Efficacy and safety of vunakizumab in patients with moderate-to-severe plaque psoriasis who have a history of systemic therapies: a post hoc analysis of a phase III trial.

OBJECTIVE

This study aimed to explore the efficacy and safety of vunakizumab in patients with moderate-to-severe plaque psoriasis who had a history of systemic therapies.

METHODS

Data were derived from a phase III trial (NCT04839016). This post hoc analysis included patients with moderate-to-severe plaque psoriasis who had a history of systemic therapies, including non-biological systemic therapies (N = 307), biological therapies (N = 32), or both (N = 10), totaling 329 unique patients. Patients were assigned to the vunakizumab (N = 210) and placebo (N = 119) groups according to the treatment regimens.

RESULTS

The proportions of patients achieving week (W) 12 Psoriasis Area and Severity Index (PASI) 75, PASI 90, PASI 100, and static Physician's Global Assessment score of 0 or 1 (sPGA 0/1) responses were higher in the vunakizumab group than in the placebo group (all P > 0.001). These trends were found at most time points over 52 weeks. The median time to achieve PASI 75/90/100 response was 4.4, 8.3, and 16.3 weeks after vunakizumab treatment. Regarding patient-reported outcomes, at W4, W8, and W12, mean Dermatology Life Quality Index (DLQI) and itch numerical rating scale scores were lower, while the proportion of patients achieving DLQI 0/1 response was higher in the vunakizumab group than in the placebo group (P < 0.05). The incidence of any adverse event during the induction period or the entire treatment period was not different between the two groups (P > 0.05).

CONCLUSION

Vunakizumab has better efficacy than placebo with satisfactory safety profiles in patients with moderate-to-severe plaque psoriasis who have a history of systemic therapies.