Tapinarof Cream 1% Once Daily is Efficacious in the Treatment of Mild to Severe Plaque Psoriasis in the Head and Neck Region
Main Article Content
Keywords
Tapinarof cream 1% once daily, head and neck psoriasis, head & neck region, plaque psoriasis, mild to severe, efficacy, safety, tolerability, target lesion Physician Global Assessment
Abstract
Introduction: Tapinarof cream 1% (VTAMA®, Dermavant Sciences, Inc.) is a non-steroidal, topical aryl hydrocarbon receptor agonist approved for the treatment of plaque psoriasis in adults, with no restrictions on location, extent, or duration of use. In the phase 3 PSOARING trial program, tapinarof cream 1% once daily (QD) was efficacious and well tolerated for treating psoriasis, including the head and neck region. However, efficacy data specific to scalp treatment were not captured.
Objective: To assess efficacy, safety, and tolerability of tapinarof cream for the treatment of adults with plaque psoriasis affecting the head and neck region, including the scalp.
Methods: In this phase 4, open-label trial, adults received tapinarof for 12 weeks. Patients had plaque psoriasis affecting the head and neck (stable for ≥3 months), and a target lesion Physician Global Assessment (tPGA) score of 2 (mild), 3 (moderate), or 4 (severe). The primary endpoint was the proportion achieving a tPGA response (tPGA score of clear [0], or almost clear [1] and ≥2-grade improvement from baseline at Week 12). Additional endpoints included time to achieve tPGA response; proportion with complete clearance (tPGA score=0); and with ≥75% and ≥90% improvement in Psoriasis Area and Severity Index score (PASI; head and neck region). Safety and tolerability evaluations included adverse events (AEs) and investigator-assessed Local Tolerability Scale (LTS) scores.
Results: 31 patients with mild to severe plaque psoriasis affecting the head and neck region received tapinarof. At baseline, 54.8% had a tPGA score of 3 and 58.1% (18/31) had the target lesion on the scalp. At Week 12, 88.5% (n=23/26) achieved a tPGA response and 80.8% (n=21/26) achieved complete clearance (tPGA=0). There was rapid onset of efficacy, with both tPGA response and complete clearance achieved as early as Week 1, the first assessment, in some patients. Median times to tPGA response and complete clearance were ~4 and 8 weeks, respectively. At Week 12, 96.2% (n=25/26) and 84.6% (n=22/26) achieved a ≥75% and ≥90% improvement in PASI (head and neck region), respectively. Most AEs were mild or moderate, consistent with previous trials; the most frequent were contact dermatitis, folliculitis, and headache. Most patients had no irritation of the head and neck region (LTS score=0) at all visits.
Conclusions: Tapinarof cream 1% QD demonstrated rapid onset of clinically meaningful efficacy as early as Week 1 in patients with plaque psoriasis affecting the head and neck region, including for scalp lesions. Tapinarof cream is a cosmetically elegant, well-tolerated, non-steroidal treatment option in adults with mild to severe plaque psoriasis, including in the head and neck region.
Funding Support: Dermavant Sciences, Inc.
References
2. National Psoriasis Foundation. Available at: https://www.psoriasis.org/locations-and-types/. Accessed November 2023.
3. Kragballe K, et al. Curr Probl Dermatol. 2009;38:160–171.
4. Gupta S, et al. Dermatol Ther. 2021;11:2057–2075.
5. Yasir M, et al. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023. https://www.ncbi.nlm.nih.gov/books/NBK531462/. Accessed November 2023.
6. Dermavant Sciences. VTAMA (tapinarof) cream, 1%: US prescribing information. 2022. https://www.accessdata.fda.gov/drugsatfda_docs/
label/2022/215272s000lbl.pdf. Accessed November 2023.
7. Lebwohl M, et al. N Engl J Med. 2021;385:2219–2229.
8. Strober B, et al. J Am Acad Dermatol. 2022;87:800–806.
9. Stein Gold L, et al. Poster Presentation at American Academy of Dermatology Annual Meeting, New Orleans, LA, USA, March 17–21, 2023.
Article Sidebar
Article Details
This work is licensed under a Creative Commons Attribution 4.0 International License.
Creative Commons Attribution (CC BY): lets others distribute and copy the article, to create extracts, abstracts, and other revised versions, adaptations or derivative works of or from an article (such as a translation), to include in a collective work (such as an anthology), to text or data mine the article, even for commercial purposes, as long as they credit the author(s), do not represent the author as endorsing their adaptation of the article, and do not modify the article in such a way as to damage the author's honor or reputation.
Authors retain copyright in their work and license the publisher to publish the content. The publisher is the National Society for Cutaneous Medicine, with production and publishing support provided by OJS, Open Journal Systems,see https://pkp.sfu.
Prior to January 2022, authors transferred copyright to the National Society for Cutaneous Medicine. However, all articles are freely available to anyone in the world. There are no subscription fees, page charges, or article processing charges.