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在对肿瘤坏死因子抑制剂反应不足的活动性银屑病关节炎患者中,司库奇尤单抗、依奇珠单抗和托法替布的疗效和安全性比较。

Comparative efficacy and safety of secukinumab, ixekizumab, and tofacitinib in patients with active psoriatic arthritis showing insufficient response to tumor necrosis factor inhibitors.

出版信息

Int J Clin Pharmacol Ther. 2021 Jul;59(7):511-518. doi: 10.5414/CP203944.

DOI:10.5414/CP203944
PMID:33835018
Abstract

OBJECTIVE

This study aimed to determine the relative effectiveness and safety of secukinumab, ixekizumab, and tofacitinib in patients with psoriatic arthritis (PsA) showing insufficient responses to tumor necrosis factor (TNF) inhibitors.

MATERIALS AND METHODS

A Bayesian network meta-analysis was conducted using direct and indirect data from five randomized controlled trials that examined the efficacy and safety of secukinumab 150 mg or 300 mg every 4 weeks, subcutaneously injected ixekizumab 80 mg every 2 weeks (Q2W) or every 4 weeks (Q4W), and tofacitinib 5 mg or 10 mg twice orally in active PsA patients responding insufficiently to TNF inhibitors.

RESULTS

Six RCTs, including 1,279 patients, fulfilled the inclusion criteria. Secukinumab 300 mg, listed at the top left of the league table diagonal, was associated with the most favorable American College of Rheumatology 20 (ACR20) response rate. Contrastingly, the placebo, listed at the bottom right of the league table diagonal, showed the least favorable results. The ixekizumab 80 mg Q2W or Q4W, secukinumab 150 mg, and tofacitinib 5 or 10 mg groups exhibited significantly higher ACR20 responses than the placebo group. The surface under the cumulative ranking curve (SUCRA)-based ranking probability suggested that secukinumab 300 mg was most likely the best treatment to achieve the ACR20 response rate, followed by ixekizumab 80 mg Q2W, secukinumab 150 mg, ixekizumab 80 mg Q4W, tofacitinib 5 and 10 mg, and the placebo.

CONCLUSION

Secukinumab, ixekizumab, and tofacitinib were effective in PsA patients with inadequate response to TNF inhibitors, without serious adverse event risks.

摘要

目的

本研究旨在确定司库奇尤单抗、依奇珠单抗和托法替布在对肿瘤坏死因子(TNF)抑制剂反应不足的银屑病关节炎(PsA)患者中的相对疗效和安全性。

材料和方法

采用贝叶斯网络荟萃分析,对五项随机对照试验的直接和间接数据进行分析,这些试验评估了皮下注射司库奇尤单抗 150mg 或 300mg,每 4 周 1 次;皮下注射依奇珠单抗 80mg,每 2 周(Q2W)或每 4 周(Q4W)1 次;以及托法替布 5mg 或 10mg,每日两次口服治疗对 TNF 抑制剂反应不足的活动性 PsA 患者的疗效和安全性。

结果

符合纳入标准的共有 6 项 RCT,共纳入 1279 例患者。司库奇尤单抗 300mg 位于疗效表左上角,与最有利的美国风湿病学会 20(ACR20)应答率相关。相比之下,疗效表右下角的安慰剂组显示出最不利的结果。依奇珠单抗 80mg Q2W 或 Q4W、司库奇尤单抗 150mg 和托法替布 5 或 10mg 组的 ACR20 应答率显著高于安慰剂组。基于累积排序曲线下面积(SUCRA)的排序概率表明,司库奇尤单抗 300mg 最有可能成为实现 ACR20 应答率的最佳治疗方法,其次是依奇珠单抗 80mg Q2W、司库奇尤单抗 150mg、依奇珠单抗 80mg Q4W、托法替布 5mg 和 10mg,以及安慰剂。

结论

司库奇尤单抗、依奇珠单抗和托法替布对 TNF 抑制剂反应不足的 PsA 患者有效,且无严重不良事件风险。

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