Phase 3 trials of tapinarof cream for plaque psoriasis
New England Journal of Medicine Dec 13, 2021
Lebwohl MG, Gold LS, Strober B, et al. - Findings demonstrate the superior efficacy of tapinarof 1% cream (a topical aryl hydrocarbon receptor–modulating agent) once daily, vs vehicle control, in decreasing the severity of plaque psoriasis over a span of 12 weeks. However, this cream was found to be associated with local adverse events and headache.
In two identical phase 3 randomized trials, patients with mild-to-severe plaque psoriasis were randomized in a 2:1 ratio to use tapinarof 1% cream or vehicle cream once daily for 12 weeks (510 and 515 patients were enrolled in trials 1 and 2).
A Physician’s Global Assessment (PGA) score of 0 (clear) or 1 (almost clear) and a reduction from baseline of at least 2 points at week 12 was the primary endpoint.
In the tapinarof group vs vehicle group, a PGA response occurred in 35.4% vs 6.0%, respectively, in trial 1 and in 40.2% and 6.3%, respectively, in trial 2.
For secondary endpoints and patient-reported outcomes, the results were generally in the same direction as those for the primary endpoint.
Folliculitis, nasopharyngitis, contact dermatitis, headache, upper respiratory tract infection, and pruritus were tapinarof cream’s adverse events.
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