Tapinarof Cream for Adults and Children with Atopic Dermatitis-Efficacy by Race and Fitzpatrick Skin Type in Two Phase 3 Randomized Clinical Trials.

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.