OBJECTIVE: Perform key efficacy subgroup analyses of daclizumab high-yield process (DAC HYP) 150 mg subcutaneous every 4 weeks vs. interferon β-1a (IFN β-1a) 30 μg intramuscular every week in DECIDE, a randomized, double-blind, 2-3 year study in relapsing-remitting multiple sclerosis (RRMS).
BACKGROUND: Efficacy of DAC HYP in RRMS was demonstrated in the placebo-controlled SELECT study, in SELECT post-hoc subgroup analyses, and vs. IFN β-1a in DECIDE.
DESIGN/METHODS: Patients were randomized to IFN β-1a (n=922) or DAC HYP (n=919). Annualized relapse rates (ARR) and MRI endpoints were analyzed in baseline demographic and disease characteristic subgroups using a negative binomial regression (NB) model, adjusted for prior IFN β-1a use and baseline age (≤35, >35 years) unless it defined the subgroup. Baseline relapses and EDSS (≤2.5, >2.5) were also covariates in the ARR NB model. 95[percnt] confidence intervals (CI) were calculated.
RESULTS: DAC HYP treatment vs. IFN β-1a resulted in significant reductions in ARR (rate ratio DAC HYP/IFN β-1a [95[percnt] CI]) for all subgroups: Age, ≤35 years, 0.41 [0.32-0.51], >35 years, 0.74 [0.59-0.92]; Gender, male, 0.46 [0.35-0.62], female, 0.59 [0.49-0.72]; and for baseline disease characteristics: Disease duration, <3 years, 0.47 [0.37-0.60], 蠅3-1, 0.51 [0.41-0.64]; EDSS, <3.5, 0.44 [0.36-0.54], 蠅3.5, 0.83 [0.65-1.06]; Prior IFN β-1a use, 0.64 [0.50-0.81], naive, 0.49 [0.40-0.61]; Gd+ lesions present, 0.46 [0.36-0.58], absent, 0.66 [0.53-0.82]; and T2-lesion volume, <median, 0.60 [0.47-0.76], 蠅median, 0.50 [0.40-0.63]. DAC HYP was similarly effective on MRI outcomes.
CONCLUSIONS: DAC HYP effectively reduced disease activity in every subgroup across the spectrum of RRMS patients.
Study Supported by: Biogen Idec and AbbVie Biotherapeutics. Disclosure: Dr. Weindl has received personal compensation for activities with Bayer HealthCare, Biogen Idec, Fresenius Medical Care, GlaxoSmithKline, GW Pharmaceuticals, Merck Serono, and Novartis. Dr. Havrdova has received research support from the Czech Ministries of Education and Health. Dr. Rose has received research support from Biogen Idec, AbbieVie, Teva Neuroscience, Cumming Foundation, National Multiple Sclerosis Society, Veterans Affairs, and the National Institutes of Health. Dr. Riester has received personal compensation for activities with Biogen Idec as an employee. Dr. Tsao has received personal compensation for activities with AbbVie. Dr. Greenberg holds stock and/or stock options in AbbVie.