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接受古塞丽珠单抗治疗长达 1 年的中重度斑块状银屑病患者的真实世界结局。

Real-world outcomes in patients with moderate-to-severe plaque psoriasis treated with guselkumab for up to 1 year.

机构信息

Department of Systems Medicine, University of Rome "Tor Vergata", Rome, Italy.

Dermatology Unit, Fondazione Policlinico "Tor Vergata", Rome, Italy.

出版信息

Expert Opin Biol Ther. 2022 Dec;22(12):1585-1592. doi: 10.1080/14712598.2022.2090835. Epub 2022 Jun 22.

Abstract

BACKGROUND

Real-world data on guselkumab, especially at times >6 months, are limited.

RESEARCH DESIGN AND METHODS

We performed a longitudinal, retrospective analysis on 307 patients with moderate-severe chronic plaque psoriasis (Psoriasis Area Severity Index [PASI] >10) treated with guselkumab for up to 12 months.

MAIN OUTCOME MEASURES

PASI 75, PASI 90, and PASI 100 were assessed at baseline and at 4, 12, 20, 28, 36, 44, and 52 weeks.

RESULTS

At 12 weeks, PASI 75, PASI 90, and PASI 100 were achieved in 56.4%, 33.6%, and 24.1% of patients, respectively. At 52 weeks, PASI 75, PASI 90, and PASI 100 were achieved in 82.7%, 68.7%, and 51.1% of patients, respectively. Patients without comorbidities and those naïve to previous biological therapy had better responses. The mean Dermatology Life Quality Index score decreased from 14.0 at baseline to 3.1 at 12 weeks and 1.6 at 6 months, which was maintained at later times. Similar improvements were seen in pruritus visual analog scale.

CONCLUSIONS

Guselkumab maintains its efficacy for up to 12 months among responders in a real-world cohort of patients with moderate-severe plaque psoriasis, confirming data from prior real-world studies with smaller cohorts and shorter duration of follow-up.

摘要

背景

关于古塞库单抗的真实世界数据,尤其是在 6 个月以上的时间内的数据,非常有限。

研究设计和方法

我们对 307 名患有中度至重度慢性斑块型银屑病(银屑病面积严重指数[PASI]>10)的患者进行了一项纵向、回顾性分析,这些患者接受古塞库单抗治疗长达 12 个月。

主要观察指标

在基线和第 4、12、20、28、36、44 和 52 周时评估 PASI 75、PASI 90 和 PASI 100。

结果

在 12 周时,分别有 56.4%、33.6%和 24.1%的患者达到了 PASI 75、PASI 90 和 PASI 100。在 52 周时,分别有 82.7%、68.7%和 51.1%的患者达到了 PASI 75、PASI 90 和 PASI 100。无合并症的患者和未接受过既往生物治疗的患者的反应更好。皮肤病生活质量指数评分从基线时的 14.0 平均下降到 12 周时的 3.1 和 6 个月时的 1.6,之后一直保持稳定。瘙痒视觉模拟量表也出现了类似的改善。

结论

古塞库单抗在一个真实世界的中度至重度斑块型银屑病患者队列中,对有应答的患者在长达 12 个月的时间内保持疗效,证实了先前在较小队列和较短随访时间内进行的真实世界研究的数据。

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