Skin Clearance, Treatment Response Off-therapy, and Safety of Tapinarof Cream 1% Once Daily: Results from ADORING 3, a 48-week Phase 3 Trial in Adults and Children Down to 2 Years of Age with Atopic Dermatitis

Main Article Content

Robert Bissonnette
Linda Stein Gold
Leon Kircik
Eric Simpson
Lawrence F. Eichenfield
John Browning
Adelaide A. Hebert
Andrew F. Alexis
Weily Soong
Stephen C. Piscitelli
Anna Tallman
David S. Rubenstein
Philip M. Brown
Jonathan I. Silverberg

Keywords

tapinarof cream 1% once daily, atopic dermatitis, long-term efficacy, treatment-free interval, remittive effect, adults & children, aryl hydrocarbon receptor agonist

Abstract

Introduction: In the ADORING 1 and 2 phase 3 trials, tapinarof cream 1% (VTAMA®, Dermavant Sciences, Inc.) once daily (QD) demonstrated significant efficacy and was well tolerated in patients down to age 2 years with atopic dermatitis (AD). We present efficacy, safety, and tolerability outcomes from ADORING 3.


Methods: Eligible patients from ADORING 1, ADORING 2, from a 4-week maximal usage pharmacokinetics trial, and tapinarof-naive patients with mild, or moderate or severe AD, that did not meet eligibility criteria for ADORING 1 or 2, received tapinarof cream 1% QD for up to 48 weeks. Efficacy endpoints included achievement of complete disease clearance (Validated Investigator Global Assessment for Atopic Dermatitis™ [vIGA-AD™] score=0 [clear]), and clear or almost clear skin (vIGA-AD™=0 or 1). Safety and tolerability were assessed. Patients entering with vIGA-AD™≥1 were treated with tapinarof until complete clearance (vIGA-AD™=0 [clear]). Those entering with or achieving complete clearance discontinued tapinarof and were assessed for maintenance of clear or almost clear skin off-treatment (duration of treatment-free interval). Patients whose AD returned to mild (vIGA-AD™≥2) were re-treated until complete clearance was achieved.


Results: 728 patients enrolled; 83.0% were pediatric (2–17 years). Overall, 51.9% (378/728) achieved complete disease clearance, and 81.6% achieved clear or almost clear skin at least once in the trial. Mean duration of first treatment-free interval was 79.8 consecutive days (standard deviation: 81.4 days). No tachyphylaxis on either continuous or intermittent therapy was observed for up to 48 weeks. Most frequent adverse events were folliculitis (12.1%), nasopharyngitis (6.9%), and upper respiratory tract infection (6.9%). Follicular events and contact dermatitis were mostly mild or moderate and associated with low discontinuations (1.0% and 0.4%, respectively). Tapinarof was well tolerated locally, even when applied on sensitive skin.


Conclusions: Tapinarof cream monotherapy demonstrated a high rate of complete disease clearance in patients down to age 2 years with AD. After discontinuing tapinarof, patients maintained clear or almost clear skin for 79.8 consecutive days. Tapinarof was well tolerated over 48 weeks.

References

1. Eichenfield LF, et al. J Am Acad Dermatol. 2014;70:338–351.

2. Eichenfield LF, et al. J Dermatolog Treat. 2024;35:2300354.

3. Ruer-Mulard M, et al. Pediatr Dermatol. 2009;26:551–558.

4. Dermavant Sciences. VTAMA® (tapinarof) cream, 1%: US Prescribing Information. 2022. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215272s000lbl.pdf. Accessed September 2024.

5. Silverberg JI, et al. J Am Acad Dermatol. 2024;91:457–446.

6. Paller A, et al. Presentation at the RAD Conference, Washington, DC, USA, April 29-May 1, 2023.

7. Hanifin JM, Rajka G. Acta Derm Venereol (Stockh). 1980;92:236.

Most read articles by the same author(s)

1 2 3 4 5 6 7 8 9 10 > >>