Objectives: To evaluate the efficacy, safety and tolerability of peginterferon beta-1a in patients with relapsing multiple sclerosis (RMS) in the pivotal Phase 3 ADVANCE study.
Methods: ADVANCE is a multicenter, randomized, double-blind, placebo-controlled study. Patients (men and women 18–65 years, with confirmed RMS [McDonald criteria 1–4] and baseline Expanded Disability Status Scale [EDSS] score ≤5.0) were randomized (1:1:1) to placebo, peginterferon beta-1a every 2 weeks, or peginterferon beta-1a every 4 weeks. Peginterferon beta-1a was self-administered subcutaneously at a dose of 125 µg. The primary efficacy endpoint is annualized relapse rate at Year 1. Secondary endpoints are total number of new or newly enlarging T2 hyperintense lesions on brain magnetic resonance imaging scans, the proportion of patients relapsing, and the proportion of patients with disability progression (defined by a ≥1.0- or ≥1.5-point increase in EDSS score, from a baseline score of ≥1.0 or 0.0, respectively, confirmed at Month 3) at Year 1. Safety, tolerability, and immunogenicity were also monitored.
Results: A total of 1512 patients were randomized and received at least one dose of study drug. Efficacy and safety results from the first year of the study (last patient, last visit: end of 2012) are being analyzed and will be presented.
Conclusions: Results from Phase 3 ADVANCE will provide information about the potential benefits of peginterferon beta-1a and its role in the treatment of MS.
Abstract Supported by: Biogen Idec Inc.