Liming Wu, Ali Kamran
Department of Dermatology, Affiliated Hangzhou First People's Hospital, Westlake University School of Medicine, Hangzhou, China.
Department of Surgery, The Fourth Affiliated Hospital of School of Medicine, and International School of Medicine, International Institutes of Medicine, Zhejiang University, Yiwu, China.
Ann Med. 2025 Dec;57(1):2449589. doi: 10.1080/07853890.2025.2449589. Epub 2025 Jan 6.
BACKGROUND/OBJECTIVE: Atopic dermatitis (AD) is a chronic, relapsing inflammatory skin disease that typically occurs in childhood/infancy and is associated with complications like extracutaneous atopic morbidity. Providing systemic treatment for pediatric AD patients with unmet comprehensive medical needs remains challenging. We present a cohort study describing the efficacy and safety of dupilumab combined with topical calcineurin inhibitors (TCI) in children with moderate-to-severe atopic dermatitis under the age of 6 years.
A retrospective cohort study was conducted at a single center to analyze the use of dupilumab in combination with topical calcineurin inhibitors (TCI) in children aged 6 years and under moderate-to-severe AD that was inadequately controlled with topical therapy.
Overall, 23 preschool children (mean [] age, 4.78 [1.278] years); 10 boys (43.5%) and 13 girls (56.5%) received 300 mg dupilumab every four weeks and TCI. The primary outcome, the average Eczema Area and Severity Index (EASI) percentage reduction from baseline, was -70.85%. Significant improvement was also observed in secondary outcomes: caregiver-reported Peak Pruritus numerical rating scale (P-NRS) (-77.73%), Body Surface Area (BSA) (-62.11%), and Investigators Global Assessment (IGA) (-36.23%) at week 16. A 1-2 grade decrease in IGA after 16 weeks of treatment was achieved by 91.3% of patients. There was a significant improvement in P-NRS and EASI scores from baseline to week 16. Injection-site reaction (one patient) and facial redness (two patients) were recorded. No severe drug-related adverse events were observed.
This study demonstrated that the combination of dupilumab and TCIs improved symptoms and quality of life in preschoolers with moderate-to-severe AD.
背景/目的：特应性皮炎（AD）是一种慢性复发性炎症性皮肤病，通常发生于儿童期/婴儿期，并伴有诸如皮肤外特应性疾病等并发症。为有未满足的综合医疗需求的儿科AD患者提供全身治疗仍然具有挑战性。我们开展了一项队列研究，描述度普利尤单抗联合外用钙调神经磷酸酶抑制剂（TCI）治疗6岁以下中重度特应性皮炎患儿的疗效和安全性。
在单一中心进行一项回顾性队列研究，分析度普利尤单抗联合外用钙调神经磷酸酶抑制剂（TCI）用于6岁及以下外用治疗控制不佳的中重度AD患儿的情况。
总体而言，23名学龄前儿童（平均年龄4.78[1.278]岁）；10名男孩（43.5%）和13名女孩（56.5%）接受每四周一次300mg度普利尤单抗及TCI治疗。主要结局指标，即湿疹面积和严重程度指数（EASI）较基线的平均降低百分比为-70.85%。次要结局指标也有显著改善：在第16周时，照料者报告的瘙痒峰值数字评定量表（P-NRS）降低了-77.73%，体表面积（BSA）降低了-62.11%，研究者整体评估（IGA）降低了-36.23%。91.3%的患者在治疗16周后IGA降低了1-2级。从基线到第16周，P-NRS和EASI评分有显著改善。记录到注射部位反应（1例患者）和面部发红（2例患者）。未观察到严重的药物相关不良事件。
本研究表明，度普利尤单抗和TCI联合使用可改善学龄前中重度AD患儿的症状和生活质量。
