ADVANCE Phase 3 Study of PEGylated Interferon Beta-1a for Relapsing Multiple Sclerosis: Patient Baseline Characteristics (P01.133)

Abstract

Objective: The ongoing phase 3 ADVANCE trial is evaluating the efficacy and safety of polyethylene glycol (PEG)–conjugated (PEGylated) interferon beta-1a (PEG-IFN beta-1a) in patients with relapsing multiple sclerosis (RMS). Background PEGylation extends the half-life of IFN beta-1a, potentially allowing dosing every 2 or 4 weeks instead of the once-weekly dosing of intramuscular IFN beta-1a. PEG-IFN beta-1a is expected to offer efficacy at least equivalent to that of intramuscular IFN beta-1a 30 μg. Recognizing that PEG-IFN beta-1a may help address unmet patient needs, the US FDA has granted this drug Fast Track designation. Design/Methods: The ADVANCE phase 3 trial is a global, 2-year, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of subcutaneous PEG-IFN beta-1a 125 μg. Eligible patients must be 18–65 years old and have confirmed RMS (McDonald criteria), a baseline Expanded Disability Status Scale (EDSS) score ≤5.0, ≥2 relapses within 3 years of randomization, and ≥1 relapse within 12 months of randomization. Approximately 1500 patients will be randomized 1:1:1 to placebo, PEG-IFN beta-1a every 2 weeks, or PEG-IFN beta-1a every 4 weeks. After 1 year, patients randomized to placebo will be re-randomized to PEG-IFN beta-1a either every 2 weeks or every 4 weeks. Dosing will remain unchanged for the remaining patients. An open-label extension study (ATTAIN) will be available after 2 years for patients participating in the ADVANCE trial. Results: . Patient baseline characteristics will be presented. Conclusions: PEG-IFN beta-1a is being developed to reduce dosing frequency and improve patient convenience while maintaining the proven efficacy, safety, and tolerability of IFN beta-1a. As such, PEG-IFN beta-1a may be an important new addition to the therapeutic armamentarium for MS. Supported by: Biogen Idec Inc. Disclosure: Dr. Calabresi has received personal compensation for activities with Teva, Biogen Idec, Novartis, Genzyme, Johnson & Johnson, and Vertex. Dr. Calabresi has received research support from Biogen Idec, Teva, EMD Serono, Vertex, Genentech, Abbott, and Bayer. Dr. Kieseier has received personal compensation for activities with Bayer Pharmaceuticals Corporation, Biogen Idec, Merck Serono, Novartis, Roche Diagnostics, Sanofi-Aventis Pharmaceuticals, and TEVA Neurosciences as speaker. Dr. Kieseier has received research support from Bayer Pharmaceuticals, Biogen Idec, Merck Serono and Teva Neurosciences. Dr. Arnold has received personal compensation for activities with Bayer Healthcare, Biogen Idec, Genentech, Inc., NeuroRx Research, Roche Diagnostics Corporation, Schering, Serono, Inc., and Teva Neuroscience. Dr. Arnold Dr. Arnold has received research support from Bayer Healthcare, Biogen Idec, Genentech, Inc., NeuroRx Research, Roche Diagnostics Corporation, Schering, Serono, Inc., and Teva Neuroscience. Dr. Balcer has received personal compensation for activities with Biogen Idec, Vaccinex and Bayer as a consultant and has received honoraria from Biogen Idec and Novartis. Dr. Boyko has received personal compensation for activities with Novartis, Merck Serono, TEVA, Gensyme, Biogen Idec, Nicomed as a member of advisory boards, a speaker and a participant of clinical trials. Dr. Pelletier has received research support from Sanofi-Aventis, Pharmaceuticals, Inc., Bayer Schering, Biogen Idec, Merck Serono, Novartis, and Teva Neuroscience. Dr. Zhu has received personal compensation for activities with Biogen Idec as an employee. Dr. Zhu holds stock and/or stock options in Biogen Idec, which sponsored research in which Dr. Zhu was involved as an investigator. Dr. Deykin has received personal compensation for activities with Biogen Idec as an employee.