Pediatric AD Data Show Strong Safety and Efficacy for Tapinarof Cream: Druhan Howell, MD

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New data supporting the safety and efficacy of tapinarof cream 1% (Vtama; Organon) for pediatric patients with atopic dermatitis (AD) were presented at the American College of Allergy, Asthma, and Immunology, based on positive outcomes from the phase 3 ADORING (NCT 05014568) clinical trial.¹

The data revealed consistent skin clearance in pediatric patients aged 2 to 17 years with AD and with or without atopic comorbidities. The ADORING trial was divided into 3 compounding trials. ADORING 1 and ADORING 2 were 8-week-long pivotal trials, and ADORING 3 was a 48-week, open-label, long-term extension trial. Safety and efficacy were consistent across all 3 trials with minimal incidence of adverse events. Patients experienced a significant decrease in disease severity and appearance measured by the Eczema Area and Severity Index (EASI) and the Validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD). The clinical trials also reported consistent improvements in patients' Patient-Oriented Eczema Measures (POEM) and POEM sleep scores.²

“When we're seeing itch control, disease state control with our vIGAs, remaining low,” said Druhan Howell, MD, a pediatric allergist and immunologist specialist at Coastal Allergy & Asthma, in an interview with The American Journal of Managed Care^®. “That is important to be talking about with our patients and families, because that is quite frankly different than a lot of the other therapies we've had in the past for atopic dermatitis.”

Improvements in patients' vIGA-AD were observed as early as week 1 and were stable through week 8 in children with and without comorbidities when compared with the vehicle (with comorbidities: 42.3% with tapinarof cream vs 11.8% with vehicle; P < .0001; without comorbidities: 49.5% vs 14.8%, respectively; P < .0001). Similarly, researchers also observed patient EASI scores improve as early as week 1 and remain consistent through week 8.

POEM and mean POEM sleep scores also improved as early as week 1 and remained consistent through week 8. Improvement in scores, Howell said, is also associated with improved performance for school and work for both patients and parents, as pediatric patients are less likely to spend the night scratching and in pain from their condition.

“When little kids don’t sleep, nobody sleeps, right?” Howell said. “And for older children, you have to think that poor quality of sleep is affecting their academic performance…. [But] when we're getting good-quality sleep again, everything else kind of improves as a consequence of that.”

Safety, Howell said, is always a significant factor when discussing starting new therapies for their children. For pediatric patients with AD in the clinical trial, the most common adverse events were upper respiratory tract infection, folliculitis, lower respiratory tract infection, headache, asthma, vomiting, ear infection, pain in the extremity, and abdominal pain; however, all had an incidence rate less than 1%.¹

“I haven't had many people come back and respond that they have had or have seen these safety signals personally,” Howell said. “That doesn't mean I won't in the future, but at least in the present, I haven't. And I talk to them so that patients’ parents are aware, and if they do see them, that they can contact me and we can guide them through.”

The improvements were sustained with treatment-free intervals up to 80 days, suggesting significant relief for parents who have been managing multiple AD therapies multiple times a day.

“It is really revolutionary from a clinical practice standpoint,” Howell said. “To be able to say, ‘Hey, I can make your skin clear, we can keep it clear, and we're not going to have to apply medicine every day.’”

References

1. New data show early and consistent response to VTAMA (tapinarof) cream, 1%, in children aged 2+ with atopic dermatitis, including those with associated comorbidities. News release. Organon. November 8, 2025. Accessed November 21, 2025. https://www.organon.com/news/new-data-show-early-and-consistent-response-to-vtama-tapinarof-cream-1-in-children-aged-2-with-atopic-dermatitis-including-those-with-associated-comorbidities/

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 inadults and children down to 2 years of age in pivotal phase 3 ADORING trials. J Am Acad Dermatol. 2024;91(3):457-456. doi:10.1016/j.jaad.2024.05.023