Tapinarof cream 1% once daily for the treatment of adults with mild to severe plaque psoriasis: A novel topical therapy targeting the aryl hydrocarbon receptor

Abstract

Plaque psoriasis is a chronic, immunemediated skin disease characterized by scaly, erythematous, pruritic plaques. The effects of psoriasis are often debilitating and stigmatizing, significantly impacting patients' physical and psychological well-being and quality of life. Current guideline-recommended psoriasis therapies (topicals, oral systemics, and biologics) have substantial limitations that include overall efficacy, safety, tolerability, sites of application, disease severity, and duration and extent of body surface area treated. Due to these limitations, psoriasis treatment regimens often require combination therapy, especially for moderate to severe disease, leading to increased treatment burden. Psoriasis is also associated with increased indirect costs (eg, reduced work productivity), leading to greater total costs expenditures. Thus, more effective, safe, well-tolerated, and cost-effective therapeutic options are needed. Tapinarof cream 1% once daily is a first-in-class, nonsteroidal, topical aryl hydrocarbon receptor agonist approved by the US Food and Drug Administration in 2022 for the treatment of plaque psoriasis in adults. Tapinarof cream has been evaluated in plaque psoriasis, including 2 pivotal phase 3 trials (NCT03956355 and NCT03983980) and a long-term extension trial (NCT04053387). These trials demonstrated high rates of complete skin clearance with tapinarof cream, durable effects while on treatment (a lack of tachyphylaxis for up to 52 weeks), an approximately 4-month remittive effect off therapy after achieving complete clearance and stopping treatment (ie, duration during which psoriasis does not recur off therapy), and no rebound effects after cessation of therapy. According to the US Food and Drug Administration-approved prescribing information, tapinarof may be used to treat plaque psoriasis of any severity and in any location, has no restrictions on duration of use or extent of total body surface area treated, and has no contraindications, warnings, precautions, or drug-drug interactions. Tapinarof cream is thus an efficacious, well-tolerated, steroid-free topical option that addresses many of the limitations of current recommended therapies. Here we review current knowledge on the physical, psychological, and financial burdens of plaque psoriasis and identify how the clinical profile of tapinarof cream can address key treatment gaps important in the management of plaque psoriasis and patient quality of life. In this article, we aim to assist pharmacists and other managed care practitioners by providing an evidence-based overview of tapinarof cream to support patient-centric decision-making.

FIGURE 1

Pharmacy Expenditure Is the Largest Driver of Psoriasis Health Care Costs in the United States

FIGURE 2

Summary of AAD-NPF Treatment Guidelines

FIGURE 3

Introduction of Tapinarof in 2022 Marked the First FDA Approval of a Novel Topical Psoriasis Monotherapy in More Than 25 Years

FIGURE 4

Biologic Effects of Tapinarof

FIGURE 5

Design of the Phase 3 Long-Term Clinical Trial of Tapinarof Cream (PSOARING 3) for the Treatment of Plaque Psoriasis in Adults

FIGURE 6

Clinical Response and Remittive Effect in a Patient With Plaque Psoriasis Treated With Tapinarof Cream 1% Once Daily: Representative Target Forearm/Elbow Lesion