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给予活动性类风湿关节炎患者15毫克和30毫克乌帕替尼的疗效及安全性比较:一项随机对照试验的贝叶斯网络荟萃分析

Comparative efficacy and safety of 15 and 30 mg upadacitinib administered to patients with active rheumatoid arthritis: a Bayesian network meta-analysis of randomized controlled trials.

作者信息

Song G G, Lee Y H

机构信息

Department of Rheumatology, Korea University College of Medicine, Seoul, Korea (Republic of).

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

出版信息

Z Rheumatol. 2020 Feb;79(1):103-111. doi: 10.1007/s00393-019-0601-3.

DOI:10.1007/s00393-019-0601-3
PMID:30725185
Abstract

OBJECTIVES

We assessed the relative efficacy and safety of once-daily administration of 15 and 30 mg upadacitinib (a JAK1-selective inhibitor) in patients with active rheumatoid arthritis (RA).

METHODS

We conducted a Bayesian network meta-analysis to combine the direct and indirect evidence from randomized controlled trials (RCTs) that examined the efficacy and safety of upadacitinib in patients with active RA.

RESULTS

Five RCTs involving 4381 patients met the inclusion criteria. There were 15 pairwise comparisons, including eight direct comparisons and six interventions. The ACR20 response rate was significantly higher in the upadacitinib 15 and 30 mg + MTX (methotrexate) groups than in the MTX group (OR: 4.98, 95% CrI: 2.66-10.10; OR: 4.73, 95% CrI: 2.25-10.98). Adalimumab 40 mg + MTX, upadacitinib 30 mg, and upadacitinib 15 mg groups showed a significantly higher ACR20 response rate than did the MTX group. Ranking probability based on the surface under the cumulative ranking curve (SUCRA) indicated that upadacitinib 15 mg + MTX was likely to achieve the best ACR20 response rate (SUCRA = 0.838), followed by upadacitinib 30 mg + MTX, adalimumab 40 mg + MTX, upadacitinib 30 mg, upadacitinib 15 mg, and MTX (SUCRA = 0.784, 0.495, 0.471, 0.404, and 0.008, respectively). The safety based on the number of serious adverse events (SAEs) did not differ significantly among the six interventions.

CONCLUSIONS

Upadacitinib 15 and 30 mg administration once daily in combination with MTX was the most efficacious intervention for active RA, with no significant risk for SAEs.

摘要

目的

我们评估了每日一次服用15毫克和30毫克乌帕替尼(一种JAK1选择性抑制剂)对活动性类风湿关节炎(RA)患者的相对疗效和安全性。

方法

我们进行了一项贝叶斯网络荟萃分析,以整合来自随机对照试验(RCT)的直接和间接证据,这些试验研究了乌帕替尼对活动性RA患者的疗效和安全性。

结果

五项涉及4381名患者的RCT符合纳入标准。有15项成对比较,包括八项直接比较和六种干预措施。乌帕替尼15毫克组和30毫克组联合甲氨蝶呤(MTX)的ACR20缓解率显著高于MTX组(OR:4.98,95% CrI:2.66 - 10.10;OR:4.73,95% CrI:2.25 - 10.98)。阿达木单抗40毫克联合MTX组、乌帕替尼30毫克组和乌帕替尼15毫克组的ACR20缓解率显著高于MTX组。基于累积排名曲线下面积(SUCRA)的排名概率表明,乌帕替尼15毫克联合MTX最有可能实现最佳ACR20缓解率(SUCRA = 0.838),其次是乌帕替尼30毫克联合MTX、阿达木单抗40毫克联合MTX、乌帕替尼30毫克、乌帕替尼15毫克和MTX(SUCRA分别为0.784、0.495、0.471、0.404和0.008)。基于严重不良事件(SAE)数量的安全性在六种干预措施之间没有显著差异。

结论

每日一次服用15毫克和30毫克乌帕替尼联合MTX是治疗活动性RA最有效的干预措施,且SAE风险不显著。

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