Advances in psoriasis treatment: topical therapies show promising results

Topical therapy remains the cornerstone of management in psoriasis disease. Prof. April Armstrong (University of California Los Angeles, CA, USA) described recent developments in topical therapies including new technologies in the formulation of topical steroid creams, as well as non-steroidal topical therapies.

Calcipotriene and betamethasone dipropionate cream

The Polyaphron Dispersion technology creates oil-in-water emulsions with high stability that require smaller quantities of surfactant than regular emulsions [1]. 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 group [2]. 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 ≥2-point improvement from baseline (43.2% vs 5.2%; P<0.0001). Overall, adverse events tended to be uncommon and were reported by >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 randomised, 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 weeks [3]. PSOARING 1 and 2 enrolled 510 and 515 participants, respectively.

The primary endpoint was Physician’s Global Assessment response (i.e. a 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 adverse events 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. Armstrong [1]. “Folliculitis/keratosis pilaris was a common adverse event 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 randomised roflumilast 0.3% cream versus vehicle alone in participants ≥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 ≥2-point improvement from baseline after 8 weeks of treatment. The 2 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 placebo [4]. “So I think efficacy is similar to a class 3 topical steroid with good tolerability and is good for intertriginous areas,” said Prof. Armstrong [1].

1. 
   
   1. Armstrong A. Psoriasis: Treatment advances in topical therapies. IFPA Conference 2024, 27–29 June, Stockholm, Sweden.
   2. Pinter A, et al. J Eur Acad Dermatol Venereol. 2022;36(2):228-236.
   3. Lebwohl MG, et al. N Engl J Med 2021;385(24):2219-2229.
   4. Lebwohl MG, et al. JAMA. 2022;328(11):1073-1084.

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Posted on 17 July 202417 July 2024