Peginterferon beta-1a in multiple sclerosis: 2-year results from ADVANCE

Bernd C. Kieseier, Douglas L. Arnold, Laura J. Balcer, Alexey A. Boyko, Jean Pelletier, Shifang Liu, Ying Zhu, Ali Seddighzadeh, Serena Hung, Aaron Deykin, Sarah I. Sheikh, Peter A. Calabresi

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish (US)
Pages (from-to)1025-1035
Number of pages11
JournalMultiple Sclerosis
Volume21
Issue number8
DOIs
StatePublished - Jul 11 2015

Keywords

  • Interferon
  • MRI
  • multiple sclerosis
  • peginterferon beta-1a
  • pegylated
  • phase 3
  • relapse
  • relapse-remitting multiple sclerosis

ASJC Scopus subject areas

  • Neurology
  • Clinical Neurology

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