Background

Biologics targeting interleukin 17A (IL-17A) allow for rapid clearance of psoriatic plaques, with a clinically favorable safety profile.

Objectives

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.

Methods

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).

Results

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).

Limitations

This study was not designed to compare safety end points related to rare events.

Conclusions

Compared with ustekinumab, ixekizumab showed superior efficacy and comparable safety outcomes through 52 weeks of treatment.

中文翻译：

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在52周的治疗中，与ustekinumab相比，伊克珠单抗提供了更高的疗效：IXORA-S的结果，一项3期研究

背景

靶向白介素17A（IL-17A）的生物制剂可快速清除银屑病斑块，并具有临床上有利的安全性。

目标

在头对头试验IXORA-S中，经过52周的治疗，比较了IL-17A拮抗剂ixekizumab的安全性和有效性与IL-12 / 23抑制剂ustekinumab的安全性和有效性。

方法

患者被随机分为依克珠单抗（n = 136）或乌斯他单抗（n = 166），并按照批准的标签给药。一年后，通过改善银屑病面积和严重程度指数（PASI）得分（PASI 90表示相对于基线PASI得分提高90％或更高）以及静态医师的整体评估（sPGA）响应为0或0来评估疗效或1，其中辍学被视为无响应。安全性分析包括治疗紧急不良事件（AE）。

结果

在第52周时，接受依克珠单抗治疗的患者显着更多（P  <.01），报告的PASI为90（104 [76.5％]），sPGA反应为0（72 [52.9％]），或sPGA反应为0或1（110） [82.1％]）的反应比接受乌斯替单抗治疗的患者高（PASI 90，98 [59.0％]; sPGA响应为0，60 [36.1％]； sPGA响应为0或1，108 [65.1％]）。在治疗组之间，出现治疗的AE，严重的AE和停药率没有差异。在依克珠单抗治疗组中，注射部位反应更频繁发生（依克珠单抗，22 [16.3％]；乌斯替单抗，2 [1.2％]）（P  <.001）。

局限性

本研究的目的不是比较与罕见事件有关的安全终点。

结论

与乌斯库单抗相比，依克珠单抗治疗52周显示出更高的疗效和可比的安全性结果。