Yasuda Shinsuke, Ohmura Kazumasa, Kanazawa Hiroshi, Kurita Takashi, Kon Yujiro, Ishii Tomonori, Fujieda Yuichiro, Jodo Satoshi, Tanimura Kazuhide, Minami Michio, Izumiyama Tomomasa, Matsumoto Takumi, Amasaki Yoshiharu, Suzuki Yoko, Kasahara Hideki, Yamauchi Naofumi, Kato Masaru, Kamishima Tamotsu, Tsutsumi Akito, Takemori Hiromitsu, Koike Takao, Atsumi Tatsuya
a Division of Rheumatology, Endocrinology and Nephrology , Hokkaido University Graduate School of Medicine , Sapporo , Japan.
b Department of Rheumatology , Aomori Prefectural Central Hospital , Aomori , Japan.
Mod Rheumatol. 2017 Nov;27(6):930-937. doi: 10.1080/14397595.2017.1286714. Epub 2017 Feb 16.
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).
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.
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.
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.
初步评估在达到缓解或低疾病活动度（LDA）后，将静脉注射阿巴西普（ABT）剂量减至250mg/体/月进行维持治疗的可行性。
2013年3月至2015年3月期间，在13个地点接受ABT治疗的类风湿关节炎（RA）患者被纳入这项前瞻性干预性试点研究。纳入标准为：（1）年龄20岁及以上；（2）正在接受批准剂量的每月一次静脉注射ABT治疗；（3）DAS28-CRP低于2.7至少6个月；（4）书面知情同意参加本试验；（5）体重低于125kg。入组患者采用250mg/体的减量每月一次静脉注射ABT进行维持治疗（MATADOR方案）。主要终点是在第48周继续采用MATADOR方案治疗的患者比例。当疾病复发或出现其他原因（如患者要求或严重不良事件（AE））时，停止MATADOR方案。还评估了疾病活动度和结构变化。
53例患者符合入选标准，随访1年。43例（81%）评估患者持续采用MATADOR方案1年。3例患者出现严重AE。ABT减量时，平均DAS28-CRP和缓解率分别为1.56和88%，1年时分别为1.80和81%。42例评估患者中有34例实现了结构缓解。
尽管有待进一步的随机试验，但建议将减量静脉注射ABT作为RA达到缓解/LDA后维持治疗的一种可行选择。
