Dermatology Department, CHU, Paul Sabatier University, Toulouse, France.
Dermatology Centre, Salford Royal Hospital, University of Manchester, Manchester Academic Health Science Centre, Manchester, United Kingdom.
J Am Acad Dermatol. 2019 Jan;80(1):70-79.e3. doi: 10.1016/j.jaad.2018.06.039. Epub 2018 Jun 30.
Biologics targeting interleukin 17A (IL-17A) allow for rapid clearance of psoriatic plaques, with a clinically favorable safety profile.
To compare the safety and efficacy of ixekizumab, an IL-17A antagonist, with the safety and efficacy of the IL-12/23 inhibitor ustekinumab through 52 weeks of treatment in the head-to-head trial IXORA-S.
Patients were randomized to ixekizumab (n = 136) or ustekinumab (n = 166) and dosed per the approved labels. After 1 year, efficacy was assessed via improvements in Psoriasis Area and Severity Index (PASI) score (with PASI 90 indicating a 90% or greater improvement from baseline PASI score) and a static Physician's Global Assessment (sPGA) response of either 0 or 0 or 1, with dropouts counted as nonresponders. Safety analyses included treatment-emergent adverse events (AEs).
At week 52, significantly more ixekizumab-treated patients (P < .01) reported PASI 90 (104 [76.5%]), an sPGA response of 0 (72 [52.9%]), or an sPGA response of 0 or 1 (110 [82.1%]) responses than did ustekinumab-treated patients (PASI 90, 98 [59.0%]; sPGA response of 0, 60 [36.1%]; and sPGA response of 0 or 1, 108 [65.1%]). Treatment-emergent AEs, serious AEs, and discontinuation rates were not different between the treatment groups. Injection site reactions occurred more frequently in the ixekizumab-treated group (ixekizumab, 22 [16.3%]; ustekinumab, 2 [1.2%]) (P < .001).
This study was not designed to compare safety end points related to rare events.
Compared with ustekinumab, ixekizumab showed superior efficacy and comparable safety outcomes through 52 weeks of treatment.
针对白细胞介素 17A（IL-17A）的生物制剂可快速清除银屑病斑块，具有临床有利的安全性特征。
通过头对头试验 IXORA-S，比较白细胞介素 12/23 抑制剂乌司奴单抗与白细胞介素 17A 拮抗剂依奇珠单抗在 52 周治疗期间的安全性和疗效。
患者随机分配至依奇珠单抗（n=136）或乌司奴单抗（n=166）组，并按批准的标签剂量给药。治疗 1 年后，通过改善银屑病面积和严重程度指数（PASI）评分（PASI90 表示与基线 PASI 评分相比改善 90%或以上）和静态医师总体评估（sPGA）反应为 0 或 0 或 1（脱落患者被计为无应答者）来评估疗效。安全性分析包括治疗出现的不良事件（AE）。
在第 52 周，接受依奇珠单抗治疗的患者（P<0.01）报告 PASI90（104[76.5%]）、sPGA 反应为 0（72[52.9%]）或 sPGA 反应为 0 或 1（110[82.1%]）的比例显著高于接受乌司奴单抗治疗的患者（PASI90，98[59.0%]；sPGA 反应为 0，60[36.1%]；sPGA 反应为 0 或 1，108[65.1%]）。治疗出现的 AE、严重 AE 和停药率在两组之间无差异。注射部位反应在依奇珠单抗治疗组更为常见（依奇珠单抗，22[16.3%]；乌司奴单抗，2[1.2%]）（P<0.001）。
本研究的设计并非旨在比较与罕见事件相关的安全性终点。
与乌司奴单抗相比，依奇珠单抗在 52 周的治疗期间显示出更好的疗效和相当的安全性。
