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A phase 2b, randomized clinical trial of tapinarof cream for the treatment of plaque psoriasis: Secondary efficacy and patient-reported outcomes - 15/02/21

Doi : 10.1016/j.jaad.2020.04.181 
Linda Stein Gold, MD a, , Neal Bhatia, MD b, Anna M. Tallman, PharmD c, David S. Rubenstein, MD, PhD d
a Henry Ford Health System, Detroit, Michigan 
b Therapeutics Clinical Research, San Diego, California 
c Dermavant Sciences, Inc, New York, New York 
d Dermavant Sciences, Inc, Durham, North Carolina 

Correspondence to: Linda Stein Gold, MD, Henry Ford Health System, 3031 W Grand Blvd, Detroit, MI 48202.Henry Ford Health System3031 W Grand BlvdDetroitMI48202

Abstract

Background

Tapinarof cream is a topical therapeutic aryl hydrocarbon receptor modulating agent under investigation for treatment of psoriasis and atopic dermatitis.

Methods

In a phase 2b, double-blind, vehicle-controlled study, adults with plaque psoriasis were randomized to tapinarof cream 0.5% or 1% once or twice daily or vehicle once or twice daily for 12 weeks with 4-week follow-up. Efficacy outcomes included Physician Global Assessment (PGA) scores, change in PGA and total target lesion grading scores, and proportion of patients achieving ≥50%, ≥75%, and ≥90% reductions in the Psoriasis Area and Severity Index scores from baseline (PASI50, PASI75, and PASI90).

Results

At week 12, improvements were observed in all tapinarof groups vs vehicle in PGA response, change in PGA and total target lesion grading scores, PASI50 (71%-92% vs 10%-32%), PASI75 (46%-65% vs 5%-16%), and PASI90 (18%-40% vs 0%); all differences were statistically significant with tapinarof 1% once daily. Tapinarof responses were apparent from week 2, with significant efficacy at week 8 maintained through week 16. Most adverse events were mild or moderate.

Limitations

The analyses reported require confirmation in larger prospective studies.

Conclusions

Tapinarof may represent an important advance in the development of topical medicines for treatment of psoriasis.

Le texte complet de cet article est disponible en PDF.

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

Abbreviations used : AE, BSA, PASI, PASI50, PASI75, PASI90, PGA, PSD


Plan


 Funding sources: Supported by Dermavant Sciences, Inc.
 Conflicts of interest: Dr Stein Gold is an investigator, consultant, and speaker with honorarium for LEO Pharma, an investigator with honorarium for Incyte, a consultant and speaker with honorarium for Mayne Pharma and Taro Pharmaceutical Industries, and a consultant with honorarium and an investigator for Dermavant Sciences, Inc. Dr Bhatia is a consultant with honorarium and investigator for Dermavant Sciences, Inc. Dr Tallman and Dr Rubenstein are employees of Dermavant Sciences, Inc. with stock options.
 IRB approval status: The study was conducted in compliance with the guidelines for Good Clinical Practice and the Declaration of Helsinki. Approval was obtained from the local ethics committee or institutional review board at each study center. All patients provided written informed consent.
 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. 624-631 - mars 2021 Retour au numéro
Article précédent Article précédent
  • Response to topical corticosteroid monotherapy in mycosis fungoides
  • Saritha Kartan, Doaa Shalabi, Megan O'Donnell, Seyfettin Onder Alpdogan, Joya Sahu, Wenyin Shi, Pierluigi Porcu, Jisun Cha, Neda Nikbakht
| Article suivant Article suivant
  • 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
  • Amy S. Paller, Linda Stein Gold, Jennifer Soung, Anna M. Tallman, David S. Rubenstein, Melinda Gooderham

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