Tapinarof cream, 1% (Vtama, Dermavant) shows “consistent and high” efficacy in atopic dermatitis (AD) patients across different self-reported racial categories and Fitzpatrick skin types, according to two Phase 3 studies presented at the American Academy of Dermatology’s 2024 meeting in San Diego, CA.
Approximately 50% of patients with skin of color were enrolled in ADORING 1 and ADORING 2.
“This study adds valuable data to support the treatment of AD patients who have historically been underrepresented in clinical trials and have a high overall burden of AD as well as nuances in clinical presentation and impact,” study author Andrew F. Alexis, MD, MPH, Vice-Chair for Diversity and Inclusion for the Department of Dermatology and Professor of Clinical Dermatology at Weill Cornell Medicine in New York City, tells TDD.
Vtama cream is a novel, aryl hydrocarbon receptor agonist in development as a once-daily, cosmetically elegant, and steroid-free, topical cream for both acute treatment and long-term management of AD. Vtama cream, 1% is currently approved for the topical treatment of plaque psoriasis in adults in the U.S. and is the same strength and formulation being studied in the ADORING Phase 3 development program for AD. Dermavant recently submitted a Supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for Vtama,1% for the topical treatment of atopic dermatitis (AD) in adults and children aged 2 and older.
In ADORING 1 (N=407) and ADORING 2 (N=406), two identical, double-blind, randomized, vehicle-controlled, pivotal Phase 3 trials, patients were randomized 2:1 to receive Vtama cream, 1% once daily or vehicle once daily for 8 weeks. The primary efficacy endpoint was the 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 the proportion of patients who achieved ≥75% improvement in the Eczema Area and Severity Index (EASI75).
| ADORING 1 | ||||||
| ASIAN | BLACK3 | WHITE | ||||
| VTAMA cream, 1% QD
(n=26) |
Vehicle QD
(n=10) |
VTAMA cream, 1% QD
(n=70) |
Vehicle QD (n=38) | VTAMA cream, 1% QD
(n=152) |
Vehicle QD
(n=79) |
|
| Primary
Endpoint1 |
39.5% | 3.7% | 47.0% | 17.5% | 49.4% | 12.2% |
| EASI752 | 47.6% | 20.2% | 55.3% | 30.0% | 61.4% | 19.6% |
Special concerns and considerations in populations with skin of color in the U.S. include a higher prevalence of AD in Black children vs. White children (15.89% vs. 9.7%), higher odds of persistence of AD from early- to mid-childhood in Black children vs. White children, higher rates of absenteeism from school secondary to AD among Black and Hispanic children, and racial/ethnic disparities in health care utilization rates among AD patients, Dr. Alexis says. “In addition, patients with AD and more pigmented skin – skin of color – also tend to present with associated pigment alterations such as hyper- and hypo-pigmentation as long-term sequelae of their AD,” he says. “This contributes to the overall burden and impact of AD on patients with skin of color.”
Typically, many patients with darker skin tones start treating AD with topical corticosteroids. However, topical corticosteroid treatments can have potential adverse effects, including hypopigmentation in patients with skin of color. “There is a need for a non-corticosteroid topical that is safe, effective, and well tolerated for people of color with atopic dermatitis, and this study provides data in support of such a product,” he says.
Adverse events reported in the ADORING pivotal trials were mostly mild or moderate; the most frequent (≥5% in any group) were folliculitis, headache, and nasopharyngitis.
Dr. Alexis serves as a paid consultant and advisory board member for Dermavant.
