Schiff Michael H, Yu Elaine B, Weinblatt Michael E, Moreland Larry W, Genovese Mark C, White Barbara, Singh Amitabh, Chon Yun, Woolley J Michael
Denver Arthritis Clinic, University of Colorado, Denver, Colorado 80230, USA.
Drugs Aging. 2006;23(2):167-78. doi: 10.2165/00002512-200623020-00006.
The impact of long-term therapy for rheumatoid arthritis (RA) in elderly (> or = 65 years of age) and younger (< 65 years of age) patients, especially on patient-reported outcomes, has not been well studied. We evaluated patient-reported outcomes in elderly patients treated with etanercept, in contrast to outcomes in younger patients, using data from multiple controlled and open-label extension studies of patients with early RA (ERA; < or = 3 years) and late RA (LRA; disease-modifying antirheumatic drug [DMARD]-refractory RA).
This post hoc analysis included adult patients with RA enrolled in controlled, double-blind studies (up to 2 years) and subsequent open-label extension studies (up to 4 years). Patients were evaluated according to age at baseline of the original study. Patients may have received etanercept, placebo or methotrexate during the blinded treatment phases, but all patients had been receiving etanercept 25 mg twice weekly for at least 4 years. Both ERA and LRA extension studies are ongoing. Patient-reported outcome assessments included improvement in Health Assessment Questionnaire-Disability Index (HAQ-DI), proportions of patients achieving an improvement in HAQ-DI > or = 0.22 points, patients exhibiting worsening of HAQ-DI and patients achieving an HAQ-DI score of 0.
Elderly patients, with either ERA or LRA, had significantly worse baseline mean HAQ-DI scores than younger patients (p < 0.05, Student's t-test) in most studies, indicating greater disability. Improvement in HAQ-DI was greatest during the first 3 months after starting etanercept treatment in the controlled phase and appeared to be sustained over 3-6 months in patients with early or DMARD-refractory RA. Across the various controlled trials, mean improvements from baseline in HAQ-DI ranged from 0.39 to 0.92 points in elderly patients and from 0.57 to 1.00 points in younger patients. Patients with ERA and LRA, regardless of age group, maintained their improvement in HAQ-DI throughout the open-label extension trials for up to a total of 6 years of etanercept therapy. Change from baseline in HAQ-DI was moderately correlated with 28-joint Disease Activity Score within each age group across the multiple trials.
Both elderly and younger patients with RA treated with etanercept exhibited similar and rapid improvements in functional status during controlled studies, and these improvements were sustained during open-label extension trials.
类风湿关节炎（RA）长期治疗对老年（≥65岁）和年轻（<65岁）患者的影响，尤其是对患者报告结局的影响，尚未得到充分研究。我们使用来自早期RA（ERA；≤3年）和晚期RA（LRA；抗风湿药物[DMARD]难治性RA）患者的多项对照和开放标签扩展研究的数据，评估了接受依那西普治疗的老年患者与年轻患者相比的患者报告结局。
这项事后分析纳入了参加对照、双盲研究（长达2年）及随后开放标签扩展研究（长达4年）的成年RA患者。根据原始研究的基线年龄对患者进行评估。在盲法治疗阶段，患者可能接受了依那西普、安慰剂或甲氨蝶呤，但所有患者均已接受每周两次25mg依那西普治疗至少4年。ERA和LRA扩展研究均在进行中。患者报告结局评估包括健康评估问卷残疾指数（HAQ-DI）的改善、HAQ-DI改善≥0.22分的患者比例、HAQ-DI恶化的患者以及HAQ-DI评分为0的患者。
在大多数研究中，无论是ERA还是LRA，老年患者的基线平均HAQ-DI评分均显著低于年轻患者（p<0.05，Student t检验），表明残疾程度更高。在对照阶段开始依那西普治疗后的前3个月，HAQ-DI的改善最为显著，并且在早期或DMARD难治性RA患者中似乎在3-6个月内持续存在。在各种对照试验中，老年患者HAQ-DI从基线的平均改善范围为0.39至0.92分，年轻患者为0.57至1.00分。无论年龄组如何，ERA和LRA患者在长达6年的依那西普治疗的开放标签扩展试验中均维持了HAQ-DI的改善。在多个试验中，每个年龄组内HAQ-DI相对于基线的变化与28关节疾病活动评分中度相关。
接受依那西普治疗的老年和年轻RA患者在对照研究期间功能状态均表现出相似且快速的改善，并且这些改善在开放标签扩展试验中得以维持。
