Sustained efficacy and safety of guselkumab in patients with palmoplantar pustulosis through 1.5years in a randomized phase 3 study.

Abstract

The safety and efficacy of guselkumab for palmoplantar pustulosis (PPP) have been established through week (W)52; however, no sufficient information is available beyond 1 year. This study was conducted to assess the efficacy and safety of guselkumab through W84, and to explore factors associated with the sustainability of its efficacy in Japanese PPP patients. Patients received guselkumab 100 or 200 mg at W0, W4, W12, and every 8 weeks (q8w) until W60, or placebo at W0, W4, and W12. At W16, patients receiving placebo were re‐randomized to receive guselkumab 100/200 mg at W16, W20, and q8w until W60. Efficacy end‐points included PPP Area and Severity Index (PPPASI), PPP Severity Index (PPSI), Physician’s Global Assessment scores, and patient reported outcomes (PRO) (Dermatology Life Quality Index, EuroQoL‐5 Dimensions, and 36‐item Short Form Health Survey). Post‐hoc comparison of patient characteristics was performed between PPPASI‐75/90 responders and non‐responders at W60, and sustained responders and non‐responders at W84. Safety was evaluated through W84. A total of 45, 43, 21, and 24 patients from the guselkumab 100 mg, guselkumab 200 mg, placebo→guselkumab 100 mg, and placebo→guselkumab 200 mg groups, respectively, completed the study through W84. Overall, the mean improvement in the guselkumab groups from baseline in the PPPASI and PPSI total scores at W84 was ~79% and ~66%, respectively. All PRO improved through W84. The proportion of responders through W60 was higher in patients who had not received prior phototherapy and non‐biologic systemic therapy for PPP. Non‐smokers and patients with no prior non‐biologic systemic treatment tended numerically towards sustained efficacy through W84. The majority of treatment‐emergent adverse events (TEAE) were mild to moderate (~88%) with low incidence of serious TEAE (7.6%). Overall, guselkumab showed sustained efficacy and safety with improvement in the health‐related quality of life through W84 in Japanese PPP patients.