Safety profile of vunakizumab in elderly patients with moderate-to-severe plaque psoriasis: a post-hoc analysis.
Аннотация
OBJECTIVE
Elderly patients with moderate-to-severe plaque psoriasis are vulnerable to adverse events (AEs), which raise safety concerns in their management. This post-hoc analysis aimed to evaluate the safety and efficacy of vunakizumab in elderly patients with moderate-to-severe plaque psoriasis, with an emphasis on safety.
METHODS
Data were extracted from a phase III trial (NCT04839016). A total of 70 elderly patients with moderate-to-severe plaque psoriasis were included and assigned to the vunakizumab (n = 49) and placebo (n = 21) groups.
RESULTS
During the induction period, the incidence of any AEs (63.3% vs. 76.2%) (p = 0.291) and serious AEs (4.1% vs. 0.0%) (p = 1.000) did not differ between the vunakizumab and placebo groups. During the entire treatment period, the incidence of any AEs (87.8% vs. 90.5%) (p = 1.000) and serious AEs (10.2% vs. 4.8%) (p = 0.661) remained unchanged between the vunakizumab and placebo groups. In the vunakizumab group, the most frequent AEs during the entire treatment period were elevated blood glucose (22.4%), hypertriglyceridemia (12.2%), elevated blood cholesterol (10.2%), eczema (10.2%), hyperuricemia (10.2%), and upper respiratory tract infection (10.2%). The rates of patients achieving psoriasis area and severity index (PASI) 75, 90, 100, and static physician's global assessment (sPGA) 0/1 responses at week (W) 12 were higher in the vunakizumab group than in the placebo group (all p < 0.001). These trends were sustained for 52 weeks. Patient-reported outcomes (PROs) at certain time points during 52 weeks were better in the vunakizumab group than in the placebo group.
CONCLUSION
Vunakizumab is safe and effective in elderly patients with moderate-to-severe plaque psoriasis.
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