Prospective Study of Efficacy, Safety, and Predictors of Response to Deucravacitinib in Chinese Patients with Moderate-to-Severe Plaque Psoriasis

Abstract

Background Psoriasis is a prevalent immune-mediated inflammatory skin disease. Deucravacitinib, an oral selective allosteric tyrosine kinase 2 (TYK2) inhibitor, provides a novel therapeutic option, but real-world data on its short-term efficacy, safety, and predictors of response among Chinese patients remain limited. Objective To evaluate the 12-week efficacy, safety, and predictors of response to deucravacitinib in Chinese patients with moderate-to-severe plaque psoriasis in a real-world setting. Methods This prospective, single-center cohort study enrolled 120 adult patients with moderate-to-severe plaque psoriasis (Psoriasis Area and Severity Index ≥10, body surface area ≥10%, or Dermatology Life Quality Index ≥10) at a tertiary hospital in Shanghai, China. All patients received oral deucravacitinib 6 mg once daily for 12 weeks. Results Among the 120 patients (mean age, 37.2 years; 58.3% male), the week 12 PASI 75, PASI 90, and PASI 100 response rates were 59.6%, 24.0%, and 4.8%, respectively. Regional PASI 75 response rates were highest for the head and neck (79%), followed by the trunk (76%), lower limbs (74%), and upper limbs (72%). Baseline body mass index <24 kg/m2 independently predicted higher PASI 90 achievement (odds ratio, 5.34; 95% CI, 1.28–22.21), but was not associated with PASI 75. Exploratory comparisons showed that PASI 75 non-responders had higher baseline levels of TNF-α, IL-1β, IL-23p19, IFN-γ, and G-CSF in exploratory comparisons, with no differences in other Th1, Th2, Th17, or regulatory T-cell cytokines. Adverse events occurred in 41 of 120 patients (34.2%); the most common events were acne (24/120, 20.0%), folliculitis (13/120, 10.8%), and upper respiratory tract infection (7/120, 5.8%), and most were mild to moderate. Conclusion In this real-world study, deucravacitinib was associated with significant clinical improvement over 12 weeks and had a favorable safety profile in Chinese patients with moderate-to-severe psoriasis, including improvement in difficult-to-treat anatomical regions. Baseline body mass index <24 kg/m2 and lower pretreatment levels of proinflammatory cytokines were associated with better treatment responses.