Photo Credit: Zhenikeyev
Topical therapy remains the cornerstone of management in psoriasis disease. Prof. April Armstrong, MD, MPH, University of California, described recent developments in topical therapies including new technologies in the formulation of topical steroid creams, as well as non-steroidal topical therapies.
Calcipotriene & Betamethasone Dipropionate Cream
The Polyaphron Dispersion technology creates oil-in-water emulsions with high stability that require smaller quantities of surfactant than regular emulsions1. A fixed-dose combination of calcipotriene and betamethasone dipropionate cream using this technology was assessed in multiple clinical trials. A pooled analysis included 551 participants in the active group and 178 participants in the vehicle group2. Compared with the vehicle, 8-week treatment with calcipotriene and betamethasone dipropionate cream versus vehicle led to a significantly higher proportion achieving Physician’s Global Assessment score of 0 or 1 and greater than or equal to 2-point improvement from baseline (43.2% vs 5.2%; P<0.0001). Overall, AEs tended to be uncommon and were reported by less than 1% of any group.
Tapinarof 1% Cream
Tapinarof is an aryl hydrocarbon receptor modulator that has been assessed as a cream in clinical trials. PSOARING 1 (NCT03956355) and 2 (NCT03983980) were randomized, placebo-controlled trials in adults with plaque psoriasis and body surface involvement of 3–20% with treatment consisting of tapinarof 1% cream or vehicle cream for 12 weeks3. PSOARING 1 and 2 enrolled 510 and 515 participants, respectively.
The primary endpoint was Physician’s Global Assessment response (i.e. score of 0 or 1 and ≥2-point improvement from baseline) and was reached by 35.4% and 6.0% of participants with tapinarof and placebo in the first trial (P<0.001) and 40.2% and 6.3% participants with tapinarof and placebo in the second trial (P<0.001). The most commonly reported AEs with tapinarof were folliculitis and contact dermatitis. “The efficacy is possibly similar to or stronger than a class 3 topical steroid and can be used anywhere on the body,” said Prof. Armstrong1. “Folliculitis/keratosis pilaris was a common AE but was manageable.”
Roflumilast 0.3% Cream
The PDE4 inhibitor roflumilast has been assessed in the phase 3 trials DERMIS-1 (NCT04211363) and DERMIS-2 (NCT04211389), which randomly assigned roflumilast 0.3% cream versus vehicle alone in participants greater than or equal to 2 years of age with a psoriasis affected body surface area 2–20%. The primary endpoint of these trials was achieving an Investigator’s Global Assessment score of 0 or 1 with greater than or equal to two point improvement from baseline after 8 weeks of treatment. The two trials enrolled 881 participants and met the primary endpoint.
In DERMIS-1, the proportions of participants who achieved the primary endpoint were 42.4% with roflumilast versus 6.1% with the vehicle (P<0.001), while the DERMIS-2 the proportions were 37.5% versus 6.9% for roflumilast and placebo (P<0.001). Overall, the safety profile with roflumilast was similar to placebo4. “So I think efficacy is similar to a class 3 topical steroid with good tolerability and is good for intertriginous areas,” said Prof. Armstrong1.
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