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-la in relapsing-remitting multiple sclerosis.
Objective: To examine the impact of daclizumab versus interferon beta-la on PROs in DECIDE. Methods: DECIDE was a randomized, double-blind, active-controlled, phase 3 study comparing daclizumab 150 mg subcutaneous every 4 weeks with interferon beta-1a 30 mcg 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-la 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-la 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-la are consistent with outcomes on clinical and brain MRI lesion measures in DECIDE (NCT01064401).