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

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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