Randomized, Double-blind, Placebo-controlled, Comparative Study of Human Anti-TNF Antibody Adalimumab in Combination with Methotrexate and Methotrexate Alone in Taiwanese Patients with Active Rheumatoid Arthritis
Randomized, Double-blind, Placebo-controlled, Comparative Study of Human Anti-TNF Antibody Adalimumab in Combination with Methotrexate and Methotrexate Alone in Taiwanese Patients with Active Rheumatoid Arthritis
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DOI：
10.1016/s0929-6646(09)60071-1
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发表时间：
2009-04-01
影响因子：
3.2
通讯作者：
Lan, Joung-Liang
中科院分区：
文献类型：
--
作者：
Chen, Der-Yuan;Chou, Show-Jan;Lan, Joung-Liang
背景/目的：阿达木单抗是一种完全人源化的单克隆抗体，可阻断肿瘤坏死因子(TNF)- α，有效治疗类风湿性关节炎（RA）患者。本研究的目的是比较阿达木单抗联合甲氨蝶呤（MTX）和单独使用MTX治疗台湾活动性RA患者的疗效和安全性。方法：47例活动性RA患者维持MTX治疗4周，稳定剂量为10- 15mg /周，随机盲目接受阿达木单抗40mg （n = 35）或安慰剂（n = 12），每隔一周皮下注射一次，为期12周。主要终点是根据美国风湿病学会在第12周的标准，压痛和肿胀的关节计数分别减少20% （ACR20）、50% （ACR50）和70% （ACR70）。治疗中出现的不良事件（teae）的发生是主要的安全性变量。结果：在治疗12周后，与单独使用MTX相比，阿达木单抗联合MTX显著减少了肿胀关节的数量（12.6 vs. 5.6, p = 0.011）、患者疾病活动性总体评估（18.0 vs. 4.8, p = 0.040）、疼痛视觉模拟量表（18.3 vs. 1.3, p = 0.015）和健康评估问卷的残疾指数（0.6 vs. 0.2, p = 0.031）。ACR20 （54.3% vs. 33.3%）、ACR50 （34.3% vs. 16.7%）和ACR70 （14.3% vs. 0%）评估了疾病活动性的总体改善，所有这些都有利于阿达木单抗加MTX组。除了阿达木单抗加MTX组的严重感染发生率略高外，治疗组之间的teae具有可比性。结论：在台湾活动性RA患者中，阿达木单抗联合MTX具有良好的耐受性，并且提供了比单独使用MTX更多的临床获益。[J]中华医学杂志，2009；108 (4): 310 - 319)
Background/Purpose: Adalimumab is a fully humanized monoclonal antibody that blocks tumor necrosis factor (TNF)-alpha, which is effective in the treatment of patients with rheumatoid arthritis (RA). The purpose of this study was to compare the efficacy and safety of adalimumab plus methotrexate (MTX) and MTX alone in Taiwanese patients with active RA.Methods: Forty-seven patients with active RA who were maintained on MTX therapy at a stable dose of 10-15 mg/week for 4 weeks were randomized blindly to receive adalimumab 40 mg (n = 35) or placebo (n = 12) by subcutaneous injection every other week over a period of 12 weeks. The primary endpoint was a reduction in tender and swollen joint counts of 20% (ACR20), 50% (ACR50) and 70% (ACR70), as determined by the American College of Rheumatology criteria in week 12. The occurrence of treatment-emergent adverse events (TEAEs) was the primary safety variable.Results: Addition of adalimumab to MTX resulted in a significant reduction in the number of swollen joints (12.6 vs. 5.6; p = 0.011), patients' global assessment of disease activity (18.0 vs. 4.8; p = 0.040), pain visual analog scale (18.3 vs. 1.3; p = 0.015), and disability indices of the Health Assessment Questionnaire (0.6 vs. 0.2; p = 0.031), compared with MTX alone after 12 weeks of therapy. Overall improvement in disease activity was assessed by ACR20 (54.3% vs. 33.3%), ACR50 (34.3% vs. 16.7%) and ACR70 (14.3% vs. 0%), and all favored the adalimumab plus MTX group. TEAEs were comparable between the treatment groups, except for a slightly higher incidence of severe infection in the adalimumab plus MTX group.Conclusion: Adalimumab in combination with MTX is well tolerated and provides significantly more clinical benefits than MTX alone in Taiwanese patients with active RA. [J Formos Med Assoc 2009;108(4): 310-319]