Tapinarof cream 1% once daily for plaque psoriasis: long-term extension trial of a novel therapeutic aryl hydrocarbon receptor modulating agent

Document Type

Conference Proceeding

Publication Date

5-27-2022

Publication Title

J Clin Aesthet Dermatol

Keywords

aromatic hydrocarbon receptor, endogenous compound, tapinarof, adult, clinical trial, conference abstract, contact dermatitis, controlled study, disease clearance, double blind procedure, drug efficacy, drug safety, drug therapy, drug withdrawal, female, folliculitis, follow up, human, incidence, major clinical study, male, phase 2 clinical trial, physician, psoriasis, psoriasis vulgaris, tachyphylaxis, therapy effect, upper respiratory tract infection

Abstract

Background: In two double-blind, 12-week pivotal trials (PSOARING 1 & 2), tapinarof cream 1% once daily (QD) demonstrated significant efficacy versus vehicle and was well tolerated in adults with mild-to-severe plaque psoriasis. Tapinarof also maintained efficacy after a 12-week phase-2b trial, warranting investigation of a potential remittive effect. PSOARING 3 was a long-term extension trial designed to assess the safety and efficacy of tapinaroff (including duration of remittive effect off-therapy and durability of response on-therapy) during repeated, intermittent treatment, based on individual patient Physician Global Assessment (PGA) score. Methods: Eligible PSOARING 1 & 2 completers could enroll in PSOARING 3 for 40-weeks'open-label treatment followed by 4-weeks'follow-up. Patients entering with PGA≥1 received tapinarof 1% QD until disease clearance (PGA=0/clear). Patients entering with/achieving PGA=0 discontinued treatment and were monitored for remittive effect (off-therapy maintenance of PGA=0/1). Patients with disease worsening (PGA≥2) were re-treated until PGA=0. Efficacy endpoints included median time from PGA=0 to first PGA≥2 and proportion of patients with PGA=0/1 after treatment. Results: 91.6 percent of eligible patients (n=763) enrolled in PSOARING 3. Common treatmentemergent adverse events, which were mostly mild/ moderate and at application sites, were folliculitis (22.7%), contact dermatitis (5.5%) and upper respiratory tract infection (4.7%). Incidence/severity of folliculitis and contact dermatitis remained stable and were associated with low discontinuation rates (1.2% and 1.4%, respectively). Efficacy continued to improve beyond the 12-week pivotal trials. Overall, 40.9 percent (n=312) of patients achieved complete disease clearance (PGA=0) at least once and 58.2 percent (n=302) entering with PGA≥2 achieved PGA=0/1. Consistent efficacy was observed across weeks overall, despite intermittent treatment and regardless of prior treatment with tapinarof or vehicle in the pivotal trials: overall, 10.4 percent (n=79) had PGA=0 and 31.6 percent (n=240) had PGA=0/1 at entry; at week 40, 16.9 percent (n=126) had PGA=0 and 44.3 percent (n=330) had PGA=0/1. Median duration of remittive effect offdrug was 4 months (115 days) for patients entering with PGA=0 (n=79). Among patients entering with/achieving, PGA=0 (n=312), mean duration of remittive effect off-drug was >4 months (130 days). Durability of response with no tachyphylaxis for up to 52 weeks was demonstrated. Conclusion: Tapinarof cream 1% QD, a nonsteroidal psoriasis therapy, was well tolerated longterm, consistent with previously reported pivotal trials. A high rate of complete disease clearance, ∼4-month remittive effect off-therapy, no tachyphylaxis, and consistent efficacy irrespective of intermittent treatment are key attributes of tapinarof, confirmed by these data.

Volume

15

Issue

4 SUPPL 1

First Page

S34

Last Page

S35

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