509 - Dupilumab improves disease severity in children less than 12 years of age with moderate-severe AD: interim results from PEDISTAD real-world registry

Abstract Introduction In phase 3 studies, dupilumab significantly improved disease severity in children with moderate-to-severe atopic dermatitis (AD). However, the impact of this systemic treatment on children in real-world treatment settings is yet to be investigated. Objectives To report the real-world effectiveness and safety of dupilumab in children the PEDISTAD registry. Methods PEDISTAD (NCT03687359) is an ongoing, international, longitudinal, observational 10-year registry study in patients aged from 6 months to 11 years at enrollment with moderate-to-severe AD, whose disease is not adequately controlled by topical prescription therapies or for whom those therapies are medically inadvisable. This interim analysis measures the effect of dupilumab on Eczema Area and Severity Index (EASI) total score and %-affected body surface area (BSA) from therapy start to up to 3 years’ follow up. Safety was also evaluated. Results A total of 214 patients received dupilumab (median treatment observation period: 16.1 months; accumulated 3-year discontinuation rate: 13.3%). The proportion of patients with clear/mild AD (EASI score <7 [range 0–28]) increased from 20.8% at therapy start to 76.7% at last observation. The mean (±SE) EASI score decreased with dupilumab use, from 19.7±1.0 at therapy start to 6.1±0.8 at last observation. The proportion of patients with <10% BSA affected by AD increased from 12.6% at therapy start to 46.5% at last observation. The mean (± SE) BSA affected decreased from 38.3%±1.7 at therapy start to 17.1%±2.0 at last observation. 24.2% of patients had adverse events, including 2.4% serious adverse events. Conclusions Dupilumab treatment significantly improved disease severity in patients aged from 6 months to 11 years in real-world practice.