A Comparative Placebo-Controlled Clinical Trial of the Efficacy and Safety of Glatiramer Acetate 20 mg in Patients with Remitting Multiple Sclerosis: First-Year Study Results

摘要

Objective. To seek evidence that Timexon (BCD-063, glatiramer acetate, Biocad, Russia) and Copaxone-Teva (Teva Pharmaceuticals Ltd., Israel) have similar efficacies in patients with remitting multiple sclerosis. Materials and methods. A multicenter, double-blind, placebo-controlled, comparative, randomized, phase III study included 158 patients with confirmed diagnoses of remitting multiple sclerosis. Patients were randomized to the BCD-063, Copaxone-Teva, and placebo groups at a ratio of 2:2:1. Results and conclusions. Efficacy analysis at 48 weeks of treatment demonstrated that there were no differences between the BCD-063 and Copaxone-Teva groups in terms of MRI parameters or exacerbation frequency. Assessment of the primary endpoint (number of MRI-confirmed exacerbations per patient per year) showed that the mean number of exacerbations was 0.098361 (0.351422) in the BCD-063 group, 0.098361 (0.351422) in the Copaxone-Teva group, and 0.178571 (0.390021) in the placebo group. Assessments on the EDSS and MSFC also demonstrated that there were no differences between the BCD-063 and Copaxone-Teva groups. Both BCD-063 and Copaxone-Teva had favorable safety profiles. These data provide evidence of the therapeutic equivalence of BCD-063 (Biocad, Russia) and Copaxone-Teva, which is an important aspect for further introduction of the reproduced glatiramer acetate formulation into the treatment of multiple sclerosis.