Ying Liu1, Timothy Vollmer2, Eva Havrdova3, Katherine Riester4, Andrew Lee5, Glenn Phillips6, Ping Wang7, Guido Sabatella8. 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.
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).
RCT Entities:
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: Stanley Cohan; Ludwig Kappos; Gavin Giovannoni; Heinz Wiendl; Krzysztof Selmaj; Eva Kubala Havrdová; John Rose; Steven Greenberg; Glenn Phillips; Wei Ma; Ping Wang; Gabriel Lima; Guido Sabatella Journal: Mult Scler Date: 2017-10-06 Impact factor: 6.312