New Data Shows ZORYVE (Roflumilast) Cream 0.3% Provided Measurable Improvement of Plaque Psoriasis in Nearly All Individuals in DERMIS Trials - Seite 2

In other data shared as a poster at the conference, ZORYVE was shown to be very well tolerated in individuals with plaque psoriasis, as measured by both investigator- and patient-rated local tolerability assessed prospectively in the DERMIS-1 and DERMIS-2 clinical trials.

• Nearly no stinging and burning was reported by patients. At first application, Week 4 and Week 8 only 0.4%, 0.0% and 0.2% treated with roflumilast cream reported hot, tingling/stinging sensation vs 0.0%, 0.4% and 0.0% treated with vehicle respectively.
• There was no evidence of irritation per investigator assessment in approximately 99% of subjects at each of the post-baseline time points, Week 4 and Week 8 (98.8% and 98.6% for roflumilast cream vs 97.7% and 98.4% for vehicle, respectively).

The findings included results in those with involvement in sensitive areas such as the face (26.6%), genital (15.6%), and intertriginous areas (20.3%), where skin touches skin.

"For a topical cream to be consistently used by patients, it needs to be safe and effective, but also well tolerated,” said Christopher Bunick, MD, PhD, associate professor of dermatology, Yale University School of Medicine, and lead author on the tolerability presentation. “The patient-reported results reinforce the excellent tolerability profile of ZORYVE and demonstrate that tolerability issues, in particular stinging and burning, are not a class effect associated with PDE4 inhibition. This makes ZORYVE an important non-steroidal topical option for patients.”

ZORYVE safety and tolerability data were comparable with vehicle, with low rates of application site adverse events (AEs), treatment-related AEs, and discontinuations due to AEs. The most common adverse reactions (≥1%) include diarrhea (3.1%), headache (2.4%), insomnia (1.4%), nausea (1.2%), application site pain (1.0%), upper respiratory tract infection (1.0%), and urinary tract infection (1.0%).

“We are pleased to be able to share these individual PASI response data with the wider dermatology community, along with data highlighting the strong alignment between both investigator and patient-reported assessments of tolerability,” said Patrick Burnett, MD, PhD, FAAD, chief medical officer of Arcutis. “As we continue to collect and analyze data highlighting the robust efficacy and tolerability of ZORYVE cream, we gain a greater understanding of the important role that this next generation topical PDE4 inhibitor may play in addressing unmet treatment needs of those with plaque psoriasis.”