Organon presents AAAAI 2026 data: VTAMA® (tapinarof) cream delivers 2x greater sleep improvements vs. vehicle in kids ≥2 with moderate-severe AD (POEM/DFI sub-analyses from ADORING 1/2). Early, significant benefits for patients and families.
Written By: Pharmacally Medical News Desk
Organon unveiled compelling sub-analysis data from its Phase 3 ADORING trials at the 2026 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting in Philadelphia on February 27, 2026. The pooled results demonstrate that VTAMA (tapinarof) cream, 1%, delivers rapid and consistent improvements in sleep disturbances for pediatric patients as young as 2 years old with moderate to severe atopic dermatitis (AD), as well as their family members.
Sleep disruption ranks among the most burdensome aspects of AD, particularly for children and caregivers. “When a child with atopic dermatitis struggles through the night, parents and caregivers are often awake as well, sharing in the fatigue and emotional stress,” noted Dr. Mark Boguniewicz, Professor of Pediatrics at National Jewish Health and the University of Colorado School of Medicine, and an author of the presented analysis. This sub-analysis underscores VTAMA’s potential to address this unmet need.
Trial Design and Key Findings
The data come from pooled results of the ADORING 1 (NCT05014568) and ADORING 2 (NCT05032859) pivotal trials, which randomized 813 adults and children (≥2 years) with moderate to severe AD 2:1 to once-daily VTAMA cream or vehicle for 8 weeks. The sub-analysis focused on 654 pediatric patients aged 2-17 years, evaluating sleep subdomains via the Patient-Oriented Eczema Measure (POEM) for children and the Dermatitis Family Impact (DFI) scale for family members of patients aged 2-15. The pooled analysis of both ADORING 1 (NCT05014568) and ADORING 2 (NCT05032859) has been published in the Journal of the American Academy of Dermatology.
VTAMA delivered early and clinically meaningful sleep improvements versus vehicle, with topline benefits at Week 8 showing approximately 2x greater score reductions across all age groups
POEM Sleep Subdomain (Children): Rapid onset (Week 1 for ages 2-6/12-17; Week 4 for 7-11), yielding 2x better reductions in sleep disturbance (e.g., ages 2-6: -1.9 vs. -0.9; P<0.0001) This means VTAMA reduced sleep disturbance scores nearly twice as much as vehicle across all pediatric groups, with highly significant statistical evidence of superiority.
DFI Sleep Subdomain (Family Members): Onset by Week 1-2, with ~1.5-2x greater family sleep impact reductions (e.g., ages 2-6: -1.1 vs. -0.6; P=0.0002). This means VTAMA nearly doubled the reduction in family sleep impact scores compared to vehicle across age groups, with strong statistical significance.
These gains align with clinically meaningful thresholds, highlighting VTAMA’s aryl hydrocarbon receptor (AhR) agonist mechanism in tackling AD’s nocturnal itch and inflammation.
Safety mirrored the prescribing information, with common treatment-emergent adverse events (≥5% in any group) including folliculitis, headache, and nasopharyngitis.
“These findings reinforce our commitment to therapies that deliver meaningful outcomes in chronic skin conditions,” said Juan Camilo Arjona Ferreira, MD, Head of R&D and Chief Medical Officer at Organon.
Regulatory Context and Broader Program
The U.S. FDA approved VTAMA cream for AD in adults and children ≥2 years in December 2024, following its May 2022 nod for adult plaque psoriasis. The full ADORING program includes a 48-week open-label extension (ADORING 3; NCT05142774).
AD affects up to 20% of children worldwide, including nearly 10 million in the U.S., causing itchy, inflamed skin that intensifies at night.
VTAMA (tapinarof) cream works as a novel aryl hydrocarbon receptor (AhR) agonist, modulating skin inflammation, barrier function, and itch pathways to restore balance without steroids. This mechanism supports broad efficacy in inflammatory skin conditions like AD and psoriasis. For full prescribing information, visit Organon’s VTAMA PI.
References
New Analysis of Organon’s VTAMA® (tapinarof) cream, 1%, Phase 3 Data Showed Early and Consistent Improvement in Patient-Reported Sleep Subdomains in Pediatric Patients Down to 2 Years of Age with Atopic Dermatitis, 27 February 2026, New Analysis of Organon’s VTAMA® (tapinarof) cream, 1%, Phase 3 Data Showed Early and Consistent Improvement in Patient-Reported Sleep Subdomains in Pediatric Patients Down to 2 Years of Age with Atopic Dermatitis | Organon
Tapinarof for the Treatment of Atopic Dermatitis in Children and Adults, ClinicalTrials.gov ID NCT05014568, https://clinicaltrials.gov/study/NCT05014568
Tapinarof for the Treatment of Atopic Dermatitis in Children and Adults (DMVT-505-3102), ClinicalTrials.gov ID NCT05032859, https://clinicaltrials.gov/study/NCT05032859
Silverberg, Jonathan I. et al., Tapinarof cream 1% once daily: Significant efficacy in the treatment of moderate to severe atopic dermatitis in adults and children down to 2 years of age in the pivotal phase 3 ADORING trials, Journal of the American Academy of Dermatology, Volume 91, Issue 3, 457 – 465, https://doi.org/10.1016/j.jaad.2024.05.023