Impact of peginterferon beta-1a and disease factors on quality of life in multiple sclerosis

Mult Scler Relat Disord. 2015 Jul;4(4):350-7. doi: 10.1016/j.msard.2015.06.004. Epub 2015 Jun 14.


Background: The Phase III ADVANCE study has shown clinical benefits for peginterferon beta-1a 125 µg dosed every 2 weeks versus placebo at 1 year in patients with relapsing-remitting multiple sclerosis (MS). This study assessed the impact of peginterferon beta-1a and disease factors on health-related quality of life (HRQoL) using data from ADVANCE.

Methods: HRQoL was assessed at baseline and 12, 24, and 48 weeks using the 29-item Multiple Sclerosis Impact Scale (MSIS-29) and other generic HRQoL measures. Changes in scores from baseline within each group and differences in mean change from baseline between groups were evaluated. Post-hoc mixed-effects repeated measures analyses were performed to assess the impact of confirmed disability progression and relapses, and the interactions of treatment and these MS events on HRQoL. Predictors with p≥0.1 were excluded from the final models, unless they were clinically meaningful.

Results: Relapses and confirmed disability progression were major drivers of HRQoL. When comparing week 48 to baseline, in placebo-treated patients (n=500), confirmed disability progression was associated with a 6.0-point worsening (p<0.0001) of MSIS-29 physical scores, relative to a 1.9-point worsening (p=0.044) with peginterferon beta-1a every 2 weeks (n=512). Such findings were observed consistently with other generic HRQoL measures. Additionally, having a recent relapse (≤29 days before the HRQoL assessment) was associated with a 10.0-point worsening (p<0.0001) of MSIS-29 psychological scores in placebo-treated patients, compared with a 3.5-point (p=0.031) worsening with peginterferon beta-1a every 2 weeks.

Conclusion: Treatment with peginterferon beta-1a could help to improve or maintain HRQoL in addition to clinical outcomes.

Trial registration: NCT00906399.

Keywords: Clinical trial; Interferon; Multiple sclerosis; Peginterferon beta-1a; Pegylation; Quality of life.

Publication types

  • Clinical Trial, Phase III
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Disability Evaluation
  • Disease Progression
  • Double-Blind Method
  • Female
  • Humans
  • Immunologic Factors / therapeutic use*
  • Interferon-beta / therapeutic use*
  • Male
  • Multiple Sclerosis, Relapsing-Remitting / drug therapy*
  • Multiple Sclerosis, Relapsing-Remitting / physiopathology*
  • Multiple Sclerosis, Relapsing-Remitting / psychology
  • Polyethylene Glycols / therapeutic use*
  • Quality of Life
  • Treatment Outcome


  • Immunologic Factors
  • Polyethylene Glycols
  • Interferon-beta
  • peginterferon beta-1a

Associated data