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. 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. 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.
Psoriatic lesions are red, inflamed, silvery-white scaly, and circumscribed papules and plaques; often affecting elbows, knees, extensor limbs, and scalp, and, less commonly, nails, ear, and umbilical region.
Psoriasis is a multifactorial disease with a genetic basis. Exacerbations of disease may be related to infection, alcohol, medications, stress, and intercurrent illness.
Diagnosis is usually clinical.
Mild or limited psoriasis is treated with topical corticosteroids and/or vitamin D analogs.
Moderate to severe and/or extensive psoriasis may require phototherapy, and systemic agents such as methotrexate, cyclosporine, acitretin, or biologic agents.
Psoriasis is a chronic inflammatory skin disease characterized by erythematous, circumscribed scaly papules and plaques. It can cause itching, irritation, burning, and stinging. Although approximately 30% of people with cutaneous psoriasis also have psoriatic arthritis, this topic only discusses cutaneous psoriasis.
History and exam
Key diagnostic factors
- skin lesions
Other diagnostic factors
- family history
- joint swelling or pain
- local trauma
- greater body mass index (BMI)
1st investigations to order
- clinical diagnosis
Investigations to consider
- skin biopsy
- Pityriasis rosea
- Seborrheic dermatitis
- 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
Psoriasis: what is it?
Psoriasis: what treatments workMore Patient leaflets
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