Tapinarof Sustains AD Remission for 75+ Days Post-Treatment

New long-term data from the ADORING 3 trial show that tapinarof cream 1% (VTAMA, Organon), a non-steroidal topical aryl hydrocarbon receptor agonist, can sustain low disease activity and pruritus in patients with atopic dermatitis (AD), including children as young as 2, during extended treatment-free intervals.

The open-label extension enrolled 728 patients, the majority (83%) pediatric, from earlier phase 3 trials (ADORING 1 and 2), a maximal usage pharmacokinetics study, or direct enrollment. Participants had a range of disease severity at baseline, including patients with moderate-to-severe AD from prior pivotal trials and milder disease among those newly enrolled. Approximately 47% were non-white, enhancing generalizability.

Following once-daily tapinarof treatment, patients who achieved complete clearance (vIGA-AD™ = 0) discontinued therapy and entered a treatment-free interval. At the end of the first treatment-free interval—averaging 80 days—84% of patients maintained mild disease (vIGA-AD™ = 2), with a mean Eczema Area and Severity Index (EASI) score of 3.4 and a mean weekly Peak Pruritus Numerical Rating Scale (PP-NRS) score of 2.9.

Across all treatment-free intervals, the average duration remained stable (approximately 75 days), suggesting that tapinarof may enable durable remittive effects uncommon with many topical therapies. The investigators noted that some interval durations were likely underestimated due to early trial termination rather than loss of disease control.

Tapinarof was well tolerated across the 48-week study period, with most patients experiencing minimal irritation, including on sensitive skin areas. The most frequently reported treatment-emergent adverse events (TEAEs) were folliculitis (12.1%), nasopharyngitis (6.9%), and upper respiratory tract infections (6.9%). Discontinuations due to TEAEs were low (2.6%), and adverse events of special interest such as follicular events and contact dermatitis were mostly mild.

“Tapinarof monotherapy induced complete disease clearance followed by prolonged treatment-free (remittive) intervals and low disease activity in adults and children down to 2 years of age with AD,” the authors concluded. “Slow re-emergence of mild symptoms during treatment-free intervals is unlike most topicals, where a rapid disease rebound is often observed”.