Genant H K, Peterfy C G, Westhovens R, Becker J-C, Aranda R, Vratsanos G, Teng J, Kremer J M
University of California, San Francisco, San Francisco, CA, USA.
Ann Rheum Dis. 2008 Aug;67(8):1084-9. doi: 10.1136/ard.2007.085084. Epub 2007 Dec 17.
Assess the effect of abatacept on progression of structural damage over 2 years in patients with rheumatoid arthritis who had an inadequate response to methotrexate.
539 patients entered an open-label extension of the AIM (Abatacept in Inadequate responders to Methotrexate) trial and received abatacept. Radiographic assessment of the hands and feet was performed at baseline, year 1 and year 2. At year 2, each patient's radiographs were scored for progression blinded to sequence and treatment allocation.
In patients treated with abatacept for 2 years, greater reduction in progression of structural damage was observed in year 2 than in year 1. The mean change in total Genant-modified Sharp scores was reduced from 1.07 units in year 1 to 0.46 units in year 2. Similar reductions were observed in erosion and joint space narrowing scores. Following 2 years of treatment with abatacept, 50% of patients had no progression of structural damage as defined by a change in the total score of < or =0 compared with baseline. 56% of patients treated with abatacept had no progression during the first year compared with 45% of patients treated with placebo. In their second year of treatment with abatacept, more patients had no progression than in the first year (66% vs 56%).
Abatacept has a sustained effect that inhibits progression of structural damage. Furthermore, the mean change in radiographic progression in patients treated with abatacept for 2 years was significantly lower in year 2 versus year 1, suggesting that abatacept may have an increasing disease-modifying effect on structural damage over time.
评估阿巴西普对甲氨蝶呤治疗反应不佳的类风湿关节炎患者2年内结构损伤进展的影响。
539名患者进入AIM(甲氨蝶呤治疗反应不佳患者使用阿巴西普)试验的开放标签扩展阶段并接受阿巴西普治疗。在基线、第1年和第2年对手部和足部进行影像学评估。在第2年,对每位患者的X线片进行评分,评分时对序列和治疗分配情况保密。
接受阿巴西普治疗2年的患者中,第2年结构损伤进展的减少幅度大于第1年。Genant改良Sharp总分的平均变化从第1年的1.07个单位降至第2年的0.46个单位。在侵蚀和关节间隙狭窄评分方面也观察到类似的降低。接受阿巴西普治疗2年后,50%的患者结构损伤无进展,定义为总分与基线相比变化≤0。接受阿巴西普治疗的患者中,56%在第一年无进展,而接受安慰剂治疗的患者为45%。在接受阿巴西普治疗的第二年,无进展的患者比第一年更多(66%对56%)。
阿巴西普具有持续抑制结构损伤进展的作用。此外,接受阿巴西普治疗2年的患者,第2年影像学进展的平均变化显著低于第1年,这表明随着时间推移,阿巴西普对结构损伤可能具有越来越强的病情改善作用。