Megna Matteo, Potestio Luca, Fabbrocini Gabriella, Ruggiero Angelo
Section of Dermatology - Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, 80131, Italy.
Psoriasis (Auckl). 2022 Jul 14;12:205-212. doi: 10.2147/PTT.S372262. eCollection 2022.
Guselkumab safety and efficacy profiles in psoriasis have been showed by VOYAGE (1 and 2) trials. Although trial results have been already previously confirmed by real-life studies, long-term real-life data, and drug survival data about guselkumab are still poor.
We performed a 3-year retrospective study, with the aim of assessing guselkumab efficacy and safety profile in the management of plaque psoriasis in a real-life setting.
Thirty-one patients completed the study. Both Psoriasis Area Severity Index (PASI) and Body Surface Area (BSA) statistically improved since week 16, and up to week 144 [PASI reduction from 16.4 ± 6.2 to 0.6 ± 0.9 (p < 0.0001) at week 144 while BSA from 33.2 ± 14.6 to 1.9 ± 1.4 (p < 0.0001)]. At week 12 PASI90 and PASI100 were achieved by 19 (61.3%) and 11 (35.4%) patients, respectively, as well as 24 (77.4%) and 18 (58.1%) subjects reached PASI 90 and PASI 100 at week 144. As regards the safety, no cases of injection site reaction, candida, serious AEs, malignancy, or major cardiovascular events were reported. Of note, mild AEs were collected with pharyngitis as the main one (7, 22.6%), followed by headache (5, 16.1%) and flu-like illness (5, 16.1%), all without requiring treatment discontinuation.
Our experience confirmed the efficacy and safety of guselkumab in daily clinical practice up to 3 years, suggesting this drug as an effective treatment option in psoriasis long-term management.
VOYAGE（1和2）试验已证明古塞库单抗治疗银屑病的安全性和有效性。尽管试验结果此前已得到现实研究的证实，但关于古塞库单抗的长期现实数据和药物生存数据仍然匮乏。
我们进行了一项为期3年的回顾性研究，旨在评估在现实环境中，古塞库单抗治疗斑块状银屑病的疗效和安全性。
31名患者完成了研究。自第16周起，银屑病面积和严重程度指数（PASI）及体表面积（BSA）均有统计学意义的改善，直至第144周[第144周时PASI从16.4±6.2降至0.6±0.9（p<0.0001），而BSA从33.2±14.6降至1.9±1.4（p<0.0001）]。在第12周时，19名（61.3%）患者达到PASI90，11名（35.4%）患者达到PASI100；在第144周时，分别有24名（77.4%）和18名（58.1%）受试者达到PASI90和PASI100。在安全性方面，未报告注射部位反应、念珠菌感染、严重不良事件、恶性肿瘤或重大心血管事件。值得注意的是，收集到的轻度不良事件以咽炎为主（7例，22.6%），其次是头痛（5例，16.1%）和流感样疾病（5例，16.1%），所有这些均无需停药治疗。
我们的经验证实了古塞库单抗在长达3年的日常临床实践中的疗效和安全性，表明该药是银屑病长期管理的有效治疗选择。
