Long-term efficacy and safety of topical therapy in pediatric moderate to severe atopic dermatitis (ROAD study)

Data on the long-term efficacy and safety of topical therapy for atopic dermatitis (AD) remain limited.

This prospective cohort study included all children with AD who had their first visit to the Allergy Center at the National Center for Child Health and Development between December 2020 and September 2022. Participants were evaluated at enrollment, 6, and 12 months, and also monitored via questionnaires. We analyzed those with an Eczema Area and Severity Index (EASI) score ≥7.1 and complete EASI data at both follow-up points. The primary endpoint was the proportion achieving ≥75 % improvement in EASI from baseline (EASI-75) at 12 months. Secondary outcomes included other clinical endpoints, QOL scores, and skin and ocular complications.

Of 763 enrolled children, 107 had EASI ≥7.1, and 77 (72.0 %) had complete follow-up data. Median age at enrollment was 57.0 months [quartile: 13.0-141.0], and 58.4 % were male. Fifty-three had moderate (7.1≤EASI≤21.0) AD, and 24 had severe to very severe (21.1≤EASI) AD. Only two children (2.6 %) required systemic therapy during the study period. Median EASI scores significantly improved from 14.8 at baseline to 0.8 at both 6 and 12 months (P < 0.001). EASI-75 was achieved by 80.5 % at 6 months and 85.7 % at 12 months. Other clinical endpoints, including POEM, pruritus and sleep-disturbance NRS, and QOL scores, were improved. New dermatologic complications were rare, and no ophthalmologic complications occurred.

Most pediatric AD cases with moderate or greater severity can be effectively and safely controlled with topical therapy alone.