Dupilumab treatment in paediatric atopic dermatitis (2-18 years): Spanish multicentre retrospective real-world study.

Background: Moderate-to-severe atopic dermatitis (AD) can be difficult to manage in paediatric patients, and there are few licensed treatments available for this age group. Dupilumab is approved for the treatment of AD in children older than 6 months.

Objectives: To assess the effectiveness and safety of dupilumab in a real-world cohort of paediatric patients with AD in Spain.

Methods: A multicentre, retrospective real-world study on the effectiveness and safety of dupilumab in patients aged 2-18 years with moderate-to-severe AD was conducted. Demographic and clinical characteristics were analysed, and effectiveness (Eczema Area and Severity Index, Investigator's Global Assessment, Dermatology Life Quality Index, Numerical Rating Scale itch), safety and drug survival measures were assessed. A comparison of our results with other real-world outcomes and with clinical trials was made.

Results: Data from 243 patients from 19 centres were collected, with a mean follow-up of 85 weeks. Dupilumab exhibited significant effectiveness, with marked reductions in severity scores from week 4. By week 16, 79.4% of patients achieved ≥ 75% improvement in Eczema Area and Severity Index (EASI) score (EASI 75) and 40.5% achieved ≥ 90% improvement in EASI score (EASI 90). Mean percentage reduction in EASI was 79.7%. Increasing improvements were observed until week 52, with 85.8% and 49.6% of patients achieving EASI 75 and EASI 90, respectively. Forty-three patients developed adverse events (AEs) (43 of 243, 17.7%). The most frequent AEs were ocular surface diseases (20 of 243, 8.2%), injection site reactions (8 of 243, 3.3%) and facial redness (7 of 243, 2.9%). Drug survival was high (96.9% and 93.1% after 1 and 2 years of follow-up, respectively), with only 19 patients (7.8%) interrupting treatment: 7 (2.9%) owing to AEs; 2 (0.82%) owing to secondary failure; 5 (2.1%) were lost to follow-up; and 5 (2.1%) entered remission and stopped treatment.

Conclusions: Real-world use of dupilumab in paediatric AD demonstrated sustained effectiveness, high drug survival and acceptable safety profiles. Longer-term studies are crucial for AE surveillance and understanding how to manage disease remission.