'As a clinician and researcher, I see first-hand how itch can negatively affect people with chronic plaque psoriasis, in particular on the quality and quantity of their sleep,' said
In the parallel-group, double-blind, vehicle-controlled phase 2b clinical trial, 331 subjects ranging from ages 18 to 89 years were randomized to roflumilast 0.3% cream, roflumilast 0.15% cream or vehicle in a 1:1:1 ratio. Roflumilast cream or vehicle was applied once daily to all psoriasis lesions for 12 weeks.
Improvement in WI-NRS was greater in individuals treated with roflumilast cream in both arms compared to vehicle beginning at Week 2 (p ? 0.002), the first timepoint measured. Among a subgroup of participants with a baseline WI-NRS >6, significantly more of those treated with roflumilast 0.3% achieved an improvement of ?4 compared to vehicle by Week 2 (p ? 0.034).
Those treated with roflumilast cream in both arms reported greater improvements in severity of itch and bother of itch, as measured by PSD, compared to vehicle at Weeks 2 to 12 (p< 0.012 and p < 0.010, respectively). Additionally, both roflumilast-treated groups experienced similar improvements in itch-related sleep loss as measured by itch-related sleep loss NRS, which was greater than the vehicle-treated group beginning at Week 6 (p ? 0.022). Improvement on the Dermatology Life Quality Index (DLQI) Score was observed at Week 6 for those treated with roflumilast cream 0.3% compared to those treated with vehicle (p = 0.045) and for both roflumilast-treated groups at Week 12.
'These findings not only help us to better understand the role of 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,' said
In
About ZORYVE (roflumilast) Cream 0.3%
ZORYVE (roflumilast) cream 0.3% is a next generation topical inhibitor of phosphodiesterase-4 (PDE4) and the first topical PDE4 inhibitor to be approved by the FDA for adults and adolescents with plaque psoriasis, including intertriginous psoriasis.
INDICATION
ZORYVE (roflumilast) cream 0.3% is indicated for topical treatment of plaque psoriasis, including intertriginous areas, in patients 12 years of age and older.
IMPORTANT SAFETY INFORMATION
The use of ZORYVE is contraindicated in patients with moderate to severe liver impairment (Child-Pugh B or C).
The most common adverse reactions (?1%) include diarrhea (3%), headache (2%), insomnia (1%), nausea (1%), application site pain (1%), upper respiratory tract infection (1%), and urinary tract infection (1%).
About Arcutis
Forward-Looking Statements
Arcutis cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on the Company's current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding the potential for ZORYVE to simplify disease management for care of plaque psoriasis; the potential of real-world use results of roflumilast cream, as well as the commercial launch of ZORYVE in plaque psoriasis. These statements are subject to substantial known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. Risks and uncertainties that may cause our actual results to differ include risks inherent in our business, reimbursement and access to our products, the impact of competition and other important factors discussed in the 'Risk Factors' section of our Form 10-K filed with the
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