Cole J C, Li T, Lin P, MacLean R, Wallenstein G V
QualityMetric, Lincoln, RI 02865-4207, USA.
Rheumatology (Oxford). 2008 Jul;47(7):1044-50. doi: 10.1093/rheumatology/ken141. Epub 2008 May 17.
Quality of life (QoL) improvement is important to demonstrate in RA clinical trials, but can be abstract. More meaningful measures of QoL include medical expenditure and job loss, aspects that have marked importance for RA patients, physicians and society. We re-examined previous positive QoL findings for abatacept over placebo by converting existing QoL measures into estimated medical expenditure and estimated likelihood of job loss.
Two double-blind, placebo-controlled, multicentre randomized clinical trials were undertaken: one for MTX failure (n = 652) and one for more severe anti-TNF failure patients (n = 391). Based on derived scores using previously published formulae, measures of monthly medical expenditure, current inability to work and job loss at 6 months, 1 yr and 2 yrs were analysed.
Abatacept led to greater reduction in medical expenditure over time in MTX failure ($152 lower) and anti-TNF failure patients ($122 lower) compared with placebo at end-point. Likewise, significantly more reduction in likelihood for current and future job loss was achieved with abatacept compared with placebo, which has 25-64% greater likelihood.
QoL changes provided greater reduction in medical expenditure and likelihood of an inability to work. The strong effect sizes obtained for all significant analyses suggest that the results are clinically meaningful. Moreover, given the nature of the variables, results should also be meaningful for patients, physicians, employers and health care insurance entities. Limitations are discussed regarding using estimated outcomes rather than analysis of actual outcomes.
在类风湿关节炎(RA)临床试验中证明生活质量(QoL)的改善很重要,但这可能比较抽象。对QoL更有意义的衡量指标包括医疗支出和失业,这些方面对RA患者、医生和社会都具有显著重要性。我们通过将现有的QoL指标转化为估计的医疗支出和估计的失业可能性,重新审视了之前关于阿巴西普相对于安慰剂在QoL方面的阳性结果。
进行了两项双盲、安慰剂对照、多中心随机临床试验:一项针对甲氨蝶呤(MTX)治疗失败的患者(n = 652),另一项针对更严重的抗TNF治疗失败的患者(n = 391)。基于使用先前发表的公式得出的分数,分析了每月医疗支出、当前无法工作以及6个月、1年和2年时失业的指标。
与安慰剂相比,在终点时,阿巴西普使MTX治疗失败患者(降低152美元)和抗TNF治疗失败患者(降低122美元)的医疗支出随着时间的推移有更大幅度的减少。同样,与安慰剂相比,阿巴西普使当前和未来失业可能性的降低幅度显著更大,其可能性高出25 - 64%。
QoL变化使医疗支出和无法工作的可能性有更大幅度的降低。所有显著分析获得的强大效应量表明结果具有临床意义。此外,鉴于变量的性质,结果对患者、医生、雇主和医疗保险实体也应该有意义。讨论了使用估计结果而非实际结果分析的局限性。