Copolymer 1 reduces relapse rate and improves disability in relapsing‐remitting multiple sclerosis Results of a phase III multicenter, double‐blind, placebo‐controlled trial

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