Longterm Safety and Efficacy of Abatacept Through 5 Years of Treatment in Patients with Rheumatoid Arthritis and an Inadequate Response to Tumor Necrosis Factor Inhibitor Therapy
Longterm Safety and Efficacy of Abatacept Through 5 Years of Treatment in Patients with Rheumatoid Arthritis and an Inadequate Response to Tumor Necrosis Factor Inhibitor Therapy
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DOI：
10.3899/jrheum.111531
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发表时间：
2012-08-01
影响因子：
3.9
通讯作者：
Dougados, Maxime
中科院分区：
文献类型：
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作者：
Genovese, Mark C.;Schiff, Michael;Dougados, Maxime
Objective.评估阿巴西普在ATTAIN试验中对抗肿瘤坏死因子（TNF）治疗反应不充分的类风湿关节炎（RA）患者中的安全性和疗效。完成6个月双盲（DB）安慰剂对照期的患者有资格进入长期扩展（LTE），其中所有患者每4周接受阿巴西普（根据体重范围，类似于10 mg/kg）。全程监测安全性、有效性、身体功能和健康相关生活质量。总共有317名患者（218名DB阿巴西普，99名DB安慰剂）进入LTE; 150名（47.3%）完成了LTE。与DB期间相比，LTE期间严重不良事件、感染、严重感染、恶性肿瘤和自身免疫事件的总体发生率没有增加。在第6个月时，美国流变学学会对阿巴西普的反应维持了5年。在第5年，在接受阿巴西普治疗5年并有可用数据的患者中，38/103（36.9%）达到了由28关节疾病活动性评分（DA 528）/C反应蛋白（CRP）定义的低疾病活动性; 23/103（22.3%）达到了DAS 28/CRP定义的缓解。第5年时，62.5%的仍在接受治疗的患者实现了健康评估问卷应答;身体健康总评和心理健康总评评分较基线的平均改善分别为7.34和6.42。如果继续接受阿巴西普治疗，在整个LTE的每个时间点，高比例的患者保持疗效和身体功能益处或改善其疾病状态。安全性保持一致，阿巴西普疗效维持6个月至5年，证明了在既往抗TNF治疗失败的难治性RA患者人群中改用阿巴西普的益处。（2012年7月15日首次发布; J Rheumol 2012;39：1546-54; doi：10.3899/jrheum.111531）
Objective. To evaluate abatacept safety and efficacy over 5 years in patients with rheumatoid arthritis (RA) who had inadequate response to anti-tumor necrosis factor (TNF) therapy in the ATTAIN trial.Methods. Patients completing the 6-month, double-blind (DB) placebo-controlled period were eligible to enter the longterm extension (LTE), where all patients received abatacept every 4 weeks (similar to 10 mg/kg, according to weight range). Safety, efficacy, physical function, and health-related quality of life were monitored throughout.Results. In total, 317 patients (218 DB abatacept, 99 DB placebo) entered the LTE; 150(47.3%) completed it. Overall incidences of serious adverse events, infections, serious infections, malignant neoplasms, and autoimmune events did not increase during the LTE versus the DB period. American College of Rheumatology responses with abatacept at Month 6 were maintained over 5 years. At Year 5, among patients who received abatacept for 5 years and had available data, 38/103 (36.9%) achieved low disease activity as defined by the 28-joint Disease Activity Score (DA528)/C-reactive protein (CRP); 23/103 (22.3%) achieved DAS28/CRP-defined remission. Health Assessment Questionnaire response was achieved by 62.5% of patients remaining on treatment at Year 5; mean improvements from baseline in physical component summary and mental component summary scores were 7.34 and 6.42, respectively. High proportions of patients maintained efficacy and physical function benefits or improved their disease state at each timepoint throughout the LTE, if remaining on abatacept treatment.Conclusion. Safety remained consistent, and abatacept efficacy was maintained from 6 months to 5 years, demonstrating the benefits of switching to abatacept in this difficult-to-treat population of patients with RA previously failing anti-TNF therapy. (First Release July 15 2012; J Rheumatol 2012;39:1546-54; doi: 10.3899/jrheum.111531)