Oregon Medical Research Center, Portland, Oregon.
Icahn School of Medicine at Mount Sinai, New York, New York.
J Am Acad Dermatol. 2021 Aug;85(2):360-368. doi: 10.1016/j.jaad.2020.11.022. Epub 2020 Nov 28.
To report the efficacy and safety of the approved ixekizumab (IXE) dose over 5 years from UNCOVER-3 (NCT01646177).
Patients (N = 1346) were randomized 1:2:2:2 to receive subcutaneous injections of placebo, etanercept 50 mg twice weekly, or IXE 80 mg every 2 weeks or every 4 weeks after an initial dose of IXE 160 mg, respectively. At week 12, patients entered the long-term extension period with dosing of IXE every 4 weeks and could escalate to every 2 weeks after week 60. Efficacy was reported for the IXE every 2 weeks/every 4 weeks group of the intent-to-treat population. Safety was reported for patients who received at least 1 dose of IXE every 2 or every 4 weeks.
Using modified nonresponder imputation, 78.8%/67.1%/46.2% of patients receiving the approved dose of IXE every 2 weeks/every 4 weeks (n = 385) achieved ≥75%, ≥90%, or 100% improvement from baseline in the Psoriasis Area and Severity Index, respectively, at week 264; static Physician's Global Assessment score of 0/1 and 0 responses were 69.2% and 45.3%, respectively. Infections were the most observed treatment-emergent adverse event (72.7% of patients).
Lack of comparison treatment group after week 12.
IXE demonstrates sustained efficacy and consistent safety through 264 weeks in patients using the approved dose.
报告依奇珠单抗（IXE）批准剂量在 UNCOVER-3 研究中的 5 年疗效和安全性（NCT01646177）。
患者（N=1346）随机分为 1:2:2:2 组，分别接受安慰剂、依那西普 50mg，每周 2 次、IXE 80mg，每 2 周或每 4 周 1 次（初始剂量为 160mg）。第 12 周时，所有患者进入长期扩展期，每 4 周接受一次 IXE 治疗，60 周后可每 2 周增加一次剂量。意向治疗人群的 IXE 每 2 周/每 4 周组报告疗效。接受至少一剂 IXE 每 2 周或每 4 周治疗的患者报告安全性。
采用改良非应答者推断法，接受批准剂量 IXE 每 2 周/每 4 周治疗的患者（n=385）在第 264 周时分别有 78.8%/67.1%/46.2%达到了银屑病面积和严重程度指数（PASI）≥75%、≥90%和 100%改善，静态医师总体评估（PGA）评分分别为 0/1 和 0 应答的患者比例为 69.2%和 45.3%。最常见的治疗中出现的不良事件为感染（72.7%的患者）。
第 12 周后无对照治疗组。
在患者使用批准剂量的情况下，IXE 表现出持续的疗效和一致的安全性，可维持 264 周。
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