Gold LS, Ehst B, Ferris LK, Brown PM, Rubenstein DS, Tallman AM, and Bagel J. 34613 Tapinarof cream 1% once daily (QD) for plaque psoriasis: Secondary efficacy outcomes from a long-term extension (LTE) trial. J Am Acad Dermatol 2022; 87(3):AB208.
J Am Acad Dermatol
Background: Tapinarof cream 1% QD was efficacious and well tolerated versus vehicle in adults with mild-to-severe plaque psoriasis in 2 double-blind 12-week Phase 3 trials (PSOARING 1&2). We report secondary efficacy from PSOARING 3, the LTE trial assessing tapinarof during intermittent treatment based on Physician Global Assessment (PGA) score.
Methods: Eligible PSOARING 1&2 completers could enroll for 40-weeks’ open-label tapinarof 1% QD and 4-weeks’ follow-up in PSOARING 3. Patients entering with PGA ≥1 were treated until PGA = 0. Patients entering with/achieving PGA = 0 discontinued tapinarof until PGA ≥2, then retreated until PGA = 0.
Results: 91.6% (n = 763) eligible patients enrolled in PSOARING 3. Efficacy improved beyond 12-week pivotal trials and was maintained over time. In PSOARING 1&2, overall mean baseline body surface area (BSA) affected was 7.6–7.9% and Psoriasis Area Severity Index (PASI) was 8.87–9.12. PSOARING 3 baseline mean BSA affected was 4.7% (3.3% and 7.3% previously treated with tapinarof and vehicle, respectively) and mean PASI was 4.76 (3.28 and 7.69 tapinarof and vehicle, respectively). At week 40, significant improvements beyond pivotal trials were observed: overall mean improvement from baseline in BSA affected was –2.0%; PASI75 and PASI90 responses were 29.4% and 17.5%, respectively (beyond the PASI75 of 36.1% and 47.6%; PASI90 of 18.8% and 20.9% in PSOARING 1&2, respectively). No new safety signals were observed.
Conclusion: Continued improvements beyond 12 weeks and durable responses/no tachyphylaxis were observed across secondary efficacy outcomes which, together with previously reported high rates of complete disease clearance (PGA = 0) and ∼4-month remittive effect off-therapy, differentiate tapinarof from other topical therapies.