度普利尤单抗治疗12例儿童慢性自发性荨麻疹回顾分析

Dupilumab in the treatment of 12 children with chronic spontaneous urticaria:a retrospective analysis

目的观察度普利尤单抗治疗儿童慢性自发性荨麻疹(CSU)的短期疗效及安全性。方法回顾分析2021年4月至2022年4月山西省儿童医院皮肤科收治的经H1抗组胺药治疗无效并接受度普利尤单抗皮下注射治疗的CSU患儿的临床资料。使用7日荨麻疹活动度评分(UAS7)、荨麻疹控制评分(UCT)、慢性荨麻疹患者生活质量评估问卷(CU-Q2oL)评估患儿的病情变化、控制情况及生活质量,监测停药后复发和不良事件。每4周评估1次,随访时间为6个月。结果12例CSU患儿纳入分析,男6例,女6例,2~6岁5例,7~12岁7例,6例患儿同时合并哮喘、过敏性鼻炎或特应性皮炎;基线期UCT为(6.00±1.48)分,UAS7为(30.17±1.99)分,CU-Q2oL为(38.08±3.87)分。度普利尤单抗治疗4周时,7例有效,其中3例完全控制;治疗12周时9例有效,其中6例完全控制;在24周观察终点时,11例有效,其中9例达到完全控制(UCT=16分),2例控制良好(UCT均为12分),1例未控制(UCT<12分);12例CSU患儿UCT升至(14.83±2.17)分,UAS7降至(0.33±0.65)分,CU-Q2oL降至(0.67±1.30)分。6例有共病的患儿经治疗后共病症状均有明显改善。1例在注射第2针后出现双足跖红斑,未经处理自行消退。结论度普利尤单抗治疗儿童CSU有效,并可改善共患病,综合提高患儿生活质量,安全性良好。

Objective To evaluate the short-term efficacy and safety of dupilumab in the treatment of chronic spontaneous urticaria(CSU)in children.Methods A retrospective analysis was conducted on the clinical data from CSU patients,who showed poor response to H1-antihistamine treatment and received subcutaneous injections of dupilumab in the Department of Dermatology,Children′s Hospital of Shanxi from April 2021 to April 2022.The 7-day urticaria activity score(UAS7),urticaria control test(UCT),and chronic urticaria quality of life questionnaire(CU-Q2oL)were used to evaluate changes in the patients′condition,disease control status,and quality of life.Relapse after discontinuation of dupilumab and adverse events were monitored.Assessments were conducted every 4 weeks,and the patients were followed up for 6 months.Results Twelve CSU patients were included in the study,including 6 males and 6 females;5 patients were aged from 2 to 6 years,and 7 were aged from 7 to 12 years;6 patients had comorbidities such as asthma,allergic rhinitis,or atopic dermatitis;at baseline,the UCT scores were 6.00±1.48 points,UAS7 scores were 30.17±1.99 points,and CU-Q2oL scores were 38.08±3.87 points.After 4 weeks of dupilumab treatment,7 patients achieved improvement,of whom 3 achieved complete disease control;at week 12,9 achieved improvement,of whom 6 achieved complete disease control;at week 24(the observation endpoint),11 achieved improvement,of whom 9 achieved complete disease control(UCT=16 points),2 achieved well-controlled conditions(both UCT=12 points),and 1 experienced uncontrolled condition(UCT<12 points);at week 24,the UCT scores of the 12 patients increased to 14.83±2.17 points,UAS7 scores decreased to 0.33±0.65 points,and CU-Q2oL scores decreased to 0.67±1.30 points.Six CSU children with comorbidities achieved marked improvement in the symptoms of comorbidities after the treatment with dupilumab.One child developed bilateral plantar erythema after the second injection of dupilumab,which spontaneously subsided without treatment.Conclusion Dupilumab was effective in the treatment of CSU in children,and could improve comorbidities and comprehensively enhance the quality of life of children,with a favorable safety profile.