D3.430 - The effect of biological treatment of atopic dermatitis in children

Atopic dermatitis is a chronic, multifactorial inflammatory skin disease characterized by immune dysregulation with predominant type 2 inflammation mediated mainly by interleukin-4  and interleukin-13. In children with moderate to severe disease inadequately controlled with conventional  treatment, international guidelines recommend biological treatment. Dupilumab is approved by the European Medicines Agency for pediatric patients from 6 months of age.  Despite these  recommendations, access to biological therapy varies across Europe. In Slovakia, reimbursement is currently limited to patients aged 12 years and older, while younger children require individual approval, which may delay effective treatment.

The aim of the study was to evaluate the effectiveness and safety of biological treatment in children younger than 12 years with severe atopic dermatitis treated at two specialized pediatric centers in Slovakia.

We performed a retrospective real-world cohort study including children under 12 years with severe atopic dermatitis treated with biological therapy. Baseline characteristics, comorbidities, previous treatments, laboratory parameters, and adverse events were recorded. Disease severity and response were assessed using the Eczema Area and Severity Index (EASI) at baseline and weeks 12, 24, 36, and 48.

Fourteen children were included. Most had atopic comorbidities, including allergic rhinoconjunctivitis (11/14) and bronchial asthma (6/14). All had previously received topical corticosteroids, and 12/14 systemic immunosuppressive therapy, most commonly ciclosporin and/or systemic corticosteroids, often associated with adverse effects or relapse. Biological therapy led to rapid and sustained improvement, with a mean EASI reduction of 81.42% at week 12 (p = 0.005), maintained at weeks 24 (p = 0.003), 36 (p = 0.036), and 48 (p = 0.003). Twelve patients remain on treatment, with a mean duration of 27.55 months. Treatment was well tolerated, with only mild and transient adverse events.

Biological therapy targeting type 2 inflammation is effective and safe in children younger than 12 years with severe atopic dermatitis. These data support early access to biological treatment and highlight the need to reduce age-related reimbursement barriers to ensure equitable pediatric care.