日本前瞻性队列方案，评估临床缓解的未控制哮喘患者的特征：J-CIRCLE

IF 2.4 Q2 RESPIRATORY SYSTEM

Respiratory investigation Pub Date : 2024-11-01 DOI:10.1016/j.resinv.2024.10.009

Naoya Tanabe , Yu Hara , Kaoruko Shimizu , Satoshi Marumo , Jun Miyata , Kyohei Morita , Tetsuya Watanabe , Keiji Oishi , Masafumi Yamaguchi , Kazuhisa Asai , Yasutaka Nakano , Tsunahiko Hirano , Kazuto Matsunaga , Toshiyuki Koya , Hisako Matsumoto , Koichi Fukunaga , Satoshi Konno , Takeshi Kaneko , Toyohiro Hirai

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引用次数: 0

摘要

背景越来越多的人希望生物制剂能用作疾病调节剂，因此在重症哮喘的治疗中引入了临床缓解（CR）的概念。鉴于计算机断层扫描（CT）和血液生物标志物的临床相关性，我们假设进一步完善 CR 标准，并将 CT 和血液生物标志物作为结构和生物缓解（SR、BR）的指标，将有助于预测接受生物制剂治疗的重症哮喘患者的长期疾病稳定性。入组患者将接受为期 3 年的纵向随访。入组时，患者将接受支气管扩张剂后肺活量测定、血液化验、呼出一氧化氮分数测定、胸部和鼻窦 CT 以及患者报告结果问卷调查。随访检查将在 1、3、6、12、24 和 36 个月时进行。将比较生物制剂治疗 1 年后不同标准导致的 CR 率，并找出生物制剂治疗 3 年后疾病长期稳定的相关因素。讨论这项在日本开展的多中心研究将提供数据，帮助建立更合适的 CR、结构缓解和生物缓解标准，以预测接受生物制剂治疗的重症哮喘患者的长期疾病稳定性。伦理与传播该研究已获得京都大学伦理委员会的批准（编号：R4419，批准日期：2024 年 6 月 11 日）。

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A protocol for a Japanese prospective cohort evaluating the features of patients with uncontrolled asthma achieving clinical remission: J-CIRCLE

Background

Increasing expectations that biologics can be used as disease-modifying agents have introduced the concept of clinical remission (CR) in managements of severe asthma. Given the clinical relevance of computed tomography (CT) and blood biomarkers, we hypothesized that further refinement of CR criteria as well as incorporation of CT and blood biomarkers as indicators for structural and biological remission (SR, BR) would enable predicting long-term disease stability in patients with severe asthma treated with biologics.

Methods

This Japanese multicenter prospective observational cohort will enroll patients with severe asthma who will start a new biologic (including a change from another biologic). The enrolled patients will be longitudinally followed up for 3 years. At enrollment, patients will undergo postbronchodilator spirometry, blood tests, fractional exhaled nitric oxide, chest and sinus CT, and patient-reported outcome questionnaires. Follow-up examinations will be performed at 1, 3, 6, 12, 24, and 36 months. The rates of CR resulting from different criteria after 1 year of treatment with biologics will be compared, and factors associated with long-term disease stability after 3 years of biologic treatments will be identified.

Discussion

This multicenter study in Japan will provide data that will help establish more appropriate criteria for CR, structural remission, and biological remission to predict long-term disease stability in patients with severe asthma who receive biologic therapy.