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生物制剂治疗银屑病关节炎的疗效和安全性:系统文献回顾和网络荟萃分析。

Efficacy and safety of biologics in psoriatic arthritis: a systematic literature review and network meta-analysis.

机构信息

Rheumatology Center, Purpan Teaching Hospital, Toulouse, France.

Rheumatology Center, UMR 1027, Inserm, Paul Sabatier University Toulouse III, Toulouse, France.

出版信息

RMD Open. 2020 Feb;6(1). doi: 10.1136/rmdopen-2019-001117.

DOI:10.1136/rmdopen-2019-001117
PMID:32094304
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7046955/
Abstract

BACKGROUND

Biologic disease-modifying antirheumatic drugs (bDMARDs) and targeted synthetic DMARDs are used in patients with psoriatic arthritis (PsA), but few studies directly compare their clinical efficacy. In such situations, network meta-analysis (NMA) can inform evidence-based decision-making.

OBJECTIVE

To evaluate the comparative efficacy and safety of approved bDMARDs in patients with PsA.

METHODS

Bayesian NMA was conducted to compare the clinical efficacy of bDMARDs at weeks 12‒16 in bDMARD-naïve patients with PsA in terms of American College of Rheumatology (ACR) criteria, Psoriatic Arthritis Response Criteria (PsARC) and Psoriasis Area and Severity Index (PASI). Safety end points were evaluated in the overall mixed population of bDMARD-naive and bDMARD-experienced patients.

RESULTS

For ACR, all treatments except abatacept were statistically superior to placebo. Infliximab was most effective, followed by golimumab and etanercept, which were statistically superior to most other treatments. Ixekizumab 80 mg every 2 weeks (Q2W) was statistically superior to abatacept subcutaneous, apremilast and both regimens of ustekinumab; similar findings were observed for ixekizumab 80 mg Q4W. For PsARC response, ixekizumab did not significantly differ from other therapies, except for golimumab, infliximab and etanercept, which were superior to most other agents including ixekizumab. For PASI response, infliximab was numerically most effective, but was not statistically superior to ixekizumab, which was the next best performing agent. Analysis of safety end points identified few differences between treatments.

CONCLUSION

Our NMA confirms the efficacy and acceptable safety profile of bDMARDs in patients with active PsA. There were generally few statistically significant differences between most treatments.

摘要

背景

生物制剂改善病情抗风湿药(bDMARDs)和靶向合成 DMARDs 用于治疗银屑病关节炎(PsA)患者,但很少有研究直接比较它们的临床疗效。在这种情况下,网络荟萃分析(NMA)可以为循证决策提供信息。

目的

评估 bDMARDs 在治疗银屑病关节炎患者中的疗效和安全性。

方法

对生物制剂初治的银屑病关节炎患者在 12-16 周时进行美国风湿病学会(ACR)标准、银屑病关节炎反应标准(PsARC)和银屑病面积和严重程度指数(PASI)的比较,采用贝叶斯 NMA 比较 bDMARD 疗效。在 bDMARD 初治和 bDMARD 经验患者的混合人群中评估安全性终点。

结果

在 ACR 方面,除阿巴西普外,所有治疗均优于安慰剂。英夫利昔单抗最有效,其次是戈利木单抗和依那西普,与大多数其他治疗相比具有统计学优势。每 2 周(Q2W) 80mg 依西单抗优于阿巴西普皮下制剂、阿普米司特和两种乌司奴单抗方案;每 4 周(Q4W) 80mg 依西单抗也有类似的发现。在 PsARC 反应方面,除戈利木单抗、英夫利昔单抗和依那西普外,依西单抗与其他治疗方法无显著差异,而这些药物均优于大多数其他药物,包括依西单抗。在 PASI 反应方面,英夫利昔单抗的效果最佳,但在统计学上并不优于依西单抗,后者是下一个表现最好的药物。安全性终点分析发现各治疗方案之间差异较小。

结论

我们的 NMA 证实了 bDMARDs 在活动期银屑病关节炎患者中的疗效和可接受的安全性。大多数治疗方法之间通常没有统计学上的显著差异。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/477c/7046955/f2d4188f371a/rmdopen-2019-001117f04.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/477c/7046955/f4db2831be93/rmdopen-2019-001117f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/477c/7046955/e8d0d5371656/rmdopen-2019-001117f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/477c/7046955/28de987cb41e/rmdopen-2019-001117f03.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/477c/7046955/f2d4188f371a/rmdopen-2019-001117f04.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/477c/7046955/f4db2831be93/rmdopen-2019-001117f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/477c/7046955/e8d0d5371656/rmdopen-2019-001117f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/477c/7046955/28de987cb41e/rmdopen-2019-001117f03.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/477c/7046955/f2d4188f371a/rmdopen-2019-001117f04.jpg

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