Secondary failure to treatment with recombinant human IL-1 receptor antagonist in Chinese patients with rheumatoid arthritis
Secondary failure to treatment with recombinant human IL-1 receptor antagonist in Chinese patients with rheumatoid arthritis
复制标题
中国类风湿关节炎患者重组人IL-1受体拮抗剂治疗继发失败
DOI：
10.1007/s10067-010-1654-5
复制
发表时间：
2011-05-01
影响因子：
3.4
通讯作者：
Dai, Sheng-Ming
中科院分区：
文献类型：
--
作者：
Bao, Jun;Yue, Tao;Dai, Sheng-Ming
本研究的目的是评估阿那白滞素（一种重组人白细胞介素1受体拮抗剂）联合甲氨蝶呤（MTX）治疗对MTX治疗无效的活动性类风湿关节炎（RA）的疗效。共有54例活动性RA患者，他们正在服用稳定剂量的MTX，随机接受阿那白滞素（80 mg）或安慰剂每日皮下注射。采用美国流变学学会的标准，每4周评估一次临床结果，持续24周。24周后，阿那白滞素联合MTX治疗组与MTX单药治疗组相比，ACR 20改善率更高（64% vs. 17%，P = 0.004）。在阿那白滞素组中，38%观察到ACR 50应答，17%观察到ACR 70应答。单用MTX治疗的患者均未获得ACR 50或ACR 70改善。然而，阿那白滞素组42例患者中有9例（21.4%）最初显示治疗反应，此后阿那白滞素治疗继发性药物失败。阿那白滞素无应答者的平均DAS 28较基线显著增加（0.83 ± 1.38 vs. −1.28 ± 0.78，P < 0.001）。阿那白滞素通过阻断IL-1有效治疗活动性RA患者。然而，阿那白滞素的疗效很快失去了约五分之一的患者，尽管最初的良好反应。
The aim of this study is to assess the efficacy of anakinra, a recombinant human interleukin 1 receptor antagonist, plus methotrexate (MTX) in patients with active rheumatoid arthritis (RA) refractory to MTX therapy. A total of 54 patients with active RA, who were taking MTX at a stable dosage, were randomized to receive daily subcutaneous injections of anakinra (80 mg) or placebo. Clinical outcomes were assessed every 4 weeks for 24 weeks by using the criteria of the American College of Rheumatology. After 24 weeks, more patients achieved clinical benefits as determined by the ACR20 improvement treated with anakinra plus MTX compared with MTX alone (64% vs. 17%,P= 0.004). In the anakinra group, an ACR50 response was observed in 38% and an ACR70 response in 17%. None of the patients treated with MTX alone achieved ACR50 or ACR 70 improvement. However, nine of 42 (21.4%) patients in the anakinra group, who showed therapeutic response initially, had secondary drug failure to anakinra therapy thereafter. A significant increase in mean DAS28 from baseline was found in the non-responders to anakinra compared with placebo (0.83 ± 1.38 vs. −1.28 ± 0.78,P< 0.001). Anakinra is effective in the treatment of patients with active RA by blocking IL-1. However, the efficacy of anakinra is soon lost in about one fifth of patients in spite of initial good response.