Once-daily application of roflumilast cream 0.3% is associated with a significantly higher rate of treatment success on the Investigator's Global Assessment (IGA) scale in Chinese patients with plaque psoriasis compared with a vehicle cream, according to the phase III DERMIS-1 and -2 studies presented at AAD 2026.
In this pooled analysis, 190 Chinese patients aged ≥6 years with plaque psoriasis (mean IGA score of 3) were randomly assigned in a 2:1 ratio to receive either roflumilast cream 0.3% (n=128) or a vehicle cream (n=62) once daily for 8 weeks.
At week 8, a significantly greater proportion of patients treated with roflumilast achieved an IGA success, defined as an IGA score of 0 or 1 (clear or almost clear skin) with ≥2-grade improvement from baseline, compared with those on the vehicle cream (38.3 percent vs 10.3 percent; p<0.0001). [AAD 2026, abstract 75175]
Significantly more roflumilast-treated patients also achieved intertriginous-IGA (I-IGA) success than vehicle-treated patients (61.3 percent vs 23.2 percent; p<0.01), with more patients achieving an I-IGA score of 0 (46.1 percent vs 22.5 percent).
The roflumilast group also achieved significantly higher PASI* 75 and 90 response rates from baseline to week 8 (43.6 percent vs 7 percent; p<0.0001 and 17.1 percent vs 3.5 percent; p<0.01, respectively) than the vehicle group.
With regard to patient-reported outcomes (PROs), more roflumilast recipients experienced a ≥4-point reduction in WI-NRS** compared with those using vehicle cream at week 8 (54.3 percent vs 16.1 percent; p<0.0001).
Moreover, the Dermatology Life Quality Index and Psoriasis Symptom Diary scores were greatly improved with roflumilast compared with the vehicle cream as early as week 2 and 4, respectively, and were maintained through week 8, according to the researchers.
In terms of safety, the rates of treatment-emergent adverse events (TEAEs) were similar between the roflumilast and vehicle groups (46.1 percent vs 45.2 percent), with no serious AEs observed in either group.
The most common TEAEs reported in both groups were upper respiratory tract infection, weight loss, and diarrhoea. These TEAEs were mostly mild to moderate in severity, the researchers noted.
Taken together, roflumilast cream 0.3% significantly improved quality of life and other PROs throughout the treatment duration, while demonstrating a favourable safety and tolerability profile in this patient population, said the researchers.
“Overall, once-daily application of roflumilast cream 0.3% was effective and well tolerated in Chinese patients aged ≥6 years with plaque psoriasis,” the researchers concluded.