DX01
The Effect of Daclizumab High-Yield Process (DAC HYP) on Patient-Centered Functional Outcomes: Results from the DECIDE Study

Friday, May 29, 2015: 2:00 PM
White River F
Michael Kaufman, MD , Cole Neurological Institute, University of Tennessee - Knoxville, Knoxville, TN
Ludwig Kappos, MD, PhD , University Hospital Basel, Basel, Switzerland
Krzysztof W Selmaj, MD, PhD , Department of Neurology, Medical Academy of Lodz, Lodz, Poland
Douglas L Arnold, MD , McGill University, Montreal, QC, Canada
Eva Havrdova, MD, PhD , Department of Neurology, First Faculty of Medicine, Charles University in Prague, Prague, Czech Republic
Alexey N Boyko, MD , Pirogov Russian National Research University & Demyelinating Diseases Center, Usupov Hospital, Moscow, Russia
Heinz Wiendl, MD , University of Munster, Munster, Germany
John Rose, MD , Department of Neurology University of Utah and Neurovirology Research Laboratory VASLCHCS, Imaging and Neuroscience Center, Salt Lake City, UT
Steven J Greenberg, MD , AbbVie Biotherapeutics Inc., Redwood City, CA
Marianne T. Sweetser, MD, PhD , Biogen Idec, Inc., Cambridge, MA
Wei Ma, PhD , Biogen Idec, Inc., Cambridge, MA
Ping Wang, PhD , Biogen Idec, Inc., Cambridge, MA
Mark Beatty, MD , Biogen Idec, Cambridge, MA


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Background:  Maintaining the functional domains associated with the ability to perform daily activities, such as ambulation and cognition, is a priority for patients with multiple sclerosis (MS). Hence, patient-centered functional outcomes have been included in recent and ongoing efficacy trials of MS therapies. One such trial, the randomized, double-blind DECIDE study, has already reported that DAC HYP reduced clinical and radiographic disease activity in patients with relapsing-remitting MS (RRMS) compared with intramuscular interferon (IFN) beta-1a.

Objectives:  To evaluate the effects of DAC HYP compared with IFN beta-1a on different patient-centered functional domains, including ambulation, hand/arm dexterity, and cognition, using the Multiple Sclerosis Functional Composite (MSFC) and Symbol Digit Modalities Test (SDMT) in the DECIDE trial.

Methods:  Patients (aged 18–55 y) with confirmed RRMS and an Expanded Disability Status Scale (EDSS) score of 0.0–5.0 were randomized to DAC HYP 150 mg subcutaneously every 4 weeks or IFN beta-1a 30 mcg once weekly. Change in MSFC and SDMT over 96 weeks were tertiary endpoints and treatment differences were evaluated using ANCOVA on ranks (MSFC) or mixed effects models (SDMT), adjusted for key baseline parameters, including baseline score.

Results:   Overall, 919 patients received DAC HYP (mean baseline EDSS 2.48) and 922 IFN beta-1a (EDSS 2.54). Over 96 weeks, the median (25th, 75th percentile) improvement from baseline in the MSFC z-score was 0.091 (-0.096, 0.287) for DAC HYP versus 0.055 (-0.136, 0.240) for IFN beta-1a (P=0.0007). Significant differences between the DAC HYP and IFN beta-1a groups were also observed in the MSFC components. Median (25th, 75th percentile) z-score change from baseline to Week 96 for the Timed 25-Foot Walk: 0.000 (-0.099, 0.083) versus -0.017 (-0.124, 0.075; P=0.0060); 9-Hole Peg Test: 0.063 (-0.195, 0.356) versus 0.017 (-0.273, 0.291; P=0.0016); and Paced Auditory Serial Addition Test 3: 0.177 (-0.088, 0.530) versus 0.177 (-0.088, 0.442; P=0.0411). For the SDMT, the mean (±SD) change from baseline over 96 weeks of DAC HYP therapy was 4.08 (±12.40) compared with 2.89 (±12.71; P=0.0274) for IFN beta-1a.

Conclusions:  Over 2 years of treatment, DAC HYP showed greater improvement compared with IFN beta-1a on the MSFC and SDMT outcomes.

See more of: Disease Management, Mechanisms, and Treatment (Platform/Oral)
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