Q&A: Tapinarof Data Highlight Unmet Pediatric Needs in Atopic Dermatitis

High-bar response endpoints, including vIGA-AD scores of clear or almost clear skin and EASI 75, a 75% improvement in disease severity from baseline, have become the standard efficacy benchmark the US Food and Drug Administration (FDA) expects from atopic dermatitis trials.¹

In the pooled phase 3 ADORING 1 and ADORING 2 population, most enrolled patients had significant baseline disease, with many meeting typical criteria for systemic therapy candidacy, yet achieved these high-bar responses with a once-daily nonsteroidal topical cream by Week 8.²

Topical corticosteroids remain the mainstay of atopic dermatitis treatment for many pediatric patients, offering effective short-term control but posing limitations for the long-term, body-wide management this chronic disease often requires.² A single nonsteroidal option applicable across multiple body surface areas, including the face and skin folds, can simplify a treatment regimen that might otherwise require several separate products.

Tapinarof cream 1% (VTAMA) is also FDA approved for plaque psoriasis in adults, positioning it within a broader class of nonsteroidal options intended to reduce reliance on topical steroids across chronic inflammatory skin diseases.³ Despite this expanding approval down to age 2, pediatric atopic dermatitis remains an area of substantial unmet need, particularly for infants and toddlers younger than the currently studied population.

Linda Stein Gold, MD, director of dermatology clinical research, Henry Ford Health, Detroit, Michigan, discusses the clinical implications of the ADORING age-stratified findings and where treatment gaps remain in the youngest patients with atopic dermatitis. The following Q&A highlights her views discussed in the interview:

HCPLive: What do endpoints like EASI 75 and vIGA-AD tell us about treatment response?

Linda Stein Gold, MD: It's interesting because I've been doing clinical trials my entire career, and when I first started, our bars for treatment success were very low. Now the FDA mandates we have these really high bars. Clear or almost clear means the skin is completely clear all over the body, or there might be a little bit of pink skin. That's really impressive. EASI 75 is a 75% improvement from where they started. What we have to realize is the patients who came into this study had significant disease. On average, they were candidates for systemic therapy. So the fact we can use a nonsteroidal topical cream once a day and see these high benchmarks as early as 8 weeks is really important.

HCPLive: How might these findings influence how clinicians manage atopic dermatitis across age groups?

Linda Stein Gold, MD: We have needed better treatment options, especially for our youngest atopic patients. We've turned to topical steroids as the mainstay of therapy, and they're a good short-term solution, but they're not a long-term solution, and this is a long-term problem. We need better options that are not steroids and can be used on multiple body surface areas. This helps simplify the treatment regimen. Imagine instead of giving patients four or five things to do, we can give them one thing to do that they can use on all body surface areas, including the face, the skin folds, the thicker areas, the hands, and they can use it to get the disease under control and keep it under control.

HCPLive: What unmet needs remain in pediatric atopic dermatitis?

Linda Stein Gold, MD: The good news is we have treatment options that are great and nonsteroidal that go down to age 2. But I'd love to see these medications like tapinarof being studied in even younger populations, a 3-month-old or a 4-month-old. So I think we have an unmet need for our even younger patients.

Editor's Note: This transcript has been edited for grammar and clarity using artificial intelligence tools.

Disclosures for Stein Gold include AbbVie, Amgen, Arcutis, Bristol Myers Squibb, Organon Health, Eli Lilly, Johnson & Johnson, Novartis, Pfizer, and UCB

References

1. Silverberg JI, Eichenfield LF, Hebert AA, et al. Tapinarof cream 1% once daily: significant efficacy in the treatment of moderate to severe atopic dermatitis in adults and children down to 2 years of age in the pivotal phase 3 ADORING trials. J Am Acad Dermatol. 2024;91(3):487-495. doi:10.1016/j.jaad.2024.05.023

2. Organon. New analysis of phase 3 pooled data for Organon's VTAMA (tapinarof) cream, 1%, demonstrates early, consistent improvements in atopic dermatitis patients across pediatric age groups and in adults. News release. Organon. Published July 24, 2026. Accessed August 5, 2026. https://www.organon.com/news/new-analysis-of-phase-3-pooled-data-for-organons-vtama-tapinarof-cream-1-demonstrates-early-consistent-improvements-in-atopic-dermatitis-patients-across-pediatric-age-groups-and-in/

3. Organon. Organon to present new analysis on VTAMA (tapinarof) cream, 1%, at the 2026 Society for Pediatric Dermatology Annual Meeting. News release. Organon. Published March 27, 2026. Accessed August 5, 2026. https://www.organon.com/news/organon-debuts-new-analysis-of-vtama-tapinarof-cream-1-phase-3-pooled-data-demonstrating-early-and-consistent-skin-clearance-and-itch-improvement-in-atopic-dermatitis-patients-down-to-2-year/