Arnold Simone, Jaeger Veronika K, Scherer Almut, Ciurea Adrian, Walker Ulrich A, Kyburz Diego
Department of Rheumatology, University Hospital Basel and University of Basel, Basel, Switzerland.
Institute for Epidemiology and Social Medicine, University of Münster, Münster, Germany.
Rheumatology (Oxford). 2021 Dec 24;61(1):131-138. doi: 10.1093/rheumatology/keab343.
Data from randomized controlled trials have shown the feasibility of discontinuation of bDMARD therapy in patients with RA that have reached remission. Criteria for selecting patients that are likely to remain in remission are still incompletely defined. We aimed to identify predictors of successful discontinuation of bDMARD therapy in the Swiss Clinical Quality Management (SCQM) registry, a real-world cohort of RA patients.
RA patients in DAS28-ESR remission who stopped bDMARD/tsDMARD treatment were included. Loss of remission was defined as a DAS28-ESR > 2.6 or restart of a bDMARD/tsDMARD. Time to loss of remission was the main outcome. Kaplan-Meier methods were applied and Cox regression was used for multivariable analyses adjusting for confounding factors. Missing data were imputed using multiple imputation.
A total of 318 patients in a bDMARD/tsDMARD-free remission were followed between 1997 and 2017. In total, 241 patients (76%) lost remission after a median time of 0.9 years (95% CI: 0.7, 1.0). The time to loss of remission was shorter in women, in patients with a longer disease duration >4yrs and in patients who did not meet clinical disease activity index (CDAI) remission criteria at baseline. Remission was longer in patients with csDMARD therapy during b/tsDMARD free remission [hazard ratio (HR) 0.8, P =0.05, 95% CI: 0.6, 1.0].
In a real-world patient population, the majority of patients who discontinued b/tsDMARD treatment lost remission within <1 year. Our study confirms that fulfilment of more rigorous remission criteria and csDMARD treatment increases the chance of maintaining b/tsDMARD-free remission.
随机对照试验的数据表明，已达到缓解的类风湿关节炎（RA）患者停用生物性改善病情抗风湿药物（bDMARD）治疗是可行的。选择可能维持缓解状态的患者的标准仍未完全明确。我们旨在瑞士临床质量管理（SCQM）登记处（一个RA患者的真实世界队列）中确定停用bDMARD治疗成功的预测因素。
纳入达到DAS28-红细胞沉降率（ESR）缓解且停用bDMARD/靶向合成DMARD（tsDMARD）治疗的RA患者。缓解的丧失定义为DAS28-ESR＞2.6或重新开始使用bDMARD/tsDMARD。缓解丧失时间是主要结局。应用Kaplan-Meier方法，并使用Cox回归进行多变量分析以调整混杂因素。使用多重填补法对缺失数据进行填补。
1997年至2017年间，共对318例处于停用bDMARD/tsDMARD后的缓解状态的患者进行了随访。总共有241例患者（76%）在中位时间0.9年（95%CI：0.7，1.0）后丧失缓解。女性、疾病病程＞4年的患者以及基线时未达到临床疾病活动指数（CDAI）缓解标准的患者缓解丧失时间较短。在停用b/tsDMARD后的缓解期接受传统合成DMARD（csDMARD）治疗的患者缓解期更长[风险比（HR）0.8，P =0.05，95%CI：0.6，1.0]。
在真实世界的患者群体中，大多数停用b/tsDMARD治疗的患者在＜1年内丧失缓解。我们的研究证实，满足更严格的缓解标准和csDMARD治疗可增加维持停用b/tsDMARD后缓解的机会。
