Roflumilast cream shows improvement in plaque psoriasis itch, severity
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BOSTON — Improvement in plaque psoriasis itch and severity, including in intertriginous areas, was significant in patients treated with roflumilast, according to a poster presented at the American Academy of Dermatology Annual Meeting.
“Roflumilast is a nonsteroid, phosphodiesterase-4 inhibitor, so it has a very benign mechanism of action,” Mark G. Lebwohl, MD, dean for clinical therapeutics and chair emeritus of the Kimberly and Eric J. Waldman Department of Dermatology at the Icahn School of Medicine at Mount Sinai, told Healio. “It is very effective, particularly in areas where we are afraid to use the current topicals that are available.”
Lebwohl presented pooled data from two identical, randomized, double-blind, vehicle-controlled, 8-week phase 3 trials of roflumilast 0.3% (Arcutis).
Investigator Global Assessment of 0 or 1, with an improvement of at least 2 grades, was achieved in 39.9% of those in the roflumilast group compared with 6.5% of those in the vehicle group. IGA of 0 or 1 without the 2-grade improvement occurred in 48% of the roflumilast group compared with 9.5% of the vehicle group.
A 75% reduction in Psoriasis Area Severity Index was achieved in 40.3% of the roflumilast group and 6.5% of the vehicle group.
Treatment emergent adverse events occurred in 25.5% of the roflumilast-treated patients and 21% of those treated with vehicle. Of these adverse events, 4% and 0.7%, respectively, were treatment-related.
“Clearly, the improvement was there, the tolerability is excellent, the pooled results and the safety profile is extremely good,” Lebwohl said. “We now have a nonsteroid that has no steroid side effects that is the equivalency in potency of a potent topical steroid.”
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Lebwohl M., et al. Poster. Pooled efficacy and safety results from the DERMIS-1 and DERMIS-2 phase 3 trials of once-daily roflumilast cream 0.3% for treatment of chronic plaque psoriasis. Presented at: American Academy of Dermatology Annual Meeting; March 25-29, 2022; Boston.
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