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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 - 15/02/21

Doi : 10.1016/j.jaad.2020.05.135 
Amy S. Paller, MD a, , Linda Stein Gold, MD b, Jennifer Soung, MD c, Anna M. Tallman, PharmD d, David S. Rubenstein, MD, PhD e, Melinda Gooderham, MD, FRCPC f
a Northwestern University Feinberg School of Medicine, Chicago, Illinois 
b Henry Ford Health System, Detroit, Michigan 
c Southern California Dermatology, Santa Ana, California 
d Dermavant Sciences, Inc, Long Beach, California 
e Dermavant Sciences, Inc, Durham, North Carolina 
f SKiN Centre for Dermatology, Probity Medical Research and Queen's University, Peterborough, Canada 

Correspondence to: Amy S. Paller, MD, Northwestern University Feinberg School of Medicine, Chicago, IL 60611.Northwestern University Feinberg School of MedicineChicagoIL60611

Abstract

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.

Le texte complet de cet article est disponible en PDF.

Key words : atopic dermatitis, patient-reported outcomes, tapinarof, therapeutic aryl hydrocarbon receptor (AhR) modulating agent (TAMA), topical therapy

Abbreviations used : AD, AE, BSA, IGA, EASI, EASI75, EASI90, ITT, NRS, POEM, PRO


Plan


 Funding sources: Supported by Dermavant Sciences, Inc.
 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.
 IRB approval status: Approval was obtained from the local ethics committee or IRB at each study center.
 Reprints not available from the authors.


© 2020  American Academy of Dermatology, Inc.. Publié par Elsevier Masson SAS. Tous droits réservés.
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Vol 84 - N° 3

P. 632-638 - mars 2021 Retour au numéro
Article précédent Article précédent
  • A phase 2b, randomized clinical trial of tapinarof cream for the treatment of plaque psoriasis: Secondary efficacy and patient-reported outcomes
  • Linda Stein Gold, Neal Bhatia, Anna M. Tallman, David S. Rubenstein
| Article suivant Article suivant
  • Comorbidities in patients with palmoplantar plaque psoriasis
  • Ran Greenberg, Tomer Goldsmith, David Zeltser, Itzhak Shapira, Shlomo Berliner, Ori Rogowski, Shani Shenhar-Tsarfaty, Eli Sprecher, Hagit Matz

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