Objectives The aim of this study is to determine whether the ‘programmed’ infliximab (IFX) treatment strategy (for which the dose of IFX was adjusted based on the baseline serum tumour necrosis factor α (TNF-α)) is beneficial to induction of clinical remission after 54 weeks and sustained discontinuation of IFX for 1 year. Methods In this multicentre randomised trial, patients with IFX-naïve rheumatoid arthritis with inadequate response to methotrexate were randomised to two groups; patients in programmed treatment group received 3 mg/kg IFX until week 6 and after 14 weeks the dose of IFX was adjusted based on the baseline levels of serum TNF-α until week 54; patients in the standard treatment group received 3 mg/kg of IFX. Patients who achieved a simplified disease activity index (SDAI) ≤3.3 at week 54 discontinued IFX. The primary endpoint was the proportion of patients who sustained discontinuation of IFX at week 106. Results A total of 337 patients were randomised. At week 54, 39.4% (67/170) in the programmed group and 32.3% (54/167) in the standard group attained remission (SDAI ≤3.3). At week 106, the 1-year sustained discontinuation rate was not significantly different between two groups; the programmed group 23.5% (40/170) and the standard group 21.6% (36/167), respectively (2.2% difference, 95% CI −6.6% to 11.0%; p=0.631). Baseline SDAI <26.0 was a statistically significant predictor of the successfully sustained discontinuation of IFX at week 106. Conclusion Programmed treatment strategy did not statistically increase the sustained remission rate after 1 year discontinuation of IFX treatment.

中文翻译：

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类风湿关节炎患者获得缓解后持续停用英夫利昔单抗并增加剂量策略：RRRR 研究，一项随机对照试验

目的 本研究的目的是确定“程序化”英夫利昔单抗 (IFX) 治疗策略（根据基线血清肿瘤坏死因子 α (TNF-α) 调整 IFX 剂量）是否有利于诱导临床疗效。 54 周后缓解，并持续停用 IFX 1 年。方法 在这项多中心随机试验中，对甲氨蝶呤反应不足的 IFX 初治类风湿性关节炎患者被随机分为两组；方案治疗组患者接受3 mg/kg IFX直至第6周，14周后根据血清TNF-α基线水平调整IFX剂量直至第54周；标准治疗组的患者接受 3 mg/kg IFX。第 54 周达到简化疾病活动指数 (SDAI) ≤ 3.3 的患者停用 IFX。主要终点是第 106 周持续停用 IFX 的患者比例。 结果 共有 337 名患者被随机分组​​。第 54 周时，编程组中有 39.4% (67/170) 和标准组中有 32.3% (54/167) 获得缓解 (SDAI ≤ 3.3)。第 106 周时，两组的 1 年持续停药率没有显着差异；编程组分别为 23.5% (40/170) 和标准组 21.6% (36/167)（差异 2.2%，95% CI -6.6% 至 11.0%；p=0.631）。基线 SDAI <26.0 是第 106 周成功持续停止 IFX 的统计学显着预测因子。 结论 计划治疗策略在停止 IFX 治疗 1 年后并没有统计学上增加持续缓解率。