Background As disease-activity-free status is now a viable treatment goal in relapsing multiple sclerosis (RMS), no evidence of disease activity (NEDA) is gaining increasing acceptance as an outcome measure.
Objective To determine the percentage of RMS patients who achieved NEDA in the DECIDE study.
Methods DECIDE was a phase 3 study of 150 mg subcutaneous daclizumab high-yield process (DAC HYP) every 4 weeks versus weekly 30 mcg intramuscular (IM) interferon (IFN) beta-1a over 96–144 weeks. NEDA was defined as no relapses, no 12-week confirmed disability progression, no new/enlarging T2 (NET2) lesions, and no gadolinium-enhancing (Gd+) lesions.
Results A greater percentage of patients receiving DAC HYP than IFN beta-1a achieved NEDA by week 96 (24.3% [198/816] vs 13.9% [116/834]; odds ratio [OR]: 1.983 [95% confidence interval (CI): 1.540–2.554]; P<0.0001). Similarly, a greater percentage of patients receiving DAC HYP than IFN beta-1a achieved clinical NEDA (no relapses or disability progression) (68.0% [625/919] vs 56.3% [519/922]; OR [95% CI]: 1.651 [1.365–1.996]; P<0.0001) and MRI NEDA (no NET2/Gd+ lesions) (36.4% [281/772] vs 23.3% [181/778]; OR 1.887 [1.512–2.356]; P<0.0001) by week 96.
Conclusions A significantly greater percentage of patients treated with DAC HYP than with IM IFN beta-1a achieved NEDA.
Sponsors: Biogen, AbbVie Biotherapeutics.
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