Division of Immunology and Rheumatology, Stanford University, Palo Alto, CA 94304, USA.
J Rheumatol. 2012 Aug;39(8):1546-54. doi: 10.3899/jrheum.111531. Epub 2012 Jul 15.
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.
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 (∼10 mg/kg, according to weight range). Safety, efficacy, physical function, and health-related quality of life were monitored throughout.
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 (DAS28)/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.
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.
评估阿巴西普在 ATTAIN 试验中对接受抗肿瘤坏死因子（TNF）治疗反应不足的类风湿关节炎（RA）患者的安全性和疗效，时间长达 5 年。
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）期，在此期间所有患者每 4 周接受一次阿巴西普（根据体重范围，约 10mg/kg）。整个过程中监测安全性、疗效、身体功能和健康相关生活质量。
共有 317 例患者（218 例 DB 阿巴西普，99 例 DB 安慰剂）进入 LTE；150 例（47.3%）完成了 LTE。与 DB 期相比，LTE 期严重不良事件、感染、严重感染、恶性肿瘤和自身免疫事件的总发生率并未增加。阿巴西普在第 6 个月的美国风湿病学会（ACR）反应在 5 年内保持不变。在第 5 年，对于接受阿巴西普治疗 5 年且有可用数据的患者，103 例中有 38 例（36.9%）达到了 28 关节疾病活动度评分（DAS28）/C 反应蛋白（CRP）定义的低疾病活动度；103 例中有 23 例（22.3%）达到了 DAS28/CRP 定义的缓解。在第 5 年仍接受治疗的患者中，有 62.5%的患者达到了健康评估问卷（HAQ）反应；与基线相比，身体成分摘要和精神成分摘要评分分别平均改善了 7.34 和 6.42。如果继续使用阿巴西普治疗，LTE 期间的每个时间点都有很大比例的患者保持疗效和身体功能获益，或改善疾病状态。
安全性保持一致，阿巴西普的疗效从 6 个月持续到 5 年，这表明在接受抗肿瘤坏死因子（TNF）治疗反应不足的类风湿关节炎（RA）患者中，从先前失败的抗 TNF 治疗切换到阿巴西普具有获益。
