Age-Stratified ADORING Data Show Consistent Tapinarof Efficacy in Eczema

Roughly 80% of participants in the pivotal phase 3 ADORING 1 and ADORING 2 trials of tapinarof cream 1% (VTAMA) were pediatric patients with moderate to severe atopic dermatitis, reflecting an enrollment strategy designed to generate robust safety and efficacy data across childhood age groups.¹

A new post hoc pooled analysis presented at the 2026 Society for Pediatric Dermatology (SPD) Annual Meeting breaks down the trials' efficacy findings by 4 discrete age cohorts: 2 to 6, 7 to 11, 12 to 17, and 18 years and older.²

The nonsteroidal, once-daily aryl hydrocarbon receptor agonist is FDA approved for AD in adults and pediatric patients 2 years and older. In the new analysis, each individual age subgroup showed statistically significant separation from vehicle on the study's primary endpoints, including vIGA-AD response of clear or almost clear skin and EASI 75.² The trials were not powered to compare age groups against one another directly, but every pediatric cohort separated from vehicle.

"Each one of these analyses showed they were statistically better than the vehicle in getting those high benchmarks of clear or almost clear or an EASI 75 response," said Linda Stein Gold, MD, director of dermatology clinical research, Henry Ford Health, Detroit, Michigan.

Stein Gold explained atopic dermatitis is a heterogeneous disease across the lifespan, and drug tolerability and efficacy signals in a toddler cannot be assumed to mirror those in a middle-aged adult. Confirming consistent efficacy at each developmental stage was the impetus for stratifying the pooled data set rather than reporting outcomes in aggregate alone.

In the following interview, Linda Stein Gold, MD, spoke with HCPLive at the 2026 SPD Annual Meeting about the age-stratified ADORING findings and their significance for pediatric management of atopic dermatitis:

HCPLive: Can you give an overview of the main ADORING 1 and 2 findings on tapinarof cream for atopic dermatitis?

Linda Stein Gold, MD: This was an interesting study because we looked at tapinarof, a topical nonsteroidal cream FDA approved for atopic dermatitis. In the phase 3 clinical trials, there were two studies that looked at the active drug versus the vehicle, and we looked at pediatric patients down to age 2, all the way up through adults. What was nice about this study was that 80% of the patients who participated were pediatric patients. Initially, we just presented the data as a whole, but this poster broke down the data by the different age groups. We looked at 2 to 6, 7 to 11, 12 to 17, and then those patients who were 18 or older. The real reason for doing this is to make sure this drug works well across all the different age groups, and that's exactly what we found. Each of these analyses showed they were statistically better than the vehicle in getting those high benchmarks of clear or almost clear or an EASI 75 response.

HCPLive: Why is age stratification so important for this analysis?

Linda Stein Gold, MD: I think stratifying by age and really looking to make sure a drug works in each of the age groups is important because this is such a heterogeneous disease. We know an infant's atopic dermatitis or a 2-year-old's atopic dermatitis might be different than a 40-year-old's, and they might react differently. They might tolerate the drug differently, there might be different efficacy signs, and so I do think it's important to really do an analysis and a deep dive to make sure we see consistent efficacy across the age groups, and that is what we found.

HCPLive: How meaningful is the early week 2 response for patients and clinicians managing atopic dermatitis?

Linda Stein Gold, MD: Atopic dermatitis is a chronic condition. For a lot of patients, they get it as babies, and they might have it their entire life, and some people get it as older children or even as adults. The main thing is this is a chronic disease. For some patients it never goes away; they always have some signs and symptoms of the disease. So you can imagine how exhausting it is every single day to wake up and have red, inflamed, itchy skin. If we give a patient a new treatment and they start to see some improvement early on, especially within the first two weeks, that's actually quite exciting. It's exciting for the patient, but it's also exciting for the prescriber, for the dermatologist, to see it's actually working. If they see something early, they're more likely to stick with their treatment regimen and get the best results.

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. 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/

2. 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