New Psoriasis Treatments: A Primer

Jeffrey Liu; April W. Armstrong, MD, MPH


August 17, 2021

Emerging Topical Treatments

Roflumilast is an emerging topical agent that selectively targets PDE-4. In a 6-week phase 2b randomized, double-blind, vehicle-controlled trial by Lebwohl and colleagues, 331 patients with mild and moderate to severe psoriasis were randomized to receive once-daily treatment with roflumilast 0.3% cream, roflumilast 0.15% cream, or vehicle (placebo) cream. At week 6, 28% of patients in the roflumilast 0.3% group achieved an IGA score of 0 or 1 compared with 23% in the roflumilast 0.15% group and 8% in the vehicle group. Importantly, this response was pronounced in patients with baseline intertriginous psoriasis, with 73% of patients in the roflumilast 0.3% group and 44% of patients in the roflumilast 0.15% group achieving an IGA score of 0 or 1 by week 6. Moreover, recent data from DERMIS-1 and DERMIS-2 phase 3 trials show a significantly higher number of patients with IGA scores of 0 or 1 in the group treated with roflumilast 0.3% by week 8 compared to the vehicle group (42.4% vs 6.1% in DERMIS 1; 37.5% vs 6.9% in DERMIS-2).

Tapinarof is another novel topical agent and one that modulates aryl hydrocarbon receptor activity. Specifically, tapinarof binds and activates the aryl hydrocarbon receptor, inducing antioxidant regulation pathways, downregulation of IL-17, and normalization of the skin barrier. Tapinarof has shown robust efficacy in mild and moderate to severe plaque psoriasis. Two ongoing randomized, double-blind, vehicle-controlled phase 3 studies, PSOARING 1 and PSOARING 2, are currently evaluating the efficacy and safety of once-daily treatment with tapinarof 1% cream vs vehicle cream. Interim results found a little more than 35% (PSOARING 1) and just over 40% (PSOARING 2) of patients receiving tapinarof 1% cream achieved Physician Global Assessment scores of 0 or 1 at week 12. In addition, around 36% of patients (PSOARING 1) and about 48% of patients (PSOARING 2) receiving tapinarof 1% cream had a PASI 75 response at week 12. Moreover, patients who experienced remittance of skin symptoms maintained skin clearance up to 115 days after discontinuing tapinarof (per interim analysis from a long-term extension study PSOARING 3). Tapinarof was well tolerated by patients in both trials; although about 15%-20% of patients in the tapinarof group developed folliculitis, they did not need to discontinue treatment.

The advent of newer-generation and upcoming treatments for plaque psoriasis is exciting, expanding the armamentarium of treatment options available for patients — especially those with moderate to severe disease. Moreover, these novel systemic oral agents, biologic agents, and topical therapies have demonstrated good efficacy and tolerability. With more emerging clinical data, these therapies can offer promising alternatives for clearance of plaque psoriasis and provide the best outcomes for patients.

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