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Copaxone

Glatiramer Acetate (GA; trademark Copaxone® by Teva Pharmaceutical Industries, Ltd.) is licensed in much of the world for relapsing-remitting multiple sclerosis. In early trials of the drug, it was known as Copolymer-1 and Cop-1. more...

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While not a cure, glatiramer acetate has been shown in clinical trials to reduce the average relapse rate in people with the relapsing-remitting (RRMS) form of the disease. That doesn't mean that it reduces the relapse rate for all the trial volunteers, just that averaged over the entire volunteer population, the relapse rate was reduced. Glatiramer has also been shown to limit the formation of new MS-related lesions in the central nervous system and to reduce brain atrophy.

Glatiramer was licensed for the treatment of RRMS in the USA by the Food and Drug Administration (FDA) in December 1996. It has been approved in Britain, Canada and most of Europe by the national drug regulation organisations.

Glatiramer is a random chain polymer of amino acids - Glutamic acid, Lysine, Alanine and Tyrosine (hence GLATiramer). It is synthesized in solution from these amino acids a ratio of approximately 5 parts Alanine to 3 of Lysine, 1.5 of Glutamic acid and 1 of Tyrosine using N-carboxyamino acid anhydrides. It was originally designed to mimic a protein in myelin, called myelin basic protein, with the intention of inducing EAE (an animal model of MS). Quite to the contrary, it was found to suppress the disease and as a result came to be trialed in human MS. For this reason, it was originally believed to act as a decoy by drawing the immune system's attack away from the myelin.

Nowadays, researchers are no longer at all sure how glatiramer works. The is some evidence that it converts the body's immune response from a Th1 type to a Th2 one, promotes suppressor T cells or acts as an altered peptide ligand.

The drug is self-administered by daily sub-cutaneous injections of 20 mg.

It is generally well tolerated. The most common problem that users experience are injection site reactions which include itching and inflammation. These reactions can be mitigated against by revolving the injection site, preparing it with ice and ensuring that the drug is at room temperature before injecting. Some users experience flushing, chest and joint pains, weakness, nausea, anxiety and muscle stiffness. These tend to resolve after about a quarter of an hour without special treatment.

Read more at Wikipedia.org


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Copaxone impacts MRI disease activity and burden
From Real Living with Multiple Sclerosis, 6/1/01 by Hinson-Smith, Vicki

THE FOLLOWING ITEMS, selected from news and medical information services, are presented not as an endorsement but for your reading and consideration.

Copaxone Impacts MRI Disease Activity and Burden

In the premiere issue of MS UPDATE, Barry Arnason, MD, reviewed the results of a T^sub 2^ magnetic resonance imaging (MRI) study of glatiramer acetate (Copaxone) in patients with relapsing-remitting multiple sclerosis (MS). A total of 239 patients with very active MS (based on gadolinium [GD]-enhanced lesions on brain MRIs) participated in the initial 9month, double-blind, placebo-controlled trial. The initial results were presented at the recent American Academy of Neurology annual meeting.

The results showed that glatiramer acetate 20 mg per day reduced the total number of enhancing lesions by 29% and the relapse rate by 33% when compared with placebo. However, the positive effects of glatiramer acetate on GD-enhanced lesions were less vigorous than those of the interferon betas (interferon beta 1-a [Avonex] and interferon beta 1-b [Betaseron]) and were not apparent for several months.

These findings suggest that the mechanism of action of glatiramer acetate is different than that of the interferon drugs, which have a rapid, anti-inflammatory, blood-brain barrier stabilizing effect.

All 225 patients who completed the double-blind phase of this study received glatiramer acetate during the 9-month, open-label extension phase. Of these, 217 patients (109 from the original glatiramer acetate group and 108 from the original placebo group) completed the 18-month follow-up study. The data from this portion of the study were presented at the recent European Committee for Treatment and Research in Multiple Sclerosis meeting.

In the group that originally received glatiramer acetate, the inhibitory effect of this agent on MRI activity and T^sub 2^ lesion load remained stable. In the group that originally received placebo, the use of glatiramer acetate was associated with a significant reduction in MRI activity and a stabilization of the T^sub 2^ lesion load. At the end of 18 months, the number of enhancing lesions was almost identical in both groups, independent of whether patients had received glatiramer acetate or placebo during initial double-blind treatment.

Interestingly, the pattern of the MRI findings and the magnitude of the effect observed during open-label treatment in the group originally randomized to placebo were similar to those observed in patients originally treated with glatiramer acetate during the doubleblind phase.

In addition, patients treated with glatiramer acetate in the original study continued to have a reduction in relapse rate, whereas patients who originally received placebo demonstrated a reduction in the relapse rate only during open-label treatment with glatiramer acetate.

This extension study confirms the positive effects of glatiramer acetate demonstrated on GD-enhanced and T^sub 2^ MRI as well as on disease exacerbations in patients with relapsingremitting MS. However, some of the T^sub 2^ MRI damage that occurred during placebo treatment persisted, despite the reduction in relapses and GD-enhanced MRI lesions that were observed during active treatment.

SOURCE: MS UPDATE

Copyright Springhouse Corporation Jun 2001
Provided by ProQuest Information and Learning Company. All rights Reserved

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