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11/08/2025 – 08:00 AM
- Sub-analysis of children with atopic dermatitis aged 2-17 in pivotal Phase 3 trials revealed early and clinically meaningful improvements in vIGA-AD™ and EASI-75 (skin clearance and severity), POEM (patient-reported outcomes) and PP-NRS (itch), regardless of comorbidity status, at week 8
JERSEY CITY, N.J. – Organon (OGN), a global healthcare company focused on women’s health, presented data at the 2025 American College of Allergy, Asthma & Immunology (ACAAI) Annual Scientific Meeting in Orlando, Florida, on November 8, 2025, highlighting the efficacy of VTAMA cream in treating atopic dermatitis (AD) in children. The data is from a sub-analysis of pooled data from the Phase 3 ADORING 1 and ADORING 2 pivotal trials evaluating VTAMA cream versus vehicle. The findings showcased early and consistent responses in children aged 2-17 with AD, irrespective of existing atopic comorbidities like asthma, allergic rhinitis, and food allergies.
Dr. Luz Fonacier, Professor of Medicine at NYU Grossman Long Island School of Medicine, emphasized the significance of the findings. “Many children with atopic dermatitis also grapple with comorbidities like allergies and asthma. It’s crucial to understand how treatments impact this specific population,” she noted. “The data is compelling, showing that tapinarof cream provides early relief, addressing bothersome symptoms such as itch, even for children as young as two years old, regardless of their comorbidity status.”
The ADORING 1 and ADORING 2 trials involved both adults and children (≥2 years; N=813) with moderate to severe AD, who were randomized to receive either VTAMA cream or a vehicle control once daily for eight weeks. The ACAAI presentation focused on a sub-analysis of 654 children aged 2-17, with and without comorbidities. The study underscored improvements in patient-reported outcomes, Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™) response, and Eczema Area and Severity Index (EASI) scores. This adds valuable information to the existing treatment landscape for pediatric AD patients .
Key findings from the sub-analysis:
- Early improvements in skin clearance, significant differences in vIGA-AD response rates as early as week 1 and maintained through week 8 in children with or without atopic comorbidities (with comorbidities: 42.3% with VTAMA cream vs. 11.8% with vehicle, p49.5% vs. 14.8%, respectively, p
- Improvement in eczema severity, as measured by EASI scores, was observed as early as week 2 and sustained through week 8 (with comorbidities: 54.5% with VTAMA cream vs. 21.8% with vehicle, p63.1% vs. 20.4%, respectively, p
- Improvements in patient-reported outcomes, including sleep, as measured by total mean Patient-Oriented Eczema Measure (POEM) and mean POEM sleep scores (based on a single question within the POEM and analyzed separately from the total POEM score), were noted as early as week 1 and maintained through week 8 (total POEM with comorbidities: 6.9 with VTAMA cream vs. 12.0 with vehicle, p
- 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 (with comorbidities: 55.6% with VTAMA cream vs. 36.3% with vehicle, p=0.0043; without comorbidities: 63.3% vs. 29.2%, respectively, p
Safety data from the study was consistent with the existing prescribing information for VTAMA cream. The most common treatment-emergent adverse events observed in the children were folliculitis (7.8%), upper respiratory tract infection (4.6%), and headache (3.7%).
“This sub-analysis shows early and consistent skin clearance with VTAMA cream, as well as clinically meaningful improvements in key atopic dermatitis measures in children 2 years and older, regardless of comorbidity status,” said Rafael Chaves Cardona, MD, Head of U.S. Medical Affairs and Outcomes Research at Organon. “This study represents the largest pediatric data set to date for VTAMA, and when added to the wealth of data from the pivotal trials, as well as the ADORING 3 open-label, long-term extension trial, these findings support Organon’s commitment to offering treatment options with a favorable safety and efficacy profile for children 2 years and older.”
The market for atopic dermatitis treatments is substantial, driven by the high prevalence of the condition, particularly in children. Analysts project continued growth in this sector as pharmaceutical companies develop more targeted and effective therapies. VTAMA cream, with its novel mechanism of action as an aryl hydrocarbon receptor (AhR) agonist, presents a competitive option within this market.
In December 2024, the U.S. Food and Drug Administration (FDA) approved VTAMA cream for the topical treatment of AD in adults and pediatric patients 2 years of age and older. VTAMA cream was initially approved by the FDA in May 2022 for the topical treatment of plaque psoriasis in adults.
About the Phase 3 Program for VTAMA cream in Atopic Dermatitis
ADORING was the Phase 3 AD clinical development program for VTAMA cream, consisting of two 8-week pivotal trials, ADORING 1 (NCT05014568) and ADORING 2 (NCT05032859), as well as ADORING 3 (NCT05142774), a 48-week, open-label, long-term extension trial.
INDICATIONS: VTAMA® (tapinarof) cream, 1% is an aryl hydrocarbon receptor (AhR) agonist indicated for:
- the topical treatment of plaque psoriasis in adults
- the topical treatment of atopic dermatitis in adults and pediatric patients 2 years of age and older
SELECTED SAFETY INFORMATION
Adverse Events: In plaque psoriasis, the most common adverse reactions (incidence ≥1%) were: folliculitis, nasopharyngitis, contact dermatitis, headache, pruritus, and influenza.
Adverse Events: In atopic dermatitis, the most common adverse reactions (incidence ≥1%) were: upper respiratory tract infection, folliculitis, lower respiratory tract infection, headache, asthma, vomiting, ear infection, pain in extremity, and abdominal pain.
© 2025 Organon group of companies. All rights reserved. vIGA-AD is the trademark of Eli Lilly and Co. US-VTA-113019 11/25
1 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
2 VTAMA (tapinarof) cream, 1%, Prescribing Information. Organon; Revised May 2025.
3 Atopic dermatitis. National Institute of Arthritis and Musculoskeletal and Skin Diseases. November 2022. Accessed August 19, 2025.
4 Eczema stats. National Eczema Association. Accessed June 5, 2025.
5 Global Report on Atopic Dermatitis 2022. International League of Dermatological Societies; 2022. Accessed February 25, 2025.
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