Real-life retrospective multicentre study to describe the use of dupilumab in paediatric patients with atopic dermatitis in Spain: Patient profile, effectiveness and safety

Abstract

Background

Dupilumab, inhibiting interleukin 4 and 13, is the first monoclonal antibody licensed for atopic dermatitis (AD) since 6 months of age.

Objectives

The study describes the patients' profile, the effectiveness and safety in real life of dupilumab in adolescents with moderate-severe AD and children with severe AD.

Methods

National, multicentre, observational, and retrospective study, based on medical records' data extracted in September 2023. Patients included were adolescents (12–17 years) with moderate-severe AD (Eczema Area and Severity Index [EASI] ≥ 16) and children (6–11 years) with severe AD (EASI ≥ 21) at the start of dupilumab therapy and treated with dupilumab for at least 3 months.

Results

Among the 211 analysed patients, at dupilumab treatment onset, 69.6% registered an Investigator's Global Assessment (IGA) = 4, a median Dermatology Life Quality Index (DLQI) = 17, and a median Peak Pruritus Numerical Rating Scale (PP-NRS) = 8. Atopic comorbidities were present in 69.7% of the patients. Overall, 97.1% of the patients had received systemic treatments before dupilumab, being oral corticosteroids (75.5%) the most frequent. At 16 and 52 weeks, the mean EASI percentage reductions from baseline were −77.5% and −84.7%, respectively, and 71.8% and 82.4% of the patients achieved EASI ≤ 7. A total of 70.5% and 36.5% (16 weeks), and 78% and 48.4% (52 weeks) of the patients had EASI-75 and EASI-90, respectively. At week 52, 70% and 87% of the patients achieved a reduction of ≥4 PP-NRS points and of ≥6 DLQI points, respectively. No serious dupilumab-related adverse events were reported; 6.2% presented treatment-related conjunctivitis and 1.4% reported eosinophilia, but without treatment discontinuation.

Conclusions

The study population had a pronounced disease burden as defined by signs, symptoms, quality of life, atopic comorbidities, and the systemic treatments' use prior dupilumab. In a short time (16 weeks), dupilumab treatment demonstrated clinically relevant improvement with an acceptable safety profile, continued over 52 weeks.