Peginterferon beta-1a reduces disability worsening in relapsing-remitting multiple sclerosis: 2-year results from ADVANCE

Scott D. Newsome, Bernd C. Kieseier, Shifang Liu, Xiaojun You, Elizabeth Kinter, Serena Hung, Bjoern Sperling

Research output: Contribution to journalArticlepeer-review

Abstract

Background: In the pivotal phase III 2-year ADVANCE study, subcutaneous peginterferon beta-1a 125 mcg every 2 weeks demonstrated significant improvements in clinical outcomes, including disability endpoints, in patients with relapsing-remitting multiple sclerosis (RRMS). Here, we aim to further evaluate disability data from ADVANCE, and explore associations between confirmed disability progression (CDP), functional status, and health-related quality of life (HRQoL). Methods: In total, 1512 patients were randomized to placebo or peginterferon beta-1a 125 mcg every 2 or 4 weeks. After 1 year, patients on placebo were re-randomized to peginterferon beta-1a every 2 or 4 weeks. CDP was defined as ≥/41.0 point increase from a baseline Expanded Disability Status Scale (EDSS) score ≥/4 1.0, or ≥/41.5-point increase from baseline 0, confirmed 12 or 24 weeks after onset. Results: Peginterferon beta-1a every 2 weeks significantly reduced risk of 12- and 24-week CDP at 1 year compared with placebo (12-week CDP: 6.8% versus 10.5%, p = 0.038; 24-week CDP: 4% versus 8.4%, p = 0.0069, peginterferon beta-1a every 2 weeks versus placebo, respectively). Benefits were maintained over 2 years (11.2% and 7.7%, peginterferon beta-1a every 2 weeks in 12- and 24-week CDP, respectively). Approximately 90% of patients with 24-week CDP had simultaneous worsening by ≥/41 point in at least one functional system score, most commonly pyramidal. Displaying a 24-week CDP was associated with worse scores on the Multiple Sclerosis Functional Composite (MSFC) scale and several HRQoL instruments; the impact of CDP was attenuated by treatment with peginterferon beta-1a every 2 weeks. Conclusions: Peginterferon beta-1a has the potential to prevent/delay worsening of disability in patients with relapsing-remitting multiple sclerosis. Furthermore, improved benefits in disability status with peginterferon beta-1a were also associated with improved functional status and HRQoL [ClinicalTrials.gov identifier: NCT00906399].

Original languageEnglish (US)
Pages (from-to)41-50
Number of pages10
JournalTherapeutic Advances in Neurological Disorders
Volume10
Issue number1
DOIs
StatePublished - Jan 1 2017

Keywords

  • functional score disability evaluation
  • multiple sclerosis
  • patient-reported outcomes
  • peginterferon beta-1a
  • pegylated interferon
  • phase III clinical trial
  • relapsing-remitting multiple sclerosis

ASJC Scopus subject areas

  • Pharmacology
  • Neurology
  • Clinical Neurology

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