Center for Rheumatology, Albany Medical College, 1367 Washington Ave, Albany, NY 12206, USA.
Ann Rheum Dis. 2011 Oct;70(10):1826-30. doi: 10.1136/ard.2010.139345.
To evaluate abatacept treatment over 3 years in patients with rheumatoid arthritis (RA) refractory to methotrexate (MTX).
Patients randomised to abatacept or placebo (+MTX) during the 1-year double-blind period of the Abatacept in Inadequate 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.
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).
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.
评估阿巴西普治疗对甲氨蝶呤（MTX）治疗反应不佳的类风湿关节炎（RA）患者 3 年的效果。
在 Abatacept 在甲氨蝶呤治疗反应不足的患者中（AIM）试验的 1 年双盲期随机分配至阿巴西普或安慰剂（+MTX）的患者在长期扩展（LTE）中接受开放标签的阿巴西普（+MTX）治疗。无论随机分组如何，均评估了接受≥1 剂阿巴西普治疗的患者的安全性。对随机分配至阿巴西普并进入 LTE 的患者进行疗效评估。
分别有 433 名和 219 名患者随机接受阿巴西普或安慰剂治疗，分别有 378 名和 161 名患者进入 LTE。在第 3 年，440/539 名患者仍在继续治疗。在 LTE 中未观察到意外的安全性事件。到第 3 年，不良事件和严重不良事件的发生率分别为 249.8/100 和 15.1/100 患者年。发生率总体上随时间稳定。在第 3 年，分别有 84.8%、63.4%和 37.5%的患者达到美国风湿病学会（ACR）标准的 20、50 和 70，而在第 1 年分别为 82.3%、54.3%和 32.4%。3 年来，Genant 改良 Sharp 评分的平均变化逐渐减少，第 3 年与第 2 年相比，抑制作用显著增加（总评分 p=0.022）。
在 MTX 治疗反应不佳的 RA 患者中，阿巴西普在 3 年内提供了一致的安全性和持续的疗效。数据表明对放射学进展的疾病缓解作用逐渐增加。
