Real-world effectiveness and safety of guselkumab in adult patients with facial and/or genital psoriasis: a 52-week analysis from the Italian multicentric GULLIVER study

Objectives: Facial and genital plaques are common manifestations of psoriasis, are challenging to treat, and significantly impact patients' quality of life (QoL). Methods: GULLIVER is a prospective, non-interventional study conducted in 2020-2023 in Italy, aimed at examining the effectiveness, safety and QoL impact of guselkumab through 52 weeks of treatment in patients with facial and/or genital psoriasis. The primary endpoint was the percentage of patients achieving a static Physician Global Assessment (sPGA) score of <= 1 and a minimum 2-grade improvement in sPGA score at Week 52. Results: Of 351 enrolled patients, 88.6% remained on guselkumab treatment at Week 52. The proportions of patients achieving the sPGA targets in the facial and genital groups, respectively, were 83.3% and 76.5% at week 12, increasing to 93.8% and 97.9% at Week 52. Mean Dermatology Life Quality Index score improved from 12.0 +/- 7.5 at baseline to 1.1 +/- 2.0 at Week 52 for patients with facial psoriasis (p-value <0.001) and from 12.0 +/- 6.9 to 1.6 +/- 3.5 for those with genital psoriasis (p-value <0.001). Guselkumab was well-tolerated and no new safety signals were identified. Conclusions: This Italian real-world study demonstrated the high effectiveness and a good safety profile of guselkumab in treating facial and genital psoriasis.