Alabama Allergy and Asthma Center, Birmingham, Alabama.
University of Michigan, Ann Arbor, Michigan.
Ann Allergy Asthma Immunol. 2021 Nov;127(5):579-587.e1. doi: 10.1016/j.anai.2021.07.010. Epub 2021 Jul 15.
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.
背景：重度哮喘（SA）患者的发作风险较高，包括住院治疗。目前尚未描述美国 SA 患者的发作情况以及专科医生验证的发作特征。
目的：描述美国 SA 患者的真实世界发作率、特征和预测因素。
方法：CHRONICLE 研究是一项正在进行的观察性研究，纳入美国接受生物治疗或维持全身皮质类固醇治疗或高剂量吸入皮质类固醇治疗加附加控制药物但仍未控制的专科治疗成年 SA 患者。对于 2018 年 2 月至 2020 年 2 月期间入组的患者，根据治疗类别总结入组前 12 个月和入组后至最新数据采集期间的年度发作相关事件发生率和特征。对感兴趣的亚组进一步进行分析。
结果：在 1884 名入组患者中，分别有 53.5%和 12.3%经历了发作和哮喘住院治疗（0.81 和 0.14 人年）。所有发作中，分别有 36%、9%和 15%需要非计划性就诊、无需住院的急诊就诊和住院治疗。在未接受生物制剂或全身皮质类固醇治疗的患者中，较高的血嗜酸性粒细胞计数、较高的呼出气一氧化氮分数和较低的总免疫球蛋白 E 水平与较高的发作率相关。开始或转换生物制剂后，发作率降低（n=1299）。对入组患者的多变量分析显示，前一年的发作或住院、缺乏哮喘控制以及地理位置也预测了事件风险。
结论：在本项美国接受专科治疗的成年重度哮喘患者真实世界队列研究中，发作和相关卫生保健资源利用的负担很大。接受生物制剂治疗的患者发作负担较低。
临床试验注册：ClinicalTrials.gov 标识符：NCT03373045。
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