A Real-World Retrospective Cohort Study on the Use of Dupilumab for Severe Atopic Dermatitis in Patients Aged 6 Months to 16 Years

Abstract

BACKGROUND: Dupilumab is a known treatment for atopic dermatitis (AD). However, there is limited data on the effectiveness and safety of its use within the paediatric population. OBJECTIVE: The objective of this study was to determine the effectiveness and safety of dupilumab in children under 16 years with moderate-to-severe AD. METHODS: 162 children aged 6 months to 16 years with moderate-to-severe AD were treated with dupilumab. Dupilumab was accessed through the Pharmaceutical Benefits Scheme (PBS) for those aged 12 and above. Those aged under 12 years accessed dupilumab with applications to the Therapeutic Goods Administration (TGA) Special Access Scheme (SAS) as a category B application. Such applications were then processed through the hospital pharmacy as an individual patient approval (IPA). Treatment was surveyed over a 3-year period from 2020 to 2023. Treatment effect was determined by overall clinical disease severity with the Eczema Area and Severity Index (EASI) score. Scores were repeated at serial appointments following dupilumab doses. All data were collected from a single Australian tertiary referral paediatric hospital and tabulated in an Excel spreadsheet. RESULTS: A significant improvement was observed for almost all patients, with 87% achieving at least a 75% reduction in EASI scores. Adverse effects occurred in 30% of patients, although these were mostly minor and transient. Only four patients (2.4%) ceased dupilumab due to adverse effects or failure to respond. LIMITATIONS: Retrospective cohort design. CONCLUSION: Our findings demonstrate dupilumab's long-term effectiveness and safety in treating atopic dermatitis in the paediatric population.