Adverse consequences of systemic corticosteroids use among a broad population of US adults with asthma: a real-world analysis

Systemic corticosteroids (SCS) are used to manage asthma exacerbations. Among the broad population of patients with asthma, SCS-related risk of adverse events (AEs), health care resource utilization (HCRU), and costs remain unclear. This retrospective cohort study used the Optum Research Database claims to identify adults with asthma from 1/1/2017 to 6/30/2022. The index date was the earliest SCS claim for SCS users; non-SCS users were randomly selected and adjusted proportionally to SCS users by index year. SCS use was measured during the first 12 months of follow-up. Inverse probability of treatment weighting balanced the two cohorts for selected baseline demographic and clinical characteristics. SCS users were further stratified into low, medium, and high dose sub-cohorts. SCS-related AEs were assessed up to 48 months, while HCRU and costs were assessed during the first 12 months of follow-up. A generalized linear model (GLM) analyzed follow-up costs by SCS exposure. The 130,739 patients included 55,363 non-SCS users (42.3%), while 75,376 were SCS users stratified into 60,319 low-, 12,235 medium-, and 2,822 high-dose users. The mean age was 49.6 years; 61.8% were female and 68.9% were non-Hispanic White. SCS users had a significantly greater risk of new-onset acute and chronic SCS-related AEs, increasing incrementally with dose exposure (all p p Retrospective administrative claims studies cannot randomize patients and may not capture all patient events. Among a broad population of adults with asthma, even low doses of SCS were associated with significantly increased risk of new-onset AEs, HCRU, and costs. Asthma is a respiratory disease characterized by symptoms that can suddenly flare up, resulting in bronchoconstriction that in some cases requires urgent medical attention. Systemic corticosteroids (SCS) have been used for decades to treat these exacerbations. While effective at relieving symptoms, SCS are associated with detrimental effects of their own. Our study examined the adverse events and costs associated with SCS use. We analyzed the health insurance claims of 130,739 adult patients with asthma: 55,363 (42.3%) did not use systemic corticosteroids, while 75,376 (57.7%) patients received SCS during our study. The SCS users were further divided into groups that were exposed to low, medium, and high SCS doses. Inverse Probability of Treatment Weighting (IPTW) was applied to address potential confounding and infer causal treatment effects of SCS use. The study showed that patients who received SCS were at a significantly increased risk of medication-related adverse events, both in terms of acute and chronic clinical complications. These complications affect a range of systems, including diseases associated with the heart, kidneys, eyes, skin, and brain. Patients who received SCS also incurred greater costs and had more hospitalization and emergency room visits in 12 months. Importantly, the risk and costs increased with the medication dose to which a patient was exposed. Health care costs were 1.43, 1.97, and 3.21 times higher among patients who received low, medium, and high doses of SCS, respectively, than non-SCS users. Even low doses of SCS were associated with a significantly increased risk of adverse events and higher costs.

全身性糖皮质激素（Systemic Corticosteroids, SCS）用于管理哮喘急性加重。在庞大的哮喘患者群体中，与SCS相关的不良事件（Adverse Events, AEs）风险、医疗资源利用（Health Care Resource Utilization, HCRU）及相关成本仍未明确。本回顾性队列研究依托Optum研究数据库的理赔数据，筛选2017年1月1日至2022年6月30日期间的成年哮喘患者。SCS使用者的索引日期为其首次提交SCS理赔的日期；非SCS使用者按索引年份与SCS使用者进行比例匹配后随机选取。随访前12个月内评估SCS使用情况，采用治疗加权逆概率平衡两组队列的选定基线人口统计学与临床特征。SCS使用者进一步被分层为低、中、高剂量亚队列。SCS相关不良事件的评估周期长达48个月，而医疗资源利用与成本则在随访前12个月内进行评估。采用广义线性模型（Generalized Linear Model, GLM）分析SCS暴露相关的随访成本。本研究共纳入130739例患者，其中55363例为非SCS使用者（占比42.3%），75376例为SCS使用者，进一步分层为60319例低剂量、12235例中剂量及2822例高剂量使用者。患者平均年龄为49.6岁，61.8%为女性，68.9%为非西班牙裔白人。SCS使用者新发急性及慢性SCS相关不良事件的风险显著更高，且随剂量暴露呈递增趋势（所有P值均<0.05）。回顾性行政理赔研究无法对患者进行随机分组，且可能无法捕获所有患者事件。在庞大的成年哮喘患者群体中，即便低剂量SCS也与新发不良事件风险、医疗资源利用及成本的显著升高相关。哮喘是一类以突发症状为特征的呼吸系统疾病，可引发支气管收缩，部分病例需接受紧急医疗干预。全身性糖皮质激素已被用于治疗此类急性加重数十年，虽可有效缓解症状，但本身也存在诸多不良影响。本研究旨在探讨SCS使用相关的不良事件与成本。我们分析了130739例成年哮喘患者的健康保险理赔数据：其中55363例（42.3%）未使用全身性糖皮质激素，75376例（57.7%）患者在研究期间接受了SCS治疗。SCS使用者进一步被划分为低、中、高剂量暴露组。采用治疗加权逆概率（Inverse Probability of Treatment Weighting, IPTW）以控制潜在混杂因素，并推断SCS使用的因果治疗效应。研究结果显示，接受SCS治疗的患者发生药物相关不良事件（包括急性与慢性临床并发症）的风险显著升高。此类并发症可累及多个系统，包括心脏、肾脏、眼部、皮肤及脑部相关疾病。接受SCS治疗的患者在12个月内的医疗成本更高，住院及急诊就诊次数也更多。值得注意的是，风险与成本随患者暴露的药物剂量增加而升高。与非SCS使用者相比，低、中、高剂量SCS使用者的医疗成本分别为其1.43倍、1.97倍及3.21倍。即便低剂量SCS也与不良事件风险的显著升高及更高的医疗成本相关。