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Phase II GAP trial: Guselkumab in palmoplantar pustulosis
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Guselkumab, an IL-23 inhibitor, has been approved for the treatment of palmoplantar pustulosis in Japan.1 Wilsmann-Theis et al.1 published the results of a phase II GAP trial (EUDRA-CT-No. 2018-004451-20) evaluating the efficacy and safety of 100 mg subcutaneous guselkumab in 50 European patients with moderate-to-severe palmoplantar pustulosis in the Journal of the American Academy of Dermatology International. The primary endpoint was reduction in palmoplantar pustulosis psoriasis area and severity index (PPPASI) at Week 24.1 |
| Key learnings |
| Guselkumab met the primary endpoint resulting in a median PPPASI reduction of 59.6% at Week 24 (p < 0.001). The proportions of patients achieving PPPASI-50 and PPPASI-75 at Week 24 were 66.0% and 34.0%, respectively. |
| At Week 24, the median DLQI decreased from 15 to 5 (p < 0.001). Changes in IL-19 serum levels at Week 4 were associated with a reduction in PPPASI (p < 0.01) and pustule count (p < 0.05) at Week 24. |
| Overall, 102 TEAEs occurred in 74% of patients and were mild to moderate in severity. No deaths were reported due to guselkumab. |
| Results suggest that guselkumab may be a potential therapeutic choice for palmoplantar pustulosis, particularly within the Caucasian population. |
Abbreviations: DLQI, Dermatology Life Quality Index; IL, interleukin; PPPASI, Palmoplantar Pustulosis Area and Severity Index; PPPASI-50, 50% improvement in Palmoplantar Pustulosis Area and Severity Index; PPPASI-75, 75% improvement in Palmoplantar Pustulosis Area and Severity Index TEAE, treatment-emergent adverse event.
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