Abstract Details

Title Clinical Efficacy and Safety of Peginterferon beta-1a in Relapsing Multiple Sclerosis: Data from the Pivotal Phase 3 ADVANCE Study

Topic MS and Related Diseases

Presentation(s) S31 - (-)

Poster/Presentation
Number 006

Objective

Background Two Phase 1 studies demonstrated that peginterferon beta-1a has an increased half-life and area under the curve (time versus interferon-beta biological response modifiers) compared with available weekly interferon beta-1a. Peginterferon beta-1a is being developed to offer patients with multiple sclerosis (MS) a more convenient alternative to currently available first-line therapies, while maintaining efficacy, safety, and tolerability comparable to currently available interferon agents.

Design/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 [micro]g. 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. Last patient, last visit is end of October 2012. Complete efficacy and safety results are being analyzed and will be presented.

Conclusions Results from ADVANCE will provide information about the potential benefits of peginterferon beta-1a and its role in the treatment of MS.

Authors/Disclosures
Peter A. Calabresi, MD, FAAN (Johns Hopkins University) PRESENTER	Dr. Calabresi has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Novartis. Dr. Calabresi has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lilly. Dr. Calabresi has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Idorsia. An immediate family member of Dr. Calabresi has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for MyMD. Dr. Calabresi has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Myelin Repair Foundation. The institution of Dr. Calabresi has received research support from Genentech. Dr. Calabresi has received publishing royalties from a publication relating to health care. Dr. Calabresi has received personal compensation in the range of $500-$4,999 for serving as a Study Section Member with NIH. Dr. Calabresi has received personal compensation in the range of $500-$4,999 for serving as a Grant reveiwer with Myelin Repair Foundation. Dr. Calabresi has received personal compensation in the range of $500-$4,999 for serving as a Speaker for CME with NYAS. Dr. Calabresi has received personal compensation in the range of $500-$4,999 for serving as a Speaker with Academic CME.
	No disclosure on file
Douglas L. Arnold, MD, FAAN (Montreal Neurological Institute, McGill Univ)	Dr. Arnold has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biogen. Dr. Arnold has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for BMS. Dr. Arnold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Frequency Therapeutics. Dr. Arnold has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Merck. Dr. Arnold has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Novartis. Dr. Arnold has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Roche. Dr. Arnold has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Sanofi. Dr. Arnold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Shionogi. Dr. Arnold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Xfacto communications. Dr. Arnold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Eli Lilly. Dr. Arnold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for EMD Serono. Dr. Arnold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biohaven. Dr. Arnold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Find therapeutics. Dr. Arnold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for GSK. Dr. Arnold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Idorsia. Dr. Arnold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Kiniksa. Dr. Arnold has stock in NeuroRx.
Laura J. Balcer, MD, MSCE, FAAN (NYU Grossman School of Medicine)	Dr. Balcer has received personal compensation for serving as an employee of North American Neuro-Ophthalmology Society. An immediate family member of Dr. Balcer has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Children's Hospital of Philadelphia.
	No disclosure on file
Jean Pelletier, MD, PhD (Dpt of Neurology, CHU Timone)	Dr. Pelletier has nothing to disclose.
Ho Jin Kim, MD (National Cancer Center)	Dr. Kim has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Altos Biologics, AstraZeneca, Biogen, Daewoong Pharmaceutical, Kaigene, Kolon Life Science, MDimune, Roche, and Sanofi. Dr. Kim has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Alexion, AstraZeneca, Eisai, GC Pharma, Merck, Mitsubishi Tanabe Pharma, and Roche. Dr. Kim has received personal compensation in the range of $5,000-$9,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Multiple Sclerosis Journal, Journal of Clinical Neurology.
Shifang Liu	No disclosure on file
Ying Zhu	No disclosure on file
Ali Seddighzadeh	No disclosure on file
Bjorn K. Sperling, MD	No disclosure on file
Serena W. Hung, MD	No disclosure on file
Aaron Deykin, MD (Biogen Idec)	No disclosure on file

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