D2.468 - Real-world effectiveness and safety of dupilumab in pediatric atopic dermatitis: a retrospective cohort study

Dupilumab is an approved biologic therapy for moderate-to-severe atopic dermatitis (AD) in pediatric patients. However, real-world data on effectiveness, safety, and treatment optimization in children and adolescents are lacking. This study aimed to assess real-world effectiveness, safety, and treatment patterns of dupilumab in pediatric AD patients.

We conducted a retrospective observational study of pediatric patients with AD treated with dupilumab at a tertiary hospital between November 2021 and October 2025. Demographic and clinical data, including prior and concomitant therapies, adverse events, and treatment interval extension, were collected. Disease severity was assessed using SCORAD(Scoring Atopic Dermatitis) and EASI(Eczema Area and Severity Index) at baseline and throughout a 1-year follow-up. A good response was defined as a >50% reduction in SCORAD or EASI. Changes over time were analyzed using non-parametric tests.

Nine patients were included (56% male), with a median age of 12.0 years (2–17; IQR: 8) at the time of dupilumab initiation. The most common atopic comorbidities were allergic rhinitis (67%), asthma (44%), and confirmed food allergy (33%). Anxiety was reported in 67% of patients. Prior systemic therapies included corticosteroids (89%) and ciclosporin (44%).

At baseline, the median SCORAD was 62.8 (42.2–76.9; IQR 20), and the median EASI was 30.6 (19.0–39.3; IQR: 16). Significant reductions in SCORAD were observed at 1–4 months, 5–8 months, and at one year (all p<0.05). During the first year of treatment, six patients (67%) achieved a >50% reduction in SCORAD or EASI, while three showed a modest decrease ranging from 17.0% to 27.5%. Patients reported perceived clinical improvement after a median of one administration (1–8; IQR: 2.0). Dosing interval extension was achieved in five patients; however, only half (3 of 5) maintained a sustained good response.

Adverse events were mild and transient in 2 patients (22%), including paradoxical facial and neck erythema and nausea. No treatment discontinuation occurred.

In this real-world pediatric cohort, dupilumab demonstrated sustained effectiveness and a favorable safety profile. Treatment interval extension may be feasible in carefully selected patients under close monitoring. These findings further support the use of dupilumab in severe pediatric AD patients.