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单中心真实世界中 Guselkumab 治疗中重度斑块状银屑病患者的疗效。

Single-Centre Real-Life Experience of Guselkumab in Patients with Moderate-to-Severe Plaque Psoriasis.

出版信息

J Drugs Dermatol. 2022 Aug 1;21(8):864-866. doi: 10.36849/JDD.6962.

DOI:10.36849/JDD.6962
PMID:35946964
Abstract

The efficacy of guselkumab has been demonstrated in randomized controlled trials, but real-life data are still missing. This study presents a single-center real-life experience in treating moderate-to-severe plaque psoriasis with guselkumab, underlying the efficacy and safety of this biological agent. Primary efficacy endpoint was the percentage of patients reaching psoriasis area and severity index (PASI) 90 response at week 28. The cohort included 79 patients of mean age 51 ± 15 years. Mean duration of guselkumab treatment was 16,5 ± 7.5 months. All 79 patients completed at least 28 weeks of treatment. At week 28, 73 (92%) patients reached PASI 50 or higher, 65 (82%) achieved PASI 75 or higher, 54 (68%) achieved PASI 90 or higher, and 35 (44%) reached PASI 100. Very similar percentages were found at week 44 and at the end of the study period. No significant adverse effects were reported. This study confirms that guselkumab is an effective and safe biologic agent capable of maintaining long-lasting clinical response efficacy in real-world clinical practice, although at slightly lower levels than in clinical trials. J Drugs Dermatol. 2022;21(8):864-866. doi:10.36849/JDD.6962.

摘要

古塞库单抗在随机对照试验中已显示出疗效,但真实世界的数据仍存在缺失。本研究介绍了古塞库单抗治疗中重度斑块状银屑病的单中心真实世界经验,强调了该生物制剂的疗效和安全性。主要疗效终点是第 28 周达到银屑病面积和严重程度指数(PASI)90 缓解的患者比例。该队列纳入了 79 名平均年龄为 51±15 岁的患者。古塞库单抗治疗的平均持续时间为 16.5±7.5 个月。所有 79 名患者均完成了至少 28 周的治疗。第 28 周时,73 名(92%)患者达到 PASI50 或更高,65 名(82%)达到 PASI75 或更高,54 名(68%)达到 PASI90 或更高,35 名(44%)达到 PASI100。第 44 周和研究结束时,发现了非常相似的比例。未报告有任何重大不良反应。本研究证实,古塞库单抗是一种有效且安全的生物制剂,能够在真实世界的临床实践中维持持久的临床缓解疗效,尽管其疗效略低于临床试验。《皮肤病药物杂志》。2022;21(8):864-866.doi:10.36849/JDD.6962.

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Single-Centre Real-Life Experience of Guselkumab in Patients with Moderate-to-Severe Plaque Psoriasis.单中心真实世界中 Guselkumab 治疗中重度斑块状银屑病患者的疗效。
J Drugs Dermatol. 2022 Aug 1;21(8):864-866. doi: 10.36849/JDD.6962.
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Clin Drug Investig. 2023 Jul;43(7):517-527. doi: 10.1007/s40261-023-01280-9. Epub 2023 Jul 4.
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