Abstract: 【Abstract】 Objective To evaluate the clinical efficacy and safety of dupilumab in the treatment of pediatric prurigo nodularis （PN）, and to explore factors associated with the treatment response. Methods A retrospective analysis was conducted on clinical data from 26 children with PN who received dupilumab treatment at the Institute of Dermatology and Venereology, Sichuan Provincial People's Hospital between December 2022 and January 2025. Primary efficacy endpoints were the proportion of patients achieving investigator's global assessment-activity （IGA PN-A） and stage （IGA PN-S） scores of 0/1 at week 8; secondary efficacy endpoints included the proportion of patients achieving a ≥ 4-point reduction in the pruritus numerical rating scale （NRS） and changes in laboratory parameters. Paired t tests or Wilcoxon signed-rank tests were used for pre- and post-treatment comparisons; generalized estimating equation models were applied to evaluate changes in eczema area and severity index （EASI） scores over time; univariate logistic regression analysis was performed to calculate odds ratios （ORs） and 95% confidence intervals （CIs） to analyze factors influencing efficacy. Results Among the 26 children with PN, 14 （53.8%） were males and 12 （46.2%） were females, with ages （M［Q1, Q3］） of 4.50 （3.00, 9.25） years and disease duration of 1.00 （0.48, 2.25） years. Twenty-four （92.3%） patients had comorbid atopic diseases, including 17 with allergic rhinitis and 15 with atopic dermatitis （AD）. At week 8, IGA PN-A scores decreased from 3.27 ± 0.53 points at baseline to 1.31 ± 0.84 points （t = 10.44, P < 0.001）, with 16 （61.5%） patients achieving IGA PN-A 0/1; IGA PN-S scores decreased from 3.15 ± 0.46 points at baseline to 1.73 ± 0.78 points （t = 10.33, P < 0.001）, with 10 （38.5%） patients achieving IGA PN-S 0/1; pruritus NRS scores decreased from 5.00 （5.00, 6.00） points at baseline to 2.00 （1.00, 3.00） points （Z = -3.82, P < 0.001）, with 10 （38.5%） patients achieving a ≥ 4-point reduction in NRS scores. At week 40, 7 patients who continued treatment achieved complete remission. Univariate logistic regression showed that head/face involvement （OR = 7.000, 95% CI: 1.200–40.829） and disease duration of < 1 year （OR = 7.000, 95% CI: 1.200–40.829） were associated with better treatment response, while baseline IGA scores of 4 points predicted poorer outcomes （OR = 0.114, 95% CI: 0.017–0.742）. During treatment, conjunctivitis and local infection occurred in 2 cases without discontinuation, and no serious adverse events occurred in any of the cases. Conclusions Dupilumab demonstrated rapid and sustained efficacy in pediatric PN with a favorable safety profile. Head/face involvement, shorter disease duration, and lower baseline severity were associated with better treatment response.

Key words: Prurigo, Prurigo nodularis, Dupilumab, Child, Treatment outcome, Influencing factor