Maintenance Treatment using Abatacept with Dose Reduction after Achievement of Low Disease Activity in Patients with Rheumatoid Arthritis (MATADOR) - A prospective, multicenter, single arm pilot clinical trial
Maintenance Treatment using Abatacept with Dose Reduction after Achievement of Low Disease Activity in Patients with Rheumatoid Arthritis (MATADOR) - A prospective, multicenter, single arm pilot clinical trial
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类风湿关节炎患者达到低疾病活动度后使用阿巴西普维持治疗并减少剂量 (MATADOR) - 一项前瞻性、多中心、单臂试点临床试验
DOI：
10.1080/14397595.2017.1286714
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发表时间：
2017
期刊：
影响因子：
2.2
通讯作者：
Atsumi T
中科院分区：
文献类型：
--
作者：
Yasuda S;Ohmura K;Kanazawa H;Kurita K;Kon Y;Ishii T;Fujieda Y;Jodo S;Tanimura K;Minami M;Izumiyama T;Matsumoto T;Amasaki Y;Suzuki Y;Kasahara H;Yamauchi N;Kato M;Kamishima T;Tsutsumi A;Takemori H;Koike T;Atsumi T
目的：初步评价缓解期或低活动性维持性治疗的可行性。患者和方法：2013年3月至2015年3月，13个部位的类风湿关节炎患者接受维持性治疗，剂量减至250 mg/体/月。纳入标准是：(1)年龄在20岁或以上，(2)正在接受按批准剂量每月静脉注射的ABT，(3)至少6个月内DAS28-CRP值低于2.7%，(4)在书面知情同意的情况下同意参加这项试验，(5)体重低于125CPK( kg)。入选的患者每月静脉注射ABT，减少剂量为250 mg/体(斗牛士方案)。主要终点是患者在48周时继续使用斗牛士方案的比例。斗牛士方案在疾病突发或其他原因，如患者的要求或严重不良事件(AE)时被终止。结果：53例患者符合入选标准，随访1年。43例(81%)患者接受斗牛士方案治疗1年。三名患者经历了严重的急性脑炎。ABT降低时DAS28-CRP平均为1.56%，缓解率为88%；1年时DAS28-CRP平均为1.80%，缓解率为81%。42例受评患者中有34例获得结构性缓解。结论：尽管进一步的随机试验有待进一步的随机试验，但减少剂量的ABT被认为是缓解/LDA后RA维持治疗的一种可行的选择。
Objectives:To preliminarily evaluate the feasibility of maintenance therapy with reduced dose of intravenous abatacept (ABT) to 250 mg/body/month after achieving remission or low disease activity (LDA).Patients and methods:RA patients treated with ABT at 13 sites were enrolled in this prospective interventional pilot study during the period between March 2013 and March 2015. Inclusion criteria were (1) age at 20 years or older, (2) under treatment with monthly intravenous ABT at approved doses, (3) DAS28-CRP lower than 2.7 at least for 6 months, (4) agreed to join this trial with written informed consent and (5) body weight under 125 kg. Enrolled patients were maintained with intravenous monthly ABT at a reduced dose of 250 mg/body (MATADOR protocol). The primary end point was the proportion of the patients continued with MATADOR protocol at week 48. MATADOR protocol was discontinued upon disease flare or other reasons such as patients’ request or severe adverse event (AE). Disease activities and structural changes were also evaluated.Results:Fifty-three patients fulfilled the entry criteria and were followed for 1-year. MATADOR protocol was continued for 1-year in 43 (81%) of the evaluated patients. Three patients experienced severe AEs. Mean DAS28-CRP and remission rate were 1.56 and 88% when ABT reduced and 1.80 and 81% at 1-year, respectively. Structural remission was achieved in 34 out of 42 evaluated patients.Conclusions:Reduced dose of intravenous ABT was proposed as a feasible choice for maintenance therapy for RA after achievement of remission/LDA, although further randomized trials would be awaited.