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).
EASI improvements were observed at week 2 and continued through week 8. Children with comorbidities had a 54.5% improvement with VTAMA cream vs 21.8% with vehicle (p<0.0001). Those without comorbidities showed a 63.1% improvement vs 20.4%, respectively (p<0.0001).
How did VTAMA cream affect patient-reported symptoms?
Total POEM scores improved as early as week 1 and remained lower through week 8. Among children with comorbidities, mean POEM was 6.9 with VTAMA cream compared with 12.0 with vehicle (p<0.0001). Children without comorbidities had scores of 6.7 vs 11.9, respectively (p<0.0001).
Sleep-related symptoms, measured through the POEM sleep domain, also improved. Children with comorbidities reported scores of 0.9 with VTAMA cream vs 1.4 with vehicle (p=0.0003). Those without comorbidities reported 0.6 vs 1.4 (p<0.0001).
Clinically meaningful improvement in itch, defined as a ≥4-point PP-NRS response, was noted at week 2. Among children with comorbidities, response rates were 55.6% with VTAMA cream vs 36.3% with vehicle (p=0.0043). Those without comorbidities demonstrated response rates of 63.3% vs 29.2% (p<0.0001).
What were the safety findings in children?
The most common treatment-emergent adverse events among children aged 2 to 17 years were folliculitis (7.8%), upper respiratory tract infection (4.6%), and headache (3.7%). These outcomes were consistent with the known safety profile.
How do these data fit into the broader pediatric AD treatment landscape?
Rafael Chaves Cardona, MD, emphasized the importance of this pediatric dataset. “We are proud to announce data from this new sub-analysis demonstrating early and consistent skin clearance with VTAMA cream, as well as other clinically meaningful improvements in key atopic dermatitis measures in children 2 years and older, regardless of comorbidity status,” he said. He noted that “this study represents the largest pediatric data set to date for VTAMA.”
The FDA approved VTAMA cream for atopic dermatitis in adults and children aged 2 years and older in December 2024. It was previously approved in 2022 for plaque psoriasis in adults.
Why is atopic dermatitis in children an important focus?
Atopic dermatitis affects an estimated 26 million people in the United States, including nearly 10 million children. International data indicate that up to 90% of children with eczema also have related conditions such as allergies or asthma, highlighting the importance of evaluating treatments across varied clinical presentations.2-4
References
- Organon. New Data Show Early and Consistent Response to VTAMA® (tapinarof) Cream, 1%, in Children Aged 2+ with Atopic Dermatitis, Including Those With Associated Comorbidities. Organon. November 8, 2025. Accessed November 14, 2025. https://organon2021tf.q4web.com/news/news-details/2025/New-Data-Show-Early-and-Consistent-Response-to-VTAMA-tapinarof-Cream-1-in-Children-Aged-2-with-Atopic-Dermatitis-Including-Those-With-Associated-Comorbidities/default.aspx
- Eczema stats. National Eczema Association. Accessed November 14, 2025. https://nationaleczema.org/research/eczema-facts/
- Global Report on Atopic Dermatitis 2022. International League of Dermatological Societies; 2022. Accessed November 14, 2025. https://www.eczemacouncil.org/assets/docs/global-report-on-atopic-dermatitis-2022.pdf
- Weidinger S, Simpson EL, Silverberg JI, et al. Burden of atopic dermatitis in paediatric patients: an international cross-sectional study. Br J Dermatol. 2024;190(6):846-857. doi:10.1093/bjd/ljad449
