DECIDE: Significantly Improved Brain MRI Results with DAC HYP versus Interferon in RRMS

Summary

Daclizumab high-yield process (DAC HYP) is a humanized monoclonal antibody specific for CD25, the alpha subunit of the interleukin 2 receptor [Gold R et al. Lancet. 2013]. This article presents the magnetic resonance imaging (MRI) data from the phase 3 Efficacy and Safety of Daclizumab High Yield Process Versus Interferon β1a in Patients With Relapsing-Remitting Multiple Sclerosis trial [DECIDE; NCT01064401].

  • Neurology Clinical Trials
  • Neuroimaging
  • Demyelinating Diseases
  • Magnetic Resonance Imaging
  • Neurology Clinical Trials
  • Neuroimaging
  • Demyelinating Diseases
  • Magnetic Resonance Imaging
  • Neurology

Daclizumab high-yield process (DAC HYP) is a humanized monoclonal antibody specific for CD25, the alpha subunit of the interleukin 2 receptor [Gold R et al. Lancet. 2013]. A phase 2 study of DAC HYP in patients with relapsing-remitting multiple sclerosis (RRMS) reported that DAC HYP reduced the annualized relapse rate by 54% and new T2 hyperintense lesions by 70% when compared with placebo [Gold R et al. Lancet. 2013]. These improvements were maintained and the safety profile was consistent over 2 years [Giovannoni G et al. Lancet Neurol. 2014; Gold R et al. Lancet. 2013].

Douglas L. Arnold, MD, McGill University, Montreal, Canada, presented the magnetic resonance imaging (MRI) data from the phase 3 Efficacy and Safety of Daclizumab High Yield Process Versus Interferon β1a in Patients With Relapsing-Remitting Multiple Sclerosis trial [DECIDE; NCT01064401]. A total of 1841 patients with RRMS were randomized to treatment with subcutaneous DAC HYP (150 mg, every 4 weeks; n = 919) versus intramuscular interferon beta-1a (IFN-β-1a; 30 μg, once weekly; n = 922) for 96 to 144 weeks. The MRI end points included the number and the volume of new and newly enlarging T2 hyperintense lesions, the number of gadolinium-enhancing (Gd+) lesions, and the number and volume of T1 hypointense lesions at weeks 24 and 96.

The significant improvements in these outcomes with DAC HYP versus IFN-β-1a are shown in Table 1.

Table 1.

Change in Mean Number of MRI-Defined Lesions at Weeks 24 and 96

At week 96, the median volume of new and newly enlarging T2 hyperintense lesions was significantly smaller in the DAC HYP group (17 mm3) versus the IFN-β-1a group (248 mm3; P < .0001). The change in volume of T2 hyperintense lesions from baseline with DAC HYP versus IFN-β-1a was −1.4% versus −0.3% (P = .0188) at week 24 and 0.2% versus 3.8% (P < .0001) at week 96. The change in volume of T1 hypointense lesions with DAC HYP versus IFN-β-1a was 2.7% versus 6.3% (P = .0003) at week 24 and 15.3% versus 25.2% (P < .0001) at week 96. Subgroup analysis by baseline disease characteristics showed that all subgroups benefited from DAC HYP versus IFN-β-1a treatment.

The percentage reduction in annualized brain volume change with DAC HYP versus IFN-b-1a was 0.67 versus 0.74 (P = .03) at week 24 and 0.52 versus 0.56 from week 24 to week 96, respectively (P < .0001).

DAC HYP significantly reduced the number of T2 hyperintense, GD+, and T1 hypointense lesions when compared with IFN-b-1a. These improvements were observed as early as week 24 and were sustained over 96 weeks. DAC HYP also reduced brain atrophy as compared with IFN-b-1a over 2 years of treatment. These results with the efficacy and safety results [Kappos L et al. ECTRIMS. 2014 (session FC1.1); Krzysztof S et al. ECTRIMS. 2014 (poster P094)] indicate that DAC HYP has the potential for greater efficacy and a positive benefit-risk profile in patients with RRMS as compared with IFN-β-1a.

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