title: Assessing the impact of multiple sclerosis disease activity and daclizumab HYP treatment on patient-reported outcomes: Results from the SELECT trial.
abstract: BACKGROUND
  The SELECT study demonstrated superior effects of daclizumab high-yield process (DAC HYP) to placebo in key endpoints in patients with relapsing and remitting multiple sclerosis (RRMS).
  
  
  OBJECTIVE
  To assess the impact of DAC HYP and disease activity on health-related quality of life (HRQoL) using data from this study.
  
  
  METHODS
  HRQoL was assessed at baseline, 12, 24, and 52 weeks using the Multiple Sclerosis Impact Scale (MSIS-29), the 12-items Short Form Health Survey, and the EuroQoL-5 Dimensions. An analysis of covariance model was used to compare treatment difference in change from baseline. Mixed-effects models were used to assess the impact of disability progression, relapse, treatment, and interaction between treatment and these events on HRQoL outcome.
  
  
  RESULTS
  DAC HYP 150mg resulted in significant positive impacts on HRQoL compared to placebo. It was also found to significantly reduce the adverse impact of relapse on the MSIS-29 physical scale (-12.45; p=0.0006). Relapse and disability progression were significantly associated with impaired HRQoL.
  
  
  CONCLUSIONS
  DAC HYP 150mg improved HRQoL in patients with RRMS compared to placebo. The treatment benefit can be partially attributed to reduction in disease activity and attenuation of the adverse impact of relapse on HRQoL.
authors.affiliation: Biogen, 300 Binney Street, Cambridge, MA 02142, United States. Electronic address: Glenn.Phillips@biogen.com.
authors.forename: Glenn
authors.initials: G
authors.lastname: Phillips
authors.affiliation: Evidera, 430 Bedford St. Suite 300 Lexington Office Park, Lexington, MA 02420, United States.
authors.forename: Shien
authors.initials: S
authors.lastname: Guo
authors.affiliation: Evidera, 7101 Wisconsin Ave., Suite 1400, Bethesda, MD 20814 United States.
authors.forename: Randall
authors.initials: R
authors.lastname: Bender
authors.affiliation: Charles University in Prague, Ovocný trh 3-5 Prague 1, 116 36, Prague, Czech Republic.
authors.forename: Eva
authors.initials: E
authors.lastname: Havrdová
authors.affiliation: Evidera, 7575 Trans-Canada Highway Suite 500, St-Laurent, Quebec, Montreal, Canada H4T 1V6.
authors.forename: Irina
authors.initials: I
authors.lastname: Proskorovsky
authors.affiliation: University of Colorado School of Medicine, Anschutz Medical Campus, Department of Neurology, Academic Office 1, Mail Stop B-185, 12631 East 17th Avenue, Aurora, CO 80045, United States.
authors.forename: Timothy
authors.initials: T
authors.lastname: Vollmer
mesh_terms: D000328:Adult; D000704:Analysis of Variance; D061067:Antibodies, Monoclonal, Humanized / Q000627:therapeutic use*; D000077561:Daclizumab; D004185:Disability Evaluation; D018450:Disease Progression; D005260:Female; D006801:Humans; D007155:Immunologic Factors / Q000627:therapeutic use*; D008297:Male; D020529:Multiple Sclerosis, Relapsing-Remitting / Q000188:drug therapy* / Q000523:psychology; D011788:Quality of Life / Q000523:psychology; D057566:Self Report; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D007155:Immunologic Factors; C000598527:daclizumab HYP; D000077561:Daclizumab
keywords: Daclizumab high-yield process; MS-specific health-related quality of life measures; Multiple Sclerosis Impact Scale; Relapsing and remitting multiple sclerosis