The First Department of Internal Medicine, School of Medicine.
Department of Laboratory and Transfusion Medicine, University of Occupational and Environmental Health, Japan, Kitakyushu.
Rheumatology (Oxford). 2022 Nov 2;61(11):4273-4285. doi: 10.1093/rheumatology/keac075.
To compare the outcome of various treatment de-escalation regimens in patients with RA who achieved sustained remission.
At period 1, 436 RA patients who were treated with MTX and bDMARDs and had maintained DAS28(ESR) at <2.6 were divided into five groups based on shared patient/physician decision-making; continuation, dose reduction and discontinuation of MTX or bDMARDs. At end of year 1, patients who achieved DAS28(ESR) <3.2 were allowed to enrol in period 2 for treatment using the de-escalation regimens for another year. The primary and secondary endpoints were the proportion of patients with DAS28(ESR) <2.6 at year 1 and 2, respectively.
Based on shared decision-making, 81.4% elected de-escalation of treatment and 48.4% selected de-escalation of MTX. At end of period 1, similar proportions of patients maintained DAS28(ESR) <2.6 (continuation, 85.2%; MTX dose reduction, 79.0%; MTX-discontinuation, 80.0%; bDMARD dose reduction, 73.9%), although the rate was significantly different between the continuation and bDMARD-discontinuation. At end of period 2, similar proportions of patients of the MTX groups maintained DAS28(ESR) <2.6 (continuation or de-escalation), but the rates were significantly lower in the bDMARD-discontinuation group. However, half of the latter group satisfactorily discontinued bDMARDs. Adverse events were numerically lower in MTX and bDMARD-de-escalation groups during period 1 and 2, compared with the continuation group.
After achieving sustained remission by combination treatment of MTX/bDMARDs, disease control was achieved comparably by continuation, dose reduction or discontinuation of MTX and dose reduction of bDMARDs at end of year 1. Subsequent de-escalation of MTX had no impacts on disease control but decreased adverse events in year 2.
比较达到持续缓解的 RA 患者各种治疗降级方案的结局。
在第 1 期，436 名接受 MTX 和 bDMARD 治疗且 DAS28（ESR）<2.6 的 RA 患者根据共同的患者/医生决策分为 5 组；继续、减少 MTX 或 bDMARD 的剂量和停止。在第 1 年末，达到 DAS28（ESR）<3.2 的患者允许参加第 2 期治疗，再使用降级方案治疗 1 年。主要和次要终点分别为第 1 年和第 2 年 DAS28（ESR）<2.6 的患者比例。
基于共同决策，81.4%的患者选择降级治疗，48.4%的患者选择减少 MTX 的剂量。第 1 期末，相似比例的患者保持 DAS28（ESR）<2.6（继续、MTX 剂量减少、MTX 停药、bDMARD 剂量减少），尽管继续治疗与 bDMARD 停药之间的比例显著不同。第 2 期末，MTX 组的相似比例的患者保持 DAS28（ESR）<2.6（继续或降级），但 bDMARD 停药组的比例显著较低。然而，后者组中有一半患者满意地停止了 bDMARD。与继续治疗组相比，第 1 期和第 2 期 MTX 和 bDMARD 降级组的不良事件数量较低。
在 MTX/bDMARD 联合治疗达到持续缓解后，在第 1 年末继续、减少 MTX 剂量和减少 bDMARD 剂量均可实现疾病控制。随后的 MTX 降级对疾病控制没有影响，但在第 2 年降低了不良事件的发生。
