Dermatology Unit, Grande Ospedale Metropolitano "Bianchi-Melacrino-Morelli" of Reggio Calabria, Italy.
Eur Rev Med Pharmacol Sci. 2021 Jan;25(1):406-412. doi: 10.26355/eurrev_202101_24408.
Guselkumab is a fully human monoclonal IgG1 antibody which, by selectively binding to the p19 subunit of IL-23, prevents it from binding to the IL-23 receptor on the cell surfaces. To date, no prospective data are available on the efficacy and safety of this drug in everyday clinical practice in patients with psoriasis (PSO).
This is a longitudinal, single arm, real-world, prospective study to investigate the effect of Guselkumab on PSO and quality of life (DLQI) in 44 PSO patients. Outcomes were PASI, BSA, DLQI at 3 and 6 months.
The longitudinal analysis showed that PASI improved from a median value of 24.1 at baseline to 2.0 at 6-months and this was also true for BSA (from 23.0 to 2.0) and DLQI (from 24.0 to 2.5) (all p<0.001). At 6-months, PASI75, PASI90 and PASI100 were 95.5%, 59.1% and 16%, respectively. The PSO improvement related with the increase of DLQI (∆PASI vs. ∆DLQI, r=0.77, p<0.001). No clinically relevant adverse events were observed.
This study demonstrates the effectiveness and safety of Guselkumab on PSO in real world and shows that the reduction of PSO severity due to the drug is directly related with the improvement of quality of life in this patient population.
古塞库单抗是一种完全人源化的单克隆 IgG1 抗体，通过选择性结合 IL-23 的 p19 亚单位，阻止其与细胞表面的 IL-23 受体结合。迄今为止，尚无关于该药在银屑病（PSO）患者日常临床实践中的疗效和安全性的前瞻性数据。
这是一项纵向、单臂、真实世界、前瞻性研究，旨在调查古塞库单抗对 44 例 PSO 患者 PSO 和生活质量（DLQI）的影响。结局指标为 PASI、BSA、治疗 3 个月和 6 个月时的 DLQI。
纵向分析显示，PASI 从基线时的中位数 24.1 改善至 6 个月时的 2.0，BSA（从 23.0 至 2.0）和 DLQI（从 24.0 至 2.5）也是如此（均 P<0.001）。在 6 个月时，PASI75、PASI90 和 PASI100 分别为 95.5%、59.1%和 16%。PSO 的改善与 DLQI 的增加相关（∆PASI 与 ∆DLQI 相关，r=0.77，P<0.001）。未观察到临床相关的不良事件。
本研究表明古塞库单抗在真实世界中对 PSO 的有效性和安全性，并表明药物引起的 PSO 严重程度的降低与该患者人群生活质量的改善直接相关。
