001]). Local injection-site reactions were observed in up to a half of the patients treated with glatiramer acetate, thus making a blind assessment of outcomes questionable.
"The trials in this review tended to focus on the effect of glatiramer on the rate of relapses, whereas the outcome that people with MS are particularly concerned about is the progression of their disease," said Dr. Filippini, Co- ordinating Editor of the MS Review Group. "The absence of clinical benefit with glatiramer reinforces the need for further research looking at clinically significant outcomes and reliable measures such as patient disability over time and quality of life."
Notes to Editors
Munari L, Lovati R, Boiko A. Therapy with glatiramer acetate for multiple sclerosis (Cochrane Review). In: The Cochrane Library, Issue 1, 2004. Chichester: Wiley.
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