Impact of daclizumab versus interferon beta-1a on patient-reported outcomes in relapsing-remitting multiple sclerosis

Ying Liu; Timothy Vollmer; Eva Havrdova; Katherine Riester; Andrew Lee; Glenn Phillips; Ping Wang; Guido Sabatella

doi:10.1016/j.msard.2016.11.005

Impact of daclizumab versus interferon beta-1a on patient-reported outcomes in relapsing-remitting multiple sclerosis

Mult Scler Relat Disord. 2017 Jan:11:18-24. doi: 10.1016/j.msard.2016.11.005. Epub 2016 Nov 13.

Authors

Ying Liu¹, Timothy Vollmer², Eva Havrdova³, Katherine Riester⁴, Andrew Lee⁵, Glenn Phillips⁶, Ping Wang⁷, Guido Sabatella⁸

Affiliations

¹ Biogen, 225 Binney Street, Cambridge, MA 02142, USA. Electronic address: ying.liu@biogen.com.
² 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.
³ 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.
⁴ Biogen, 225 Binney Street, Cambridge, MA 02142, USA. Electronic address: katherine.riester@biogen.com.
⁵ Biogen, 225 Binney Street, Cambridge, MA 02142, USA. Electronic address: andrew.lee@biogen.com.
⁶ Biogen, 225 Binney Street, Cambridge, MA 02142, USA. Electronic address: glenn.phillips@biogen.com.
⁷ Biogen, 225 Binney Street, Cambridge, MA 02142, USA. Electronic address: ping.wang@biogen.com.
⁸ Biogen, 225 Binney Street, Cambridge, MA 02142, USA. Electronic address: guido.sabatella@biogen.com.

PMID: 28104250
DOI: 10.1016/j.msard.2016.11.005

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).

Keywords: Daclizumab; Multiple sclerosis; Patient-reported outcomes; Relapsing-remitting.

Publication types

Clinical Trial, Phase III
Comparative Study
Randomized Controlled Trial

MeSH terms

Adolescent
Adult
Antibodies, Monoclonal, Humanized / therapeutic use*
Daclizumab
Double-Blind Method
Humans
Immunoglobulin G / therapeutic use*
Immunologic Factors / therapeutic use*
Interferon beta-1a / therapeutic use*
Middle Aged
Multiple Sclerosis, Relapsing-Remitting / drug therapy*
Patient Reported Outcome Measures
Time Factors
Young Adult

Substances

Antibodies, Monoclonal, Humanized
Immunoglobulin G
Immunologic Factors
Daclizumab
Interferon beta-1a

Associated data

ClinicalTrials.gov/NCT01064401