Effectiveness of guselkumab in patients with facial and/or genital psoriasis: Interim analysis results at Week 12 from the GULLIVER study

Abstract

AbstractBackgroundFacial (FP) and genital psoriasis (GP) significantly affect patients' quality of life. Despite the advances in treatments, limited data on efficacy and safety are available on these difficult‐to‐treat areas. Guselkumab is an interleukin (IL)‐23 inhibitor which has been proven effective in treating patients with moderate‐to‐severe plaque psoriasis.ObjectivesThe aim of this interim analysis was to report the efficacy and safety of guselkumab in the treatment of patients with FP and/or GP.Materials and MethodsGULLIVER is a 52‐week Italian observational study to evaluate the effectiveness and safety of guselkumab in a real‐life setting in patients with FP and/or GP. Adult patients with facial and/or genital moderate‐to‐severe psoriasis (sPGA score ≥ 3) were included. The primary endpoint of this analysis was the percentage of patients achieving a facial or genital sPGA score of 0 (clear) or 1 (almost clear), at Week 12. The change in the score of the facial or genital sPGA components in patients with a score ≥3 for each sPGA component was assessed. PASI score in patients with a baseline PASI above or below 10 was evaluated.ResultsOverall, 351 patients were included in the study; 83.3% of FP and 76.5% of GP patients achieved the primary endpoint. Similar response rates were observed for the facial or genital sPGA components in patients with a baseline facial or genital sPGA score ≥3 in each component. Among patients with a baseline PASI score >10, mean PASI score improved from 19.0 (SD 8.3) to 2.2 (SD 4.8). Forty‐four AEs were observed in 32 patients; two mild and transient AEs (fatigue and nausea) were considered treatment related. No SAEs were observed.ConclusionsGuselkumab, showing to be effective and safe in treating FP and GP, may be a valid therapeutic option for patients with psoriasis localized in these difficult‐to‐treat areas.