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Tapinarof cream was found to improve the severity of atopic dermatitis in patients as young as 2 years old, according to findings from the phase 3 ADORING 2 trial.
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 study (ClinicalTrials.gov Identifier: NCT05032859) included pediatric and adult patients with atopic dermatitis that was present for at least 6 months for individuals 6 years and older or 3 months for those 2 to 5 years of age. Study participants (N=406) were randomly assigned 2:1 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 a minimum 2-grade improvement from baseline to week 8.
Results showed a significantly greater proportion of patients treated with tapinarof cream achieved vIGA-AD success compared with those who received vehicle (46.4% vs 18.0%; P <.0001). Additionally, 59.1% of patients treated with tapinarof experienced ≥75% improvement in Eczema Area and Severity Index (EASI) from baseline to week 8 compared with 21.2% of the vehicle arm (secondary endpoint; P <.0001).
Among patients 12 years and older with a baseline Peak Pruritus Numeric Rating Scale (PP-NRS) score of 4 or greater, 52.8% treated with tapinarof cream achieved a 4-point or greater reduction in PP-NRS at week 8 vs 24.1% of vehicle-treated patients (secondary endpoint; P =.0015).
“We are highly encouraged by the positive results from ADORING 2, which suggests Vtama cream can be a potentially important nonsteroidal, topical treatment option for atopic dermatitis patients, including children as young as 2 years old where we know there is a compelling need,” said Philip M. Brown, MD, JD, Chief Medical Officer at Dermavant. “We now keenly anticipate topline data from our identically designed ADORING 1 trial in May 2023.”
Reference
Dermavant reports positive topline results from ADORING 2 atopic dermatitis phase 3 trial of Vtama® (tapinarof) cream, 1% once daily in adults and children as young as 2 years old. News release. Dermavant. March 15, 2023. https://www.businesswire.com/news/home/20230315005395/en/Dermavant-Reports-Positive-Topline-Results-from-ADORING-2-Atopic-Dermatitis-Phase-3-Trial-of-VTAMA%C2%AE-tapinarof-Cream-1-Once-Daily-in-Adults-and-Children-as-Young-as-2-Years-Old.
