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

Abstract

Background: Dupilumab is an antibody against interleukin-4 receptor α, 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 30·6 years; 71·5% male patients) were randomized; 82 patients were randomized to dupilumab and 83 patients were randomized to placebo. At week 16, 26·8% of patients in the dupilumab group and 4·8% of patients in the placebo group achieved the primary endpoint [difference 22·0%, 95% confidence interval (CI) 11·37-32·65; P < 0·001]. Compared with placebo, higher proportions of patients in the dupilumab group achieved ≥ 75% reduction in the Eczema Area and Severity Index score (57·3% vs. 14·5%; difference 42·9%, 95% CI 29·75-55·97; P < 0·001) and had ≥ 3-point (52·4% vs. 9·6%; difference 42·8%, 95% CI 30·26-55·34; P < 0·001) and ≥ 4-point (39·0% vs. 4·8%; difference 34·2%, 95% CI 22·69-45·72; P < 0·001) 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.

Figure 1

Distribution of patients throughout the study. q2w, every 2 weeks.

Figure 2

Proportion of patients who had an Investigator’s Global Assessment (IGA) score of 0 or 1 and achieved a reduction of ≥ 2 points in their IGA score from baseline at week 16 (primary endpoint). *P < 0·001 for difference (95% confidence interval).

Figure 3

Proportions of patients who achieved Eczema Area and Severity Index (EASI) 50, EASI 75 and EASI 90 at week 16. *P < 0·001 for difference (95% confidence interval).

Figure 4

Change in weekly average peak pruritus NRS score at week 16. (a) Proportions of patients who had ≥ 3‐point and ≥ 4‐point reduction in weekly average peak pruritus NRS score from baseline. (b) Percentage change in weekly average of peak daily pruritus NRS score from baseline. CI, confidence interval; LS, least squares; NRS, numerical rating scale; SE standard error. *P < 0·001 for difference (95% CI). **P < 0·001 for LS mean difference (95% CI).

Figure 5

Patient‐reported outcomes. DLQI, Dermatology Life Quality Index; LS, least squares; POEM, Patient‐Oriented Eczema Measure; SE, standard error. *P < 0·001 for LS mean difference (95% confidence interval).