The efficacy and safety of dupilumab in Chinese patients with moderate-to-severe atopic dermatitis: a randomized, double-blind, placebo-controlled study

Background Dupilumab is an antibody against interleukin-4 receptor alpha, used in the treatment of atopic dermatitis (AD). Objectives To evaluate the efficacy and safety of dupilumab in adult Chinese patients with moderate-to-severe AD. Methods In this randomized, double-blind, placebo-controlled, parallel-group, phase III study, conducted between December 2018 and February 2020, patients with AD received dupilumab (300 mg) or placebo once every 2 weeks for 16 weeks, and were followed up for 12 weeks. The primary efficacy endpoint was the proportion of patients with both an Investigator's Global Assessment score of 0-1 and a reduction from baseline of >= 2 points at week 16. Results Overall, 165 patients (mean age 30 center dot 6 years; 71 center dot 5% male patients) were randomized; 82 patients were randomized to dupilumab and 83 patients were randomized to placebo. At week 16, 26 center dot 8% of patients in the dupilumab group and 4 center dot 8% of patients in the placebo group achieved the primary endpoint [difference 22 center dot 0%, 95% confidence interval (CI) 11 center dot 37-32 center dot 65; P < 0 center dot 001]. Compared with placebo, higher proportions of patients in the dupilumab group achieved >= 75% reduction in the Eczema Area and Severity Index score (57 center dot 3% vs. 14 center dot 5%; difference 42 center dot 9%, 95% CI 29 center dot 75-55 center dot 97; P < 0 center dot 001) and had >= 3-point (52 center dot 4% vs. 9 center dot 6%; difference 42 center dot 8%, 95% CI 30 center dot 26-55 center dot 34; P < 0 center dot 001) and >= 4-point (39 center dot 0% vs. 4 center dot 8%; difference 34 center dot 2%, 95% CI 22 center dot 69-45 center dot 72; P < 0 center dot 001) reductions in weekly average daily peak daily pruritus numerical rating scale scores. The incidence of treatment-emergent adverse events during the treatment period was similar in the two groups. The incidence of conjunctivitis, allergic conjunctivitis and injection site reaction was higher in the dupilumab group than in the placebo group. Conclusions In adult Chinese patients, dupilumab was effective in improving the signs and symptoms of AD and demonstrated a favourable safety profile.