■ Overall, 40.9% (312/763) of patients achieved complete disease clearance at least once during the study; this included 233 patients who entered the study with a Physician Global Assessment (PGA) score of ≥1 and 79 patients who entered with a PGA of 04 ■ The median duration of remittive effect while off therapy for patients who entered the study with a PGA of 0 was 115 days, and the mean total duration of remittive effect off therapy for patients who entered with, or achieved, a PGA of 0 was 130 days4 ■ Durability of response of up to 52 weeks was demonstrated with intermittent use of tapinarof cream 1% QD, indicating no observation of tachyphylaxis (defined as loss of response) while on therapy4 ■ Tapinarof cream 1% QD was well tolerated with long-term use and had a safety profile consistent with previous studies2,5 RESULTS Patient Satisfaction Questionnaire ■ 91.6% of eligible patients (n=763) completing PSOARING 1 and 2 elected to enroll in PSOARING 3 ■ Patient Satisfaction Questionnaires were completed by 78.5% (599/763) of patients in PSOARING 3 ■ Patients consistently reported high satisfaction rates across all parameters, including patients’ satisfaction with tapinarof efficacy, formulation elegance, application ease, impact on daily life, and preference for tapinarof cream versus prior psoriasis therapies Confidence and Satisfaction with the Efficacy of Tapinarof Cream ■ Most patients either strongly agreed or agreed with all questions on confidence and satisfaction with the efficacy of tapinarof cream (Figure 3) ■ 85.8% felt they could easily manage their psoriasis with tapinarof, and 83.6% were satisfied with how well tapinarof worked ■ In addition to the 40.9% of patients who achieved complete disease clearance and the observed remittive effect of ~4 months, 62.9% of patients either strongly agreed or agreed that tapinarof cleared their skin and kept psoriasis from coming back ■ 84.1% had confidence in tapinarof, and 84.0% would recommend tapinarof to other patients with psoriasis ■ 82.5% of patients would use tapinarof again or continue on tapinarof if it was available Figure 3. Confidence and Satisfaction with the Efficacy of Tapinarof Cream (n=599) Ease of Application and Cosmetic Elegance of Tapinarof Cream ■ Patients were consistently very satisfied with the tapinarof cream formulation and elegance (Figure 4) ■ 93.2% were satisfied with the time spent applying tapinarof, and 96.3% considered it easy to apply ■ In addition, most patients either strongly agreed or agreed that tapinarof was quickly absorbed (89.5%), felt good on their skin (79.9%), and was not greasy (89.0%) ■ 87.7% were very satisfied with the look and feel of tapinarof Figure 4. Ease of Application and Cosmetic Elegance of Tapinarof Cream (n= 599) *n number for question is 598. †n number for question is 587. Patient Satisfaction with Tapinarof Cream 1% Once Daily for Plaque Psoriasis in a Long-Term Extension Trial Jerry Bagel,1 Linda Stein Gold,2 James Del Rosso,3 Neal Bhatia,4 Sandy Johnson,5 Paul Yamauchi,6 Angela Y. Moore,7 Anna M. Tallman8 1Psoriasis Treatment Center of Central New Jersey, East Windsor, NJ, USA; 2Henry Ford Health System, Detroit, MI, USA; 3JDR Dermatology Research/Thomas Dermatology, Las Vegas, NV, USA and Advanced Dermatology & Cutaneous Surgery, Maitland, FL, USA; 4Therapeutics Clinical Research, San Diego, CA, USA; 5Johnson Dermatology, Fort Smith, AR, USA; 6Dermatology Institute & Skin Care Center, Santa Monica, CA, USA; 7Arlington Center for Dermatology, Arlington Research Center, Arlington, TX, USA; 8Dermavant Sciences, Inc., Morrisville, NC, USA BACKGROUND ■ Patient dissatisfaction with current therapies is an important barrier to optimal care of psoriasis (52% of psoriasis patients have reported dissatisfaction with their treatment1) and there is a need for efficacious, tolerable, easy-to-use topical therapies that can be used long term, including on sensitive skin areas ■ Tapinarof 1% is a cosmetically elegant, once daily (QD) topical cream that does not contain added fragrance and is free of petrolatum, parabens, and gluten. The vehicle is specifically designed to reduce skin irritation and optimize the delivery of tapinarof to the target site ■ Tapinarof cream 1% QD demonstrated significant efficacy and was well tolerated in two 12-week pivotal phase 3 trials of 1,025 adults with mild-to-severe plaque psoriasis, PSOARING 1 (NCT03956355) and PSOARING 2 (NCT03983980), and demonstrated favorable patient-reported local tolerability and investigator-assessed irritation scores including sensitive skin areas2,3 ■ PSOARING 3 (NCT04053387) was a 40-week, long-term, open-label extension trial to assess the efficacy, durability of response on therapy, duration of remittive effect off therapy, safety, and tolerability of tapinarof cream 1% QD ■ Figure 1 displays photographs of the clinical response of a patient treated with tapinarof 1% QD who achieved primary and secondary efficacy, and patient-reported outcome (PRO) endpoints Figure 1. Clinical Response of a Patient with Plaque Psoriasis who Achieved Primary and Secondary Efficacy, and PRO Endpoints PGA and PASI are global efficacy assessments. Example of one representative target lesion of one tapinarof-treated patient from PSOARING 1 clinical trial. *DLQI was assessed at baseline, Week 4 (no evaluation at Week 8), and Week 12. DLQI, Dermatology Life Quality Index; PASI, Psoriasis Area and Severity Index; PGA, Physician Global Assessment; PP-NRS, Peak Pruritus Numeric Rating Scale. OBJECTIVE ■ Given that patient dissatisfaction with current therapies has a significant impact on disease management, we assessed patient satisfaction using a Patient Satisfaction Questionnaire; here we present the results from PSOARING 3, a long-term, open-label extension trial of tapinarof cream 1% QD METHODS Study Design ■ Patients completing PSOARING 1 and PSOARING 2 were eligible to enroll in PSOARING 3 for up to 40 weeks of open-label treatment with tapinarof cream 1% QD, followed by 4 weeks of follow-up (Figure 2) ■ The Patient Satisfaction Questionnaire was designed to assess patients’ satisfaction with tapinarof efficacy, formulation elegance, application ease, impact on daily life, and preference for tapinarof cream versus prior psoriasis therapies – The questionnaire included a series of 18 questions with responses on a scale of strongly agree, agree, neutral, disagree, or strongly disagree ■ Patient Satisfaction Questionnaire responses were assessed at Week 40 (or Early Termination Visit) and summarized overall Figure 2. PSOARING 3 Study Design Four patients (3 tapinarof, 1 vehicle) did not have a baseline PGA and are listed as missing. PGA, Physician Global Assessment; QD, once daily. Previously Reported Efficacy Outcomes from PSOARING 3 ■ Tapinarof cream 1% QD demonstrated continued and substantial improvement in efficacy with long-term use, beyond the improvements already observed in the 12-week pivotal trials, PSOARING 1 and 22,4 • PGA=4 • PASI=18.4 • DLQI=16 • PP-NRS=6 • PGA=2 • PASI=0.9 • DLQI=4* • PP-NRS=0 • PGA=1 • PASI=0.6 • DLQI=1 • PP-NRS=0 BASELINE WEEK 8 WEEK 12 Off treatment Off treatment PGA=0 (n=79) PGA=0 Stop treatment PGA≥2 Re-start treatment PGA≥1 (n=680) Tapinarof 1% QD Pivotal (n=508) Tapinarof 1% QD Vehicle QD Pivotal (n=255) Long-term open-label extension (40 weeks) Follow-up (4 weeks) Double-blind treatment (12 weeks) 85.8 4.5 2.5 7.2 Easily manage psoriasis with tapinarof 83.6 6.3 2.3 7.7 Satisfied with how well tapinarof worked 84.1 5.2 1.5 9.2 Have confidence in tapinarof 62.9 12.5 5.2 19.4 Tapinarof cleared skin and prevented psoriasis from coming back 84.0 4.2 2.3 9.5 If available would recommend tapinarof to others 82.5 6.2 3.2 8.2 If available would use tapinarof again or continue on it P ro p o rt io n o f p a ti e n ts , % 30 40 70 80 90 100 60 50 20 10 0 Strongly Agree + Agree Neutral Disagree Strongly Disagree 96.3 0.5 0.5 2.7 93.2 2.0 0.7 4.2 89.0 2.5 0.5 8.0 89.5 2.0 0.3 8.2 79.9 2.2 0.8 17.1 87.7 1.7 0.3 10.2 P ro p o rt io n o f p a ti e n ts , % 30 40 70 80 90 100 60 50 20 10 0 Tapinarof was easy to apply Time spent applying was acceptable and did not impact everyday life Tapinarof was not greasy Tapinarof quickly absorbs Tapinarof feels good on skin* Satisfied with look and feel of tapinarof† Strongly Agree + Agree Neutral Disagree Strongly Disagree Strongly Agree + Agree Neutral Disagree Strongly Disagree 81.7 4.2 1.9 12.1 65.3 2.9 0.6 31.2 81.1 4.2 1.5 13.1 55.3 12.6 7.0 25.1 63.8 10.1 4.5 21.6 67.8 11.1 4.5 16.6 P ro p o rt io n o f p a ti e n ts , % a. Versus prior topical therapies (n=519) b. Versus prior systemic therapies (n=199) 30 40 70 80 90 100 60 50 20 10 0 Tapinarof was more effective than topical drugs I have used in the past Tapinarof was easier to use than topical drugs I have used in the past I prefer tapinarof to topical drugs I have used in the past Tapinarof was more effective than systemic drugs I have used in the past Tapinarof was easier to use than systemic drugs I have used in the past I prefer tapinarof to systemic drugs I have used in the past Preference for Tapinarof Cream Versus Prior Topical Psoriasis Therapies ■ For patients who reported having used other topical drugs to treat psoriasis in the past, 81.7% considered tapinarof to be more effective than prior therapies, and 65.3% considered tapinarof easier to use (Figure 5a) ■ 81.1% of patients preferred tapinarof to other topical drugs used to treat their psoriasis in the past Preference for Tapinarof Cream Versus Prior Systemic Psoriasis Therapies ■ For patients who reported having used systemic drugs to treat psoriasis in the past, 55.3% considered tapinarof to be more effective than prior therapies, and 63.8% considered tapinarof to be easier to use (Figure 5b) ■ Most patients (67.8%) also preferred tapinarof to systemic drugs used to treat their psoriasis in the past Figure 5. Patient Preference for Tapinarof Cream Versus Prior Topical and Systemic Therapies CONCLUSION ■ Patient satisfaction data from PSOARING 3 demonstrate a consistent and highly positive perception of tapinarof cream 1% QD across all patient relevant parameters, including satisfaction with tapinarof efficacy, formulation elegance, application ease, impact on daily life, and preference for tapinarof cream versus prior psoriasis therapies REFERENCES 1. Armstrong AW, et al. JAMA Dermatol. 2013;149:1180–1185; 2. Lebwohl M, et al. N Engl J Med. 2021;385:2219–2229; 3. Bissonnette R, et al. Poster presented at: International Federation of Psoriasis Associations; June 30–July 3, 2021; Virtual; 4. Strober B, et al. Oral presented at: European Academy of Dermatology and Venereology; September 30, 2021; Virtual; 5. Robbins K, et al. J Am Acad Dermatol. 2019;80:714–721. ACKNOWLEDGMENTS Trials were funded by Dermavant Sciences, Inc. and the authors thank the investigators, patients and their families, and colleagues involved in their conduct. J.B. has received research funds payable to Psoriasis Treatment Center and/or speaking/consultant fees from AbbVie, Amgen, Arcutis Biotherapeutics, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Corrona LLC, Dermavant Sciences, Ltd, Dermira/UCB, Eli Lilly, Glenmark Pharmaceuticals Ltd, Janssen Biotech, Kadmon Corporation, LEO Pharma, Lycera Corp, Menlo Therapeutics, Novartis, Pfizer, Regeneron, Sun Pharma, Taro Pharmaceutical Industries Ltd, UCB, and Valeant Pharmaceuticals. L.S.G. 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 Dermatologic, and UCB Biopharma. J.D.R. is a consultant and research investigator for Dermavant Sciences, Inc. N.B. is a consultant with honorarium and an investigator for Dermavant Sciences, Inc. SJ is an advisor and/or speaker and/or editor and/or involved in clinical trials for AbbVie, Aclaris, AFMC, Allergan, Candela Syneron, Cassiopea, Celgene, Amgen, Chemocentryx, Dermavant Sciences, Inc., Dermira, Foamix, Gage, Galderma, GSK, Journal of Arkansas Medical Society, LEO, Eli Lilly, National Psoriasis Foundation, Nielsen, Novartis, Practical Dermatology, Regeneron, Sanofi Genzyme, Skin Medical, TARGET Therapeutics, and the University of Pennsylvania. P.Y. has served as an investigator and/or speaker and/or consultant for AbbVie, Amgen, Arcutis, BMS, Dermavant, EPI Health, Incyte, Janssen, Lilly, Leo, Novartis, Pfizer, Sun Pharma, and UCB. A.Y.M. has served as an investigator for Dermavant Sciences, Inc. A.M.T. is an employee of Dermavant Sciences Inc., with stock options. Editorial and medical writing support under the guidance of the authors was provided by ApotheCom, UK, and was funded by Dermavant Sciences, Inc. in accordance with Good Publication Practice (GPP3) guidelines (Ann Intern Med. 2015;163:461–464). Contact Dr Bagel at dreamacres1@aol.com with questions or comments.