DX05 Peginterferon Beta-1a in Relapsing Multiple Sclerosis: Phase 3 ADVANCE

Friday, May 31, 2013: 2:20 PM
Lake Mizzel AB
Peter A Calabresi, MD, FAAN , Johns Hopkins University, Baltimore, MD, USA, Baltimore, MD
Bernd C Kieseier, MD , Department of Neurology, Heinrich-Heine University, Dusseldorf, Germany, Duesseldorf, Germany
Douglas L Arnold, MD , Montreal Neurological Institute, McGill University, and NeuroRx Research, Montreal, QC, Canada
Laura Balcer, MD, MSCE , NYU Langone Medical Center, New York, NY
Alexey Boyko, MD , Moscow MS Center at RSMU, Moscow, Russia, Moscow, Russia
Jean Pelletier, MD, PhD , Departments of Neurology and Research (CRMBM), CHU Timone, Marseille, France, Marseille, France
Serena Hung, MD , Biogen Idec Inc, Cambridge, MA
Ali Seddighzadeh, MD , Biogen Idec Inc, Cambridge, MA
Shifang Liu, PhD , Biogen Idec Inc, Cambridge, MA
Ying Zhu, PhD , Biogen Idec Inc, Cambridge, MA
Bjorn Sperling, MD , Biogen Idec Inc, Cambridge, MA
Aaron Deykin, MD , Biogen Idec Inc, Cambridge, MA

Background: Substantial progress has been made in the treatment of multiple sclerosis (MS) with the development of disease modifying therapies (DMTs) that have a meaningful impact relapse rate and disability progression. Despite these advances, there remains a need for alternative safe, effective, and convenient therapies for patients with MS, to improve the quality of life of patients on long-term DMTs. Polyethylene glycol-interferon beta-1a (peginterferon beta-1a) is being developed as a less frequently-injected alternative to existing first-line DMTs that may provide comparable safety and efficacy to currently available interferon agents. Peginterferon beta-1a has an increased half-life and area under the curve (time versus interferon-beta biological response modifiers) compared with parent interferon beta-1a.

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.