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.
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Bonifati Claudio, Argenziano Giuseppe, Lembo Serena, Richetta Antonio Giovanni, Romanelli Marco, Satolli Francesca, Corazza Monica, Atzori Laura, Lasagni Claudia, Potenza Concetta, Savoia Paola, Bardazzi Federico, Di Lernia Vito Giuseppe, Galluzzo Marco, Megna Matteo, Giofrè Claudia, Zichichi Leonardo, Guarneri Claudio, Pallotta Sabatino, Fargnoli Maria Concetta, Loconsole Francesco, Offidani Annamaria, Burlando Martina, Piaserico Stefano, Peris Ketty, Papini Manuela, Carrera Carlo Giovanni, Prignano Francesca, Bongiorno Maria Rita, Dapavo Paolo, Stingeni Luca, Donini Massimo, Micali Giuseppe, Rongioletti Franco, Stinco Giuseppe, Saibene Federico, Gramiccia Talia, Costanzo Antonio
Аннотация
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.