NIHR Clinical Research Facility, University Hospital Southampton, Southampton, Hampshire, UK.
Pfizer, Collegeville, PA, USA.
Drugs Aging. 2019 Sep;36(9):853-862. doi: 10.1007/s40266-019-00691-8.
Elderly individuals are disproportionately affected by rheumatoid arthritis (RA), but few studies have addressed the efficacy and safety of treatments in this population.
Our objective was to assess the efficacy and safety of etanercept in elderly patients (aged ≥ 65 years) with RA.
The efficacy analysis was a post hoc analysis of data from the open-label period of three phase IV clinical trials of etanercept for RA. Least squares (LS) change from baseline (cfb) in 28-joint Disease Activity Score (DAS28), Health Assessment Questionnaire Disability Index (HAQ-DI), and modified Total Sharp Scores (mTSS) were analyzed by age (< 65 vs. ≥ 65 years) for each study. The safety analyses were of data pooled from the double-blind, placebo-controlled periods of 19 phase I-IV randomized studies of etanercept in patients with RA. The percentage occurrence of adverse events (AEs) in placebo- and etanercept-treated patients was analyzed by age (< 65 vs. ≥ 65 years).
There were no significant differences in LS mean cfb in DAS28 or mTSS between the two age groups. LS mean cfb in HAQ-DI scores was consistently lower in elderly than in non-elderly patients, although significant differences were not observed in all trials. Overall, AE occurrence was higher in elderly than non-elderly patients, regardless of treatment. In etanercept-treated patients, there were small yet statistically significant increases in the occurrence of congestive heart failure, serious infections, and non-melanoma skin cancers in elderly versus non-elderly patients. For most AEs, occurrence did not significantly differ between elderly and non-elderly patients.
Overall, there were no substantial differences in the efficacy or safety of etanercept between elderly and non-elderly patients with RA.
类风湿关节炎（RA）在老年人中发病率不成比例，但很少有研究针对这一人群的治疗效果和安全性。
我们旨在评估依那西普在老年（≥65 岁）RA 患者中的疗效和安全性。
疗效分析是对依那西普治疗 RA 的三项 IV 期临床试验开放标签期数据的事后分析。每个研究均根据年龄（<65 岁与≥65 岁）分析了从基线（cfb）开始的 28 关节疾病活动度评分（DAS28）、健康评估问卷残疾指数（HAQ-DI）和改良总 Sharp 评分（mTSS）的最小二乘（LS）变化。安全性分析是对依那西普治疗 RA 的 19 项 I-IV 期随机研究的双盲、安慰剂对照期数据的汇总。分析了安慰剂和依那西普治疗患者中不良事件（AE）的发生率，按年龄（<65 岁与≥65 岁）分组。
两组患者 DAS28 或 mTSS 的 LS 均值 cfb 无显著差异。HAQ-DI 评分的 LS 均值 cfb 始终在老年患者中低于非老年患者，但并非所有试验均观察到显著差异。总体而言，AE 的发生率在老年患者中高于非老年患者，无论治疗如何。在依那西普治疗患者中，与非老年患者相比，老年患者心力衰竭、严重感染和非黑素瘤皮肤癌的发生有小但有统计学意义的增加。对于大多数 AE，老年患者与非老年患者的发生率无显著差异。
总体而言，老年和非老年 RA 患者的依那西普疗效和安全性无显著差异。
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