A Comparative Placebo-Controlled Clinical Trial of the Efficacy and Safety of Interferon β-1a Formulations for S.C. Administration in Patients with Remitting Multiple Sclerosis: First-Year Results

Objectives. To demonstrate equivalence of the efficacies of the drugs Teberif (BCD-033, interferon β-1a) and Rebif (interferon β-1a) in patients with remitting multiple sclerosis (RMS). Materials and methods. A multicenter, double-blind, placebo-controlled, comparative, randomized phase III trial included 163 patients with diagnoses of MS. Patients were randomized to the Teberif, Rebif, and placebo groups at a ratio of 1:1:1. Results and conclusions. Analysis of efficacy after 52 weeks of the trial demonstrated equivalence between the study drug Teberif and the original formulation Rebif in patients with RMS. Evaluation of primary endpoint results – CUA (combined unique active lesions, i.e., the total number of MRI T1 plaques and new T2 plaques or cases of increases in T2 plaques without double counting) – demonstrated that there were no significant differences (0.727 ± 1.042 and 0.652 ± 1.059, p = 0.7354, Student’s t test) between the Teberif and Rebif groups. There were no statistically significant between-group differences in other MRI indicators or measures associated with exacerbations. The safety profile and tolerance of Teberif were satisfactory and comparable with the safety and tolerance profile of Rebif. These data provide evidence of therapeutic equivalence of these drugs, which may provide grounds for the use of the interferon β-1a bioanalog in patients with RMS.