Curtis Jeffrey R, Emery Paul, Kricorian Greg, Yen Priscilla K, Collier David H, Bykerk Vivian, Haraoui Boulos
J.R. Curtis, MD, MS, MPH, University of Alabama at Birmingham, Birmingham, Alabama, USA;
P. Emery, MD, Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Leeds, UK.
J Rheumatol. 2023 Sep;50(9):1114-1120. doi: 10.3899/jrheum.2022-1008. Epub 2023 Apr 15.
Some patients with rheumatoid arthritis (RA) who persist in remission may decide to stop their therapy. We evaluated baseline characteristics associated with remaining in remission or low disease activity (LDA) following medication withdrawal.
The Study of Etanercept and Methotrexate in Combination or as Monotherapy in Subjects With Rheumatoid Arthritis (SEAM-RA) was a phase III, multicenter, randomized withdrawal, double-blind, controlled study in patients with RA on methotrexate (MTX) + etanercept (ETN). If remission (Simplified Disease Activity Index [SDAI] ≤ 3.3) was sustained through a 24-week run-in period, patients then entered a 48-week double-blind period and were randomized 2:2:1 to receive MTX monotherapy, ETN monotherapy, or continue combination therapy. Multivariate logistic regression analysis was performed to identify baseline factors associated with remission or LDA at the end of both periods.
Of 371 patients enrolled, 253 entered the double-blind period. After adjusting for other factors, covariates associated with achieving SDAI remission at the end of the run-in period included younger age, longer duration of MTX treatment, and less severe clinical disease variables. Covariates associated with maintaining remission/LDA at the end of the 48-week double-blind period included lower patient global assessment of disease activity (PtGA), lower C-reactive protein, rheumatoid factor (RF) negativity, longer RA duration in the MTX arm, shorter duration of ETN treatment, and lower magnesium.
These findings indicate patients with overall lower disease activity are more likely to remain in SDAI remission/LDA after switching from combination therapy to monotherapy. RF-negative status and lower PtGA scores were strongly associated with increased likelihood of remaining in remission/LDA with MTX or ETN monotherapy. (SEAM-RA; ClinicalTrials.gov: NCT02373813).
一些类风湿关节炎（RA）患者病情持续缓解后可能会决定停药。我们评估了停药后仍处于缓解期或低疾病活动度（LDA）状态相关的基线特征。
类风湿关节炎患者使用依那西普和甲氨蝶呤联合或单药治疗的研究（SEAM-RA）是一项III期、多中心、随机撤药、双盲、对照研究，研究对象为正在接受甲氨蝶呤（MTX）+依那西普（ETN）治疗的RA患者。如果在24周的导入期内病情持续缓解（简化疾病活动指数[SDAI]≤3.3），患者随后进入48周的双盲期，并按2:2:1随机分组，分别接受MTX单药治疗、ETN单药治疗或继续联合治疗。进行多变量逻辑回归分析以确定两个阶段结束时与缓解或LDA相关的基线因素。
在纳入的371例患者中，253例进入双盲期。在调整其他因素后，与导入期结束时达到SDAI缓解相关的协变量包括年龄较小、MTX治疗时间较长以及临床疾病变量较轻。与48周双盲期结束时维持缓解/LDA相关的协变量包括患者对疾病活动度的总体评估（PtGA）较低、C反应蛋白较低、类风湿因子（RF）阴性、MTX组的RA病程较长、ETN治疗时间较短以及镁水平较低。
这些发现表明，疾病活动度总体较低的患者从联合治疗转换为单药治疗后更有可能维持SDAI缓解/LDA状态。RF阴性状态和较低的PtGA评分与使用MTX或ETN单药治疗时维持缓解/LDA的可能性增加密切相关。（SEAM-RA；ClinicalTrials.gov：NCT02373813）
