Daclizumab in active relapsing multiple sclerosis (CHOICE study): a phase 2, randomised, double-blind,...

Area of Science:

• Neurology
• Immunology
• Pharmacology

Background:

• Daclizumab, a humanized monoclonal antibody, has shown promise in reducing multiple sclerosis (MS) disease activity in prior studies.
• This study investigated daclizumab's efficacy as an add-on therapy for patients with active relapsing MS already on interferon beta treatment.

Purpose of the Study:

• To evaluate the effectiveness of daclizumab in reducing new or enlarged gadolinium-enhancing MRI lesions in patients with active relapsing multiple sclerosis.
• To assess the impact of daclizumab on disease activity when used in combination with interferon beta therapy.

Main Methods:

• A phase 2, randomized, double-blind, placebo-controlled trial involving 230 patients across 51 centers.
• Patients received either high-dose daclizumab, low-dose daclizumab, or placebo, all in addition to subcutaneous interferon beta, for 24 weeks.
• The primary endpoint was the count of new or enlarged gadolinium-enhancing lesions on brain MRI scans, assessed every four weeks from week 8 to week 24.

Main Results:

• High-dose daclizumab reduced new/enlarged gadolinium-enhancing lesions by 72% compared to placebo (p=0.004).
• Low-dose daclizumab showed a non-significant 25% reduction (p=0.51).
• Daclizumab treatment led to a significant increase in CD56(bright) natural killer cells, while other immune cell populations and T-cell responses remained largely unchanged.

Conclusions:

• Add-on daclizumab treatment demonstrated a significant reduction in MRI-detected disease activity in patients with active relapsing multiple sclerosis receiving interferon beta.
• Daclizumab may offer a greater benefit in reducing multiple sclerosis disease activity compared to interferon beta monotherapy.