Long-Term Efficacy and Safety of Guselkumab for Moderate to Severe Psoriasis: A 3-Year Real-Life Retrospective Study.

IF 5.2 Q1 DERMATOLOGY Psoriasis (Auckland, N.Z.) Pub Date : 2022-07-14 eCollection Date: 2022-01-01 DOI:10.2147/PTT.S372262
Matteo Megna, Luca Potestio, Gabriella Fabbrocini, Angelo Ruggiero
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引用次数: 3

Abstract

Introduction: 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.

Patients and methods: 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.

Results: 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.

Conclusion: 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.

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Guselkumab治疗中重度牛皮癣的长期疗效和安全性:一项为期3年的现实回顾性研究
VOYAGE(1和2)试验显示了Guselkumab治疗银屑病的安全性和有效性。尽管试验结果之前已经被现实生活中的研究证实,但关于guselkumab的长期现实生活数据和药物生存数据仍然很差。患者和方法:我们进行了一项为期3年的回顾性研究,目的是评估guselkumab在现实生活中治疗斑块性银屑病的疗效和安全性。结果:31例患者完成了研究。牛皮癣区域严重指数(PASI)和体表面积(BSA)从第16周开始,持续到第144周均有统计学改善[144周时PASI从16.4±6.2降至0.6±0.9 (p < 0.0001), BSA从33.2±14.6降至1.9±1.4 (p < 0.0001)]。12周时,分别有19名(61.3%)和11名(35.4%)患者达到PASI90和PASI100, 144周时分别有24名(77.4%)和18名(58.1%)患者达到PASI90和PASI100。安全性方面,无注射部位反应、念珠菌、严重ae、恶性肿瘤或主要心血管事件报告。值得注意的是,收集到的轻度不良事件以咽炎为主要(7例,22.6%),其次是头痛(5例,16.1%)和流感样疾病(5例,16.1%),均不需要停药。结论:我们的经验在长达3年的日常临床实践中证实了guselkumab的有效性和安全性,表明该药物是银屑病长期治疗的有效治疗选择。
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