Arcutis Biotherapeutics, Inc. announced new safety and efficacy durability data from its open label Phase 2 long-term safety study evaluating once-daily roflumilast cream (0.3%) in adults with chronic plaque psoriasis. Roflumilast cream 0.3% (ZORYVE®) is a once-daily steroid free topical phosphodiesterase-4 (PDE4) inhibitor approved by the US Food and Drug Administration in July 2022. The study, which was presented at the Winter Clinical dermatology meeting, showed that during the trial, 57.1% (n=185) of roflumilast cream-treated patients achieved an Investigator Global Assessment (IGA) score of clear or almost clear (IGA 0/1) at any time in study, and these participants had a median duration of IGA of clear or almost clear of more than 10 months (40.1 weeks).

Additionally, the%ages of participants achieving IGA success (defined as clear/almost clear plus 2-grade improvement from baseline) and an IGA of clear or almost clear were maintained over the course of the 52 weeks and were consistent with the DERMIS trials. Roflumilast cream was safe and very well tolerated, with the majority of adverse events (AEs) mild-to-moderate in severity. In the multicenter, open-label, single-arm, long-term Phase 2 safety trial, two cohorts of participants were enrolled (n=332).

Cohort-1 participants (n=230) were those who completed the Phase 2b trial through Week 12 (roflumilast 0.3% treated, roflumilast 0.15% treated, and vehicle treated), whereas Cohort-2 participants (n=102) were newly enrolled (treatment-naïve at baseline). Additional key findings following 52 weeks of treatment with roflumilast cream 0.3% include: IGA success was achieved by 35.3% of participants previously treated with roflumilast cream and 37.5% of roflumilast-naïve participants. IGA success was defined as clear/almost clear plus 2-grade improvement from baseline 42% of participants previously treated with roflumilast cream and 47.5% of roflumilast-naïve participants achieved an IGA score of clear or almost clear (IGA 0/1) at Week 52 66.7% of participants in Cohort-21 achieved Intertriginous-IGA (I-IGA) success, defined as clear or almost clear plus 2-grade improvement from baseline No tachyphylaxis occurred, and efficacy was consistent over time among participants who achieved an IGA of clear or almost clear.

Safety data showed rates of discontinuations due to AEs were low, and =97% of patients had no evidence of irritation per investigator local tolerability assessment at each visit. The most common AEs over the course of the trial (>2%) were upper respiratory tract infection/viral URTI (6.6%), nasopharyngitis (3.6%), urinary tract infection (3.3%), and sinusitis (2.4%). ZORYVE (roflumilast) cream 0.3% is indicated for topical treatment of plaque psoriasis, including intertriginous areas, in patients 12 years of age and older.

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%).