Results from the Phase 3 ADORING 2 trial found that Tapinarof cream improved the severity of atopic dermatitis in patients as young as 2 years old.
Tapinarof is an aryl hydrocarbon receptor agonist currently marketed under the brand name Vtama® for the topical treatment of plaque psoriasis in adults.
The ADORING 2 trial (ClinicalTrials.gov identifier: NCT05032859) enrolled pediatric and adult patients with atopic dermatitis lasting at least 6 months in those 6 years of age and older and 3 months in those 2 to 5 years of age, respectively. Study participants (N=406) were randomly assigned in a 2:1 ratio to receive once daily treatment with Tapinarof cream, 1%, or vehicle cream.
The primary endpoint of the study was the proportion of patients who achieved a validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of clear (0) or almost clear (1) with at least a two-stage improvement from baseline to Week 8.
Results showed that a significantly greater proportion of patients treated with tapinarof cream achieved vIGA-AD success than those who received vehicle (46.4% vs. 18.0%; P <.0001). In addition, 59.1% of tapinarof-treated patients experienced ≥75% improvement in Eczema Area and Severity Index (EASI) from baseline to week 8, compared to 21.2% in the vehicle arm (secondary endpoint; P <.0001).
Among patients 12 years of age or older with a baseline Peak Pruritus Numeric Rating Scale (PP-NRS) score of 4 or greater, 52.8% of Tapinarof cream-treated patients achieved a 4 point or greater reduction in PP-NRS at week 8 compared to 24.1% of vehicle-treated patients (secondary endpoint; P =.0015).
“We are very encouraged by the positive results from ADORING 2. They suggest that Vtama Cream may be a potentially important nonsteroidal topical treatment option for patients with atopic dermatitis, including children ages 2 years and older, where we know there is compelling need,” said Philip M. Brown, MD, JD, Chief Medical Officer at Dermavant. “We are now eagerly awaiting the topline data from our identically designed ADORING 1 study in May 2023.”
reference
Dermavant Announces Positive Topline Results from Phase 3 ADORING 2 Atopic Dermatitis Study with Vtama® (Tapinarof) cream, 1% once daily in adults and children 2 years and older. Press release. Dermavant. March 15, 2023. https://www.businesswire.com/news/home/20230315005395/en/Dermavant-Reports-Positive-Topline-Results-from-ADORING-2-Atop ic-Dermatitis-Phase-3-Trial-of-VTAMA%C2%AE-tapinarof-Cream-1-Once-Daily-in-Adults-and-Children-as-Young-as-2-Years-Old.
This article originally appeared on MPR
