Tapinarof cream, 1% (Vtama, Organon) provides “early and consistent” improvements in skin clearance for kids aged 2–17 with atopic dermatitis (AD) with or without atopic comorbidities, according to a sub-analysis of pooled data from the Phase 3 ADORING 1 and ADORING 2 pivotal trials that was presented at the 2025 American College of Allergy, Asthma & Immunology (ACAAI) Annual Scientific Meeting in Orlando, FL.
In the ADORING 1 and ADORING 2 trials, adults and children with moderate-to-severe AD were randomized to tapinarof cream or vehicle once daily for eight weeks. The new results are from a sub-analysis of the 654 children in the trials aged 2–17, with and without comorbidities associated with AD.
Key takeaways include:
- Early improvements in skin clearance were observed, with differences in Validated Investigator’s Global Assessment for Atopic Dermatitis (vIGA-AD) response rates as early as Week 1 and maintained through Week 8 in children with or without atopic comorbidities.
- Improvement in eczema severity, as measured by Eczema Area and Severity Index (EASI) scores, was observed as early as Week 2 and sustained through Week 8 in children with or without atopic comorbidities.
- Improvements in patient-reported outcomes, including sleep, as measured by total mean Patient-Oriented Eczema Measure (POEM) and mean POEM sleep scores, were seen as early as Week 1 and maintained through Week 8.
- Clinically meaningful improvements in itch (a ≥4-point Peak Pruritus-Numeric Rating Scale [PP-NRS] response) were observed at Week 2, based on responder analysis, with continued improvement through Week 8.
The most frequently reported treatment-emergent adverse events in the sub-analysis of children aged 2–17 in the ADORING 1 and ADORING 2 trials were consistent with the prescribing information, and included folliculitis, upper respiratory tract infection, and headache.
“As many children with atopic dermatitis may also be living with potential comorbidities such as allergies and asthma that may add to their disease burden, it’s important to understand the effects of approved treatments on this population,” says Luz Fonacier, MD, a Professor of Medicine and Section Head of Allergy and Training Program Director at the NYU Grossman Long Island School of Medicine in Mineola, NY, in a news release. “These reassuring data show tapinarof cream provided early relief, including on bothersome symptoms such as itch, for children as young as 2 years of age with and without comorbidities.”
Tapinarof cream, an aryl hydrocarbon receptor (AHR) agonist, is approved by the U.S. Food and Drug Administration (FDA) for the treatment of atopic dermatitis in children ages 2 and up.
