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. 2022 Oct;87(4):800-806.
doi: 10.1016/j.jaad.2022.06.1171. Epub 2022 Jun 27.

One-year safety and efficacy of tapinarof cream for the treatment of plaque psoriasis: Results from the PSOARING 3 trial

Bruce Strober  1 , Linda Stein Gold  2 , Robert Bissonnette  3 , April W Armstrong  4 , Leon Kircik  5 , Stephen K Tyring  6 , Stephen C Piscitelli  7 , Philip M Brown  7 , David S Rubenstein  7 , Anna M Tallman  7 , Mark G Lebwohl  8
Affiliations
Free article

One-year safety and efficacy of tapinarof cream for the treatment of plaque psoriasis: Results from the PSOARING 3 trial

Bruce Strober et al. J Am Acad Dermatol. 2022 Oct.
Free article

Abstract

Background: Tapinarof cream 1% once daily, an aryl hydrocarbon receptor-modulating agent, was significantly more efficacious than vehicle and well tolerated in two 12-week phase 3 trials in adults with mild to severe plaque psoriasis.

Objective: To assess long-term safety, efficacy, remittive effect, durability of response, and tolerability of tapinarof.

Methods: Patients completing the 12-week trials were eligible for 40-weeks' open-label treatment and 4-weeks' follow-up. Treatment was based on the Physician Global Assessment (PGA) score. Patients entering with PGA≥1 received tapinarof until PGA = 0. Patients with PGA = 0 discontinued tapinarof and were monitored for remittive effect. Patients with PGA≥2 were re-treated until PGA = 0.

Results: Overall, 91.6% (n = 763) of eligible patients enrolled; 40.9% of patients achieved complete disease clearance (PGA = 0), and 58.2% entering with PGA≥2 achieved PGA = 0 or 1. Mean duration of off therapy remittive effect for patients achieving PGA = 0 was 130.1 days. No new safety signals were observed. Most frequent adverse events were folliculitis (22.7%), contact dermatitis (5.5%), and upper respiratory tract infection (4.7%).

Limitations: Open-label; no control; may not be generalizable to all forms of psoriasis; remittive effect/response rate potentially underestimated.

Conclusions: Efficacy improved beyond the 12-week trials, with a 40.9% complete disease clearance rate, ∼4-month off therapy remittive effect, durability on therapy, and consistent safety.

Keywords: PSOARING 3 trial; plaque psoriasis; remittive effect; tapinarof; therapeutic aryl hydrocarbon receptor (AhR)-modulating agent.

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Conflict of interest statement

Conflicts of interest Dr Strober is a consultant (honoraria) for AbbVie, Alumis, Almirall, Amgen, Arcutis, Arena, Aristea, Asana, Boehringer Ingelheim, Immunic Therapeutics, Bristol Myers Squibb, Connect Biopharma, Dermavant Sciences, Inc, EPI Health, Evelo Biosciences, Janssen, Leo, Eli Lilly, Maruho, Meiji Seika Pharma, Mindera Health, Novartis, Ono, Pfizer, UCB Pharma, Sun Pharma, Regeneron, Sanofi-Genzyme, Union Therapeutics, Ventyxbio, and vTv Therapeutics; a speaker for AbbVie, Eli Lilly, Incyte, Janssen, Regeneron, and Sanofi-Genzyme; an investigator for AbbVie, CorEvitas (formerly Corrona) Psoriasis Registry, Dermavant Sciences, Inc, Dermira, Cara, and Novartis; a scientific co-director (receiving consulting fee) for CorEvitas Psoriasis Registry; an Editor-in-chief (honorarium) for the Journal of Psoriasis and Psoriatic Arthritis; and owns stock options in Connect Biopharma and Mindera Health. Dr Stein Gold has served as a consultant and/or has received payment for the development of educational presentations and/or has received grants from Arcutis, Amgen, Bristol Myers Squibb, Dermavant Sciences, Inc, Eli Lilly, LEO Pharma, Ortho Dermatologics, Pfizer, and UCB Biopharma. Dr Bissonnette has served as a consultant/investigator/advisory board member for AbbVie, Alumis, Almirall, Amgen, AnaptysBio, Arcutis, Aristea, Bausch Health, Boehringer Ingelheim, Boston, Bristol Myers Squibb, Dermavant Sciences, Inc, Eli Lilly, Escalier, Janssen, Kyowa Kirin, LEO Pharma, Nimbus, Novartis, Pfizer, Regeneron, Sienna, and UCB; and is an employee and shareholder of Innovaderm Research. Dr Armstrong has served as a research investigator and/or scientific advisor to AbbVie, Boehringer Ingelheim, Bristol Myers Squibb, Dermavant Sciences, Inc, Dermira, EPI, Incyte, Janssen, LEO Pharma, Lilly, Modmed, Novartis, Ortho Dermatologics, Pfizer, Regeneron, Sanofi, Sun, and UCB. Dr Kircik has served as a consultant/speaker/investigator/advisory board member for Abbott Laboratories, AbbVie, Ablynx, Aclaris, Acambis, Allergan, Inc, Almirall, Amgen, Inc, Anacor Pharmaceuticals, Anaptys, Arcutis, Arena, Assos Pharma, Astellas Pharma US, Inc, Asubio, Bausch Health, Berlex Laboratories (Bayer HealthCare Pharmaceuticals), Biogen-Idec, Biolife, Biopelle, Bristol Myers Squibb, Boehringer Ingelheim, Breckinridge Pharma, Cassiopea, Centocor, Inc, Cellceutix, Cipher, Coherus, Colbar, Combinatrix, Connetics Corporation, Coria, Dermavant Sciences, Inc, Dermira, Dermik Laboratories, Dow Pharmaceutical Sciences, Inc, Dr Reddy's Lab, Dusa, Embil Pharmaceuticals, Eli Lilly, EOS, Exeltis, Ferndale Laboratories, Inc, Foamix, Ferrer, Galderma, Genentech, Inc, GlaxoSmithKline, PLC, Glenmark, Health Point, LTD, Idera, Incyte, Intendis, Innocutis, Innovail, Isdin, Johnson & Johnson, Kyowa Kirin, Laboratory Skin Care, Inc, LEO Pharma, L’Oréal, 3M, Maruho, Medical International Technologies, Merck, Medicis Pharmaceutical Corp., Merz, Nano Bio, Novartis AG, Noven Pharmaceuticals, Nucryst Pharmaceuticals Corp, Obagi, Onset, OrthoNeutrogena, PediaPharma, Pfizer, Promius, PuraCap, PharmaDerm, QLT, Inc, Quinnova, Quatrix, Regeneron, Sanofi, Serono (Merck Serono International SA), SkinMedica, Inc, Stiefel Laboratories, Inc, Sun Pharma, Taro, TolerRx, Triax, UCB, Valeant Pharmaceuticals Intl, Warner-Chilcott, XenoPort, and ZAGE. Dr Tyring has been an investigator for Dermavant Sciences, Inc. Drs Piscitelli, Brown, Rubenstein, and Tallman are employees of Dermavant Sciences Inc, with stock options. Dr Lebwohl has received grants and/or is a consultant for AbbVie, Amgen, Aditum Bio, Almirall, AltruBio Inc, AnaptysBio, Arcutis, Aristea Therapeutics, Arrive Technologies, Avotres, BiomX, Boehringer Ingelheim, Bristol Myers Squibb, Cara Therapeutics, Castle Biosciences, Corrona, Dermavant Sciences, Inc, Dr Reddy's Laboratories, Eli Lilly, Evelo Biosciences, Evommune, Inc, Facilitation of International Dermatology Education, Forte Biosciences, Foundation for Research and Education in Dermatology, Helsinn Therapeutics, Hexima Ltd, Incyte, Janssen Research & Development, LEO Pharma, LLC, Meiji Seika Pharma, Mindera, Ortho Dermatologics, Pfizer, Regeneron, Seanergy, UCB, Inc, and Verrica.

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