Daclizumab HYP Efficacious in Relapsing Multiple Sclerosis Trial
Biogen Idec and AbbVie announced results from the Phase 3 DECIDE clinical trial evaluating the use of subcutaneous daclizumab high-yield process (DAC HYP) vs. intramuscular interferon beta-1a (IFN β-1a) in patients with relapsing multiple sclerosis (RRMS).
DAC HYP is a humanized monoclonal antibody that binds to CD25, which modulates IL-2 signaling without causing general immune cell depletion. DAC HYP is believed to work by decreasing abnormally-activated T-cells and pro-inflammatory lymphoid tissue inducer cells, and increasing CD56bright natural killer (NK) cells.
DECIDE was a 2–3 year global, randomized, double-blind, multicenter study designed to determine if DAC HYP would provide superior outcomes for certain clinical endpoints compared to treatment with IFN β-1a. The study enrolled more than 1,800 people with RRMS. DECIDE was an active comparator study with two groups: 150mg of subcutaneous DAC HYP every four weeks was compared to IFN β-1a 30mcg intramuscular injection once weekly. The primary endpoint in DECIDE was the reduction in ARR. After completing the DECIDE study, patients have the option to participate in an open-label extension study called EXTEND.
Results showed that DAC HYP was superior on the study's primary endpoint, demonstrating a statistically significant 45% reduction in annualized relapse rate (ARR) compared to IFN β-1a (P<0.0001).