Long-term safety, efficacy and inhibition of radiographic progression with abatacept treatment in patients with rheumatoid arthritis and an inadequate response to methotrexate: 3-year results from the AIM trial
Long-term safety, efficacy and inhibition of radiographic progression with abatacept treatment in patients with rheumatoid arthritis and an inadequate response to methotrexate: 3-year results from the AIM trial
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DOI：
10.1136/ard.2010.139345
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发表时间：
2011-10-01
影响因子：
27.4
通讯作者：
Genant, Harry K.
中科院分区：
文献类型：
--
作者：
Kremer, Joel M.;Russell, Anthony S.;Genant, Harry K.
目的评价阿巴接受对甲氨蝶呤（MTX）难治性类风湿关节炎（RA）患者治疗3年以上的疗效。方法在甲氨蝶呤充分应答（AIM）试验中，在为期1年的A batacept双盲期，随机分配到abatacept或安慰剂（+ MTX）的患者在长期延长（LTE）中接受开放标签abatacept （+ MTX）治疗。无论随机分组如何，对接受1剂量阿巴接受的患者进行安全性评估。对随机分配到abataccept的进入LTE的患者进行疗效评估。结果：433例和219例患者被随机分组，分别接受阿巴接受或安慰剂治疗；378和161进入LTE。在第3440 /539例患者仍在进行中。在LTE中未观察到意外安全事件。到第3年，不良事件和严重不良事件发生率分别为249.8/100和15.1/100患者-年。随着时间的推移，发病率总体上保持稳定。在第3年，84.8%、63.4%和37.5%的患者分别达到了美国风湿病学会（American College of Rheumatology， ACR） 20、50和70的标准，而在第1年，这一比例分别为82.3%、54.3%和32.4%。Genant-modified Sharp评分的平均变化在3年内逐渐减少，与第2年相比，第3年的抑制作用明显更大（总分p=0.022）。结论：在甲氨蝶呤不足的RA应答者中，abataccept提供了一致的安全性和持续3年的疗效。数据表明，抑制疾病改善作用对影像学进展的影响越来越大。
Objective To evaluate abatacept treatment over 3 years in patients with rheumatoid arthritis (RA) refractory to methotrexate (MTX).Methods Patients randomised to abatacept or placebo (+ MTX) during the 1-year double-blind period of the A batacept in I nadequate responders to Methotrexate (AIM) trial received open-label abatacept (+ MTX) in the long-term extension (LTE). Safety was assessed for patients who received = 1 dose of abatacept, regardless of randomisation group. Efficacy was assessed for patients randomised to abatacept who entered the LTE.Results 433 and 219 patients were randomised and treated with abatacept or placebo, respectively; 378 and 161 entered the LTE. At year 3, 440/539 patients were ongoing. No unexpected safety events were observed in the LTE. By year 3, incidence rates of adverse event and serious adverse events were 249.8/100 and 15.1/100 patient-years, respectively. Incidence rates were generally stable over time. At year 3, 84.8%, 63.4% and 37.5% of patients achieved American College of Rheumatology (ACR) criteria of 20, 50 and 70, respectively, compared with 82.3%, 54.3% and 32.4% of patients at year 1. Mean changes in Genant-modified Sharp scores were reduced progressively over 3 years, with significantly greater inhibition during year 3 compared with year 2 (p=0.022 for total score).Conclusion In MTX-inadequate responders with RA, abatacept provided consistent safety and sustained efficacy over 3 years. The data suggest an increasing inhibitory disease-modifying effect on radiographic progression.