Tapinarof Cream for Adults and Children with Atopic Dermatitis-Efficacy by Race and Fitzpatrick Skin Type in Two Phase 3 Randomized Clinical Trials.
Academic Article
Overview
abstract
INTRODUCTION: Patients with atopic dermatitis (AD) and skin of color have heterogeneous presentations and treatment outcomes, however, they are underrepresented in trials. In the ADORING 1 and 2 phase 3, 8-week randomized trials, tapinarof cream 1% once daily (QD) demonstrated superior efficacy versus vehicle in adults and children down to age 2 years with AD. These analyses evaluate efficacy of tapinarof cream 1% QD stratified by race and Fitzpatrick skin type. METHODS: The primary endpoint was a Validated Investigator Global Assessment for Atopic Dermatitis™ (vIGA-AD™) score of 0 (clear) or 1 (almost clear) and ≥ 2-grade improvement from baseline at week 8. Secondary endpoints included achieving ≥ 75% improvement in Eczema Area and Severity Index (EASI75). Efficacy evaluations used race categories of Asian, Black or African American, and white, and Fitzpatrick skin types I-III and IV-VI. RESULTS: In ADORING 1 and 2, 407 and 406 patients were randomized to tapinarof or vehicle QD (7.3-17.0% Asian; 25.9-35.1% Black/African American 43.0-57.7% white), respectively. Across trials, > 50% had Fitzpatrick skin types IV-VI. Tapinarof demonstrated significant efficacy in adults and children. By race in both trials, the primary endpoint was met by consistently higher proportions treated with tapinarof than vehicle: Asian, 39.5-48.9% versus 3.7-18.5%; Black/African American, 43.1-47.0% versus 17.5-24.1%; white, 49.4-52.1% versus 12.2-14.5%, respectively. Similar, superior responses were reported across Fitzpatrick skin type groups with tapinarof versus vehicle: I-III, 44.8-49.9% versus 13.5-17.7%; IV-VI, 46.8-49.6% versus 15.3-19.5%. EASI75 responses were similarly higher and consistent with tapinarof versus vehicle. Adverse events were mostly mild or moderate, leading to low trial discontinuations (lower with tapinarof than vehicle). CONCLUSIONS: Tapinarof demonstrated consistent efficacy and was well tolerated versus vehicle in a large, diverse population with AD, regardless of race or Fitzpatrick skin type. TRIAL REGISTRATION: Clinicaltrials.gov, NCT05014568, NCT05032859. Graphical Abstract avaliable for this article.
