Tremfya at 100 mg and 200 mg doses showed therapeutic and quality-of-life improvement through week 52 in a phase 3 clinical trial of Japanese patients with moderate to severe palmoplantar pustulosis, according to findings published in JAMA Dermatology.
“Because palmoplantar pustulosis is often difficult to manage owing to limited available treatment options, results of this study provide robust evidence for guselkumab as an efficacious new potential treatment option of palmoplantar pustulosis,” Tadashi Terui, MD, PhD, of the division of dermatological science, department of dermatology, Nihon University School of Medicine, Tokyo, and colleagues wrote.
The randomized, double-blind, multicenter, placebo-controlled trial was conducted across 40 sites in Japan in 159 adults diagnosed with the condition who had an inadequate response to conventional therapies for 24 or more weeks. Patients were randomly assigned in a 1:1:1 ratio to subcutaneous Tremfya (guselkumab, Janssen) at 100 mg (n = 54) or 200 mg (n = 52) at weeks 0, 4 and 12 and every 8 weeks thereafter or placebo (n = 53) at week 0, 4 and 12. Patients randomly assigned to placebo were re-randomly assigned to guselkumab 100 mg or 200 mg at weeks 16 and 20 and every 8 weeks thereafter through week 60.
Both guselkumab groups showed significant improvement in Palmoplantar Pustulosis Area and Severity Index (PPPASI) score vs. placebo at week 16.
The least squares mean change in PPPASI score from baseline was –15.3 (P < .001) in the guselkumab 100 mg group and –11.7 (P = .02) for the guselkumab 200 mg group compared with –7.6 in the placebo group, according to researchers.
Thirty-one patients in the guselkumab 100 mg group achieved a PPPASI-50 response at week 16 compared with only 18 patients in the placebo group at week 16 (P = .02).
Through week 16, higher proportions of patients in both guselkumab groups achieved a PPPASI-75 response compared with placebo. The guselkumab groups showed improvements in erythema and pustules/vesicles as early as week 8.
Additionally, in the guselkumab groups, the proportions of patients achieving a PPPASI-50 response increased over time. These groups also reported a significant decrease in Dermatology Life Quality Index scores from baseline.
Adverse events were comparable between the guselkumab 200 mg group (76.9%) and the placebo group (75.5%) and lowest among the 100 mg group (61.1%).
Overall, the researchers report a favorable benefit-to-risk profile in both guselkumab 100 mg and 200 mg doses. – by Abigail Sutton
Disclosures: Terui reports no relevant financial disclosures. Please see the study for all other authors’ relevant financial disclosures.