Takeaways
- VTAMA cream (tapinarof) demonstrated early improvements in skin clearance, eczema severity, itch, and sleep-related symptoms in children aged 2 to 17 years, with responses observed as early as week 1.
- Clinical and patient-reported outcomes improved regardless of atopic comorbidity status, including in children with asthma, allergic rhinitis, or food allergies.
- Safety findings were consistent with established prescribing information, with the most common adverse events including folliculitis, upper respiratory tract infection, and headache.
Organon presented new findings from a sub-analysis of pooled phase 3 ADORING 1 and ADORING 2 trials evaluating tapinarof cream, 1% (VTAMA cream) in children with atopic dermatitis (AD) at the 2025 American College of Allergy, Asthma & Immunology (ACAAI) Annual Scientific Meeting. The analysis focused on children aged 2 to 17 years, with and without atopic comorbidities such as asthma, allergic rhinitis, and food allergies.1
Luz Fonacier, MD, commented on the relevance of understanding treatment effects in children who may have multiple atopic conditions. “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,” she said. She added, “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.”
What was included in the ADORING trial sub-analysis?
The ADORING trials randomized adults and children aged 2 years and older (N=813) with moderate to severe atopic dermatitis to receive VTAMA cream or vehicle once daily for 8 weeks. The sub-analysis evaluated outcomes among 654 pediatric participants. Endpoints included Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) response, Eczema Area and Severity Index (EASI) scores, Patient-Oriented Eczema Measure (POEM) total and sleep scores, and Peak Pruritus–Numeric Rating Scale (PP-NRS).
How early were improvements seen with VTAMA cream?
Early improvements in skin clearance were seen as early as week 1. Among children with comorbidities, vIGA-AD response rates reached 42.3% with VTAMA cream vs 11.8% with vehicle (p<0.0001). In children without comorbidities, response rates were 49.5% vs 14.8%, respectively (p<0.0001).
EASI75 responses were observed as early as week 2 and continued through week 8. Among children with comorbidities, 54.5% treated with VTAMA cream achieved EASI75 vs 21.8% with vehicle (p<0.0001). In those without comorbidities, EASI75 rates were 63.1% vs 20.4%, respectively (p<0.0001).
