Division of Immunology and Rheumatology, Stanford University School of Medicine, Palo Alto, California 94305, USA.
Drugs. 2010;70(2):121-45. doi: 10.2165/11531980-000000000-00000.
Health-related quality of life (HR-QOL) in patients with rheumatoid arthritis (RA) is significantly impaired as a result of pain, deficits in physical function and fatigue associated with this disease. Decrements in HR-QOL are also associated with an increased probability of no longer working, absence from work due to RA-associated sickness, and reduced productivity while at work or in the home, all of which have consequences for the patient as well as society. HR-QOL and productivity are thus important components in the assessment of outcomes in RA, and assessment of HR-QOL is now recommended in clinical trials that assess the efficacy of new treatments for RA. Measures to assess HR-QOL include the Medical Outcomes Study Short Form 36 (SF-36), EuroQol (EQ-5D) and the Health Utilities Index - Mark 3 (HUI3); these measures not only provide an indication of the clinical (i.e. statistical) efficacy of a treatment, but also provide information on whether this efficacy is truly 'meaningful' from a patient's perspective. These measures have been utilized in clinical trials of biological agents in patients with RA, including tumour necrosis factor inhibitors (etanercept, infliximab, adalimumab, certolizumab pegol and golimumab), the co-stimulatory inhibitor molecule abatacept, the B-cell depletion agent rituximab and the interleukin-6 receptor antagonist tocilizumab, and have demonstrated that these agents can significantly improve HR-QOL. Assessment of work productivity in patients with RA and the impact of treatment is a practical way to measure disability from RA from individual and societal perspectives. As RA affects women three times more frequently than men, there is also a critical need for productivity assessment within the home as well as participation in family/social/leisure activities. Data from recent trials of biological agents demonstrate that these agents can reverse disease-related decrements in productivity and limitations in participation in family, social and leisure activities in patients with active RA. However, despite this recognition, several challenges in the assessment of productivity remain, including standardization of instruments. Development of additional instruments to assess HR-QOL and productivity that are easier to use in daily practice may further improve our ability to monitor the effectiveness of therapies.
类风湿关节炎(RA)患者的健康相关生活质量(HR-QOL)因疼痛、身体功能缺陷和疲劳而显著受损,这些都是与该疾病相关的。HR-QOL 的下降也与不再工作的可能性增加、因 RA 相关疾病缺勤以及工作或在家时的生产力下降有关,所有这些都对患者和社会产生了影响。因此,HR-QOL 和生产力是 RA 评估结果的重要组成部分,现在建议在评估 RA 新治疗方法疗效的临床试验中评估 HR-QOL。评估 HR-QOL 的措施包括医疗结局研究短表 36(SF-36)、欧洲五维健康量表(EQ-5D)和健康效用指数 - 标记 3 版(HUI3);这些措施不仅提供了治疗临床(即统计学)疗效的指示,还提供了关于从患者角度来看这种疗效是否真正“有意义”的信息。这些措施已用于 RA 患者的生物制剂临床试验,包括肿瘤坏死因子抑制剂(依那西普、英夫利昔单抗、阿达木单抗、培塞利珠单抗和戈利木单抗)、共刺激抑制剂分子阿巴西普、B 细胞耗竭剂利妥昔单抗和白细胞介素-6 受体拮抗剂托珠单抗,这些试验表明这些药物可显著改善 HR-QOL。评估 RA 患者的工作生产力和治疗的影响是从个人和社会角度衡量 RA 致残的一种实用方法。由于 RA 对女性的影响是男性的三倍,因此也需要从家庭、参与家庭/社会/休闲活动的角度评估生产力。来自最近的生物制剂试验的数据表明,这些药物可以逆转活跃 RA 患者与疾病相关的生产力下降和参与家庭、社会和休闲活动的能力受限。然而,尽管认识到这一点,在评估生产力方面仍存在一些挑战,包括仪器的标准化。开发用于评估 HR-QOL 和生产力的额外工具,使其在日常实践中更易于使用,可能会进一步提高我们监测治疗效果的能力。