Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK.
NIHR Leeds Musculoskeletal Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Leeds, UK.
RMD Open. 2019 Feb 8;5(1):e000840. doi: 10.1136/rmdopen-2018-000840. eCollection 2019.
To complete reporting of outcomes after total withdrawal of all rheumatoid arthritis (RA) therapy and re-treatment after flare in Assessing Very Early Rheumatoid arthritis Treatment study (NCT01142726).
Patients with early RA were initially randomised to double-blind, weekly subcutaneous abatacept plus methotrexate, or abatacept or methotrexate monotherapy. At month 12, patients with Disease Activity Score (DAS)28 C reactive protein (CRP) <3.2 had all RA treatments rapidly withdrawn and were observed for ≤12 months or until flare. After ≥3 months' withdrawal, patients with protocol-defined RA flare received open-label abatacept plus methotrexate for 6 months (re-treatment).
Proportion of patients in DAS28-CRP-defined remission remained numerically higher in original abatacept plus methotrexate and abatacept arms versus methotrexate arm up to day 253 of withdrawal. At the end of the withdrawal period, few patients remained in remission across all arms: 9/73 (12.3%), 7/50 (14.0%) and 6/53 (11.3%), respectively. For patients entering re-treatment, after 6 months' re-treatment, 95/124 (76.6%) and 78/124 (62.9%) patients achieved DAS28-CRP <3.2 and <2.6, respectively; mean changes in DAS28-CRP and Health Assessment Questionnaire-Disability Index scores from re-treatment baseline were -2.87 and 0.76, respectively. Re-treatment was well tolerated; exposure-adjusted infection rates per 100 patient-years were lower with abatacept plus methotrexate during withdrawal (7.2) and re-treatment (17.2) versus initial treatment periods of months 0-6 (116.6) and 6-12 (64.6).
Most patients flared within 6 months of therapy withdrawal and few sustained major responses for 1 year. Re-treatment with abatacept plus methotrexate was effective and well tolerated in this controlled setting.
在评估早期类风湿关节炎治疗研究（NCT01142726）中，完成所有类风湿关节炎（RA）治疗完全停药和病情复发后再治疗的结局报告。
最初将早期 RA 患者随机分为双盲、每周皮下阿巴西普加甲氨蝶呤，或阿巴西普或甲氨蝶呤单药治疗。在第 12 个月时，DAS28-CRP<3.2 的患者快速停用所有 RA 治疗，并观察≤12 个月或直至病情复发。停药≥3 个月后，符合方案定义的 RA 复发患者接受开放标签阿巴西普加甲氨蝶呤治疗 6 个月（再治疗）。
在停药 253 天内，原始阿巴西普加甲氨蝶呤和阿巴西普组中 DAS28-CRP 定义的缓解患者比例在数值上仍高于甲氨蝶呤组。在停药期结束时，所有组中很少有患者仍处于缓解状态：分别为 9/73（12.3%）、7/50（14.0%）和 6/53（11.3%）。对于进入再治疗的患者，在 6 个月的再治疗后，95/124（76.6%）和 78/124（62.9%）患者分别达到 DAS28-CRP<3.2 和<2.6；再治疗基线时 DAS28-CRP 和健康评估问卷残疾指数的平均变化分别为-2.87 和 0.76。再治疗耐受性良好；与初始治疗的 0-6 个月（116.6）和 6-12 个月（64.6）期间相比，在停药期间（7.2）和再治疗期间（17.2），阿巴西普加甲氨蝶呤的暴露调整感染率每 100 患者年较低。
大多数患者在停药后 6 个月内病情复发，很少有患者在 1 年内持续获得主要缓解。在该对照环境中，阿巴西普加甲氨蝶呤再治疗是有效且耐受良好的。
