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Glatiramer acetate (also known as Copolymer 1, Cop-1, or Copaxone - as marketed by Teva Pharmaceuticals) is an immunomodulator drug currently used to treat multiple sclerosis. It is a random polymer of four amino acids found in myelin basic protein, namely glutamic acid, lysine, alanine, and tyrosine, and may work as a decoy for the immune system. Glatiramer acetate is approved by the Food and Drug Administration (FDA) for reducing the frequency of relapses, but not for reducing the progression of disability. Observational studies, but not randomized controlled trials, suggest that it may reduce progression of disability. Although the clinical definition of multiple sclerosis requires two or more episodes of symptoms and signs, glatiramer acetate is approved for treatment after single episodes. It is also used to treat relapsing-remitting multiple sclerosis. It is administered by subcutaneous injection. == Medical uses == A 2004 Cochrane review concluded that glatiramer acetate "did not show any beneficial effect on the main outcome measures in MS, i.e. disease progression, and it does not substantially affect the risk of clinical relapses."〔(Cochrane Database of Systematic Reviews 2004 , Issue 1 . Art. No.: CD004678. DOI: 10.1002/14651858.CD004678 )〕〔La Mantia L, Munari LM, Lovati R. Glatiramer acetate for multiple sclerosis. Cochrane Database of Systematic Reviews 2010, Issue 5. Art. No.: CD004678. DOI: 10.1002/14651858.CD004678.pub2〕 In its pivotal trial of 251 patients, after two years it failed to show any advantage in halting disability progression. As a result, it is approved by the FDA for reducing the frequency of relapses, but not for reducing the progression of disability.〔(Prescribing Information (Package insert) ) Label approved on 02/27/2009 (PDF) for COPAXONE, NDA no. 020622 at Drugs@FDA〕 A 15-year followup of the original trial compared patients who continued with glatiramer to patients who dropped out of the trial. Patients with glatiramer had reduced relapse rates, and decreased disability progression and transition to secondary progressive MS, compared to patients who did not continue glatiramer. However, the two groups were not necessarily comparable, as it was no longer a randomized trial. There were no long-term safety issues. In two recent studies, both reported at the 2007 ECTRIMS meeting, the efficacy of glatiramer acetate was compared to high-dose/high-frequency interferon beta. In the REGARD study, Rebif was compared to glatiramer, and in the BEYOND study, Betaseron was compared to glatiramer. In both trials, there was no significant difference between interferon and glatiramer in the primary endpoints (time to relapse) or in any clinical endpoints, although some differences in MRI measures of disease activity have been claimed. A double-blind 3-year study found no effect of glatiramer acetate on Primary-Progressive Multiple Sclerosis. It has FDA approval for clinically isolated syndrome, based on the PreCISe trial, which showed that glatiramer delayed the progression from the first clinical event to clinically definite multiple sclerosis with a risk reduction of 45%. 43% of patients in the placebo group converted, compared to 25% in the glatiramer group.〔(Early Treatment With COPAXONE Demonstrated Robust Protection Against Progression To Clinically Definite Multiple Sclerosis In The PreCISe Study )〕 抄文引用元・出典: フリー百科事典『 ウィキペディア（Wikipedia）』 ■ウィキペディアで「Glatiramer acetate」の詳細全文を読む スポンサード リンク
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