TY - JOUR
T1 - Efficacy and patient-reported outcomes from a phase 2b, randomized clinical trial of tapinarof cream for the treatment of adolescents and adults with atopic dermatitis
AU - Paller, Amy S.
AU - Stein Gold, Linda
AU - Soung, Jennifer
AU - Tallman, Anna M.
AU - Rubenstein, David S.
AU - Gooderham, Melinda
N1 - Funding Information:
Funding sources: Supported by Dermavant Sciences, Inc .
Funding Information:
Disclosure: Dr Paller is an investigator (without personal compensation) for AbbVie, AnaptysBio, Eli Lilly, Galderma, Incyte, LEO Pharma, Janssen, Novartis, and Sanofi-Regeneron and a consultant (with honoraria) for AbbVie, Amgen, Asana, Dermavant Sciences, Inc, Dermira, Galderma, Eli Lilly, Forte, LEO Pharma, Matrisys, Menlo, MorphoSys/Galapagos, Novartis, Pfizer, and Sanofi-Regeneron. Dr Stein Gold is an investigator, consultant, and speaker with honoraria for Galderma, LEO Pharma, Ortho Dermatologics, and Pfizer Inc; an investigator with research grants for Incyte , AbbVie , and Eli Lily ; a consultant and speaker with honoraria for Mayne and Taro; and a consultant with honoraria and an investigator for Dermavant Sciences, Inc. Dr Soung has received research grants and/or honoraria as an investigator for AbbVie , Actavis , Actelion , Allergan , Boehringer Ingelheim , Cassiopea , Dermira , Eli Lilly , Galderma , Janssen , Kadmon Corporation , Kyowa Kirin , LEO Pharma , Menlo , Ortho Dermatologics , Pfizer , and UCB ; an investigator and consultant for Novartis and Dermavant Sciences, Inc; a speaker for AbbVie, Actelion, Amgen Inc, Celgene Corporation, Dermira, Eli Lilly, the National Psoriasis Foundation (nonprofit), Novartis, Ortho Dermatologics, and Regeneron; and an advisor for Eli Lilly and LEO Pharma. Dr Tallman is an employee of Dermavant Sciences, Inc, with stock options. Dr Rubenstein is an employee of Dermavant Sciences, Inc, with stock options. Dr Gooderham has been an investigator, speaker, advisory board member, or consultant for AbbVie, Amgen, Akros, Arcutis, Bausch Health, Boehringer Ingelheim, Celgene, Dermavant Sciences, Inc, Dermira, Eli Lilly, Galderma, GlaxoSmithKline, Janssen, Kyowa Kirin, LEO Pharma, Medimmune, Merck, Novartis, Pfizer, Regeneron, Sanofi Genzyme, and UCB.
Funding Information:
The authors thank the participating investigators, patients, and their families, as well as colleagues involved in the conduct of the study. Editorial and medical writing support under the guidance of the authors was provided by Emily Singleton, ApotheCom, UK, and was funded by Dermavant Sciences, Inc, in accordance with Good Publication Practice guidelines (Ann Intern Med. 2015;163:461-464).
PY - 2021
Y1 - 2021
N2 - Background: Tapinarof is a topical therapeutic aryl hydrocarbon receptor modulating agent under investigation for atopic dermatitis (AD) and psoriasis treatment. Methods: A phase 2b, double-blind, vehicle-controlled study randomly assigned adolescents and adults with AD to receive tapinarof cream 0.5%, 1%, or vehicle, once or twice daily, for 12 weeks with a 4-week follow-up. Outcomes included Investigator Global Assessment (IGA), Eczema Area and Severity Index (EASI), body surface area affected, pruritus numeric rating scale scores, patients' impressions of AD and pruritus symptom severity, and Patient-Oriented Eczema Measure (POEM) scores. Results: Overall, 191 of 247 randomized patients completed the study. Week 12 IGA responses were higher in the tapinarof groups versus the vehicle group, reaching statistical significance with tapinarof 1% twice daily, ≥75%/90% improvement in EASI from baseline were significantly higher in the tapinarof groups (except 0.5% once daily and 0.5% twice daily), EASI scores were significantly improved in all tapinarof groups, and body surface area affected was significantly reduced in the tapinarof groups (except 0.5% twice daily). More patients reported AD and pruritus symptom severity as very/moderately improved in tapinarof groups, and POEM improvements were observed in all groups. Most adverse events were mild or moderate. Limitations: Larger prospective studies are required to confirm the reported analyses. Conclusions: Tapinarof is a potential important advance in topical medicine development for AD.
AB - Background: Tapinarof is a topical therapeutic aryl hydrocarbon receptor modulating agent under investigation for atopic dermatitis (AD) and psoriasis treatment. Methods: A phase 2b, double-blind, vehicle-controlled study randomly assigned adolescents and adults with AD to receive tapinarof cream 0.5%, 1%, or vehicle, once or twice daily, for 12 weeks with a 4-week follow-up. Outcomes included Investigator Global Assessment (IGA), Eczema Area and Severity Index (EASI), body surface area affected, pruritus numeric rating scale scores, patients' impressions of AD and pruritus symptom severity, and Patient-Oriented Eczema Measure (POEM) scores. Results: Overall, 191 of 247 randomized patients completed the study. Week 12 IGA responses were higher in the tapinarof groups versus the vehicle group, reaching statistical significance with tapinarof 1% twice daily, ≥75%/90% improvement in EASI from baseline were significantly higher in the tapinarof groups (except 0.5% once daily and 0.5% twice daily), EASI scores were significantly improved in all tapinarof groups, and body surface area affected was significantly reduced in the tapinarof groups (except 0.5% twice daily). More patients reported AD and pruritus symptom severity as very/moderately improved in tapinarof groups, and POEM improvements were observed in all groups. Most adverse events were mild or moderate. Limitations: Larger prospective studies are required to confirm the reported analyses. Conclusions: Tapinarof is a potential important advance in topical medicine development for AD.
KW - atopic dermatitis
KW - patient-reported outcomes
KW - tapinarof
KW - therapeutic aryl hydrocarbon receptor (AhR) modulating agent (TAMA)
KW - topical therapy
UR - http://www.scopus.com/inward/record.url?scp=85099140270&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85099140270&partnerID=8YFLogxK
U2 - 10.1016/j.jaad.2020.05.135
DO - 10.1016/j.jaad.2020.05.135
M3 - Article
C2 - 32502588
AN - SCOPUS:85099140270
JO - Journal of the American Academy of Dermatology
JF - Journal of the American Academy of Dermatology
SN - 0190-9622
ER -