Abstract: 【Abstract】 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.

Key words: Urticaria, Chronic spontaneous urticaria, Children, Dupilumab