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比较托珠单抗、沙利鲁单抗和 sirukumab 在活动性类风湿关节炎患者中的疗效和耐受性:一项基于随机对照试验的贝叶斯网状荟萃分析。

Comparison of the efficacy and tolerability of tocilizumab, sarilumab, and sirukumab in patients with active rheumatoid arthritis: a Bayesian network meta-analysis of randomized controlled trials.

机构信息

Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, South Korea.

Department of Rheumatology, Korea University College of Medicine, 73, Inchon-ro, Seongbuk-gu, Seoul, 02841, South Korea.

出版信息

Clin Rheumatol. 2018 Jun;37(6):1471-1479. doi: 10.1007/s10067-018-4006-5. Epub 2018 Feb 5.

Abstract

The relative efficacy and tolerability of tocilizumab, sarilumab, and sirukumab were assessed in patients with rheumatoid arthritis (RA) and an inadequate response to methotrexate (MTX) or tumor necrosis factor (TNF) inhibitors. We performed a Bayesian network meta-analysis to combine direct and indirect evidence from randomized controlled trials (RCTs) to examine the efficacy and safety of tocilizumab, sarilumab, and sirukumab in RA patients and an inadequate MTX or TNF inhibitor response. Fourteen RCTs, comprising 9753 patients, met the inclusion criteria. Tocilizumab 8 mg combined with MTX or as monotherapy was the most effective treatment for active RA with an inadequate MTX or TNF antagonist response, followed by sarilumab and sirukumab, regardless of MTX combination. The ranking probability based on the surface under the cumulative ranking curve (SUCRA) indicated that tocilizumab 8 mg + MTX had the highest probability of being the best treatment to achieve the ACR50 response rate, followed by tocilizumab 8 mg, sarilumab 200 mg, sarilumab 200 mg + MTX, sirukumab 100 mg, tocilizumab 4 mg + MTX, sirukumab 100 mg + MTX, sirukumab 50 mg + MTX, sarilumab 150 mg + MTX, adalimumab 40 mg, and sirukumab 50 mg, and placebo + MTX. No significant differences were observed in withdrawals owing to adverse events after treatment with tocilizumab 8 mg + MTX, sirukumab 100 mg + MTX, or sarilumab 200 mg + MTX. In RA patients with an inadequate MTX or anti-TNF therapy response, tocilizumab 8 mg as monotherapy and combined with MTX showed acceptable tolerability and the highest performance based on the ACR50 response rate, followed by sarilumab and sirukumab.

摘要

在对甲氨蝶呤(MTX)或肿瘤坏死因子(TNF)抑制剂应答不足的类风湿关节炎(RA)患者中,评估了托珠单抗、沙利鲁单抗和 sirukumab 的相对疗效和耐受性。我们进行了贝叶斯网络荟萃分析,以结合来自随机对照试验(RCT)的直接和间接证据,检查托珠单抗、沙利鲁单抗和 sirukumab 在应答不足的 MTX 或 TNF 抑制剂的 RA 患者中的疗效和安全性。14 项 RCT,共纳入 9753 例患者,符合纳入标准。托珠单抗 8mg 联合 MTX 或作为单药治疗是治疗应答不足的 MTX 或 TNF 拮抗剂的 RA 最有效的方法,其次是沙利鲁单抗和 sirukumab,而不论是否联合 MTX。基于累积排序曲线下面积(SUCRA)的排序概率表明,托珠单抗 8mg+MTX 达到 ACR50 应答率的最佳治疗方法的可能性最高,其次是托珠单抗 8mg、沙利鲁单抗 200mg、沙利鲁单抗 200mg+MTX、sirukumab 100mg、托珠单抗 4mg+MTX、sirukumab 100mg+MTX、sirukumab 50mg+MTX、沙利鲁单抗 150mg+MTX、阿达木单抗 40mg 和 sirukumab 50mg,以及安慰剂+MTX。托珠单抗 8mg+MTX、sirukumab 100mg+MTX 或沙利鲁单抗 200mg+MTX 治疗后因不良反应停药的比例无显著差异。在对 MTX 或抗 TNF 治疗应答不足的 RA 患者中,托珠单抗 8mg 单药治疗和联合 MTX 显示出可接受的耐受性和最高的 ACR50 应答率,其次是沙利鲁单抗和 sirukumab。

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