Tapinarof Cream 1% Once Daily is Efficacious in the Treatment of Mild to Severe Plaque Psoriasis in the Head and Neck Region

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.