儿童中重度特应性皮炎首次皮下注射度普利尤单抗短期疗效和安全性分析

目的:了解度普利尤单抗皮下注射治疗儿童中重度特应性皮炎（AD）的短期疗效及安全性。方法:采用回顾性研究设计，收集2021年3 - 8月于首都医科大学附属北京儿童医院皮肤科诊断为中重度AD且同时接受度普利尤单抗注射液皮下注射治疗的患儿临床资料，评估度普利尤单抗注射液首次皮下注射治疗前、治疗后4周患儿湿疹面积及严重程度指数...

Analysis of short-term efficacy and safety of the first subcutaneous injection of dupilumab in the treatment of moderate-to-severe childhood atopic dermatitis

【Abstract】 Objective To investigate short-term efficacy and safety of subcutaneous injection of dupilumab in the treatment of moderate-to-severe childhood atopic dermatitis （AD）. Methods A retrospective study was conducted on clinical data from children who were diagnosed with moderate-to-severe AD and subcutaneously injected with dupilumab in Department of Dermatology, Beijing Children′s Hospital, Capital Medical University from March 2021 to August 2021. Changes in the Eczema Area and Severity Index （EASI）, itch Numeric Rating Scale （NRS） score, SCORing Atopic Dermatitis （SCORAD）index, and Dermatology Family quality of life Index （DFI） were analyzed before and 4 weeks after the first subcutaneous injection of dupilumab. Adverse events were collected during the first injection to the first follow-up visit at week 4 after the start of treatment. Normally distributed measurement indices were compared by using paired t test, non-normally distributed measurement indices were compared by using signed rank test, and logistic regression analysis was used to evaluate the effects of disease duration, eosinophil counts, IgE levels, personal and family history of allergic diseases on EASI50 （≥ 50% decrease in the EASI score） after dupilumab treatment. Results A total of 39 children were enrolled in this study, including 21 males and 18 females. Twenty-one patients were aged 2 to < 6 years, 18 were aged 6 to < 18 years, and their median age （Q1, Q3） was 65.0（53.0, 111.0） months. Four weeks after the single-dose subcutaneous injection of dupilumab, 18 patients （84.85%） achieved ≥ 50% decrease in EASI score, 13 （60.61%） ≥ 75% decrease in EASI score; 18 （75.76%） experienced a decrease of ≥ 4 points in peak NRS, and 20 （81.82%） ≥ 3 points in peak NRS; the SCORAD score decreased by ≥ 50% in 15 （68.75%） patients, and by ≥ 75% in 7 （18.75%）. Neither common adverse events such as conjunctivitis, skin infections, injection site reactions, nor serious adverse events were observed in any of the children from the first injection to the first follow-up visit at week 4. Logistic regression analysis showed no significant effect of the disease duration, eosinophil counts, IgE levels, personal or family history of allergic diseases on EASI50 （all P > 0.05）. Conclusion A single-dose subcutaneous injection of dupilumab can markedly improve pruritus and severity of skin lesions in children with moderate-to-severe AD, and enhance the family quality of life, with favorable short-term safety.