Phase 2b Study: Arcutis' Roflumilast Cream Shows Sustained Efficacy in Adults with Chronic Plaque Psoriasis

The participants had a median duration of IGA of clear or almost clear of more than ten months.

Arcutis' roflumilast cream showed sustained efficacy with clearance for median of 10 Months in adults with chronic plaque psoriasis, according to an open label Phase 2 long-term safety study presented at the Winter Clinical dermatology meeting.

Roflumilast cream 0.3% (Zoryve) is a once-daily steroid-free topical phosphodiesterase-4 inhibitor approved by the US Food and Drug Administration in July 2022.

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. The participants had a median duration of IGA of clear or almost clear of more than ten months (40.1 weeks).

Moreover, 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. Fully 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, the study showed.

Close to 67% 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. There was a low discontinuation rates due to AEs, and ≥97% of patients showed no irritation.