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

IF 3.5 3区医学 Q1 DERMATOLOGY

Dermatology and Therapy Pub Date : 2025-07-22 DOI:10.1007/s13555-025-01489-w

Andrew F Alexis, Leon Kircik, Raj Chovatiya, Zakiya P Rice, Weily Soong, Tina Bhutani, Philip M Brown, Stephen C Piscitelli, David S Rubenstein, Anna M Tallman, April W Armstrong

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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.

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Tapinarof乳膏治疗成人和儿童特应性皮炎：两项3期随机临床试验中种族和Fitzpatrick皮肤类型的疗效

引言：特应性皮炎（AD）和有色皮肤患者具有不同的表现和治疗结果，然而，他们在试验中的代表性不足。在ADORING 1期和2期8周随机试验中，tapinarof霜1%每日一次（QD）对患有AD的成人和2岁以下儿童的疗效优于对照剂。这些分析评估了1% QD tapinarof乳膏的疗效，按种族和Fitzpatrick皮肤类型分层。方法：主要终点是针对特应性皮炎™（vIGA-AD™）的有效研究者全球评估评分为0（明确）或1（几乎明确），并且在第8周时较基线改善≥2级。次要终点包括湿疹面积和严重程度指数（EASI75）改善≥75%。疗效评估采用种族分类，包括亚洲人、黑人或非裔美国人、白人和菲茨帕特里克皮肤类型I-III和IV-VI。结果：在ADORING 1和2中，407名和406名患者被随机分配到tapinarof或车辆QD组(7.3-17.0%亚洲人；25.9-35.1%黑人/非裔美国人43.0-57.7%白人)。在所有试验中，50%的人患有IV-VI型菲茨帕特里克皮肤。Tapinarof对成人和儿童均有显著疗效。在两项试验中，从种族来看，tapinarof治疗的主要终点达到的比例始终高于对照：亚洲患者，39.5-48.9%对3.7-18.5%；黑人/非裔美国人，43.1-47.0%对17.5-24.1%；白人，分别为49.4-52.1%和12.2-14.5%。同样，在Fitzpatrick皮肤类型组中，tapinarof与对照剂的疗效也较好：I-III， 44.8-49.9%对13.5-17.7%；IV-VI 46.8-49.6% vs 15.3-19.5%。EASI75反应同样更高，与tapinarof和vehicle一致。不良事件大多为轻度或中度，导致试验中断率低（tapinarof比对照品低）。结论：Tapinarof在大量不同种族或Fitzpatrick皮肤类型的AD患者中表现出一致的疗效和良好的耐受性。试验注册：Clinicaltrials.gov, NCT05014568, NCT05032859。本文提供图形摘要。

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来源期刊

Dermatology and Therapy Medicine-Dermatology

CiteScore

6.00

自引率

8.80%

发文量

187

审稿时长

6 weeks

期刊介绍： Dermatology and Therapy is an international, open access, peer-reviewed, rapid publication journal (peer review in 2 weeks, published 3–4 weeks from acceptance). The journal is dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of dermatological therapies. Studies relating to diagnosis, pharmacoeconomics, public health and epidemiology, quality of life, and patient care, management, and education are also encouraged. Areas of focus include, but are not limited to all clinical aspects of dermatology, such as skin pharmacology; skin development and aging; prevention, diagnosis, and management of skin disorders and melanomas; research into dermal structures and pathology; and all areas of aesthetic dermatology, including skin maintenance, dermatological surgery, and lasers. The journal is of interest to a broad audience of pharmaceutical and healthcare professionals and publishes original research, reviews, case reports/case series, trial protocols, and short communications. Dermatology and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an International and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of quality research, which may be considered of insufficient interest by other journals. The journal appeals to a global audience and receives submissions from all over the world.