Bathon Joan M, Fleischmann Roy M, Van der Heijde Désirée, Tesser John R, Peloso Paul M, Chon Yun, White Barbara
Division of Rheumatology, Johns Hopkins University, Baltimore, MD 21224, USA.
J Rheumatol. 2006 Feb;33(2):234-43.
To evaluate safety and efficacy of etanercept treatment in elderly (age > or = 65 yrs) and younger adult subjects (age < 65 yrs) with rheumatoid arthritis (RA).
Subset analyses were used to describe the safety and efficacy of etanercept in elderly and younger subjects treated for early and disease modifying antirheumatic drug-resistant or late-stage RA (ERA and LRA) in one of 4 randomized controlled clinical studies (N = 1353) or 2 longterm extensions (N = 1049).
Rates of serious adverse events tended to be higher in elderly than younger subjects; however, rates of safety events observed in elderly etanercept-treated subjects did not exceed rates in elderly placebo or methotrexate (MTX)-treated subjects. With regard to efficacy measures [American College of Rheumatology 20% response (ACR20), ACR50, and ACR70], elderly subjects tended to have somewhat less robust responses to treatment than younger subjects. However, for both age groups, treatment with etanercept resulted in improved efficacy and function compared with control treatment, and combination therapy with etanercept plus MTX resulted in greater efficacy than either etanercept or MTX used alone. Efficacy responses of elderly subjects were sustained for up to 6 years. Radiographic progression (measured using modified Sharp Score) after one year of treatment was lower in subjects treated with both etanercept and MTX compared with subjects treated with either agent used alone, and this pattern was similar in both age groups.
Consistent with responses in younger subjects, elderly subjects with RA treated with etanercept experienced significant improvement in disease activity and function without incurring additional safety concerns.
评估依那西普治疗老年（年龄≥65岁）和年轻成人（年龄<65岁）类风湿关节炎（RA）的安全性和有效性。
在4项随机对照临床研究之一（N = 1353）或2项长期扩展研究（N = 1049）中，采用亚组分析来描述依那西普在治疗早期、抗风湿药物耐药或晚期RA（ERA和LRA）的老年和年轻受试者中的安全性和有效性。
老年受试者严重不良事件的发生率往往高于年轻受试者；然而，在接受依那西普治疗的老年受试者中观察到的安全事件发生率并未超过接受安慰剂或甲氨蝶呤（MTX）治疗的老年受试者的发生率。关于疗效指标[美国风湿病学会20%反应率（ACR20）、ACR50和ACR70]，老年受试者对治疗的反应往往不如年轻受试者强烈。然而，对于两个年龄组，与对照治疗相比，依那西普治疗均能提高疗效和功能，依那西普联合MTX治疗的疗效优于单独使用依那西普或MTX。老年受试者的疗效反应可持续长达6年。与单独使用任何一种药物治疗的受试者相比，接受依那西普和MTX联合治疗的受试者在治疗1年后的影像学进展（使用改良Sharp评分测量）更低，且两个年龄组的这种模式相似。
与年轻受试者的反应一致，接受依那西普治疗的老年RA患者疾病活动度和功能有显著改善，且未产生额外的安全问题。
