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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.MS

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+Show Affiliations

Biogen, 225 Binney Street, Cambridge, MA 02142, USA. Electronic address: ying.liu@biogen.com.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.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.Biogen, 225 Binney Street, Cambridge, MA 02142, USA. Electronic address: katherine.riester@biogen.com.Biogen, 225 Binney Street, Cambridge, MA 02142, USA. Electronic address: andrew.lee@biogen.com.Biogen, 225 Binney Street, Cambridge, MA 02142, USA. Electronic address: glenn.phillips@biogen.com.Biogen, 225 Binney Street, Cambridge, MA 02142, USA. Electronic address: ping.wang@biogen.com.Biogen, 225 Binney Street, Cambridge, MA 02142, USA. Electronic address: guido.sabatella@biogen.com.

Pub Type(s)

Clinical Trial, Phase III
Comparative Study
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

28104250

Citation

Liu, Ying, et al. "Impact of Daclizumab Versus Interferon Beta-1a On Patient-reported Outcomes in Relapsing-remitting Multiple Sclerosis." Multiple Sclerosis and Related Disorders, vol. 11, 2017, pp. 18-24.
Liu Y, Vollmer T, Havrdova E, et al. Impact of daclizumab versus interferon beta-1a on patient-reported outcomes in relapsing-remitting multiple sclerosis. Mult Scler Relat Disord. 2017;11:18-24.
Liu, Y., Vollmer, T., Havrdova, E., Riester, K., Lee, A., Phillips, G., Wang, P., & Sabatella, G. (2017). Impact of daclizumab versus interferon beta-1a on patient-reported outcomes in relapsing-remitting multiple sclerosis. Multiple Sclerosis and Related Disorders, 11, 18-24. https://doi.org/10.1016/j.msard.2016.11.005
Liu Y, et al. Impact of Daclizumab Versus Interferon Beta-1a On Patient-reported Outcomes in Relapsing-remitting Multiple Sclerosis. Mult Scler Relat Disord. 2017;11:18-24. PubMed PMID: 28104250.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Impact of daclizumab versus interferon beta-1a on patient-reported outcomes in relapsing-remitting multiple sclerosis. AU - Liu,Ying, AU - Vollmer,Timothy, AU - Havrdova,Eva, AU - Riester,Katherine, AU - Lee,Andrew, AU - Phillips,Glenn, AU - Wang,Ping, AU - Sabatella,Guido, Y1 - 2016/11/13/ PY - 2016/01/21/received PY - 2016/09/07/revised PY - 2016/11/10/accepted PY - 2017/1/21/entrez PY - 2017/1/21/pubmed PY - 2017/2/28/medline KW - Daclizumab KW - Multiple sclerosis KW - Patient-reported outcomes KW - Relapsing-remitting SP - 18 EP - 24 JF - Multiple sclerosis and related disorders JO - Mult Scler Relat Disord VL - 11 N2 - 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). SN - 2211-0356 UR - https://www.unboundmedicine.com/medline/citation/28104250/Impact_of_daclizumab_versus_interferon_beta_1a_on_patient_reported_outcomes_in_relapsing_remitting_multiple_sclerosis_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S2211-0348(16)30199-7 DB - PRIME DP - Unbound Medicine ER -