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

Abstract

Summary 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.

Laboratory Safety of Dupilumab, and Its Effect on Inflammatory Biomarkers, in Chinese Adults With Moderate-to-Severe Atopic Dermatitis: An Analysis of a Randomized, Double-Blind Phase III Study

“…The participants' baseline demographic and clinical characteristics have been previously published. 8 In brief, the 2 groups were well balanced at baseline; in the overall study population, the median age was 28.0 years, and 71.5% of the participants were male. Most of the participants completed the study treatment period (93% of dupilumab recipients and 80% of placebo recipients).…”

“…As detailed in the primary publication of this study, 8 concomitant treatment with the following was prohibited: live (attenuated) vaccines, immunomodulating biologics, topical calcineurin inhibitors, topical or systemic corticosteroids, systemic nonsteroidal immunomodulating or immunosuppressive drugs, or initiation or up-titration of antigen-specific immunotherapy. However, rescue treatment with otherwise prohibited agents was permitted at the discretion of the study investigators.…”

“…The study design and methodological details have been previously described. 8 Briefly, Chinese adults with moderate to severe AD that was uncontrolled with topical medications, or for which such medications were inadvisable, were randomized to receive subcutaneous dupilumab (loading dose of 600 mg, followed by 300 mg) or matching placebo once every 2 weeks for 16 weeks. Follow-up was then performed for 12 weeks.…”

Treatment With Dupilumab in Patients With Atopic Dermatitis: Systematic Review and Meta-Analysis

“…We retrieved 744 citations from our search in the literature (361 in PubMed and 383 in CENTRAL) and after screening and review, 11 articles (14 studies) were considered eligible for further evaluation (Supplemental Figure 1). 19,20,25 -33 The included studies are presented in Supplemental Table 1. Trials were published between 2014−2021.…”

“…Our meta-analysis includes up to seven additional studies and more than 25% larger sample size compared to previous meta-analyses that have been conducted addressing the same research question 36,37 updating the evidence with several more recent studies. 19,20,32,33 Additionally, we performed subgroup meta-analyses in two age groups (adults vs adolescents/children) to investigate any possible differences in efficacy and safety between them. Finally, we performed a meta-analysis for a substantial number of outcomes (n = 14) to examine the efficacy of dupilumab in many different levels.…”