Psoriasis

Last reviewed: 1 Jan 2023
Last updated: 30 Sep 2022
30 Sep 2022

FDA approves tapinarof for adults with plaque psoriasis

Tapinarof, a small-molecule topical aryl hydrocarbon receptor (AhR) agonist, is the first topical novel chemical entity (corticosteroid-free) treatment to be approved by the US Food and Drug Administration in 25 years for adults with any severity of plaque psoriasis.

Two identical phase 3 randomised controlled trials demonstrated tapinarof significantly reduced the severity of plaque psoriasis, compared with vehicle, in patients with mild to severe plaque psoriasis at 12 weeks.[118] Patients who completed the 12 week trial were eligible to be included in a 40 week phase 3 open label trial with a 4 week follow up.[119] The trial reported that 41% of patients achieved complete disease clearance (physician global assessment [PGA] score 0), and that 58% of patients who entered the trial with PGA ≥2 achieved PGA of 0 or 1. The mean duration of remission for patients who achieved PGA 0 was 130 days. The most frequent adverse effects were folliculitis, contact dermatitis, and upper respiratory tract infection.[119]

See Management: emerging

Original source of update

Summary

Definition

History and exam

Key diagnostic factors

  • skin lesions
More key diagnostic factors

Other diagnostic factors

  • family history
  • joint swelling or pain
Other diagnostic factors

Risk factors

  • genetic
  • infection
  • local trauma
  • medications
  • stress
  • smoking
  • ethnicity
  • alcohol
  • greater body mass index (BMI)
More risk factors

Diagnostic investigations

1st investigations to order

  • clinical diagnosis
More 1st investigations to order

Investigations to consider

  • skin biopsy
More investigations to consider

Treatment algorithm

ONGOING

plaque

guttate

pustular

Contributors

Authors

Andrea Chiricozzi, MD

Assistant Professor

University of Pisa

Consultant Dermatologist

University Hospital of Pisa

Pisa

Italy

Disclosures

AC has served as an advisory board member and consultant and has received fees and speaker's honoraria or has participated in clinical trials for AbbVie, Almirall, Biogen, Fresenius Kabi, Leo Pharma, Lilly, Janssen, Novartis, Sanofi Genzyme, and UCB Pharma; AC is also an author of a reference cited in this topic.

Acknowledgements

Dr Andrea Chiricozzi would like to gratefully acknowledge Dr April W. Armstrong and Dr Tsu-Yi Chuang, previous contributors to this topic.

Disclosures

TC declares that he has no competing interests. AWA is an investigator and consultant for Abbott, Amgen, and Janssen; AWA is also an author of references cited in this topic.

Peer reviewers

David Burden, MD, FRCP

Western Infirmary, Glasgow

Consultant Dermatologist Dermatology

Glasgow

UK

Disclosures

DB has been reimbursed as a consultant, researcher, and lecturer for Abbott, Leo, Pfizer, Merck, Janssen-Cilag, and Novartis.

Paradi Mirmirani, MD

Physician

Department of Dermatology

Kaiser Permanente Vallejo Medical Center

Vallejo

CA

Disclosures

PM declares that she has no competing interests.

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