Roflumilast cream significantly reduces itch in chronic plaque psoriasis
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Arcutis Biotherapeutics announced positive results from two pivotal phase 3 studies evaluating Zoryve cream as a once daily, topic treatment for chronic plaque psoriasis, according to a company press release.
The results evaluating Zoryve (roflumilast cream 0.3%), a nonsteroid, phosphodiesterase-4 inhibitor, were published in The Journal of the American Medical Association.
“Itch is the symptom that psoriasis patients identify as the main driver of their disease severity, so it is important for any psoriasis therapy to control this symptom,” Patrick Burnett MD, PhD, FAAD, Chief Medical Officer at Arcutis, told Healio. “These findings not only help dermatologists to better understand the role of ZORYVE roflumilast cream in addressing the often-challenging symptom of itch in individuals with chronic plaque psoriasis, but also shed light on how people living with the disease may experience itch, regardless of their disease severity, and its impact on their lives.”
The identical phase 3, double-blind, vehicle-controlled studies evaluated roflumilast cream 0.3%, applied once daily for 8 weeks, as a treatment for patients aged 2 years and older with mild, moderate or severe chronic plaque psoriasis.
In both studies, significantly more patients in the roflumilast group achieved IGA success at week 8 compared with the vehicle group (42.4% and 37.5% vs. 6.1% and 6.9%; P < .001 for both). Additionally, patients on roflumilast with a baseline Worst Itch Numerical Rating Scale rating greater than or equal to 4 achieved a 4-point decrease by week 8.
“These data, which were confirmed in the DERMIS pivotal phase 3 trials, show that ZORYVE roflumilast cream is an important new nonsteroidal treatment option that is able to address this burdensome symptom of plaque psoriasis and provide those struggling with itch much-needed and rapid relief in as early as 2 weeks,” Burnett said.