BioDrugs ( IF 5.4 ) Pub Date : 2022-06-30 , DOI: 10.1007/s40259-022-00542-w Yinzhu Jin 1 , Joan E Landon 1 , Whitney Krueger 2 , Alexander Liede 2 , Rishi J Desai 1 , Seoyoung C Kim 1, 3
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Background
Previous observational studies utilizing administrative claims data have largely been unable to consider clinical factors that may be related to patterns of drug use among patients with rheumatoid arthritis (RA).
Objective
To understand predictors of treatment changes following initiation of a tumor necrosis factor inhibitor (TNFi) using nation-wide electronic health record (EHR) data in the USA.
Methods
The Optum Immunology Condition EHR data (01/01/2011–09/30/2019) was used to identify a population of adult patients with RA initiating a TNFi as the first line biologic disease-modifying anti-rheumatic drug (DMARD). The primary outcome was any treatment change during the 1-year post-index period defined as cycling to a different TNFi or switching to non-TNFi biologic or targeted synthetic DMARDs. Secondary outcomes were the individual components of TNFi cycling and switching, examined separately. To identify predictors of DMARD treatment changes, we used a least absolute shrinkage and selection operator (LASSO) regression model. Model c-statistics and odds ratios (ORs, 95% confidence intervals (CIs)) of predictors were reported.
Results
We identified 24,871 patients with RA who initiated a TNFi. The mean age was 55.5 (± 13.7) years and 77.2% were female. Among the TNFi initiators, 22.2% experienced TNFi cycling or switching during the 1-year follow-up time. Predictors that are associated with higher likelihood of TNFi cycling or switching included female gender (OR: 1.26, 95% CI: 1.16–1.36) and glucocorticoid use (OR: 1.30, 95% CI: 1.21–1.40). In contrast, inflammatory bowel disease (OR: 0.62, 95% CI: 0.48–0.78), psoriasis (OR: 0.82, 95% CI: 0.70–0.95), recent use of methotrexate (OR: 0.89, 95% CI: 0.81–0.97), and vitamin D intake (OR: 0.92, 95% CI: 0.85–0.99) were negatively associated with TNFi cycling or switch.
Conclusions
Gender, glucocorticoid use, inflammatory bowel disease, psoriasis, and vitamin D intake were identified as significant predictors of TNFi cycling or switching for TNFi initiators in the RA population. Predicting treatment change remains challenging even with large detailed EHR data.
Plain Language Summary
This study aimed to identify key determinants of treatment changes among patients with rheumatoid arthritis (RA) initiating a tumor necrosis factor inhibitor (TNFi) as their first-line biologic disease-modifying antirheumatic drug (DMARD) in routine care settings using a US nation-wide longitudinal electronic health record (EHR). Among 24,871 patients with RA who initiated a TNFi, 22.2% experienced TNFi cycling or switching during the 1-year follow-up time. Female patients and those who used glucocorticoids were more likely to experience TNFi cycling or switching, whereas inflammatory bowel disease, psoriasis, recent methotrexate use, and vitamin D intake were negatively associated with the outcome. However, predicting treatment change remains challenging even with larger detailed EHR data potentially due to unmeasured factors such as prescriber’s preference or patient’s belief in the medication.
中文翻译：
美国以 TNF 抑制剂作为一线生物制剂治疗的类风湿关节炎患者治疗变化的预测因素：纵向电子健康记录的队列研究
背景
以前使用行政索赔数据的观察性研究在很大程度上无法考虑可能与类风湿关节炎 (RA) 患者的药物使用模式相关的临床因素。
客观的
使用美国全国范围的电子健康记录 (EHR) 数据了解启动肿瘤坏死因子抑制剂 (TNFi) 后治疗变化的预测因素。
方法
Optum Immunology Condition EHR 数据 (01/01/2011–09/30/2019) 用于确定 RA 成年患者群体，该患者使用 TNFi 作为一线生物疾病缓解抗风湿药物 (DMARD)。主要结果是指标后 1 年期间的任何治疗变化，定义为循环使用不同的 TNFi 或切换到非 TNFi 生物或靶向合成 DMARD。次要结果是 TNFi 循环和转换的各个组成部分，分别进行检查。为了确定 DMARD 治疗变化的预测因子，我们使用了最小绝对收缩和选择算子 (LASSO) 回归模型。报告了预测变量的模型 c 统计量和优势比（OR，95% 置信区间 (CI)）。
结果
我们确定了 24,871 名启动 TNFi 的 RA 患者。平均年龄为 55.5 (± 13.7) 岁，77.2% 为女性。在 TNFi 启动者中，22.2% 在 1 年的随访期间经历了 TNFi 循环或转换。与更高的 TNFi 循环或转换可能性相关的预测因素包括女性（OR：1.26，95% CI：1.16-1.36）和糖皮质激素使用（OR：1.30，95% CI：1.21-1.40）。相比之下，炎症性肠病 (OR: 0.62, 95% CI: 0.48–0.78)、银屑病 (OR: 0.82, 95% CI: 0.70–0.95)、近期使用甲氨蝶呤 (OR: 0.89, 95% CI: 0.81– 0.97）和维生素 D 摄入量（OR：0.92，95% CI：0.85-0.99）与 TNFi 循环或转换呈负相关。
结论
性别、糖皮质激素使用、炎症性肠病、银屑病和维生素 D 摄入量被确定为 RA 人群中 TNFi 循环或转换 TNFi 引发剂的重要预测因素。即使有大量详细的 EHR 数据，预测治疗变化仍然具有挑战性。
简单的语言摘要
本研究旨在确定类风湿性关节炎 (RA) 患者在常规护理环境中使用肿瘤坏死因子抑制剂 (TNFi) 作为一线生物疾病缓解抗风湿药 (DMARD) 治疗变化的关键决定因素。广泛的纵向电子健康记录（EHR）。在启动 TNFi 的 24,871 名 RA 患者中，22.2% 在 1 年的随访期间经历了 TNFi 循环或转换。女性患者和使用糖皮质激素的患者更有可能经历 TNFi 循环或转换，而炎症性肠病、银屑病、近期使用甲氨蝶呤和维生素 D 摄入与结果呈负相关。然而，
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