Tapinarof Cream 1% Once Daily is Efficacious for the Treatment of Atopic Dermatitis in Patients with Skin of Color Down to 2 Years of Age in Two Pivotal Phase 3 Trials

Abstract

Introduction: Patients with atopic dermatitis (AD) and skin of color can have heterogeneous presentations and treatment responses. In the pivotal phase 3 ADORING 1 and 2 trials, tapinarof cream 1% (VTAMA^®, Dermavant Sciences, Inc.) once daily (QD) was significantly efficacious and well tolerated versus vehicle in adults and children down to 2 years of age with AD.

Objective: Here, we report analyses of efficacy by skin color in ADORING 1 and 2, based on patients’ self-identified race and investigator-assessed Fitzpatrick skin type.

Methods: In ADORING 1 and 2, patients with a Validated Investigator Global Assessment for Atopic Dermatitis^TM (vIGA-AD^TM) score of ≥3, an Eczema Area and Severity Index score of ≥6, and body surface area involvement of 5–35% were randomized 2:1 to tapinarof cream or vehicle QD for 8 weeks. The primary efficacy endpoint was a vIGA-AD^TM score of 0 (clear) or 1 (almost clear) and ≥2-grade improvement from baseline at Week 8. Secondary endpoints included proportion of patients with a ≥75% improvement in Eczema Area and Severity Index (EASI75).

Results: Of the 407 and 406 randomized patients, 8.8–15.3% were Asian, 26.5–35.0% were Black, 44.8–56.8% were White, and 2.7–5.2% were Other groups (American Indian or Alaska Native, Native Hawaiian or Pacific Islander, or multiple races) across trials. Patients with Fitzpatrick skin types IV, V, and VI represented 23.8–25.1%, 20.6–22.2%, and 7.6–8.9%, respectively, of patients (>50% in both trials). Across trials, vIGA-AD^TM responses (ranges) for tapinarof versus vehicle were: Asian, 39.5–48.9% vs 3.7–18.5%; Black, 43.1–47.0% vs 17.5–24.1%; White, 49.4–52.1% vs 12.2–14.5%; and Other, 26.0–44.8% vs 0.0–40.2%. EASI75 responses for tapinarof versus vehicle were: Asian, 47.6–76.6% vs 17.7–20.2%; Black, 48.9–55.3% vs 25.7–30.0%; White, 61.4–67.8% vs 19.6–20.7%; and Other, 38.3–63.3% vs 0.0–40.6%. Similarly, high and consistent vIGA-AD^TM and EASI75 responses were reported with tapinarof versus vehicle in patients with Fitzpatrick skin types I–III and IV–VI.

Conclusion: Tapinarof cream 1% QD was consistently efficacious among all racial groups and Fitzpatrick skin types in adults and children down to 2 years of age with AD, including patients with skin of color, who were highly represented in these trials.