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• 一项 3 期、随机、双盲、安慰剂对照临床研究（IXORA-Q）评估了依奇珠单抗在中度至重度生殖器银屑病（GP）患者中的安全性和疗效。¹

安全性

• 总体而言，在 IXORA-Q 研究的 12 周盲态治疗期间，依奇珠单抗组（56%）发生治疗期间出现的不良事件（TEAE）的频率高于安慰剂组（45%），但两个治疗组之间无统计学上显著差异。¹
• 表 1 列出了至第 12 周的安慰剂对照、盲态治疗期间报告的 TEAE 和特别关注的 TEAE 的严重程度，以及至第 52 周的盲态治疗期间或开放标签治疗期间接受至少 1 剂依奇珠单抗的所有患者的安全性概述。作者得出结论，IXORA-Q 研究中依奇珠单抗的安全性结果与既往研究中依奇珠单抗的总体安全性概况一致。^1-3

表 1. IXORA-Q 研究：在 12 周盲态治疗期间以及至第 52 周的所有依奇珠单抗暴露期间报告的 TEAE ^1,4

缩略词：AE = 不良事件；IXE = 依奇珠单抗；IXE Q2W = 160 mg 初始剂量后，依奇珠单抗每 2 周一次；PBO = 安慰剂；SAE = 严重不良事件；TEAE = 治疗期间出现的不良事件。

^a 包括在盲态治疗期间或开放标签治疗期间接受 ≥1 剂依奇珠单抗的患者。

上次审阅日期：2024年1月3日

参考文献

1. Ryan C, Menter A, Guenther L, et al; the IXORA‐Q Study Group. Efficacy and safety of ixekizumab in a randomized, double-blinded, placebo-controlled phase IIIb study of patients with moderate-to-severe genital psoriasis. Br J Dermatol. 2018;179(4):844-852. https://dx.doi.org/10.1111/bjd.16736

2. Ryan C, Menter A, Guenther L, et al. Efficacy and safety of ixekizumab in a randomized, double-blinded, placebo-controlled, phase 3b clinical trial in patients with moderate-to-severe genital psoriasis. Poster presented at: 26th Congress of the European Academy of Dermatology and Venereology (EADV); September 13-17, 2017: Geneva, Switzerland.

3. Guenther L, Potts Bleakman A, Weisman J, et al. Persistent clinical improvement in genital psoriasis through one year of treatment with ixekizumab: results of a randomized, placebo-controlled phase 3 clinical trial in patients with moderate-to-severe genital psoriasis (IXORA-Q). Poster presented at: 77th Annual Meeting of the American Academy of Dermatology; March 1-5, 2019; Washington, DC

4. Guenther L, Potts Bleakman A, Weisman J, et al. Ixekizumab results in persistent clinical improvement in moderate-to-severe genital psoriasis during a 52 week, randomized, placebo-controlled, phase 3 clinical trial. Acta Derm Venereol. 2020;100(1):adv00006. https://doi.org/10.2340/00015555-3353