Abstract: Objective: To evaluate the efficacy and safety of dupilumab in infants aged 6 months to 1 year with moderate-to-severe atopic dermatitis. Methods: A retrospective analysis was performed in 32 children aged 6 months to 1 year with moderate-to-severe atopic dermatitis who received dupilumab at Xuzhou Children's Hospital from June 2023 to April 2026 and completed 16 weeks of follow-up. Demographic and clinical data were collected. The Eczema Area and Severity Index (EASI), Investigator Global Assessment (IGA), SCORing Atopic Dermatitis (SCORAD), pruritus Numerical Rating Scale (NRS), Infants' Dermatitis Quality of Life Index (IDQoL), and Atopic Dermatitis Control Tool (ADCT) were assessed at baseline and at weeks 4, 8, 12, and 16. Adverse events were recorded. Results: At week 16, the EASI score decreased from 19.80 (17.38, 22.18) to 2.15 (0.70, 5.33). The IGA score decreased from 3.00 (3.00, 4.00) to 1.00 (1.00, 2.00). Other scores also decreased over time (all P＜0.001).The disease duration in the EASI 90 responder group was 3.00 (2.00, 3.00) months, which was significantly shorter than that in the non-responder group ［6.00 (4.50, 7.00) months］ (P ＜ 0.001). The proportions of patients with disease duration ≤3.5 months (76.5% vs 20.0%) and concomitant food allergy (58.8% vs 13.3%) were higher in the responder group than in the non-responder group (all P ＜ 0.05). Adverse events occurred in 4 children (12.5%). No serious adverse events were observed. Conclusion: Dupilumab showed good efficacy and safety in infants with moderate-to-severe atopic dermatitis.Comorbid food allergy and shorter disease duration may be associated with efficacy, but they cannot yet be regarded as independent predictors,further validation in larger studies with long-term follow-up is warranted.

Key words: dupilumab, atopic dermatitis, infant, efficacy, safety