Snast Igor, Sherman Shany, Holzman Roie, Hodak Emmilia, Pavlovsky Lev
Division of Dermatology, Rabin Medical Center-Beilinson Hospital, Petach Tikva, Israel.
Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
Dermatol Ther. 2020 Nov;33(6):e13964. doi: 10.1111/dth.13964. Epub 2020 Jul 14.
High levels of efficacy were demonstrated in randomized controlled trials assessing the efficacy of guselkumab; however, real-life data are lacking. In this retrospective cohort study, we assessed the efficacy and safety of guselkumab in a cohort of psoriasis patients heavily pretreated with biologic agents. Primary efficacy endpoint was the percentage of patients achieving ≥psoriasis area and severity index (PASI) 90 response at week 24. The cohort included 33 patients of mean age 60 ± 13 years. Guselkumab was initiated after a mean of 4.0 ± 1.0 prior biologics failed over a mean period of 7. 4 ± 3.8 years. The mean duration of guselkumab treatment was 9.5 ± 3.7 months; 29 patients completed at least 24 weeks of treatment. At week 24, 22 patients (76%) achieved response of PASI 75 or higher, 18 (62%) achieved PASI 90 or higher, five (17%) PASI 100, and seven (24%) ≤PASI 50. No adverse effects were observed. This study confirms the efficacy and safety of guselkumab in real-world clinical practice, although for a lesser degree compared with clinical trials.
在评估古塞库单抗疗效的随机对照试验中已证明其具有高疗效；然而，缺乏实际应用数据。在这项回顾性队列研究中，我们评估了古塞库单抗在一组接受过大量生物制剂预处理的银屑病患者中的疗效和安全性。主要疗效终点是在第24周时达到银屑病面积和严重程度指数（PASI）改善≥90%的患者百分比。该队列包括33名平均年龄为60±13岁的患者。在平均4.0±1.0种先前生物制剂在平均7.4±3.8年的时间内治疗失败后，开始使用古塞库单抗。古塞库单抗的平均治疗持续时间为9.5±3.7个月；29名患者完成了至少24周的治疗。在第24周时，22名患者（76%）达到PASI 75或更高的改善，18名（62%）达到PASI 90或更高，5名（17%）达到PASI 100，7名（24%）≤PASI 50。未观察到不良反应。本研究证实了古塞库单抗在实际临床实践中的疗效和安全性，尽管与临床试验相比程度较低。
