The CHOICE study is the first randomized, double-blind, placebo-controlled trial that evaluated the efficacy and safety of daclizumab (DAC) when added to IFNβ therapy. The study enrolled 230 patients, ages 18 to 55 years, with active relapsing MS who had an entry score of five or less on the Expanded Disability Status Scale (EDSS). The patients had to be taking a stable IFNβ regimen for a minimum of six months prior to enrollment. During the year prior to enrollment, patients had to have experienced at least one MS relapse or incurred at least one MS lesion of the brain or spinal cord while on a stable IFNβ regimen.
Patients remained on their baseline IFNβ regimens and were randomized in a ratio of 1:1:1 to three "add-on" treatment groups for 24 weeks: 2mg/kg daclizumab administered subcutaneously every two weeks (DAC high dose/ IFNβ); 1mg/kg daclizumab administered every four weeks (DAC low dose/ IFNβ); or placebo (placebo/ IFNβ).
The primary endpoint of the study was the total number of new or enlarged Gd-CELs measured monthly on brain MRI scans collected between weeks eight to 24. Additional endpoints included changes in the number and volume of lesions on TI- and T2-weighted MRIs, clinical relapse as assessed by the annualized relapse rate (ARR) and time to relapse, changes in EDSS and Multiple Sclerosis Functional Composite-3 (MSFC-3) scores, immunogenicity, pharmacokinetics (PK), pharmacodynamics (PD), clinical laboratory abnormalities and adverse events (AEs).
Compared with patients on placebo/IFNβ therapy alone, there was a 72 percent reduction in the number of new or enlarged Gd-CELs between weeks eight and 24 in the DAC high dose/IFNβ group (p=0.004, 95% CI 34%, 88%) and a 25 percent reduction in the DAC low dose/IFN&
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