Russell A S, Wallenstein G V, Li T, Martin M C, Maclean R, Blaisdell B, Gajria K, Cole J C, Becker J-C, Emery P
562 Heritage Medical Research Centre, University of Alberta, Edmonton, AB, T6G 2S2 Canada.
Ann Rheum Dis. 2007 Feb;66(2):189-94. doi: 10.1136/ard.2006.057018. Epub 2006 Sep 19.
To examine the impact of added abatacept treatment on health related quality of life (HRQoL) in patients with rheumatoid arthritis (RA) who have inadequate response to methotrexate (MTX).
The impact of abatacept treatment on HRQoL was examined in a longitudinal, randomised double blind, placebo controlled clinical trial. Effects of treatment on HRQoL were examined using repeated measures analysis of covariance and comparing rates of change in HRQoL across treatment groups. The relationship between American College of Rheumatology (ACR) clinical markers and disease duration with changes in HRQoL indicators was also examined. Finally, a responder analysis was used to examine the percentage of patients who improved by 0.5 SD in 12 months or who reached the normative levels seen in the US general population.
Statistically significant improvements in the abatacept group relative to controls were observed across a range of HRQoL measures, including physical function, fatigue, all eight domains of the SF-36, and the physical and mental component summaries (PCS and MCS). Improvements were seen as early as day 29 for fatigue and for five out of eight SF-36 domains. By day 169, all HRQoL measures were significantly better with abatacept than with placebo. HRQoL gains were associated with greater ACR clinical improvement, and the effects were consistent for patients with different disease duration. A significantly greater percentage of patients treated with abatacept reached normative levels of PCS, MCS, physical functioning, and fatigue compared with patients treated with MTX alone.
Combined abatacept and MTX treatment produces significant improvements across a wide range of HRQoL domains in patients with RA.
探讨在对甲氨蝶呤(MTX)反应不足的类风湿关节炎(RA)患者中,添加阿巴西普治疗对健康相关生活质量(HRQoL)的影响。
在一项纵向、随机双盲、安慰剂对照临床试验中,研究阿巴西普治疗对HRQoL的影响。使用重复测量协方差分析并比较各治疗组间HRQoL的变化率,来检验治疗对HRQoL的效果。还研究了美国风湿病学会(ACR)临床指标和病程与HRQoL指标变化之间的关系。最后,采用反应者分析来检验在12个月内改善0.5标准差或达到美国普通人群正常水平的患者百分比。
在一系列HRQoL测量指标中,包括身体功能、疲劳、SF-36的所有八个领域以及身体和心理成分总结(PCS和MCS),观察到阿巴西普组相对于对照组有统计学意义的改善。疲劳以及SF-36八个领域中的五个领域,早在第29天就出现了改善。到第169天,阿巴西普治疗的所有HRQoL测量指标均显著优于安慰剂。HRQoL的改善与更大程度的ACR临床改善相关,并且对不同病程的患者效果一致。与单独使用MTX治疗的患者相比,接受阿巴西普治疗的患者达到PCS、MCS、身体功能和疲劳正常水平的百分比显著更高。
阿巴西普联合MTX治疗可使RA患者在广泛HRQoL领域中取得显著改善。