• 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.

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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