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.
This study is to investigate the relationships between prevalent cardiovascular events (myocardial infarction, stroke and peripheral arterial disease) and carotid intima-media thickness (CIMT) in middle-aged and older adults; to assess which of the indexes, IMT in the common carotid artery (CCA), internal carotid artery (ICA) and carotid bifurcation (CB) separately or in combination, is a better correlate. IMT of the CCA, ICA and CB were measured with duplex ultrasound in 1058 individuals (aged between 37 and 86 years old) in a suburban community of Beijing. Histories of cardiovascular events as well as prevalent risk factors were obtained. CIMT were compared between groups with and without cardiovascular events. Associations of cardiovascular events with IMT measurements in CCA, CB and ICA were ascertained. The group with cardiovascular events had higher mean CIMT (0.74 (0.60-0.98) mm vs 0.65 (0.54-0.80) mm, P ¼ 0.000) and higher abnormal CIMT proportion (77.20 vs 64.45%, P ¼ 0.000). The odds ratio (OR) for myocardial infarction was 1.74 (P ¼ 0.010), for stroke 1.98 (P ¼ 0.001) and for peripheral arterial disease 1.80 (P ¼ 0.072) in abnormal CIMT. However, after adjustment of traditional risk factors, the correlations disappeared, implying that CIMT may act via other risk factors. After adjustment of age, mean CIMT correlated best with total cardiovascular events (OR: 4.39 (2.39-8.04), P ¼ 0.000) and stroke (OR: 4.98 (2.55-9.71), P ¼ 0.000) separately; mean posterior CIMT correlated with myocardial infarction best (OR: 2.97 (1.68-5.24), P ¼ 0.000). CIMT may act as an intermediate point for cardiovascular diseases. Combined CIMT might be the best index associated with cardiovascular diseases.
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