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In PSO-1 and PSO-2, efficacy was assessed in 1,684 subjects randomized to either Deucravacitinib (6 mg orally once daily), placebo, or apremilast (30 mg orally twice daily)
Across both trials, 40% of subjects had received prior phototherapy, 42% were naive to any systemic therapy (including biologic and/or non-biologic treatment), 41% received prior non-biologic systemic treatment, and 35% had received prior biologic therapy.
Examination of age, gender, race, body weight, baseline disease severity, and prior systemic therapy did not identify differences in response to Deucravacitinib at Week 16 among these subgroups.
A greater proportion of subjects treated with Deucravacitinib compared to placebo achieved Psoriasis Symptoms and Signs Diary (PSSD) symptom score of 0 (absence of itch, pain, burning, stinging, and skin tightness) at Week 16 (8% in Deucravacitinib vs.1% in placebo) in both trials.
from FDA，2022.09
