Etanercept or Methotrexate Withdrawal in Rheumatoid Arthritis Patients in Sustained Remission.
Etanercept or Methotrexate Withdrawal in Rheumatoid Arthritis Patients in Sustained Remission.
复制标题
DOI：
10.1002/art.41589
复制
发表时间：
2021-05
期刊：
影响因子：
--
通讯作者：
Chung JB
中科院分区：
文献类型：
--
作者：
Curtis JR;Emery P;Karis E;Haraoui B;Bykerk V;Yen PK;Kricorian G;Chung JB
类风湿性关节炎（RA）患者在甲氨蝶呤加依那西普联合治疗后获得缓解，但仍面临持续的药物负担。本研究旨在调查甲氨蝶呤或依那西普单药治疗是否能维持联合治疗的持续缓解，并在停止联合治疗中的一种或另一种药物后进行评估。在371名接受甲氨蝶呤+依那西普联合治疗的成年RA患者中，253名患者在24周的开放标签期内持续缓解（定义为简化疾病活动指数[SDAI]评分≤3.3）。这253名患者随后进入48周的双盲期，随机接受1)甲氨蝶呤单药治疗（n = 101）， 2)依那西普单药治疗（n = 101），或3)甲氨蝶呤加依那西普联合治疗（n = 51）。随后出现疾病恶化的患者接受与初始磨合期相同剂量的联合治疗方案。主要终点是与甲氨蝶呤单药治疗组相比，依那西普单药治疗组在第48周维持SDAI定义的缓解而无疾病恶化的患者比例。次要终点包括疾病恶化的时间，以及SDAI定义的缓解在开始救助治疗后重新恢复的患者比例。治疗组RA患者的基线人口学和临床特征相似。在第48周，依那西普单药治疗组维持SDAI定义缓解的患者明显多于甲氨蝶呤单药治疗组（49.5% vs 28.7%; P = 0.004）。此外，作为次要终点，接受联合治疗的患者比接受甲氨蝶呤单药治疗的患者获得持续的SDAI定义的缓解（52.9% vs 28.7%; P = 0.006）。接受甲氨蝶呤单药治疗的患者到疾病恶化的时间比接受依那西普单药治疗或联合治疗的患者短（与接受甲氨蝶呤单药治疗相比，P < 0.001）。在接受抢救治疗的患者中，每个治疗组70-80%的SDAI定义的缓解复发。没有新的安全信号报道。在维持RA患者缓解方面，依那西普单药优于甲氨蝶呤单药，与联合治疗相似。SDAI定义的缓解在大多数接受救援治疗的患者中再次出现。这些数据可以为控制良好的类风湿性关节炎患者考虑停药以减轻治疗负担的决策提供信息。
Patients with rheumatoid arthritis (RA) in whom remission is achieved following combination therapy with methotrexate plus etanercept face an ongoing medication burden. This study was undertaken to investigate whether sustained remission achieved on combination therapy can be maintained with either methotrexate or etanercept monotherapy, as assessed following discontinuation of one or the other medication from the combination. Of the 371 adult patients with RA who received combination therapy with methotrexate plus etanercept, remission (defined as a Simplified Disease Activity Index [SDAI] score of ≤3.3) was sustained in 253 patients through a 24‐week open‐label period. These 253 patients then entered a 48‐week, double‐blind period and were randomized to receive either 1) methotrexate monotherapy (n = 101), 2) etanercept monotherapy (n = 101), or 3) methotrexate plus etanercept combination therapy (n = 51). Patients who subsequently experienced disease‐worsening received rescue therapy with the combination regimen at the same dosages as used in the initial run‐in period. The primary end point was the proportion of patients in whom SDAI‐defined remission was maintained without disease‐worsening at week 48 in the etanercept monotherapy group as compared to the methotrexate monotherapy group. Secondary end points included time to disease‐worsening, and the proportion of patients in whom SDAI‐defined remission was recaptured after initiation of rescue therapy. Baseline demographic and clinical characteristics of the RA patients were similar across the treatment groups. At week 48, SDAI‐defined remission was maintained in significantly more patients in the etanercept monotherapy group than in the methotrexate monotherapy group (49.5% versus 28.7%; P = 0.004). Moreover, as a secondary end point, sustained SDAI‐defined remission was achieved in significantly more patients who received combination therapy than in those who received methotrexate monotherapy (52.9% versus 28.7%; P = 0.006). Time to disease‐worsening was shorter in those who received methotrexate monotherapy than in those who received etanercept monotherapy or those who received combination therapy (each P < 0.001 versus methotrexate monotherapy). Among the patients who received rescue therapy, SDAI‐defined remission was recaptured in 70–80% in each treatment group. No new safety signals were reported. The efficacy of etanercept monotherapy was superior to that of methotrexate monotherapy and similar to that of combination therapy in maintaining remission in patients with RA. SDAI‐defined remission was recaptured in most of the patients who were given rescue therapy. These data could inform decision‐making when withdrawal of therapy is being considered to reduce treatment burden in patients with well‐controlled RA.
登录
查看更多内容
DOI：
10.1056/nejmoa1809798
发表时间：
2019-02-21
期刊：
The New England journal of medicine
影响因子：
--
作者：
Ridker PM;Everett BM;Pradhan A;MacFadyen JG;Solomon DH;Zaharris E;Mam V;Hasan A;Rosenberg Y;Iturriaga E;Gupta M;Tsigoulis M;Verma S;Clearfield M;Libby P;Goldhaber SZ;Seagle R;Ofori C;Saklayen M;Butman S;Singh N;Le May M;Bertrand O;Johnston J;Paynter NP;Glynn RJ;CIRT Investigators
通讯作者：
CIRT Investigators
影响因子：
13.6
作者：
Edwards, Christopher J.;Galeazzi, Mauro;Kitas, George
通讯作者：
Kitas, George
影响因子：
4
作者：
Pappas DA;Litman HJ;Lesperance T;Kricorian G;Karis E;Rebello S;Hua W;Accortt NA;Stryker S
通讯作者：
Stryker S
影响因子：
1.3
作者：
Treharne, G. J.;Douglas, K. M. J.;Kitas, G. D.
通讯作者：
Kitas, G. D.
影响因子：
4.7
作者：
Singh, Jasvinder A.;Saag, Kenneth G.;McAlindon, Timothy
通讯作者：
McAlindon, Timothy