Relapse After Dupilumab Discontinuation in Pediatric Moderate-to-Severe Atopic Dermatitis: A Single-Center Retrospective Study From China.

Abstract

Purpose: Dupilumab has been demonstrated to be an effective and safe treatment for atopic dermatitis (AD) in pediatric patients in clinical trials. However, data on postdiscontinuation relapse are scarce. This study aimed to describe relapse patterns and explore factors associated with relapse after dupilumab discontinuation in pediatric patients with moderate-to-severe AD.

Methods: This retrospective study included 37 children treated with dupilumab for at least 16 weeks. Of these, 35 discontinued dupilumab and entered postdiscontinuation follow-up through May 2025. Relapse-free survival was evaluated using the Kaplan-Meier method. A prespecified exploratory Cox model including age at AD onset and baseline absolute eosinophil count was fitted using complete cases. An exploratory logistic regression analysis was reported separately as a supplementary analysis.

Findings: Among the 35 patients who entered postdiscontinuation follow-up, 27 (77.1%) experienced relapse. The overall median relapse-free survival time was 150 days (95% CI, 120-240 days). No statistically significant difference was observed between dupilumab monotherapy and dupilumab plus subcutaneous immunotherapy (log-rank P = 0.709). In the prespecified two-variable Cox model, the estimated relapse hazards were lower with later age at AD onset (HR = 0.76; 95% CI, 0.54-1.07; P = 0.115) and higher baseline eosinophil count (HR = 0.39; 95% CI, 0.13-1.18; P = 0.094), but neither association reached statistical significance.

Implications: Relapse was common after dupilumab discontinuation in this small retrospective cohort. The directions of the Cox estimates suggest that age at AD onset and baseline eosinophil count may warrant further investigation, but the current data do not establish either variable as a predictor of relapse. Larger prospective studies are required.