Takeuchi Tsutomu, Matsubara Tsukasa, Ohta Shuji, Mukai Masaya, Amano Koichi, Tohma Shigeto, Tanaka Yoshiya, Yamanaka Hisashi, Miyasaka Nobuyuki
Division of Rheumatology, Department of Internal Medicine, School of Medicine, Keio University, Tokyo, Department of Rheumatology, Matsubara Mayflower Hospital, Kato, Department of Rheumatology, Taga General Hospital, Hitachi, Division of Rheumatology and Clinical Immunology, Department of Medicine, Sapporo City General Hospital, Sapporo, Department of Rheumatology and Clinical Immunology, Saitama Medical Center, Saitama Medical University, Kawagoe, Clinical Research Center for Allergy and Rheumatology, National Hospital Organization Sagamihara National Hospital, Sagamihara, First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health Hospital, Kitakyushu, Institute of Rheumatology, Tokyo Women's Medical University, Tokyo and Tokyo Medical and Dental University, Tokyo, Japan.
Rheumatology (Oxford). 2015 Apr;54(4):683-91. doi: 10.1093/rheumatology/keu338. Epub 2014 Sep 24.
The aim of this study was to determine whether biologic-free remission of RA is possible with discontinuation of abatacept.
Japanese RA patients in 28-joint DAS with CRP (DAS28-CRP) remission (<2.3) after >2 years of abatacept treatment in a phase II study and its long-term extension entered this 52 week, multicentre, non-blinded, prospective, observational study. At enrolment, the patients were offered the option to continue abatacept or not. The primary endpoint was the proportion of patients who remained biologic-free at 52 weeks after discontinuation. Clinical, functional and structural outcomes were compared between those who continued and those who discontinued abatacept.
Of 51 patients enrolled, 34 discontinued and 17 continued abatacept treatment. After 52 weeks, 22 of the 34 patients (64.7%) remained biologic-free. Compared with the continuation group, the discontinuation group had a similar remission rate (41.2% vs 64.7%, P = 0.144) although they had a significantly higher mean DAS28-CRP score at week 52 (2.9 vs 2.0, P = 0.012). The two groups were also similar with regard to mean HAQ Disability Index (HAQ-DI) score (0.6 for both, P = 0.920), mean change in total Sharp score (ΔTSS; 0.80 vs 0.32, P = 0.374) and proportion of patients in radiographic remission (ΔTSS ≤ 0.5) at the endpoint (64.3% vs 70.6%, P = 0.752). Those attaining DAS28-CRP < 2.3 or < 2.7 without abatacept at the endpoint had significantly lower HAQ-DI score and/or CRP at enrolment. Non-serious adverse events occurred in three patients who continued or resumed abatacept.
Biologic-free remission of RA is possible in some patients after attaining clinical remission with abatacept. Lower baseline HAQ-DI or CRP may predict maintenance of remission or low disease activity after discontinuation of abatacept.
UMIN Clinical Trials Registry, http://www.umin.ac.jp/ctr/ (UMIN000004137).
本研究旨在确定停用阿巴西普后类风湿关节炎（RA）是否有可能实现无生物制剂缓解。
在一项II期研究及其长期扩展研究中，接受阿巴西普治疗超过2年且处于28关节疾病活动度评分（DAS）联合C反应蛋白（CRP）缓解（DAS28-CRP<2.3）的日本RA患者进入了这项为期52周的多中心、非盲、前瞻性观察性研究。在入组时，患者可选择继续使用或停用阿巴西普。主要终点是停药后52周仍保持无生物制剂治疗的患者比例。比较了继续使用和停用阿巴西普的患者的临床、功能和结构结局。
51例入组患者中，34例停药，17例继续使用阿巴西普治疗。52周后，34例患者中有22例（64.7%）保持无生物制剂治疗。与继续用药组相比，停药组缓解率相似（41.2%对64.7%，P=0.144），尽管在第52周时其平均DAS28-CRP评分显著更高（2.9对2.0，P=0.012）。两组在平均健康评估问卷残疾指数（HAQ-DI）评分（均为0.6，P=0.920）、总Sharp评分的平均变化（ΔTSS；0.80对0.32，P=0.374）以及终点时影像学缓解（ΔTSS≤0.5）患者比例（64.3%对70.6%，P=0.752）方面也相似。在终点时未使用阿巴西普而达到DAS28-CRP<2.3或<2.7的患者在入组时HAQ-DI评分和/或CRP显著更低。3例继续使用或重新开始使用阿巴西普的患者发生了非严重不良事件。
在使用阿巴西普达到临床缓解后，部分患者的RA有可能实现无生物制剂缓解。较低的基线HAQ-DI或CRP可能预测停用阿巴西普后缓解的维持或低疾病活动度。
UMIN临床试验注册中心，http://www.umin.ac.jp/ctr/（UMIN000004137）
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