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一项在埃及类风湿关节炎患者样本中进行的 JAK 抑制剂(巴瑞替尼)与 TNF-α 抑制剂和常规 DMARDs 的前瞻性随机对照非盲比较研究。

A prospective randomized-controlled non-blinded comparative study of the JAK inhibitor (baricitinib) with TNF-α inhibitors and conventional DMARDs in a sample of Egyptian rheumatoid arthritis patients.

机构信息

Rheumatology and Rehabilitation Department, Faculty of Medicine, Sohag University, Sohag, Egypt.

出版信息

Clin Rheumatol. 2024 Dec;43(12):3657-3668. doi: 10.1007/s10067-024-07194-x. Epub 2024 Oct 31.

Abstract

To evaluate the efficacy of baricitinib compared to TNF-α Inhibitors and conventional DMARDs (cDMARDs) in patients with RA. Our study included 334 RA patients classified into 3 groups: the first receiving baricitinib, the second receiving TNF-α Inhibitors, and the third receiving cDMARDs. Patients were evaluated at baseline, week 12, and week 24 using TJC, SJC, VAS, DAS28, CDAI, and HAQ-DI. Larsen score was measured at baseline and 24 weeks. The response to therapy was assessed at weeks 12 and 24 using ACR 20, ACR 50, and ACR 70 response criteria. Emerging treatment side effects were monitored. Patients receiving baricitinib showed significant improvement regarding all outcome measures at weeks 12 and 24. In addition, baricitinib was comparable to TNF Inhibitors in all outcome measures except the ACR 70 at week 12, which was higher in the baricitinib group. Furthermore, baricitinib group showed significantly better outcome measures and response to therapy in comparison to cDMARDs group. The most common side effects in the baricitinib group were infection, GIT, and CVS complications. The most common side effects in the TNF inhibitors group were infection and skin complications. The cDMARDs had the least side effects, mostly GIT complications. Baricitinib is an effective drug for treating RA refractory to cDMARDs, improving disease activity measures and functional status and reducing the progression of structural joint damage. It has a comparable efficacy and safety profile to TNF Inhibitors. Multicenter studies are recommended to support our results. Key Points • Baricitinib is an effective therapeutic choice for rheumatoid arthritis refractory to cDMARDs. • Patients treated with baricitinib showed improvement in all outcome measures and functional status. • Bricitinib delayed the progression of radiographic joint damage more effectively than cDMARDs. • The efficacy and safety of baricitinib for treating rheumatoid arthritis is comparable to that of TNF inhibitors.

摘要

评估巴瑞替尼与 TNF-α 抑制剂和传统 DMARDs(cDMARDs)在 RA 患者中的疗效。我们的研究纳入了 334 例 RA 患者,分为 3 组:第一组接受巴瑞替尼治疗,第二组接受 TNF-α 抑制剂治疗,第三组接受 cDMARDs 治疗。患者在基线、12 周和 24 周时接受 TJC、SJC、VAS、DAS28、CDAI 和 HAQ-DI 评估。在基线和 24 周时测量 Larsen 评分。在 12 周和 24 周时使用 ACR 20、ACR 50 和 ACR 70 缓解标准评估治疗反应。监测新出现的治疗副作用。在 12 周和 24 周时,接受巴瑞替尼治疗的患者在所有结局指标上均显示出显著改善。此外,除了在 12 周时 ACR 70 巴瑞替尼组更高外,巴瑞替尼在所有结局指标上与 TNF 抑制剂相当。此外,与 cDMARDs 组相比,巴瑞替尼组的结局指标和治疗反应明显更好。巴瑞替尼组最常见的副作用是感染、胃肠道和心血管并发症。TNF 抑制剂组最常见的副作用是感染和皮肤并发症。cDMARDs 组的副作用最少,主要是胃肠道并发症。巴瑞替尼是治疗对 cDMARDs 难治的 RA 的有效药物,可改善疾病活动度指标和功能状态,减少结构关节损伤的进展。它的疗效和安全性与 TNF 抑制剂相当。建议开展多中心研究以支持我们的结果。主要观点 • 巴瑞替尼是治疗对 cDMARDs 难治的 RA 的有效治疗选择。 • 接受巴瑞替尼治疗的患者在所有结局指标和功能状态上均有改善。 • 巴瑞替尼比 cDMARDs 更有效地延缓放射学关节损伤的进展。 • 巴瑞替尼治疗类风湿关节炎的疗效和安全性与 TNF 抑制剂相当。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7278/11582163/3a594d9321d4/10067_2024_7194_Fig1_HTML.jpg

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