Organon has reported findings from a post hoc analysis of pooled data from its Phase III ADORING 1 and ADORING 2 pivotal trials of Vtama (tapinarof) cream, 1%, in the treatment of atopic dermatitis (AD).
The trials included data from 813 adults and children aged two years and older with moderate to severe AD, stratified into four age groups: two to six years, seven to 11 years, 12–17 years, and 18 years and older.
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In these studies, the data showed that Vtama cream produced early and persistent improvements in disease severity, assessed by the validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) and Eczema Area and Severity Index (EASI75), across all age groups.
The majority (80.4%) of those participating in the trials were aged between two and 17 years, aligning with a higher rate of AD reported in paediatric populations.
Improvements with Vtama cream were detected as soon as week two of treatment and continued through week eight.
At week eight, a higher proportion of Vtama-treated patients achieved skin clearance, as measured by vIGA-AD, than those given vehicle.
Rates recorded were 56.3% versus 11.8% for ages two to six years, 44.9% versus 23.8% for ages seven to 11 years, 48.8% versus 13.4% for 12 to 17 years, and 38% versus 18.1% for adults.
EASI75 response rates at week eight were also higher with Vtama: 70.2% versus 20.5% (two to six years), 53.6% versus 31.3% (seven to 11 years), 62.2% versus 18.3% (12–17 years), and 50.8% versus 20.6% (adults).
Common treatment-emergent adverse events included folliculitis, headache, and nasopharyngitis.
Most events were mild or moderate, and discontinuations due to treatment-related adverse events were less frequent among those receiving Vtama compared to the vehicle group.
Organon chief medical officer and research and development head Juan Camilo Arjona Ferreira said: “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.
“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.”
Vtama is approved in the US for the topical treatment of plaque psoriasis in adults and AD in adults and children aged two years and older.
The Phase III AD programme for Vtama cream included two eight-week pivotal trials and one 48-week open-label extension study.
