title: Impact of peginterferon beta-1a and disease factors on quality of life in multiple sclerosis.
abstract: 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.
  
  
  CONCLUSIONS
  Treatment with peginterferon beta-1a could help to improve or maintain HRQoL in addition to clinical outcomes.
  
  
  BACKGROUND
  ClinicalTrials.gov: NCT00906399.
authors.affiliation: Department of Neurology, Johns Hopkins University, Baltimore, MD, USA. Electronic address: snewsom2@jhmi.edu.
authors.forename: S D
authors.initials: SD
authors.lastname: Newsome
authors.affiliation: Evidera, 430 Bedford Street, Suite 300, Lexington Office Park, Lexington, MA 02420, USA. Electronic address: shien.guo@evidera.com.
authors.forename: S
authors.initials: S
authors.lastname: Guo
authors.affiliation: Evidera, 430 Bedford Street, Suite 300, Lexington Office Park, Lexington, MA 02420, USA. Electronic address: arman.altincatal@evidera.com.
authors.forename: A
authors.initials: A
authors.lastname: Altincatal
authors.affiliation: Evidera, 7575 Trans-Canada Highway, Suite 500, St-Laurent, Quebec, Canada H4T 1V6. Electronic address: irina.proskorovsky@evidera.com.
authors.forename: I
authors.initials: I
authors.lastname: Proskorovsky
authors.affiliation: Biogen, 225 Binney Street, Cambridge, MA 02142, USA. Electronic address: Elizabeth.Kinter@biogenidec.com.
authors.forename: E
authors.initials: E
authors.lastname: Kinter
authors.affiliation: Biogen, 225 Binney Street, Cambridge, MA 02142, USA. Electronic address: glenn.phillips@biogenidec.com.
authors.forename: G
authors.initials: G
authors.lastname: Phillips
authors.affiliation: Biogen, 225 Binney Street, Cambridge, MA 02142, USA. Electronic address: phil.you@biogenidec.com.
authors.forename: X
authors.initials: X
authors.lastname: You
authors.affiliation: Biogen, 225 Binney Street, Cambridge, MA 02142, USA. Electronic address: guido.sabatella@biogenidec.com.
authors.forename: G
authors.initials: G
authors.lastname: Sabatella
mesh_terms: D000328:Adult; D004185:Disability Evaluation; D018450:Disease Progression; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007155:Immunologic Factors / Q000627:therapeutic use*; D016899:Interferon-beta / Q000627:therapeutic use*; D008297:Male; D020529:Multiple Sclerosis, Relapsing-Remitting / Q000188:drug therapy* / Q000503:physiopathology* / Q000523:psychology; D011092:Polyethylene Glycols / Q000627:therapeutic use*; D011788:Quality of Life; D016896:Treatment Outcome
chemical_list: D007155:Immunologic Factors; D011092:Polyethylene Glycols; D016899:Interferon-beta; C428112:peginterferon beta-1a
keywords: Clinical trial; Interferon; Multiple sclerosis; Peginterferon beta-1a; Pegylation; Quality of life