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司库奇尤单抗 75mg、150mg 和 300mg 在活动性强直性脊柱炎患者中的疗效和安全性比较。

Comparative efficacy and safety of secukinumab 75 mg, 150 mg, and 300 mg in patients with active ankylosing spondylitis.

出版信息

Int J Clin Pharmacol Ther. 2021 Sep;59(9):610-617. doi: 10.5414/CP203927.

Abstract

OBJECTIVE

The purpose of this research was to assess the efficacy and safety of secukinumab at various doses in patients with active ankylosing spondylitis (AS).

MATERIALS AND METHODS

A Bayesian network meta-analysis was performed using direct and indirect data from randomized controlled trials (RCTs) investigating the efficacy and safety of secukinumab 75, 150, and 300 mg in patients with active AS.

RESULTS

Data of 1,049 patients from three RCTs were examined. In AS patients with inadequate response (IR) to tumor necrosis factor inhibitor (TNFI), secukinumab 300 mg was associated with the most favorable assessment of Spondyloarthritis International Society 40% (ASAS40) response rate according to surface under the cumulative ranking curve (SUCRA), while placebo was associated with the least favorable outcomes. In TNFI-IR patients with AS, ASAS40 was significantly higher in the secukinumab 300, 150, and 75 mg groups than in the placebo group. SUCRA-based rating of likelihood indicated that secukinumab 300 mg was most likely to be the best therapy to achieve ASAS40 response rate, followed by secukinumab 150 mg and 75 mg and placebo. ASAS20 response rate showed a distribution pattern identical to ASAS40 response rate. In TNFI-naïve patients with AS, the response rates for ASAS40 and ASAS20 were also significantly higher in the 300, 150, and 75 mg groups than in the placebo group. There was no substantial difference in the number of severe adverse effects (SAEs) between the treatment groups.

CONCLUSION

Secukinumab demonstrated dose-dependent efficacy in TNFI-IR patients with AS without increasing the risk of SAEs.

摘要

目的

本研究旨在评估不同剂量司库奇尤单抗治疗活动期强直性脊柱炎(AS)患者的疗效和安全性。

材料与方法

采用贝叶斯网络荟萃分析,对评估司库奇尤单抗 75、150 和 300mg 治疗活动期 AS 患者疗效和安全性的随机对照试验(RCT)的直接和间接数据进行分析。

结果

纳入 3 项 RCT 的 1049 例患者的数据。在对肿瘤坏死因子抑制剂(TNFI)应答不足(IR)的 AS 患者中,根据累积排序曲线下面积(SUCRA),司库奇尤单抗 300mg 与最佳的 SpA 国际学会 40%缓解率(ASAS40)应答率相关,而安慰剂与最差的结局相关。在 TNFI-IR 的 AS 患者中,与安慰剂组相比,司库奇尤单抗 300、150 和 75mg 组的 ASAS40 更高。基于 SUCRA 的疗效评分表明,司库奇尤单抗 300mg 最有可能成为实现 ASAS40 应答率的最佳治疗方法,其次是司库奇尤单抗 150mg 和 75mg,安慰剂最差。ASAS20 缓解率与 ASAS40 缓解率分布模式相同。在 TNFI 初治的 AS 患者中,300、150 和 75mg 组的 ASAS40 和 ASAS20 缓解率也显著高于安慰剂组。治疗组之间严重不良事件(SAE)的数量没有显著差异。

结论

司库奇尤单抗在 TNFI-IR 的 AS 患者中显示出剂量依赖性疗效,且不会增加 SAE 的风险。

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