Peginterferon beta-1a in multiple sclerosis: 2-year results from ADVANCE. (July 2015)

• Record Type: Journal Article
• Authors: Kieseier, Bernd C; Arnold, Douglas L; Balcer, Laura J; Boyko, Alexey A; Pelletier, Jean; Liu, Shifang; Zhu, Ying; Seddighzadeh, Ali; Hung, Serena; Deykin, Aaron; Sheikh, Sarah I; Calabresi, Peter A
• Is Part Of: Multiple sclerosis. Volume 21:Number 8(2015)
• Page Start: 1025
• Page End: 1035
• Publication Date: 2015-07
• Subjects: Interferon -- pegylated -- peginterferon beta-1a -- relapse -- multiple sclerosis -- relapse-remitting multiple sclerosis -- MRI -- phase 3; Central nervous system -- Diseases -- Periodicals; Myelin sheath -- Diseases -- Periodicals; Inflammation -- Periodicals; Multiple sclerosis -- Periodicals; Central Nervous System Diseases -- Periodicals; Demyelinating Diseases -- Periodicals; Inflammation -- Periodicals; Multiple Sclerosis -- Periodicals; Système nerveux central -- Maladies -- Périodiques; Gaine de myéline -- Maladies -- Périodiques; Inflammation (Pathologie) -- Périodiques; Sclérose en plaques -- Périodiques; Electronic journals; 616.834005
• DOI: 10.1177/1352458514557986
• Languages: English
• ISSNs: 1352-4585

Abstract

Objective: To evaluate the efficacy and safety of subcutaneous peginterferon beta-1a over 2 years in patients with relapsing–remitting multiple sclerosis in the ADVANCE study. Methods: Patients were randomized to placebo or 125 µg peginterferon beta-1a every 2 or 4 weeks. For Year 2 (Y2), patients originally randomized to placebo were re-randomized to peginterferon beta-1a every 2 weeks or every 4 weeks. Patients randomized to peginterferon beta-1a in Year 1 (Y1) remained on the same dosing regimen in Y2. Results: Compared with Y1, annualized relapse rate (ARR) was further reduced in Y2 with every 2 week dosing (Y1: 0.230 [95% CI 0.183–0.291], Y2: 0.178 [0.136–0.233]) and maintained with every 4 week dosing (Y1: 0.286 [0.231–0.355], Y2: 0.291 [0.231–0.368]). Patients starting peginterferon beta-1a from Y1 displayed improved efficacy versus patients initially assigned placebo, with reductions in ARR (every 2 weeks: 37%, p <0.0001; every 4 weeks: 17%, p =0.0906), risk of relapse (every 2 weeks: 39%, p <0.0001; every 4 weeks: 19%, p =0.0465), 12-week disability progression (every 2 weeks: 33%, p =0.0257; every 4 weeks: 25%, p =0.0960), and 24-week disability progression (every 2 weeks: 41%, p =0.0137; every 4 weeks: 9%, p =0.6243). Over 2 years, greater reductions were observed with every 2 week versus every 4 week dosing for all endpoints and peginterferon beta-1a was well tolerated. Conclusions: Peginterferon beta-1a efficacy is maintained beyond 1 year, with greater effects observed with every 2 week versus every 4 week dosing, and a similar safety profile to Y1. Clinicaltrials.gov Registration Number: NCT00906399.