Real-world efficacy and safety of dupilumab in Chinese patients with atopic dermatitis: a single-centre, prospective, open-label study
Real-world efficacy and safety of dupilumab in Chinese patients with atopic dermatitis: a single-centre, prospective, open-label study
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DOI：
10.1111/jdv.18109
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发表时间：
2022-04-01
影响因子：
9.2
通讯作者：
Li, W.
中科院分区：
文献类型：
--
作者：
Gu, C.;Wu, Y.;Li, W.
背景：Dupilumab是一种针对白细胞介素4受体α的抗体，在中重度特应性皮炎(AD)患者中显示出良好的疗效和安全性。然而，不同AD患者的治疗效果不同，与高加索人群相比，针对亚洲人群，尤其是中国AD患者的DUPILUMA数据非常有限。目的观察杜匹单抗治疗阿尔茨海默病(AD)的有效性和安全性。方法选择上海华山医院收治的138例中重度AD患者，中国进行为期16周的单中心前瞻性开放研究。这些患者在首次使用dupiumab后的基线、2、4、8和16周进行评估，以评估医生和患者报告的多项结果。检测外周血嗜酸粒细胞计数和血清总IgE。结果用药后各项疗效评价指标均有早期和持续改善。在第16周，64.5%的AD患者湿疹面积和严重程度指数较基线有75%的改善，60.9%的患者达到调查者全球评估0/1(或较基线下降2分)。与身体其他部位相比，躯干的疗效评分下降最显著[中位数下降96.24%(四分位数范围，89.04至100%)]。女性(调整后OR：2.12，95%可信区间：0.79-5.74)和体重指数(BMI)60(0.57；0.10-3.28)预测反应差。34.1%的患者报告了不良反应，其中面部红斑(13%)和眼部症状(10.9%)最为常见。结论多匹鲁单抗在中国AD患者中具有良好的临床疗效和良好的耐受性。
Background Dupilumab, an antibody against interleukin-4 receptor alpha, has demonstrated elegant efficacy and safety profiles in patients with moderate-to-severe atopic dermatitis (AD). However, the efficacy of dupilumab varies among AD patients, and compared with the Caucasian population, the data of dupilumab for Asian people, especially Chinese AD patients, is very limited. Objective To investigate the efficacy and safety of dupilumab for AD in a real-world Chinese single-centre prospective cohort. Methods We enrolled 138 moderate-to-severe AD patients receiving dupilumab treatment at Huashan Hospital, Shanghai, China in this 16-week, single-centre, prospective, open-label study. The patients were evaluated at baseline, 2, 4, 8 and 16 weeks after first dupilumab administration for multiple physician- and patient-reported outcome measures. Blood eosinophil counts and total serum IgE were measured. Results There were early and sustained improvement in all the efficacy measures evaluated after dupilumab administration. 64.5% AD patients achieved an improvement of >= 75% in the Eczema Area and Severity Index from baseline, and 60.9% patients achieved the Investigator's Global Assessment 0/1 (or a reduction of >= 2 points from baseline) at week 16. The trunk demonstrated the most significantly decreased efficacy score [median decreased 96.24% (interquartile range, 89.04 to 100%)] compared with other body sites. Female (adjusted OR: 2.12, 95% confidence interval: 0.79-5.74) and body mass index (BMI) 60 (0.57; 0.10-3.28) predicted poor response. Adverse events were reported by 34.1% patients, and facial erythema (13%) and ocular symptoms (10.9%) were the most common. Conclusions Dupilumab demonstrated favourable efficacy and well-tolerated safety in Chinese AD patients in real-world practice.