Erasmus MC - University Medical Center Rotterdam, CA Rotterdam, The Netherlands.
Rheumatology (Oxford). 2010 Oct;49(10):1900-10. doi: 10.1093/rheumatology/keq109. Epub 2010 Jun 14.
To evaluate the association between improvements in physical function, fatigue and pain and improvements in productivity at work and at home in patients treated with certolizumab pegol (CZP) in combination with MTX.
Physical function, fatigue and pain were assessed in two CZP clinical trials (Rheumatoid Arthritis PreventIon of structural Damage 1 and 2) using the HAQ-Disability Index (HAQ-DI), Fatigue Assessment Scale (FAS) and Patient Assessment of Pain, with minimal clinically important differences (MCIDs) defined as ≥ 0.22, ≥ 1 and ≥ 10 points, respectively. Work and home productivity were evaluated using the RA-specific Work Productivity Survey (WPS-RA). The odds of achieving an HAQ-DI, FAS or pain 'response' at Week 12, defined as improvements ≥ MCID, were compared between CZP and control groups. Improvements in productivity at Week 12 were compared between CZP-treated HAQ-DI, FAS or pain responders and non-responders.
The odds of achieving improvements ≥ MCID were five times higher for pain, and two to three times higher for physical function and fatigue, in patients receiving CZP vs control. Per month, responders reported significantly greater improvements in productivity at work and reduced interference of RA with their work productivity than non-responders. Responders also reported significantly greater improvements in productivity at home and participation in family, social and leisure activities.
This study demonstrated a clear association between patient-reported improvements in physical function, fatigue and pain, and improvements in productivity both at work and home.
评估在接受培塞丽珠(CZP)联合甲氨蝶呤治疗的患者中,身体功能、疲劳和疼痛的改善与工作和家庭生产力改善之间的关联。
使用健康评估问卷残疾指数(HAQ-DI)、疲劳评估量表(FAS)和患者疼痛评估,对两项 CZP 临床试验(类风湿关节炎预防结构损伤 1 和 2)中的身体功能、疲劳和疼痛进行评估,其最小临床重要差异(MCID)分别定义为≥0.22、≥1 和≥10 分。使用特定于类风湿关节炎的工作生产力调查(WPS-RA)评估工作和家庭生产力。比较第 12 周时达到 HAQ-DI、FAS 或疼痛“应答”的 CZP 和对照组的患者比例,应答定义为改善≥MCID。比较第 12 周时 CZP 治疗后 HAQ-DI、FAS 或疼痛应答者和无应答者的生产力改善情况。
与接受对照治疗的患者相比,接受 CZP 治疗的患者疼痛改善达到 MCID 的可能性高 5 倍,身体功能和疲劳改善的可能性高 2 至 3 倍。每月,应答者报告的工作生产力改善和减少 RA 对其工作生产力的干扰明显大于无应答者。应答者还报告称,家庭生产力、参与家庭、社会和休闲活动的改善明显更大。
本研究清楚地表明,患者报告的身体功能、疲劳和疼痛的改善与工作和家庭生产力的改善之间存在明显关联。