Copolymer 1 reduces relapse rate and improves disability in relapsing‐remitting multiple sclerosis

Abstract

We studied copolymer 1 (Copaxone) in a multicenter (11-university) phase III trial of patients with relapsing-remitting multiple sclerosis (MS). Two hundred fifty-one patients were randomized to receive copolymer 1 (n = 125) or placebo (n = 126) at a dosage of 20 mg by daily subcutaneous injection for 2 years. The primary end point was a difference in the MS relapse rate. The final 2-year relapse rate was 1.19 +/- 0.13 for patients receiving copolymer 1 and 1.68 +/- 0.13 for those receiving placebo, a 29% reduction in favor of copolymer 1 (p = 0.007) (annualized rates = 0.59 for copolymer 1 and 0.84 for placebo). Trends in the proportion of relapse-free patients and median time to first relapse favored copolymer 1. Disability was measured by the Expanded Disability Status Scale (EDSS), using a two-neurologist (examining and treating) protocol. When the proportion of patients who improved, were unchanged, or worsened by > or = 1 EDSS step from baseline to conclusion (2 years) was evaluated, significantly more patients receiving copolymer 1 were found to have improved and more receiving placebo worsened (p = 0.037). Patient withdrawals were 19 (15.2%) from the copolymer 1 group and 17 (13.5%) from the placebo group at approximately the same intervals. The treatment was well tolerated. The most common adverse experience was an injection-site reaction. Rarely, a transient self-limited systemic reaction followed the injection in 15.2% of those receiving copolymer 1 and 3.2% of those receiving placebo.(ABSTRACT TRUNCATED AT 250 WORDS)

Interferon Beta and Glatiramer Acetate Therapy

“…Patients experience flushing, chest tightness, dyspnea, palpitations, and anxiety. The duration is about 30 seconds to 30 minutes, resolving spontaneously [84]. In the initial phase three trial, IPISRs were observed in 19 participants (15.2 %) compared with 4 (3.2 %) of placebo.…”

“…Beginning in October 1991, the Copolymer 1 Multiple Sclerosis Study group conducted a 2 year, double-blind, placebo-controlled trial with 251 participants who had an EDSS of 0-5 and a history of at least 2 relapses in the prior 2 years, including 1 in the last year [84]. Participants were well matched and withdrawals from each group were similar with 15 % withdrawing from the GA group and 13.5 % from placebo.…”

Antioxidants and polyunsaturated fatty acids in multiple sclerosis

“…Their long-term beneficial effects are uncertain and often detrimental side-effects have been reported (Johnson et al, 1995;Filippini et al, 2003). This review addresses the role of nutrition in MS. We discuss the potential of directly acting nonenzymatic antioxidants for dietary supplementation and elaborate on the role of longchain n-6 and n-3 PUFAs in immunosuppression, cellular function and remyelination.…”

Recent progress in the diagnosis and treatment of multiple sclerosis

“…It was designed to simulate myelin basic protein, a putative target antigen in MS. After it was found to inhibit experimental autoimmune encephalomyelitis (EAE), a pilot study suggested that it had a beneficial effect in relapsing-remitting MS. 48 An extensive multi-centre, double-blind, placebocontrolled trial has now shown that the daily S.C. injection of 20 mg of copolymer 1 for 2 years significantly reduces the relapse rate of relapsing-remitting MS by 29% compared to placebo. 49 There was also some evidence that copolymer 1 had a beneficial effect on the progression of disability. The treatment was well tolerated.…”