Objective:

To evaluate the efficacy and safety of cendakimab in adult patients with moderate to severe atopic dermatitis who had an inadequate response to topical medications.

Approach:

• Study Design: A randomized, double-blind, placebo-controlled phase II clinical trial.
• Participants: 221 patients with a mean age of 37.7 years from 69 sites across the United States, Japan, Canada, Poland, and Czech Republic.
• Intervention: Patients received subcutaneous cendakimab at doses of 360 mg every 2 weeks, 720 mg every 2 weeks, or 720 mg once weekly; or placebo for 16 weeks.
• Primary Endpoint: Reduction in Eczema Area and Severity Index (EASI) scores at week 16.

Key Findings:

• Cendakimab met its primary endpoint with significant EASI score reduction at week 16 compared to placebo.
• The mean percentage change in EASI scores was -84.4% for 720 mg once weekly vs -62.7% for placebo (P = .003).
• 33.3% of patients receiving 720 mg once weekly achieved a clear/almost clear Validated Investigator Global Assessment score vs 9.4% in the placebo group.
• EASI-75 achievement was 50.0% in the 720 mg once weekly group vs 26.3% in the placebo group.
• Treatment-emergent adverse events were mostly mild to moderate, with higher rates of conjunctivitis in cendakimab groups.

Interpretation:

Limitations:

• The 720 mg every 2 weeks group did not reach statistical significance for the primary endpoint.
• The 360 mg every 2 weeks group showed a treatment effect but could not claim significance due to hierarchical testing.

Conclusion:

Sources:

• JAMA Dermatology