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. 2024 Jan;14(1):201-211.
doi: 10.1007/s13555-023-01068-x. Epub 2023 Dec 21.

Rapid Improvements in Itch with Tapinarof Cream 1% Once Daily in Two Phase 3 Trials in Adults with Mild to Severe Plaque Psoriasis

Leon Kircik  1 , Matthew Zirwas  2 , Shawn G Kwatra  3 , G Michael Lewitt  4 , Holly Glover  5 , Tomas Chao  6 , Philip M Brown  7 , David S Rubenstein  7 , Anna M Tallman  7
Affiliations

Rapid Improvements in Itch with Tapinarof Cream 1% Once Daily in Two Phase 3 Trials in Adults with Mild to Severe Plaque Psoriasis

Leon Kircik et al. Dermatol Ther (Heidelb). 2024 Jan.

Abstract

Introduction: Patients with psoriasis report pruritus as their most bothersome symptom. Tapinarof cream 1% once daily demonstrated significant efficacy versus vehicle and was well tolerated in adults with mild to severe plaque psoriasis in two 12-week trials: PSOARING 1 (NCT03956355) and PSOARING 2 (NCT03983980). Here, we present patient-reported pruritus outcomes from these trials.

Methods: Outcomes included a Peak Pruritus Numerical Rating Scale (PP-NRS) score of 0 or 1 (itch-free state); Dermatology Life Quality Index (DLQI) itch item scores; and Psoriasis Symptom Diary (PSD) itch item scores.

Results: Analyses included 683 tapinarof- and 342 vehicle-treated patients. At baseline, mean pruritus scores were similar across trials with only 7-11% of patients reporting an itch-free state. At week 12, the proportion of tapinarof-treated patients achieving an itch-free state was 50% in both trials compared with 32% (P = 0.0007) and 27% (P < 0.0001) in the vehicle groups. Improvements were apparent at the earliest assessments with continued improvement over the course of the trials. There were rapid and statistically significant improvements in the proportion of patients with a ≥ 4-point improvement in PP-NRS for tapinarof-treated patients versus vehicle from week 2 with 68% vs 46% (P = 0.0004) and 60% vs 31% (P = 0.0001) at week 12 achieving a response in each trial. Significantly greater reductions in itch with tapinarof versus vehicle were also demonstrated at week 12 for DLQI itch item 1 (P = 0.0026 and P < 0.0001), PSD item 1 (both P < 0.0001), and PSD item 2 (both P < 0.0001).

Conclusion: Tapinarof was highly efficacious in reducing pruritus across multiple patient-reported outcome measures, with rapid, statistically significant, and clinically meaningful improvements. The high proportion of patients achieving the treatment target of an itch-free state at week 12 (50%) is a noteworthy clinical outcome for a non-steroidal topical cream in the treatment of mild to severe plaque psoriasis.

Trial registration: Clinical trial registration information: NCT03956355, NCT03983980.

Keywords: Aryl hydrocarbon receptor agonist; Itch; Phase 3 PSOARING trials; Plaque psoriasis; Pruritus; Tapinarof cream 1% QD; Topical therapy.

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Conflict of interest statement

Leon Kircik has served as a consultant, speaker, investigator, or advisory board member for Abbott Laboratories, AbbVie, Ablynx, Aclaris, Acambis, Allergan, Inc., Almirall, Amgen, Inc., Anacor Pharmaceuticals, AnaptysBio, Arcutis Biotherapeutics, Arena Pharmaceuticals, Assos Pharmaceuticals, Astellas Pharma US, Inc., Asubio Pharmaceuticals, Bausch Health, Berlex Laboratories (Bayer HealthCare Pharmaceuticals), Biogen Idec, BioLife, Biopelle, Bristol Myers Squibb, Boehringer Ingelheim, Breckenridge Pharma, Cassiopea SpA, Centocor, Inc., Cellceutix, Cipher Pharmaceuticals, Coherus BioSciences, Colbar LifeScience, Combinatrix, Connetics Corporation, Coria Laboratories, Dermavant Sciences, Inc., Dermira, Dermik Laboratories, Dow Pharmaceutical Sciences, Inc., Dr. Reddy’s Laboratories, DUSA Pharmaceuticals, Embil Pharmaceutical Co. Ltd., Eli Lilly, EOS, Exeltis, Ferndale Laboratories, Inc., Ferrer, Foamix Pharmaceuticals, Galderma, Genentech, Inc., GlaxoSmithKline, Glenmark Pharmaceuticals, Healthpoint, Ltd, Idera Pharmaceuticals, Incyte, Intendis, Innocutis, Innovail, ISDIN, Johnson & Johnson, Kyowa Kirin, Laboratory Skin Care Inc., LEO Pharma, L’Oréal, 3M, Maruho Co., Ltd., Medical International Technologies, Merck, Medicis Pharmaceutical Corp., Merz Pharma, NanoBio, Novartis AG, Noven Pharmaceuticals, Nucryst Pharmaceuticals Corp., Obagi, Onset Dermatologics, Ortho Neutrogena, Pediapharma, Pfizer, Promius Pharma, PuraCap, Pharmaderm, QLT, Inc., Quinnova Pharmaceuticals, Quatrix, Regeneron, Sanofi, Serono (Merck Serono International SA), SkinMedica, Inc., Stiefel Laboratories, Inc., Sun Pharma, Taro Pharmaceutical Industries, Toler Rx, Triax Pharmaceuticals, UCB Pharma, Valeant Pharmaceuticals Intl., Warner Chilcott, XenoPort, and ZAGE. Matthew Zirwas has served as an advisor, consultant, investigator, owner, or speaker for AbbVie, All Free Clear, Amgen, Inc., AnaptysBio, Arcutis Biotherapeutics, Aseptic MD, Biocon, Cara Therapeutics, Concert Pharmaceuticals, Dermavant Sciences, Inc., Edessa Biotech, Eli Lilly, EPI Health, Evelo Biosciences, Fitbit, Galderma, Genentech, Inc., Incyte, L’Oréal, LEO Pharma, Level Ex, LUUM, Novartis, Oculus Innovative Sciences, Peloton, Pfizer, Regeneron Pharmaceuticals, Sanofi, Sun Pharma, Trevi Therapeutics, UCB Pharma, and Vial. Shawn G. Kwatra has served as an investigator, advisory board member, or consultant for AbbVie, Aslan Pharmaceuticals, Arcutis Biotherapeutics, Castle Biosciences, Celldex Therapeutics, Galderma, Genzada Pharmaceuticals, Incyte, Johnson & Johnson, LEO Pharma, Novartis Pharmaceuticals Corporation, Pfizer, Regeneron Pharmaceuticals, and Sanofi. G. Michael Lewitt has served as a consultant, speaker, investigator, or advisory board member for and/or has received grants from AbbVie, Amgen, Inc., Bristol Myers Squibb, Dermavant Sciences, Inc., DermTech, Eli Lilly, Galderma, LEO Pharma, Janssen, Novan, Inc., Pfizer, Orthodermatologics, and UCB Pharma. Holly Glover has served as a consultant, speaker, investigator, or advisory board member of AbbVie, Almirall, Bristol Myers Squibb, Cassiopea SpA, Dermavant Sciences, Inc., Eli Lilly, Galderma, Incyte, ISDIN, LEO Pharma, Pfizer, and Sun Pharma. Tomas Chao has served as an advisor and speaker for Dermavant Sciences, Inc. Philip M. Brown, David S. Rubenstein, and Anna M. Tallman are employees of Dermavant Sciences, Inc., with stock options.

Figures

Fig. 1
Fig. 1
Early, statistically significant, and continued improvement in PP-NRS score from baseline in a PSOARING 1 and b PSOARING 2. Intention-to-treat population, observed cases. Least squares mean (standard error). PP-NRS Peak Pruritus Numerical Rating Scale, QD once daily
Fig. 2
Fig. 2
Early and statistically significant achievement of a minimum 4-point improvement in PP-NRS from baseline to week 12 with tapinarof cream 1% QD in a PSOARING 1 and b PSOARING 2. Intention-to-treat populationa, observed cases. Mean proportion (standard error). aOnly includes patients with baseline PP-NRS ≥ 4. PP-NRS Peak Pruritus Numerical Rating Scale, QD once daily
Fig. 3
Fig. 3
Rapid and statistically significant achievement of an itch-free state (PP-NRS score of 0 or 1) with tapinarof cream 1% QD in a PSOARING 1 and b PSOARING 2. Intention-to-treat population, observed cases. PP-NRS Peak Pruritus Numerical Rating Scale, QD once daily
Fig. 4
Fig. 4
Statistically significant improvement in DLQI itch item 1a rating from baseline at weeks 4 and 12 in a PSOARING 1 and b PSOARING 2. aDLQI item 1 evaluates itch, soreness, painfulness, or stinging on a 4-point scale rating, where 0 indicates “not at all” and 3 indicates “very much” impact on quality of life. Intention-to-treat population, observed cases. Least squares mean (standard error). DLQI Dermatology Life Quality Index, QD once daily
Fig. 5
Fig. 5
Early, statistically significant, and sustained improvement in PSD itch severity item rating from baseline at weeks 2, 4, 8, and 12 in a PSOARING 1 and b PSOARING 2. Intention-to-treat population, observed cases. Least squares mean (standard error). PSD Psoriasis Symptom Diary, QD once daily
Fig. 6
Fig. 6
Rapid and statistically significant improvement in PSD itch bother item rating from baseline at weeks 2, 4, 8, and 12 in a PSOARING 1 and b PSOARING 2. Intention-to-treat population, observed cases. Least squares mean (standard error). PSD Psoriasis Symptom Diary, QD once daily
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References

    1. Parisi R, Iskandar IYK, Kontopantelis E, et al. National, regional, and worldwide epidemiology of psoriasis: systematic analysis and modelling study. BMJ. 2020;369:m1590. doi: 10.1136/bmj.m1590. - DOI - PMC - PubMed
    1. Amatya B, Wennersten G, Nordlind K. Patients' perspective of pruritus in chronic plaque psoriasis: a questionnaire-based study. J Eur Acad Dermatol Venereol. 2008;22:822–826. doi: 10.1111/j.1468-3083.2008.02591.x. - DOI - PubMed
    1. Komiya E, Tominaga M, Kamata Y, Suga Y, Takamori K. Molecular and cellular mechanisms of itch in psoriasis. Int J Mol Sci. 2020;21:8406. doi: 10.3390/ijms21218406. - DOI - PMC - PubMed
    1. Szepietowski JC, Reich A. Pruritus in psoriasis: an update. Eur J Pain. 2016;20:41–46. doi: 10.1002/ejp.768. - DOI - PubMed
    1. Yosipovitch G, Goon A, Wee J, Chan YH, Goh CL. The prevalence and clinical characteristics of pruritus among patients with extensive psoriasis. Br J Dermatol. 2000;143:969–973. doi: 10.1046/j.1365-2133.2000.03829.x. - DOI - PubMed

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