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.
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)
Use of dupilumab within 6 months prior to study entry.
Participants currently participating in any interventional clinical trial that modifies patient care.
Any condition that, in the opinion of the Investigator, may interfere with participant's ability to participate in the study (e.g., substance abuse).
Sanofi
Lead sponsor
Regeneron Pharmaceuticals
Collaborator