A Prospective Observational Study of Pediatric Patients With Severe Atopic Dermatitis Despite Less Extensive Skin Lesions (Eczema Area and Severity Index Score < 16 for Adolescents and < 21 for Children) Receiving Dupilumab
In adolescents treated with dupilumab, clinical trials showed significant improvement of atopic dermatitis (AD) signs and symptoms, with a good safety profile. In these clinical trials, only patients with Eczema Area and Severity Index (EASI) score greater than or equal to (≥) 16 were enrolled, and effectiveness on sensitive/visible areas was not specifically evaluated. Further data about the effectiveness of dupilumab in adolescent and children participants with moderate to mild EASI score and severe itching and/or localized AD to better understand the potential clinical benefits of dupilumab in these populations. The main objective of the study us to assess the real-word effectiveness and safety of dupilumab in pediatric patients (age 6 months-17 years) who suffer from severe AD with EASI score \< 16 for adolescents (age 12-17 years) and \< 21 for children (age 6 months-11 years), and who are eligible for systemic therapy according to Italian reimbursement criteria.
• Male or female, aged between 6 months and 17 years at the baseline visit.
• Patients with AD who have been prescribed dupilumab as per clinical practice (according to AIFA reimbursement policy) and who fulfill the following criteria:
• \-- Adolescents (12 to 17 years old) with EASI \< 16 and children (6 months to 11 years of age) with EASI \< 21 and.
⁃ Children's Dermatology Life Quality Index (cDLQI)\* ≥ 10 and / or
⁃ Itch NRS ≥ 7 and / or
⁃ Localization in visible or sensitive areas (head/neck/hands or genitals)
• Participants/ caregivers able to understand and complete study-related questionnaires.
• Provided signed informed consent or parental/legally acceptable representative consent and participant assent where applicable.
⁃ Only for adolescents and children 6-11 years of age.