D1.438 - Dupilumab for Moderate-to-Severe Atopic Dermatitis in Children and Adolescents: Real-Life Assessment of Efficacy and Safety

Moderate-to-severe atopic dermatitis (AD) is a chronic inflammatory disease associated with intense itching, sleep disturbance, pain, and significant impairment of health-related quality of life (QoL) for both patients and caregivers. Dupilumab, a monoclonal antibody targeting IL-4/IL-13 signaling, has proven efficacy in clinical trials, but real-life evidence remains crucial to confirm its effectiveness and safety in routine practice.

A real-life observational study was conducted in 10 pediatric patients (mean age 13.6 ± 2.9 years) affected by moderate-to-severe AD treated with dupilumab, followed at the Pediatric Allergy Unit, Fondazione IRCCS Policlinico San Matteo, University of Pavia. Patients were evaluated at baseline (T0), 6 months (T1), and 12 months (T2) using objective and patient-reported outcome measures: Eczema Area and Severity Index (EASI), CDLQI (Children’s Dermatology Life Quality Index), Numerical Rating Scale (NRS) for pruritus, sleep, and pain, Patient-Oriented Eczema Measure (POEM), and Dermatitis Family Impact Questionnaire (DFIQ).

Dupilumab induced rapid and clinically meaningful improvement across all endpoints. At T1, 100% of patients achieved EASI-50, while 90% achieved EASI-75 and EASI-90, with a significant reduction in EASI (p = 0.001). Significant improvements were also observed in QoL and symptom burden: CDLQI (p = 0.007), NRS pruritus (p = 0.001), NRS sleep (p = 0.007), and NRS pain (p = 0.015). Disease-related impact scores were significantly reduced, including POEM (p = 0.003) and DFIQ (p = 0.003), indicating decreased caregiver burden. At T2, outcomes remained consistently improved in the 7 patients with available 12-month follow-up. EASI remained significantly reduced versus baseline (p = 0.015), with sustained benefits in CDLQI (p = 0.031) and NRS pruritus (p = 0.015). Improvements were maintained for NRS sleep (p = 0.031), POEM (p = 0.015), and DFIQ (p = 0.015). Pain showed a favorable trend without statistical significance at T12 (p = 0.062). No serious adverse events were reported and no patient discontinued dupilumab due to safety concerns.

In this real-life pediatric cohort with moderate-to-severe AD, dupilumab demonstrated rapid and sustained effectiveness with significant improvements in objective severity, symptom control, and QoL for patients and families, confirming a favorable safety profile in routine clinical practice.