Treatment with tapinarof cream led to significant symptom improvement in adult and pediatric patients with atopic dermatitis, according to findings from the phase 3 ADORING 1 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 1 study (ClinicalTrials.gov Identifier: NCT05014568) 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 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 at least a 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 (45.4% vs 13.9%; P <.0001). Additionally, 55.8% of patients treated with tapinarof experienced ≥75% improvement in Eczema Area and Severity Index (EASI) from baseline to week 8 compared with 22.9% 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, 55.8% treated with tapinarof cream achieved a 4-point or greater reduction in PP-NRS at week 8 vs 34.2% of vehicle-treated patients (secondary endpoint; P =.0366). Findings also showed that 61.1% of tapinarof-treated patients experienced a statistically significant improvement in itch.
“Similar to our ADORING 2 data, Vtama hit all its primary and secondary endpoints,” said Philip M. Brown, MD, JD, and Chief Medical Officer at Dermavant. “Subject to FDA approval, we believe that the positive safety and efficacy profile of Vtama, combined with its treatment simplicity, has the potential to change the approach in the way patients are treated.”
The Company plans to submit a supplemental New Drug Application with the Food and Drug Administration for Vtama in atopic dermatitis in the first quarter of 2024.
Dermavant reports positive topline results from ADORING 1, the second atopic dermatitis phase 3 trial of Vtama® (tapinarof) Cream, 1% in adults and children as young as 2 years old. News release. May 16, 2023. https://www.businesswire.com/news/home/20230516005549/en/Dermavant-Reports-Positive-Topline-Results-from-ADORING-1-the-Second-Atopic-Dermatitis-Phase-3-Trial-of-VTAMA%C2%AE-tapinarof-Cream-1-in-Adults-and-Children-as-Young-as-2-Years-Old.