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古塞单抗作为中重度银屑病患者接受抗 TNF-α、抗 IL-17 或抗 IL-12/23 治疗后的一种转换策略。

Guselkumab as a switching strategy after anti-TNFα, anti-IL17, or anti-IL12/23 therapies in moderate-to-severe psoriasis.

机构信息

Dermatology Department, Hospital Universitario San Cecilio, Granada, Spain.

Dermatology Department, Hospital Universitario Virgen del Rocio, Sevilla, Spain.

出版信息

Dermatol Ther. 2022 Oct;35(10):e15760. doi: 10.1111/dth.15760. Epub 2022 Aug 15.

DOI:10.1111/dth.15760
PMID:35971573
Abstract

The IL23/Th17 axis plays a strategic role in psoriasis (PSO). Guselkumab (GUS) is a selective inhibitor of the IL23p19 subunit. Its introduction has managed to increase the levels of efficacy, safety and survival in PSO. In real clinical practice, patients can loss effectiveness or suffered adverse events that forces a change in their treatments. There is scarce evidence of the effectiveness, safety, and survival of GUS in real clinical practice after anti-TNFα, anti-IL17, and/or anti-IL12/23. This is multicenter, observational and retrospective study of real clinical practice includes patients with moderate-to-severe plaque PSO in treatment with GUS. The objective of the study was to evaluate the effectiveness of GUS after anti-TNFα, anti-IL17, and anti-IL12/23. The study includes clinical information from February 2019 to February 2022. PASI, BSA, Pruritus, DLQI, survival, and safety were evaluated up to 76 weeks. Analyses were performed "as observed" using GraphPad Prism version 8.3.0 for Windows. A total of 103 patients were included in the analysis. At baseline there were significant differences between the anti-TNF, anti-IL17, and anti-IL12/23 groups for (1) dyslipidemia; (2) number of previous biological treatments and (3) PASI, BSA, VAS Pruritus, and DLQI scores. The effectiveness of GUS in terms of PASI, BSA, Pruritus, and DLQI was not impacted by previous biological alternatives. Treatment survival including discontinuations due to lack of effectiveness or safety reasons was 100%, 92.7%, and 92.1% for anti-TNFα, anti-IL17, and anti-IL12/23, respectively, at 130 weeks. No differences were found between groups. One adverse event was reported in the anti-LI12/23 group. The mid-term effectiveness, safety and survival of GUS if not impacted by previous biological therapy as anti-TNFα, anti-IL17, and/or anti-IL12/23. Our results indicate that GUS could be a switching strategy in patients who fail or present AE to other biological alternatives in moderate-to-severe PSO.

摘要

IL23/Th17 轴在银屑病(PSO)中起着重要作用。 Guselkumab(GUS)是 IL23p19 亚基的选择性抑制剂。它的引入成功提高了 PSO 的疗效、安全性和生存率。在实际临床实践中,患者可能会失去疗效或出现不良反应,从而需要改变治疗方法。在抗 TNFα、抗 IL17 和/或抗 IL12/23 之后,GUS 在实际临床实践中的有效性、安全性和生存率的证据很少。这是一项多中心、观察性和回顾性研究,涉及接受 GUS 治疗的中重度斑块型 PSO 患者。该研究的目的是评估抗 TNFα、抗 IL17 和抗 IL12/23 后 GUS 的疗效。该研究包括 2019 年 2 月至 2022 年 2 月的临床信息。在 76 周内评估 PASI、BSA、瘙痒、DLQI、生存率和安全性。使用 GraphPad Prism 版本 8.3.0 for Windows 进行“观察到的”分析。共纳入 103 例患者进行分析。基线时,抗 TNF、抗 IL17 和抗 IL12/23 组之间在(1)血脂异常;(2)既往生物治疗次数;(3)PASI、BSA、VAS 瘙痒和 DLQI 评分方面存在显著差异。GUS 在 PASI、BSA、瘙痒和 DLQI 方面的疗效不受既往生物替代物的影响。抗 TNFα、抗 IL17 和抗 IL12/23 的治疗生存率(包括因缺乏疗效或安全性原因而停药)分别为 100%、92.7%和 92.1%,在 130 周时。各组间无差异。抗 IL12/23 组报告了 1 例不良事件。如果不受抗 TNFα、抗 IL17 和/或抗 IL12/23 等既往生物治疗的影响,GUS 的中期疗效、安全性和生存率不受影响。我们的研究结果表明,GUS 可能是中重度 PSO 患者对其他生物替代物治疗失败或出现不良反应时的一种转换策略。

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引用本文的文献

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Long-Term Efficacy and Safety of Guselkumab in Psoriasis Patients Who Failed Anti-IL17: A Two-Year Real-Life Study.古塞库单抗在抗IL-17治疗失败的银屑病患者中的长期疗效和安全性:一项为期两年的真实世界研究。
J Clin Med. 2024 May 3;13(9):2691. doi: 10.3390/jcm13092691.
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Real-Life Effectiveness and Safety of Guselkumab in Patients with Psoriasis Who Have an Inadequate Response to Ustekinumab: A 3-Year Multicenter Study.古塞库单抗在对司库奇尤单抗反应不足的银屑病患者中的真实疗效和安全性:一项为期3年的多中心研究。
J Clin Med. 2024 Apr 26;13(9):2552. doi: 10.3390/jcm13092552.
3
Super-Responders in Moderate-Severe Psoriasis under Guselkumab Treatment: Myths, Realities and Future Perspectives.
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Life (Basel). 2022 Sep 10;12(9):1412. doi: 10.3390/life12091412.