63046 Tapinarof Cream 1% Once Daily for Atopic Dermatitis: Validated Investigator Global Assessment for Atopic Dermatitis™ x Body Surface Area (vIGA-AD™xBSA) Composite in Two Pivotal Phase 3 Trials in Adults and Children Down to 2 Years of Age

Document Type

Conference Proceeding

Publication Date

9-1-2025

Publication Title

J Am Acad Dermatol

Abstract

Tapinarof cream 1% once daily (QD) demonstrated significant efficacy and was well tolerated in patients down to 2 years of age with atopic dermatitis (AD) in the ADORING 1 and 2 phase 3 trials. The primary endpoint was a Validated Investigator Global Assessment for Atopic Dermatitis™ (vIGA-AD™) score of 0 or 1 and ≥2-grade improvement from baseline at Week 8. Secondary endpoints included ≥75% improvement in Eczema Area and Severity Index (EASI75) and change in body surface area (BSA) affected. All primary and secondary endpoints were achieved. The vIGA-AD™ and BSA composite (vIGA-AD™xBSA) may provide a sensitive and simple measure of treatment response in clinical practice and has been shown to correlate with EASI. Here we report prespecified vIGA-AD™xBSA analyses from ADORING 1 and 2. In total, 813 patients were randomized to tapinarof cream 1% or vehicle QD. At baseline, 83.7–90.4% of patients had vIGA-AD™=3 (moderate), mean EASI=12.2–13.5, and mean BSA=15.8–17.7%. Baseline mean vIGA-AD™xBSA was 51.1–56.1 across treatment groups and trials. From baseline at Week 8, mean percentage change in vIGA-AD™xBSA for ADORING 1 and 2, respectively, was –72.5% and –76.0% versus –38.8% and –35.0% (tapinarof vs vehicle; both P<0.0001). The vIGA-AD™ primary endpoint was achieved by 45.4% and 46.4% versus 13.9% and 18.0%; EASI75 was achieved by 55.8% and 59.1% versus 22.9% and 21.2% at Week 8 (tapinarof vs vehicle; all P<0.0001). Tapinarof cream 1% QD demonstrated consistent, robust efficacy across all measures, including vIGA-AD™, EASI75, and vIGA-AD™xBSA in adults and children with AD.

Volume

93

First Page

AB309

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