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.

Background Sham acupuncture is usually used to assess the specific effects of acupuncture. However, the reporting quality of sham acupuncture remains unclear despite its critical importance in understanding and analyzing the effects of acupuncture. This paper presents a literature review aimed at assessing the quality of reporting of sham acupuncture in randomized controlled trials (RCTs) based on STRICTA 2010 and TIDieR-Placebo. Methods Three electronic English-language databases (PubMed, MEDLINE and Embase) were searched from inception to March 7, 2022, and RCTs of sham acupuncture were identified. The reporting quality of sham acupuncture was assessed in accordance with the items recommended in STRICTA 2010 and TIDieR-Placebo. The reporting quality of other items related to sham acupuncture apart from items from these two checklists was also captured to further assess the reporting quality of sham acupuncture. Results A total of 609 eligible studies were included. For all of the items recommended in STRICTA 2010 and TIDieR-Placebo, 100% of the studies reported a brief name that described the sham acupuncture, 93.9% studies reported the needle type, and 90.0% reported the names of the points used. Other items for which the reporting rates were above 50% included the number, frequency and duration of treatment sessions; needle retention time; and number of needle insertions per subject per session. Overall, 49.4% of the studies revealed the rationale why sham acupuncture was chosen, 39.7% of the studies involving insertion processes reported the depth of insertion, and 37.9% of the studies reported the needle manufacturer. Other items for which the reporting rates were below 30% included practitioner-related information, response sought, evaluation of blinding, intervention mode and environment, assisting tools, and the extent to which the treatment was varied. The items “Modifications”, “How well (planned)” and “How well (actual)” were not reported in any of the analyzed studies. Conclusions The overall reporting quality of sham acupuncture in RCTs was suboptimal. Although STRICTA 2010 and TIDieR-Placebo could be beneficial for describing sham acupuncture, neither can offer recommendations specifically for sham acupuncture. There is thus an urgent need to develop specialized guidelines for reporting sham acupuncture in clinical trials.

No abstract