title: Impact of daclizumab versus interferon beta-1a on patient-reported outcomes in relapsing-remitting multiple sclerosis.
abstract: BACKGROUND
  Patient-reported outcomes (PROs) provide information on treatment effects from the patient's perspective that complement outcomes on clinical measures. In DECIDE, daclizumab demonstrated superior efficacy in reducing relapses, 24-week confirmed disability progression, and brain lesions (assessed by magnetic resonance imaging [MRI]) versus intramuscular interferon beta-1a in relapsing-remitting multiple sclerosis.
  
  
  OBJECTIVE
  To examine the impact of daclizumab versus interferon beta-1a on PROs in DECIDE.
  
  
  METHODS
  DECIDE was a randomized, double-blind, active-controlled, phase 3 study comparing daclizumab 150mg subcutaneous every 4 weeks with interferon beta-1a 30mcg intramuscular once weekly. The 29-item Multiple Sclerosis Impact Scale (MSIS-29) and EuroQoL 5-Dimensions (EQ-5D) were assessed at baseline and every 24 weeks. Mean changes from baseline were analyzed using analysis of covariance models. Individual items for the MSIS-29 physical (PHYS) and psychological (PSYCH) subscales were analyzed post hoc.
  
  
  RESULTS
  Daclizumab treatment resulted in greater mean improvements relative to baseline in MSIS-29 PHYS and PSYCH scores starting at week 24 that persisted over 96 weeks. Mean improvements from baseline in MSIS-29 PHYS and PSYCH scores were significantly greater for daclizumab versus intramuscular interferon beta-1a at week 96. Daclizumab-treated patients showed steady improvements in EQ-5D health utility index and EQ-5D visual analog scale scores over the study period, with significantly greater improvements versus intramuscular interferon beta-1a at week 96 (p=0.0048 and p=0.0006, respectively).
  
  
  CONCLUSIONS
  Improvements in patient-reported physical and psychological functioning and general health status with daclizumab compared with intramuscular interferon beta-1a are consistent with outcomes on clinical and brain MRI lesion measures in DECIDE (NCT01064401).
authors.affiliation: Biogen, 225 Binney Street, Cambridge, MA 02142, USA. Electronic address: ying.liu@biogen.com.
authors.forename: Ying
authors.initials: Y
authors.lastname: Liu
authors.affiliation: Department of Neurology, University of Colorado School of Medicine, Mail Stop B182, Research Complex 2, 12700 East 19th Avenue, Aurora, CO 80045, USA. Electronic address: timothy.vollmer@ucdenver.edu.
authors.forename: Timothy
authors.initials: T
authors.lastname: Vollmer
authors.affiliation: Department of Neurology, First Faculty of Medicine, Charles University in Prague, Kateřinská 1660/32, 121 08 Praha, Czechia. Electronic address: Eva.Havrdova@lf1.cuni.cz.
authors.forename: Eva
authors.initials: E
authors.lastname: Havrdova
authors.affiliation: Biogen, 225 Binney Street, Cambridge, MA 02142, USA. Electronic address: katherine.riester@biogen.com.
authors.forename: Katherine
authors.initials: K
authors.lastname: Riester
authors.affiliation: Biogen, 225 Binney Street, Cambridge, MA 02142, USA. Electronic address: andrew.lee@biogen.com.
authors.forename: Andrew
authors.initials: A
authors.lastname: Lee
authors.affiliation: Biogen, 225 Binney Street, Cambridge, MA 02142, USA. Electronic address: glenn.phillips@biogen.com.
authors.forename: Glenn
authors.initials: G
authors.lastname: Phillips
authors.affiliation: Biogen, 225 Binney Street, Cambridge, MA 02142, USA. Electronic address: ping.wang@biogen.com.
authors.forename: Ping
authors.initials: P
authors.lastname: Wang
authors.affiliation: Biogen, 225 Binney Street, Cambridge, MA 02142, USA. Electronic address: guido.sabatella@biogen.com.
authors.forename: Guido
authors.initials: G
authors.lastname: Sabatella
mesh_terms: D000293:Adolescent; D000328:Adult; D061067:Antibodies, Monoclonal, Humanized / Q000627:therapeutic use*; D000077561:Daclizumab; D004311:Double-Blind Method; D006801:Humans; D007074:Immunoglobulin G / Q000627:therapeutic use*; D007155:Immunologic Factors / Q000627:therapeutic use*; D000068556:Interferon beta-1a / Q000627:therapeutic use*; D008875:Middle Aged; D020529:Multiple Sclerosis, Relapsing-Remitting / Q000188:drug therapy*; D000071066:Patient Reported Outcome Measures; D013997:Time Factors; D055815:Young Adult
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D007074:Immunoglobulin G; D007155:Immunologic Factors; D000077561:Daclizumab; D000068556:Interferon beta-1a
keywords: Daclizumab; Multiple sclerosis; Patient-reported outcomes; Relapsing-remitting