Organon’s pooled Phase 3 ADORING analysis shows VTAMA efficacy across atopic dermatitis subgroups based on disease severity, duration and prior systemic treatment.
Written By: Pavani Polepaka, PharmD
Reviewed By: Pharmacally Editorial Team
Organon reported new pooled post-hoc findings from the Phase 3 ADORING 1 and ADORING 2 pivotal trials evaluating VTAMA® (tapinarof) cream, 1%, in adults and pediatric patients aged 2 years and older with moderate-to-severe atopic dermatitis (AD). The analysis will be presented at the 2026 American College of Allergy, Asthma & Immunology (ACAAI) Annual Scientific Meeting on November 14 in Phoenix, Arizona.
The analysis included 813 participants randomized to receive once-daily VTAMA cream or vehicle for eight weeks. Investigators assessed treatment responses across subgroups defined by baseline body surface area (BSA) involvement, disease duration and history of systemic AD treatment.
The findings showed improvements in disease severity and itch across all evaluated subgroups, with responses reported from Week 1 through Week 8. The results provide additional clinical context on whether baseline disease characteristics and previous treatment exposure influence responses to topical tapinarof.
Clinical outcomes across patient subgroups
At Week 8, EASI75 response rates, representing at least a 75% improvement in the Eczema Area and Severity Index, were consistently higher with VTAMA than vehicle.
Among participants with less than 10% BSA involvement, EASI75 responses were 57.8% with VTAMA versus 32.2% with vehicle. In those with at least 10% BSA involvement, rates were 64.4% versus 23.2%, respectively.
Disease duration also did not appear to materially restrict treatment response. EASI75 was achieved by 70.0% of participants with AD duration of 0–5 years and 58.8% of those with disease lasting at least six years, compared with 31.8% and 21.7%, respectively, with vehicle.
Responses were also observed irrespective of previous systemic treatment history. Among participants with prior systemic AD treatment, EASI75 responses were 64.3% with VTAMA versus 3.8% with vehicle. Corresponding rates among those without prior systemic treatment were 62.4% and 28.4%.
A similar pattern emerged for validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) response, defined by clear or almost-clear skin with at least a two-grade improvement from baseline. At Week 8, response rates with VTAMA versus vehicle were 53.9% versus 22.0% in the less-than-10% BSA subgroup and 46.0% versus 15.2% in the at-least-10% subgroup.
Rates were 53.2% versus 17.6% for disease duration of 0–5 years and 45.3% versus 16.7% for at least six years. Participants with and without prior systemic treatment had response rates of 45.7% and 48.4%, respectively, compared with 7.7% and 18.3% with vehicle.
Improvements in itch, measured using the Peak Pruritus-Numeric Rating Scale (PP-NRS), were also observed across all subgroups. Response rates with VTAMA ranged from 55.0% to 64.9%, compared with 20.8% to 35.8% with vehicle. The highest response was observed among participants with shorter disease duration, while patients with prior systemic treatment also demonstrated improvement.
Together, these findings suggest that the observed treatment response was not confined to patients with limited disease involvement, shorter disease duration or no previous systemic treatment.
Mechanism and clinical positioning
Tapinarof is a topical aryl hydrocarbon receptor (AhR) agonist and a non-steroidal treatment that offers an alternative therapeutic approach to topical corticosteroids. The ADORING programme comprises two eight-week pivotal Phase 3 studies, ADORING 1 (NCT05014568) and ADORING 2 (NCT05032859), and ADORING 3 (NCT05142774), a 48-week open-label long-term extension study.
The US Food and Drug Administration approved VTAMA cream for topical treatment of AD in adults and pediatric patients aged two years and older in December 2024. It had previously received approval for plaque psoriasis in adults in May 2022.
Longer-term evidence is also available from ADORING 3, published in 2025. Among 728 enrolled participants, 51.9% achieved complete skin clearance (vIGA-AD score of 0) at least once, while 81.6% achieved clear or almost-clear skin. Following complete clearance and treatment discontinuation, the mean first treatment-free interval was 79.8 consecutive days. No new safety signals were identified.
Safety and clinical interpretation
VTAMA was reported to be well tolerated in the pooled subgroup analysis. Treatment-emergent adverse events reported in at least 3% of participants in any group included folliculitis, headache, upper respiratory tract infection and nasopharyngitis. However, the announcement did not provide detailed subgroup-specific safety rates.
The new analysis adds evidence that VTAMA’s clinical response extends across different baseline disease profiles, including patients with greater skin involvement, longer disease duration and previous systemic treatment exposure. The comparable numerical EASI75 response rates among patients with and without prior systemic treatment are particularly relevant to understanding its potential role as a topical treatment option in moderate-to-severe AD.
Nevertheless, these findings are derived from a pooled post-hoc analysis and should be interpreted as supportive evidence rather than proof of equivalent efficacy across subgroups. They also do not establish comparative effectiveness against other active treatments. The findings therefore broaden the understanding of VTAMA’s clinical response profile without independently changing its established regulatory positioning.
References
Organon Presents New Analysis of Pooled Post-Hoc Phase 3 Data on VTAMA® (tapinarof) cream, 1%, Demonstrating Consistent Efficacy in Atopic Dermatitis Across Diverse Patient Subgroups at ACAAI, Organon, 12 November 2026
Tapinarof for the Treatment of Atopic Dermatitis in Children and Adults, ClinicalTrials.gov ID NCT05014568
Tapinarof for the Treatment of Atopic Dermatitis in Children and Adults (DMVT-505-3102), ClinicalTrials.gov ID NCT05032859
Long Term Extension Study of Tapinarof Cream, 1% for Subjects with Atopic Dermatitis, ClinicalTrials.gov ID NCT05142774
About the Writer
Pavani Polepaka, Pharm.D., (Linkedin) is a clinically trained pharmacy professional with hands-on exposure to hospital settings and experience in patient case documentation, medical record review, adverse drug reaction (ADR) reporting, pharmacovigilance, literature review and patient counselling. She possesses a strong foundation in pharmacotherapy, drug safety, clinical research and evidence-based healthcare practices, with an interest in translating clinical evidence into scientifically accurate medical content. She demonstrates research and analytical skills through academic activities and medical literature evaluation.