Efficacy and safety of guselkumab in European patients with palmoplantar pustulosis: A multi-center, single-arm clinical trial (GAP study)
Wilsmann-Theis D, Patt S, Pinter A, Gerdes S, Magnolo N, Németh R, Schmitz J, Paul C, Augustin M, Staubach P, Weyergraf A, Hüffmeier U, Wolk K, Sabat R, Mößner R (2025)
Publication Type: Journal article
Publication year: 2025
Journal
Book Volume: 18
Pages Range: 69-78
DOI: 10.1016/j.jdin.2024.09.001
Abstract
Background: Palmoplantar pustulosis (PPP) is a chronic inflammatory skin disorder that affects palms and soles. Patients suffer significant pain, itching, and daily activity impairment. Guselkumab, an interleukin-23 inhibitor, has been approved for PPP treatment in Japan. However, there is no effective therapy licensed for PPP in Europe and the USA. Objective: To explore the efficacy and safety of guselkumab in patients with moderate-to-severe PPP in the Caucasian population. Methods: A multicenter, single-arm, phase II study involving 50 patients with moderate-to-severe PPP treated with 100 mg guselkumab subcutaneously for 24 weeks was conducted (GAP). Primary endpoint was the reduction of palmoplantar-pustulosis psoriasis area and severity index (PPPASI) at week 24 compared to baseline. Secondary endpoints included physician-assessed and patient-reported measures. Serum samples were taken for exploratory studies. Results: The primary endpoint was met with a significant median PPPASI reduction by 59.6% at week 24 compared to baseline (P < .001). The proportions of patients achieving PPPASI-50 and PPPASI-75 at week 24 were 66.0% and 34.0%, respectively. Median dermatology life quality index dropped from 15 at baseline to 5 at week 24 (P < .001). Week 4 changes in interleukin-19 serum levels predicted week 24 clinical response. Conclusion: Guselkumab may be a promising therapeutic option for PPP in Caucasian patients.
Authors with CRIS profile
Involved external institutions
Charité - Universitätsmedizin Berlin
Germany (DE)
Universitätsklinikum Göttingen
Germany (DE)
Universitätsklinikum Bonn
Germany (DE)
Rheinische Friedrich-Wilhelms-Universität Bonn
Germany (DE)
Universitätsklinikum Hamburg-Eppendorf (UKE)
Germany (DE)
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Germany (DE)
Universitätsklinikum Frankfurt am Main (KGU)
Germany (DE)
Universitätsklinikum Schleswig-Holstein (UKSH)
Germany (DE)
Universitätsklinikum Münster
Germany (DE)
Germany (DE)
Universitätsklinikum Göttingen
Germany (DE)
Universitätsklinikum Bonn
Germany (DE)
Rheinische Friedrich-Wilhelms-Universität Bonn
Germany (DE)
Universitätsklinikum Hamburg-Eppendorf (UKE)
Germany (DE)
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Germany (DE)
Universitätsklinikum Frankfurt am Main (KGU)
Germany (DE)
Universitätsklinikum Schleswig-Holstein (UKSH)
Germany (DE)
Universitätsklinikum Münster
Germany (DE)
How to cite
APA:
Wilsmann-Theis, D., Patt, S., Pinter, A., Gerdes, S., Magnolo, N., Németh, R.,... Mößner, R. (2025). Efficacy and safety of guselkumab in European patients with palmoplantar pustulosis: A multi-center, single-arm clinical trial (GAP study). JAAD International, 18, 69-78. https://doi.org/10.1016/j.jdin.2024.09.001
MLA:
Wilsmann-Theis, Dagmar, et al. "Efficacy and safety of guselkumab in European patients with palmoplantar pustulosis: A multi-center, single-arm clinical trial (GAP study)." JAAD International 18 (2025): 69-78.
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