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一项回顾性索赔数据库研究,以明确2型高炎症或低炎症重度哮喘患者的疾病负担。

A Retrospective Claims Database Study to Clarify Disease Burden of Severe Asthma Patients with Type 2 High or Low Inflammation.

作者信息

Harada Norihiro, Makita Naoyuki, Fukui Kenya, Nishida Kenichiro, Oneda Kaori, Tashiro Naoki

机构信息

Department of Respiratory Medicine, Juntendo University Faculty of Medicine and Graduate School of Medicine, Tokyo, Japan.

AstraZeneca K.K., Osaka, Japan.

出版信息

J Asthma Allergy. 2023 Jan 5;16:83-93. doi: 10.2147/JAA.S378505. eCollection 2023.

Abstract

PURPOSE

The disease burden of severe asthma patients stratified by type 2 (T2) biomarkers is not well studied in large patient samples, especially for T2-low severe asthma patients. Using a Japanese medical record database, we investigated disease and economic burdens in T2-high and T2-low severe asthma patients.

PATIENTS AND METHODS

Data of severe asthma patients (receiving high-dose inhaled corticosteroids and additional asthma-related controller medications or oral corticosteroids [OCS] prescription [≥183 days] during the 1-year baseline period) were analyzed in the Real World Data database, comprising electronic medical records from Japanese medical institutions. Severe asthma patients were stratified into a T2-high population with higher eosinophils (≥150 cells/μL) and/or higher total immunoglobulin E (IgE, ≥75 IU/mL) or a T2-low population with lower eosinophils (<150 cells/μL) and lower total IgE (<75 IU/mL). The incidence of asthma exacerbation events and drug costs were analyzed for each population. Different T2 thresholds were explored, including eosinophil count 300 cells/μL and/or IgE 150 IU/mL.

RESULTS

Of the 732 severe asthma patients, 599 (81.8%) patients had T2-high type, and 133 (18.2%) had T2-low type. Proportions of the T2-high patients (30.6%) with asthma exacerbations, defined as a composite outcome, including OCS burst, injectable steroid use, and hospitalization, were similar to those of T2-low type (34.6%). The annual drug cost was similar between T2-high (175,487 JPY) and T2-low (165,322 JPY) populations.

CONCLUSION

In this large-scale study, both T2-high and T2-low severe asthma patients in Japan were shown to have a high disease burden and high economic burden, suggesting an unmet treatment need.

摘要

目的

在大型患者样本中,按2型(T2)生物标志物分层的重度哮喘患者的疾病负担尚未得到充分研究,尤其是对于T2低的重度哮喘患者。利用日本医疗记录数据库,我们调查了T2高和T2低的重度哮喘患者的疾病和经济负担。

患者与方法

在真实世界数据数据库中分析重度哮喘患者的数据(在1年基线期内接受高剂量吸入性糖皮质激素和额外的哮喘相关控制药物或口服糖皮质激素[OCS]处方[≥183天]),该数据库包含来自日本医疗机构的电子病历。重度哮喘患者被分为T2高组(嗜酸性粒细胞≥150个细胞/μL和/或总免疫球蛋白E[IgE]≥75 IU/mL)或T2低组(嗜酸性粒细胞<150个细胞/μL且总IgE<75 IU/mL)。分析了每组人群哮喘急性发作事件的发生率和药物成本。探索了不同的T2阈值,包括嗜酸性粒细胞计数300个细胞/μL和/或IgE 150 IU/mL。

结果

732例重度哮喘患者中,599例(81.8%)为T2高型,133例(18.2%)为T2低型。T2高型患者(30.6%)发生哮喘急性发作(定义为包括OCS冲击、使用注射用类固醇和住院的综合结局)的比例与T2低型患者(34.6%)相似。T2高组(175,487日元)和T2低组(165,322日元)人群的年度药物成本相似。

结论

在这项大规模研究中,日本T2高和T2低的重度哮喘患者均显示出高疾病负担和高经济负担,表明存在未满足的治疗需求。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ed88/9830705/a842ff223706/JAA-16-83-g0001.jpg

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