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真实世界研究比较了 Janus 激酶抑制剂在治疗困难的类风湿关节炎患者中的疗效。

Real-world study comparing the efficacy of Janus kinase inhibitors in patients with difficult-to-treat rheumatoid arthritis.

机构信息

Department of Orthopedic Surgery, Kobe University Graduate School of Medicine, 7-5-1 Kusunoki-Cho, Chuo-Ku, Kobe, 650-0017, Japan.

Department of Rheumatology and Clinical Immunology, Kobe University Graduate School of Medicine, Kobe, Japan.

出版信息

Clin Rheumatol. 2024 Nov;43(11):3285-3292. doi: 10.1007/s10067-024-07117-w. Epub 2024 Sep 7.

Abstract

OBJECTIVE

This study aimed to analyze the clinical efficacy of JAK inhibitors in difficult-to-treat rheumatoid arthritis (D2TRA) and non-D2TRA patients and evaluate the factors influencing their efficacy using real-world data.

METHOD

Here, 159 JAK inhibitor-treated patients with rheumatoid arthritis were categorized into D2TRA and non-D2TRA groups. Data including the Clinical Disease Activity Index (CDAI) at initiation and 6 months after drug administration, drug retention months, and reason for discontinuation due to toxic adverse events were collected.

RESULTS

The retention rates at 6 months were 64.0% (D2TRA) and 78.4% (non-D2TRA) and were significantly different between the two groups (p = 0.030). The discontinuation rate owing to toxic adverse events significantly differed between the two groups (p = 0.030). The CDAI-low disease activity (LDA) rates differed significantly between the two groups (non-D2TRA, 62.3%; D2TRA, 34%; p < 0.001). CDAI-LDA achievement at 6 months after drug introduction was significantly associated with the number of times that biologic and/or targeted synthetic disease-modifying anti-rheumatic drugs were previously used and the CDAI at baseline in all patients treated with JAK inhibitors. However, no predictive factors were identified for D2TRA patients treated with JAK inhibitors.

CONCLUSION

Compared to non-D2TRA patients, D2TRA patients demonstrated significantly lower drug retention rates, CDAI-LDA achievement rates, and safety of JAK inhibitors. No significant predictive factor for CDAI-LDA achievement 6 months after drug introduction was detected in D2TRA patients. Key Points • The retention of JAK inhibitors were significantly lower for the treatment of D2TRA patients in comparison with non-D2TRA patients. • The efficacy and safety of JAK inhibitors were significantly lower for the treatment of D2TRA patients. • Number of previous uses of b/tsDMARDs and CDAI at baseline were identified as the predictive factors for resistance to CDAI-LDA achievement to JAK inhibitor treatment. • No significant predictive factor for CDAI-LDA achievement 6 months after drug introduction was detected in D2TRA patients.

摘要

目的

本研究旨在分析 JAK 抑制剂在治疗难治性类风湿关节炎(D2TRA)和非 D2TRA 患者中的临床疗效,并利用真实世界数据评估影响疗效的因素。

方法

在这里,将 159 名接受 JAK 抑制剂治疗的类风湿关节炎患者分为 D2TRA 和非 D2TRA 两组。收集的数据包括药物治疗开始时和 6 个月后的临床疾病活动指数(CDAI)、药物保留月数以及因毒性不良反应而停药的原因。

结果

6 个月时的保留率分别为 64.0%(D2TRA)和 78.4%(非 D2TRA),两组之间差异有统计学意义(p=0.030)。两组之间因毒性不良反应而停药的比例差异有统计学意义(p=0.030)。两组之间的低疾病活动率(LDA)差异有统计学意义(非 D2TRA,62.3%;D2TRA,34%;p<0.001)。药物治疗开始后 6 个月时达到 CDAI-LDA 的比例与所有接受 JAK 抑制剂治疗的患者之前使用生物制剂和/或靶向合成疾病修饰抗风湿药物的次数以及基线时的 CDAI 显著相关。然而,未发现 D2TRA 患者的预测因素。

结论

与非 D2TRA 患者相比,D2TRA 患者的 JAK 抑制剂保留率、CDAI-LDA 达标率和安全性显著降低。未发现 D2TRA 患者药物治疗开始后 6 个月时达到 CDAI-LDA 的显著预测因素。

关键点

  • 与非 D2TRA 患者相比,D2TRA 患者接受 JAK 抑制剂治疗的保留率显著降低。

  • D2TRA 患者接受 JAK 抑制剂治疗的疗效和安全性显著降低。

  • 之前使用生物制剂和/或靶向合成疾病修饰抗风湿药物的次数以及基线时的 CDAI 是 JAK 抑制剂治疗抵抗达到 CDAI-LDA 的预测因素。

  • 未发现 D2TRA 患者药物治疗开始后 6 个月时达到 CDAI-LDA 的显著预测因素。

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