Dermavant Sciences announced that new ADORING data, including treatment of patients with skin of color, from phase 3 trials of Vtama (tapinarof) cream 1% in adults and children 2 years of age and older with atopic dermatitis (AD), will be presented at the 2024 American Academy of Dermatology annual meeting, to be held from March 8-12 in San Diego, California.
Vtama cream is a novel, aryl hydrocarbon receptor agonist in development as a once-daily, cosmetically elegant, and steroid-free, topical cream for both acute treatment and long-term management of AD. Vtama is currently approved for the topical treatment of plaque psoriasis in adults in the US and is the same strength and formulation being studied in the ADORING phase 3 development program for AD.
The following posters will be viewable onsite at the San Diego Convention Center. In addition, two of the abstracts have been selected for oral presentations during the conference, which will take place in the Upper Level, Sails Pavilion, Poster Center 2.
Oral and Poster Presentations:
Title: Tapinarof Cream 1% Once Daily in Adults and Children Down to 2 Years of Age with Moderate to Severe Atopic Dermatitis in Two Phase 3 Trials: Patient-reported Outcomes (Accepted as Oral Presentation)
Authors: Eric L. Simpson, Adelaide A. Hebert, Howard Sofen, John Browning, Philip M. Brown, Anna M. Tallman, Stephen C. Piscitelli, David S. Rubenstein
Oral Presentation Date/Time: Friday, March 8, 9:00 a.m.-9:05 a.m. PT
Presenter: Eric Simpson, MD, MCR
This oral presentation will highlight patient-reported outcomes (PROs) including quality of life measures (DLQI, CDLQI, IDQOL) and assessment of AD symptoms (POEM), for adults and children with atopic dermatitis treated with tapinarof cream 1% once daily (QD), from the phase 3 ADORING 1 (N=407) and ADORING 2 (N=406) pivotal trials.
Title: Tapinarof Cream 1% Once Daily: Interim Analysis of ADORING 3 Phase 3 Long-term Extension Trial in Adults and Children Down to 2 Years of Age with Atopic Dermatitis (Accepted as Oral Presentation)
Authors: Robert Bissonnette, Linda Stein Gold, Leon Kircik, Lawrence F. Eichenfield, H. Chih-Ho Hong, Kim A. Papp, Anna M. Tallman, Stephen C. Piscitelli, David S. Rubenstein, Philip M. Brown, Jonathan I. Silverberg
Oral Presentation Date/Time: Friday, March 8, 11:45 a.m.-11:50 a.m. PT
Presenter: Robert Bissonnette, MD
This oral presentation will include data on the baseline characteristics of patients enrolling in ADORING 3, the open-label, long-term extension trial assessing the safety and efficacy of tapinarof cream 1% once daily (QD) for up to 48-weeks in adults and children down to 2 years of age with AD.
Title: Tapinarof Cream 1% Once Daily is Efficacious for the Treatment of Moderate to Severe Atopic Dermatitis in Patients with Skin of Color Down to 2 Years of Age in Two Pivotal Phase 3 Trials
Authors: Andrew F. Alexis, Leon Kircik, Raj Chovatiya, Zakiya P. Rice, Tina Bhutani, Philip M. Brown, Stephen C. Piscitelli, David S. Rubenstein, Anna M. Tallman, April W. Armstrong
This poster will present data on the efficacy of tapinarof cream 1% once daily (QD), among patients by Fitzpatrick Skin Types and self-identified race, in ADORING 1 and ADORING 2, which are two pivotal phase 3 trials in adults and children down to 2 years of age with atopic dermatitis. The data will include the proportion of patients who achieved a Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of 0 (clear) or 1 (almost clear) with at least a 2-grade improvement from baseline at Week 8, as well as the proportion of subjects who achieved ≥75% Improvement in Eczema Area and Severity Index (EASI75) score at Week 8.
Title: Tapinarof Cream 1% Once Daily was Well Tolerated for the Treatment of Adults and Children Down to 2 Years of Age with Moderate to Severe Atopic Dermatitis Across Two Pivotal Phase 3 Trials
Authors: Linda Stein Gold, James Del Rosso, Benjamin D. Ehst, Matthew J. Zirwas, Lawrence J. Green, Philip M. Brown, Anna M. Tallman, David S. Rubenstein, Stephen C. Piscitelli
This poster will present data on patient and investigator-assessed Local Tolerability Scale (LTS) scores, including in sensitive and intertriginous skin areas, from ADORING 1 and ADORING 2, two pivotal phase 3 trials that evaluated the safety and efficacy of tapinarof cream, 1% once daily (QD) in adults and children with AD.