A Study to Observe How Pediatric Patients With Severe Atopic Dermatitis Despite Less Extensive Skin Lesions Respond to Dupilumab Treatment

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.

Inclusion 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.

  1. Children's Dermatology Life Quality Index (cDLQI)* ≥ 10 and / or
  2. Itch NRS ≥ 7 and / or
  3. 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.

Exclusion Criteria:

• 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).

The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.