Guselkumab 在中重度斑块状银屑病中的真实疗效和安全性:一项 104 周的回顾性单中心研究。

Real-life Effectiveness and Safety of Guselkumab in Moderate-to-Severe Plaque Psoriasis: A 104-Week Retrospective Single-Center Study.

出版信息

J Drugs Dermatol. 2024 Aug 1;23(8):632-639. doi: 10.36849/JDD.7486.

Abstract

BACKGROUND

Guselkumab is a monoclonal antibody approved for treating moderate-to-severe plaque psoriasis. Long-term data on the effectiveness and safety of guselkumab in a real-world setting are still limited.

MATERIALS AND METHODS

We conducted a 104-week monocentric retrospective study on 102 psoriasis patients, all treated with guselkumab for at least 16 weeks. At each visit, we used the Psoriasis Area and Severity Index (PASI): effectiveness endpoints were the percentages of patients achieving 75%/90%/100% (PASI 75/90/100) improvement in PASI compared with baseline. The Kaplan-Meier curve was used to assess the drug survival.

RESULTS

At week 16, PASI 90 and PASI 100 were achieved by 49.02% and 32.35% of patients. At week 52, PASI 90 and PASI 100 were achieved by 71.58% and 55.79% of patients. After 2 years, PASI 90 and PASI 100 were achieved by 79.63% and 61.11% of patients. Obese and overweight patients had comparable PASI 90 and PASI 100 responses throughout the study. At week 104, no significant differences were observed between bio-naïve and bio-experienced patients regarding all effectiveness endpoints. No significant safety signals were reported in our study. After 24 months, 91.57% of our cohort was still on treatment with guselkumab.

CONCLUSION

Our findings, although limited by the study's retrospective nature, confirm that guselkumab is a safe and effective therapeutic option for a "real-life" cohort of patients with psoriasis. J Drugs Dermatol. 2024;23(8):632-639.  doi:10.36849/JDD.7486R1.

摘要

背景

古塞库单抗是一种已获批用于治疗中重度斑块状银屑病的单克隆抗体。古塞库单抗在真实世界环境中的长期有效性和安全性数据仍然有限。

材料和方法

我们对 102 例接受古塞库单抗治疗至少 16 周的银屑病患者进行了一项为期 104 周的单中心回顾性研究。在每次就诊时,我们使用银屑病面积和严重程度指数(PASI):有效性终点是与基线相比,达到 PASI 改善 75%/90%/100%(PASI 75/90/100)的患者比例。我们使用 Kaplan-Meier 曲线评估药物的存活率。

结果

在第 16 周,49.02%和 32.35%的患者达到 PASI 90 和 PASI 100。在第 52 周,71.58%和 55.79%的患者达到 PASI 90 和 PASI 100。2 年后,79.63%和 61.11%的患者达到 PASI 90 和 PASI 100。在整个研究过程中,肥胖和超重患者的 PASI 90 和 PASI 100 反应相当。在第 104 周,与生物初治患者相比,生物经验患者在所有有效性终点方面均无显著差异。本研究未报告明显的安全性信号。24 个月后,我们队列中有 91.57%的患者仍在接受古塞库单抗治疗。

结论

尽管受研究回顾性的限制,但我们的研究结果证实,古塞库单抗是一种安全有效的治疗选择,适用于银屑病的“真实世界”患者群体。皮肤病药物杂志。2024;23(8):632-639。doi:10.36849/JDD.7486R1.

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