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 randomized 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]
Summary
Definition
History and exam
Key diagnostic factors
- skin lesions
Other diagnostic factors
- family history
- joint swelling or pain
Risk factors
- genetic
- infection
- local trauma
- medications
- stress
- smoking
- ethnicity
- alcohol
- greater body mass index (BMI)
Diagnostic investigations
1st investigations to order
- clinical diagnosis
Investigations to consider
- skin biopsy
Treatment algorithm
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.
Differentials
- Eczema
- Pityriasis rosea
- Seborrheic dermatitis
More DifferentialsGuidelines
- Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with topical therapy and alternative medicine modalities for psoriasis severity measures
- EuroGuiDerm guideline on the systemic treatment of psoriasis vulgaris – part 2: specific clinical and comorbid situations
More GuidelinesPatient leaflets
Psoriasis: what is it?
Psoriasis: what treatments work
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