Background

Patients with severe asthma (SA) have a heightened risk of exacerbations including hospitalization. The real-world, specialist-verified incidence and characteristics of exacerbations among patients with SA in the United States have not been described.

Objective

To describe the real-world incidence, characteristics, and predictors of exacerbations among patients with SA in the United States.

Methods

The CHRONICLE study is an ongoing observational study of specialist-treated adults with SA in the United States receiving biologic treatment or maintenance systemic corticosteroids or uncontrolled by high-dosage inhaled corticosteroids with additional controllers. For patients enrolled from February 2018 to February 2020, annualized rates and characteristics of exacerbation-related events were summarized by treatment category for 12 months before enrollment and after enrollment through the latest data collection. Results were further analyzed for subgroups of interest.

Results

Among 1884 enrolled patients, 53.5% and 12.3% experienced an exacerbation and asthma hospitalization, respectively (0.81 and 0.14 per person-year). Of all exacerbations, 36%, 9%, and 15% required an unscheduled health care provider visit, emergency department visit without hospitalization, and hospitalization, respectively. Among patients not receiving biologics or systemic corticosteroids, higher blood eosinophil count, higher fractional exhaled nitric oxide, and lower total immunoglobulin E level were associated with higher exacerbation rates. Exacerbation rates decreased after starting or switching biologics (n = 1299). Multivariate analyses of enrolled patients revealed previous-year exacerbations or hospitalizations, lack of asthma control, and the geographic region also predicted event risk.

Conclusion

In this real-world cohort of specialist-treated adults with SA in the United States, there was a substantial burden of exacerbations and associated health care resource utilization. Patients receiving biologics had a lower exacerbation burden.

Trial Registration

ClinicalTrials.gov Identifier: NCT03373045.

中文翻译：

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美国的严重哮喘发作：

背景

患有严重哮喘 (SA) 的患者出现恶化的风险更高，包括住院治疗。尚未描述美国 SA 患者的真实世界、专家验证的发生率和恶化的特征。

客观的

描述美国 SA 患者的真实世界发病率、特征和恶化的预测因素。

方法

CHRONICLE 研究是一项正在进行的观察性研究，对象是美国接受生物治疗或维持全身皮质类固醇的专家治疗的 SA 成人，或不受高剂量吸入皮质类固醇和额外控制剂控制的成人。对于 2018 年 2 月至 2020 年 2 月入组的患者，通过最新的数据收集，按治疗类别汇总了入组前和入组后 12 个月的恶化相关事件的年化率和特征。进一步分析了感兴趣的亚组的结果。

结果

在 1884 名登记患者中，53.5% 和 12.3% 分别经历了恶化和哮喘住院治疗（每人年 0.81 和 0.14）。在所有恶化中，分别有 36%、9% 和 15% 需要不定期的医疗保健提供者就诊、无需住院的急诊就诊和住院。在未接受生物制剂或全身性皮质类固醇治疗的患者中，较高的血嗜酸性粒细胞计数、较高的呼出一氧化氮分数和较低的总免疫球蛋白 E 水平与较高的急性加重率相关。开始或更换生物制剂后恶化率降低（n = 1299）。对入组患者的多变量分析显示，前一年病情加重或住院、哮喘控制不足，地理区域也预测了事件风险。

结论

在美国这个由专科治疗的成人 SA 的真实世界队列中，存在加重和相关医疗资源利用的沉重负担。接受生物制剂治疗的患者加重负担较低。

试用注册

ClinicalTrials.gov 标识符：NCT03373045。