Conference Coverage
INDIANAPOLIS—Compared with interferon β-1a, daclizumab high-yield process (DAC HYP) may provide greater improvement in the patient-centered outcomes of ambulation and cognition for patients with relapsing-remitting multiple sclerosis (MS), according to data presented at the 2015 CMSC Annual Meeting.
The results come from a post hoc analysis of results from the DECIDE study. In that randomized, double-blind trial, Michael Kaufman, MD, a neurologist at Cole Neuroscience Center in Knoxville, Tennessee, and colleagues found that DAC HYP reduced clinical and radiographic disease activity in patients with relapsing-remitting MS, compared with interferon β-1a. The researchers incorporated changes in the MS Functional Composite (MSFC) and the Symbol Digit Modalities Test (SDMT) over 96 weeks as tertiary end points in the DECIDE trial to compare the effects of the two therapies on ambulation, hand and arm dexterity, and cognition.
Eligible participants were between ages 18 and 55 and had an Expanded Disability Status Scale (EDSS) score between 0 and 5. Patients were randomized to 150 mg of DAC HYP subcutaneously every four weeks or 30 mg of interferon β-1a once weekly. The study lasted for 144 weeks.
In all, 919 patients received DAC HYP, and 922 participants received interferon β-1a. Mean baseline EDSS was 2.48 for the DAC HYP group and 2.54 for the interferon β-1a group. Over 96 weeks, the median improvement from baseline in MSFC z score was 0.091 for patients receiving DAC HYP, compared with 0.055 for patients receiving interferon β-1a.
The most significant median z score change in an individual component of the MSFC was in the Nine-Hole Peg Test. This change was 0.063 for patients receiving DAC HYP and 0.017 for patients receiving interferon β-1a. Median z score change for the Timed 25-Foot Walk was 0.000 for the DAC HYP group and –0.017 for the interferon β-1a group. Median z score change for the Paced Auditory Serial Addition Test-3 was not different between groups at Week 96, but patients receiving DAC HYP showed earlier improvements in this measure. Mean change in SDMT from baseline over 96 weeks was 4.08 for the DAC HYP group, compared with 2.89 for the interferon β-1a group.
The data suggest that DAC HYP has beneficial effects for cognitive function, “which is extremely important to MS patients,” said Dr. Kaufman. The study “supports the idea that daclizumab may in the future have a place in the therapeutic armamentarium of MS,” he concluded.
—Erik Greb