Organon pooled data from 813 participants in the Phase III ADORING 1 and 2 trials and found that Vtama (tapinarof) cream 1% produced rapid (by week 2) and sustained improvements through week 8 in atopic dermatitis across paediatric and adult age groups. Vtama outperformed vehicle on both vIGA-AD skin clearance and EASI75 response rates in every cohort. Common adverse events—folliculitis, headache and nasopharyngitis—were generally mild or moderate, with fewer treatment-related discontinuations in the Vtama arms. Vtama is approved in the US for plaque psoriasis (adults) and AD in patients aged two years and older.
Organon Pooled Phase III Data: Vtama Cream Delivers Rapid, Sustained Improvement in Atopic Dermatitis Across All Ages
Vtama cream is approved in the US for plaque psoriasis and atopic dermatitis in adults and children aged two and older. Credit: bangoland / Shutterstock.com.
Organon has released a post hoc pooled analysis of its Phase III ADORING 1 and ADORING 2 trials showing that Vtama (tapinarof) cream 1% produced early and sustained improvements in atopic dermatitis (AD) across paediatric and adult populations.
Study Design and Participants
The analysis combined data from 813 participants aged two years and older with moderate to severe AD. Patients were grouped into four age cohorts: 2–6 years, 7–11 years, 12–17 years and 18 years and older. Children and adolescents made up 80.4% of the pooled population, reflecting the higher prevalence of AD in younger patients.
Clinical Efficacy
Vtama produced measurable improvements as early as week 2, with benefits maintained through the 8-week pivotal period. Disease severity was assessed using the validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) and the Eczema Area and Severity Index (EASI75).
At week 8, the proportion of patients achieving vIGA-AD skin clearance (clear or almost clear) was higher with Vtama than vehicle across all age groups:
- Ages 2–6: 56.3% vs 11.8%
- Ages 7–11: 44.9% vs 23.8%
- Ages 12–17: 48.8% vs 13.4%
- Adults (18+): 38.0% vs 18.1%
EASI75 response rates at week 8 were also consistently higher with Vtama:
- Ages 2–6: 70.2% vs 20.5%
- Ages 7–11: 53.6% vs 31.3%
- Ages 12–17: 62.2% vs 18.3%
- Adults (18+): 50.8% vs 20.6%
Safety
Common treatment-emergent adverse events included folliculitis, headache and nasopharyngitis. Most events were mild or moderate, and discontinuations due to treatment-related adverse events occurred less often in the Vtama arms than in the vehicle arms.
"What stands out in these data is not just the skin clearance patients achieved by week eight, but that these results were seen consistently across paediatric age groups as early as week two," said Juan Camilo Arjona Ferreira, Organon Chief Medical Officer and Head of Research and Development. "Organon is committed to advancing dermatology care, and findings like these reinforce Vtama cream as a valuable nonsteroidal option for a wide range of patients."
Regulatory Status and Programme
Vtama is approved in the United States for topical plaque psoriasis in adults and for atopic dermatitis in adults and children aged two years and older. The Phase III programme for Vtama cream comprised two eight-week pivotal trials and a 48-week open-label extension study.
The pooled data were originally reported by Clinical Trials Arena, a GlobalData brand.
Help us improve.
