Wallace Beth I, England Bryant R, Baker Joshua F, Rojas Jorge, Sauer Brian C, Roul Punyasha, Kunkel Gary A, Braaten Tawnie J, Petro Alison, Mikuls Ted R, Cannon Grant W
Center for Clinical Management Research, VA Ann Arbor Healthcare System and University of Michigan, Ann Arbor.
University of Nebraska Medical Center and Veterans Affairs Nebraska-Western Iowa Health Care System, Omaha.
ACR Open Rheumatol. 2023 Sep;5(9):437-442. doi: 10.1002/acr2.11584. Epub 2023 Jul 25.
In the Steroid EliMination In Rheumatoid Arthritis (SEMIRA) trial, 65% of patients with rheumatoid arthritis (RA) in low disease activity (LDA) on stable biologic therapy successfully tapered glucocorticoids. We aimed to evaluate real-world rates of glucocorticoid tapering among similar patients in the Veterans Affairs Rheumatoid Arthritis registry.
Within a multicenter, prospective RA cohort, we used registry data and linked pharmacy claims from 2003 to 2021 to identify chronic prednisone users achieving LDA after initiating a new biologic or targeted synthetic disease-modifying antirheumatic drug (b/tsDMARD). We defined the index date as first LDA occurring 60 to 180 days after b/tsDMARD initiation. The primary outcome of successful tapering, assessed at day 180 after LDA, required a 30-day averaged prednisone dose both less than or equal to 5mg/day and at least 50% lower than at the index date. The secondary outcome was discontinuation, defined as a prednisone dose of 0 mg/day at days 180 through 210. We used univariate statistics to compare patient characteristics by fulfillment of the primary outcome.
We evaluated 100 b/tsDMARD courses among 95 patients. Fifty-four courses resulted in successful tapering; 33 resulted in discontinuation. Positive rheumatoid factor, higher erythrocyte sedimentation rate, more background DMARDs, shorter time from b/tsDMARD initiation to LDA, and higher glucocorticoid dose 30 days before LDA were associated with greater likelihood of successful tapering.
In a real-world RA cohort of chronic glucocorticoid users in LDA, half successfully tapered and a third discontinued prednisone within 6 months of initiating a new b/tsDMARD. Claims-based algorithms of glucocorticoid tapering and discontinuation may be useful to evaluate predictors of tapering in administrative data sets.
在类风湿关节炎类固醇消除(SEMIRA)试验中,65%处于疾病低活动度(LDA)且接受稳定生物治疗的类风湿关节炎(RA)患者成功减少了糖皮质激素用量。我们旨在评估退伍军人事务部类风湿关节炎登记处中类似患者的糖皮质激素减量的实际发生率。
在一个多中心前瞻性RA队列中,我们使用登记数据以及2003年至2021年的关联药房报销记录,来识别在开始使用新的生物制剂或靶向合成改善病情抗风湿药物(b/tsDMARD)后达到LDA的慢性泼尼松使用者。我们将索引日期定义为b/tsDMARD开始使用后60至180天首次出现的LDA。在LDA后180天评估的成功减量的主要结局要求30天平均泼尼松剂量小于或等于5mg/天且比索引日期时至少低50%。次要结局为停药,定义为在第180天至210天泼尼松剂量为0mg/天。我们使用单变量统计按主要结局的达成情况比较患者特征。
我们评估了95例患者的100个b/tsDMARD疗程。54个疗程成功减量;33个疗程停药。类风湿因子阳性、红细胞沉降率较高、使用更多背景DMARD、从b/tsDMARD开始使用到LDA的时间较短以及LDA前30天糖皮质激素剂量较高与成功减量的可能性更大相关。
在一个LDA的慢性糖皮质激素使用者的真实世界RA队列中,一半患者在开始新的b/tsDMARD后6个月内成功减少了泼尼松用量,三分之一患者停药。基于报销记录的糖皮质激素减量和停药算法可能有助于评估行政数据集中减量的预测因素。