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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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