Tapinarof Demonstrates Consistent Efficacy Across Body Regions in People With Atopic Dermatitis

Tapinarof was well-tolerated and demonstrated consistent efficacy across body regions in people as young as 2 years old.1

These findings were presented at the 2025 American Academy of Allergy, Asthma, and Immunology (AAAAI)/World Allergy Organization (WAO) Joint Congress, February 28-March 3, in San Diego, California, by Justin Greiwe, MD, Bernstein Allergy Group, and Clinical Assistant Professor of Medicine, Division of Immunology, Allergy, and Rheumatology, University of Cincinnati.

“In the ADORING 1 and 2 phase 3 trials, tapinarof cream 1% (VTAMA®, Dermavant Sciences, Inc.) once daily (QD) demonstrated significant efficacy and was well tolerated in patients with atopic dermatitis (AD) down to age 2 years. Efficacy and tolerability of topicals may vary by body region, particularly sensitive areas including the face/neck. We present Eczema Area and Severity Index (EASI) scores by body region,” Greiwe and colleagues wrote.1

The trials had a total of 813 participants who were randomized to tapinarof or vehicle QD for 8 weeks. Participants had moderate-to-severe AD with mean baseline EASI scores of 12.2–13.5 (standard deviation, 4.7–5.6). In ADORING 1, 55.8% of the tapinarof group and 22.9% of the placebo group achieved at least a 75% improvement in EASI at week 8 (P <.0001). In ADORING 2, 59.1% of the tapinarof group and 21.2% group achieved at least a 75% improvement in EASI at week 8 (P <.0001).1

In ADORING 1, least squares (LS) mean overall EASI score improvements were –8.4 vs –4.1 (P <.0001) at week 8 and in ADORING 2, LS mean overall EASI score improvements were –10.1 vs –5.2 (P <.0001). By body region, LS mean changes in EASI scores by body region at Week 8 were: head/neck –8.7 vs –4.4 (ADORING 1) and –8.8 vs –4.7 (ADORING 2); trunk –5.9 vs –2.6 (ADORING 1) and –7.2 vs –3.8 (ADORING 2); upper extremities –12.0 vs –5.2 (ADORING 1) and –15.0 vs –6.6 (ADORING 2); and lower extremities –8.6 vs –4.4 (ADORING 1) and –9.9 vs –5.5 (ADORING 2; all P <.0001). Investigators found that tapinarof was well tolerated across sensitive areas, including the face/neck.1

In other AD news, the FDA yesterday cleared Alphyn Biologics’ investigational new drug (IND) application for Zabalafin Hydrogel for treating mild-to-moderate AD. The hydrogel is a first-in-class botanical drug and contains multiple bioactive compounds that work through diverse mechanisms of action. It is designed to address an array of aspects of atopic dermatitis simultaneously, reducing the characteristic pruritus associated with the condition, targeting the bacterial component of atopic dermatitis, and modulating the underlying immuno-inflammatory response.

“We believe it will be the compelling therapeutic choice to treat [atopic dermatitis], offering excellent patient tolerability for worry free, long-term and continuous use, and comprehensive treatment for itch, inflammation, and managing the bacterial microbiome imbalance on the skin that exacerbates the disease and its flare-ups,” Koller said in his statement,” Neal Koller, CEO at Alphyn, said in a statement.2

REFERENCES

1. Greiwe J, Tallman A, Sublett JW, et al. Tapinarof Cream 1% Once Daily: Consistent Efficacy Across All Body Regions, Including Head And Neck, In Adults And Children Down To 2 Years Of Age With Atopic Dermatitis. Presented at: 2025 AAAAI/WAO Joint Congress, February 28-March 3. Abstract 595

2. 2. Alphyn Secures FDA Clearance of Investigational New Drug Application for Atopic Dermatitis Treatment. Alphyn Biologics, Inc. February 19, 2025. https://www.prnewswire.com/news-releases/alphyn-secures-fda-clearance-of-investigational-new-drug-application-for-atopic-dermatitis-treatment-302379675.html.