Tapinarof Demonstrates Consistent Efficacy Across Pediatric and Adult Patients With Atopic Dermatitis
Organon will present new data from a post hoc pooled analysis of the Phase 3 ADORING 1 and ADORING 2 trials at the 2026 Society for Pediatric Dermatology (SPD) Annual Meeting in Minneapolis, Minnesota, showing that tapinarof (VTAMA) cream 1% produced early and consistent improvements in patients with moderate-to-severe atopic dermatitis across pediatric and adult age groups.
The analysis included 813 adults and children aged 2 years and older who were randomized 2:1 to once-daily tapinarof cream or vehicle for 8 weeks. Approximately 80.4% of participants were between 2 and 17 years of age, reflecting the predominance of pediatric atopic dermatitis.
Age-Stratified Analysis Shows Early Clinical Improvement
Across all age groups, improvements were observed by Week 2, the first post-treatment assessment, and continued through Week 8. At Week 8, significantly more patients treated with VTAMA cream achieved a validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) response compared with vehicle:
- Ages 2-6 years: 56.3% vs 11.8% (P < .0001)
- Ages 7-11 years: 44.9% vs 23.8% (P = .0172)
- Ages 12-17 years: 48.8% vs 13.4% (P < .0001)
- Adults (18 years and older): 38.0% vs 18.1% (P = .0280).^1
Similarly, significantly more patients receiving tapinarof cream achieved at least a 75% improvement in Eczema Area and Severity Index (EASI75) scores at week 8:
- Ages 2-6 years: 70.2% vs 20.5% (P < .0001)
- Ages 7-11 years: 53.6% vs 31.3% (P = .0158)
- Ages 12-17 years: 62.2% vs 18.3% (P < .0001)
- Adults: 50.8% vs 20.6% (P = .0020).
"Patients can experience atopic dermatitis differently across all stages of life. In my practice, I might treat a toddler differently than a teenager or adult. Having robust, age-stratified data gives us real confidence in how we counsel patients and families," said lead author Luz Fonacier, MD, professor in the Department of Medicine at NYU Grossman Long Island School of Medicine, in a company statement. "This data is encouraging, as it shows whether patients were young children or adults, have moderate or severe atopic dermatitis, VTAMA cream demonstrated clinically meaningful early and consistent improvements in skin clearance."
The most common treatment-emergent adverse events were folliculitis, headache, and nasopharyngitis. According to the analysis, these events were generally mild to moderate in severity, and treatment-related discontinuations occurred less frequently with tapinarof cream than with vehicle.
"The data show that skin clearance achieved by week 8 was seen consistently across pediatric age groups as early as Week 2," said Juan Camilo Arjona Ferreira, MD, Head of Research and Development and Chief Medical Officer at Organon, in the company announcement.
The investigators concluded that tapinarof cream demonstrated consistent efficacy across pediatric and adult age groups with moderate to severe atopic dermatitis, supporting its use as a nonsteroidal topical treatment option. Findings were presented as a conference poster and should be considered preliminary pending peer-reviewed publication.