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托法替布与阿普米司特治疗活动性银屑病关节炎患者的疗效和安全性比较:一项基于随机对照试验的贝叶斯网状Meta 分析。

Comparison of the Efficacy and Safety of Tofacitinib and Apremilast in Patients with Active Psoriatic Arthritis: A Bayesian Network Meta-Analysis of Randomized Controlled Trials.

机构信息

Department of Rheumatology, Korea University College of Medicine, Seoul, Korea.

Division of Rheumatology, Department of Internal Medicine, Korea University Anam Hospital, Korea University College of Medicine, 73, Inchon-ro, Seongbuk-gu, Seoul, 02841, Korea.

出版信息

Clin Drug Investig. 2019 May;39(5):421-428. doi: 10.1007/s40261-019-00765-w.

Abstract

BACKGROUND

Tofacitinib and apremilast have shown considerable efficacy in placebo-controlled trials of active psoriatic arthritis, but the relative efficacy and safety remain unclear because of a lack of head-to-head comparisons.

OBJECTIVE

The aim of this study was to assess the relative efficacy and safety of tofacitinib and apremilast at different doses in patients with active psoriatic arthritis.

METHOD

We performed a Bayesian network meta-analysis to combine evidence from randomized controlled trials for examination of the efficacy and safety of tofacitinib 10 mg, tofacitinib 5 mg, apremilast 30 mg, and apremilast 20 mg in psoriatic arthritis.

RESULTS

Eight randomized controlled trials including 3086 patients met the inclusion criteria. There were ten pairwise comparisons including six direct comparisons of five interventions. All the interventions achieved a significant American College of Rheumatology 20 response compared with placebo. Tofacitinib 10 mg and apremilast 30 mg were among the most effective treatments for active psoriatic arthritis, followed by tofacitinib 5 mg, and apremilast 20 mg. The ranking probability based on the surface under the cumulative ranking curve (SUCRA) indicated that tofacitinib 10 mg had the highest probability of being the best treatment in terms of the American College of Rheumatology 20 response rate (SUCRA = 0.785). This was followed by apremilast 30 mg (SUCRA = 0.670), tofacitinib 5 mg (SUCRA = 0.596), apremilast 20 mg (SUCRA = 0.448), and placebo (SUCRA = 0.001). We observed no significant differences in the incidence of serious adverse events after treatment with tofacitinib 10 mg, apremilast 30 mg, tofacitinib 5 mg, apremilast 20 mg, or placebo.

CONCLUSIONS

In patients with active psoriatic arthritis, tofacitinib 10 mg and apremilast 30 mg were the most efficacious interventions and were not associated with a significant risk of serious adverse events.

摘要

背景

托法替尼和阿普米司特在活动性银屑病关节炎的安慰剂对照试验中显示出显著疗效,但由于缺乏头对头比较,其相对疗效和安全性仍不清楚。

目的

本研究旨在评估不同剂量的托法替尼和阿普米司特在活动性银屑病关节炎患者中的相对疗效和安全性。

方法

我们进行了贝叶斯网络荟萃分析,以结合随机对照试验的证据,检查托法替尼 10mg、托法替尼 5mg、阿普米司特 30mg 和阿普米司特 20mg 在银屑病关节炎中的疗效和安全性。

结果

八项纳入了 3086 名患者的随机对照试验符合纳入标准。共有 10 项两两比较,包括 5 种干预措施的 6 项直接比较。与安慰剂相比,所有干预措施均达到美国风湿病学会 20 缓解标准。托法替尼 10mg 和阿普米司特 30mg 是治疗活动性银屑病关节炎最有效的药物之一,其次是托法替尼 5mg 和阿普米司特 20mg。基于累积排序曲线下面积(SUCRA)的排序概率表明,托法替尼 10mg 在达到美国风湿病学会 20 缓解率方面最有可能成为最佳治疗方法(SUCRA=0.785)。其次是阿普米司特 30mg(SUCRA=0.670)、托法替尼 5mg(SUCRA=0.596)、阿普米司特 20mg(SUCRA=0.448)和安慰剂(SUCRA=0.001)。我们没有观察到接受托法替尼 10mg、阿普米司特 30mg、托法替尼 5mg、阿普米司特 20mg 或安慰剂治疗后严重不良事件的发生率有显著差异。

结论

在活动性银屑病关节炎患者中,托法替尼 10mg 和阿普米司特 30mg 是最有效的干预措施,且与严重不良事件的发生无显著相关性。

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