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实现国家银屑病基金会的治疗目标与 ixekizumab:来自 4 项临床研究的汇总分析。

Achievement of the National Psoriasis Foundation treatment targets with ixekizumab: Pooled analyses from 4 clinical studies.

机构信息

Department of Dermatology, Keck School of Medicine of USC, University of Southern California, Los Angeles, California.

Eli Lilly and Company, Indianapolis, Indiana.

出版信息

J Am Acad Dermatol. 2021 Aug;85(2):330-336. doi: 10.1016/j.jaad.2019.09.030. Epub 2019 Sep 25.

DOI:10.1016/j.jaad.2019.09.030
PMID:31562945
Abstract

BACKGROUND

The National Psoriasis Foundation (NPF) published treatment targets for US patients with plaque psoriasis. However, data are lacking on how well existing therapies help achieve these goals.

OBJECTIVE

To examine the ability of an interleukin 17 inhibitor, ixekizumab, in achieving these treatment targets.

METHODS

Post hoc analysis was performed on pooled data from 4 phase III clinical trials assessing ixekizumab for plaque psoriasis: the UNCOVER-1, -2, and -3 trials and the IXORA-S trial. Treatment response was evaluated using the NPF-defined acceptable response (affected body surface area [BSA] of 3% or less or BSA improvement of 75% or higher at 12 weeks of treatment) and target response (BSA of 1% or less at 12 weeks and every 6 months thereafter).

RESULTS

In the UNCOVER trials (n = 2701), acceptable and target response rates at week 12 were 73.9% and 51.8% with ixekizumab 80 mg every 2 weeks, 35.7% and 14.9% with etanercept 50 mg, and 3.0% and 0.6% with placebo, respectively. In the IXORA-S trial (n = 302), acceptable and target response rates at week 12 were significantly higher with ixekizumab every 2 weeks versus ustekinumab (acceptable response 68.4% vs 38.6%, P < .0001; target response 50.7% vs 24.1%, P < .0001).

LIMITATIONS

Data were from controlled studies and may not reflect real-world practice.

CONCLUSION

The majority of patients treated with ixekizumab in 4 phase III clinical trials achieved NPF, patient-centered treatment targets.

摘要

背景

国家银屑病基金会(NPF)为美国斑块状银屑病患者发布了治疗目标。然而,目前缺乏关于现有疗法在多大程度上有助于实现这些目标的数据。

目的

研究白细胞介素 17 抑制剂依奇珠单抗在实现这些治疗目标方面的作用。

方法

对评估依奇珠单抗治疗斑块状银屑病的 4 项 III 期临床试验(UNCOVER-1、-2 和 -3 试验和 IXORA-S 试验)的汇总数据进行了事后分析。使用 NPF 定义的可接受应答(治疗 12 周时受影响的体表面积[BSA]小于或等于 3%或 BSA 改善大于或等于 75%)和目标应答(治疗 12 周时 BSA 小于或等于 1%,此后每 6 个月一次)来评估治疗反应。

结果

在 UNCOVER 试验(n=2701)中,依奇珠单抗 80mg 每 2 周、依那西普 50mg 和安慰剂的 12 周时可接受和目标应答率分别为 73.9%和 51.8%、35.7%和 14.9%、3.0%和 0.6%。在 IXORA-S 试验(n=302)中,依奇珠单抗每 2 周与乌司奴单抗相比,12 周时可接受和目标应答率显著更高(可接受应答 68.4%比 38.6%,P<0.0001;目标应答 50.7%比 24.1%,P<0.0001)。

局限性

数据来自对照研究,可能无法反映真实世界的实践。

结论

在 4 项 III 期临床试验中,接受依奇珠单抗治疗的大多数患者达到了 NPF、以患者为中心的治疗目标。

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