特泽利尤单抗（Tezepelumab）治疗成人重度哮喘实现临床缓解及生物缓解：一项真实世界研究
2025/06/16
摘要
介绍:特泽利尤单抗（Tezepelumab ）是一种获批用于治疗重度哮喘的抗TSLP单克隆抗体。该药具有广泛的下游抗T2型炎症效应，有望实现生物缓解。目前尚缺乏真实世界中Tezepelumab的临床缓解率数据，且临床缓解与生物缓解之间的关系尚不明确。此外，Tezepelumab对现有生物制剂治疗失败患者的有效性尚未可知。
方法:本研究对真实世界中接受Tezepelumab治疗的成人重度哮喘患者的临床及生物标志物数据进行分析。记录包括临床缓解在内的临床结局指标，以及生物缓解率（定义为：外周血嗜酸性粒细胞计数< 300个/μL且FeNO < 25 ppb）。
结果:研究共纳入175例患者，其中98例（56%）患者由其他生物制剂治疗转换而来。在开始Tezepelumab治疗后，哮喘年化急性加重率由3.1±2.5 (均值 ± 标准差)次显著降低至0.8±1.4 次 (p < 0.001)，59%的患者在1年内无急性发作。54%的患者达到哮喘控制问卷（ACQ）评分< 1.5。1年内观察到36%的患者达到临床缓解，其中高T2型重度哮喘患者的缓解率为55%，而低T2型重度患者仅为19%。初次使用生物制剂患者与转换生物制剂使用患者的临床应答率相似。FeNO从41 ppb（IQR24-76）降至24 ppb（IQR16-38），血嗜酸性粒细胞计数（BEC）从300个/μL（IQR60-610）降至180个/μL（IQR105-320）（两者p值均<0.001）。38%的患者达到生物学缓解，15%的患者同时达到临床和生物缓解。
结论：Tezepelumab 治疗显著改善了重度哮喘患者的临床结局，高达55% 的高T2型重度哮喘患者中实现临床缓解。研究中观察到临床缓解与生物缓解之间存在脱节现象。目前，对于残留的T2型炎症在Tezepelumab治疗下的长期意义尚不清楚。
关键词：哮喘；哮喘治疗；生物制剂；Tezepelumab；临床缓解；生物缓解；真实世界研究；T2 炎症。
文献来源：（Gates J, Haris F, et, al. Clinical and Biological Remission With Tezepelumab: The Real-World Response in Severe Uncontrolled Asthma. Allergy. 2025 May 14. doi: 10.1111/all.16590. Epub ahead of print. PMID: 40365686.）
Abstract
Introduction: Tezepelumab is an anti-TSLP monoclonal antibody approved for the treatment of severe asthma. It has broad downstream anti-T2 effects, offering the prospect of biological remission. Real-world data on clinical remission rates with tezepelumab is lacking, and the relationship between clinical and biological remission is unclear. Finally, the effectiveness of tezepelumab in patients who have failed to respond to existing biologic therapies is unknown.
Methods: Clinical and biomarker data from adults with severe asthma treated with tezepelumab in a real-world setting was analyzed. Clinical outcome measures including clinical remission were recorded along with rates of biological remission (defined as blood eosinophil count < 300 cells/mcL and FeNO < 25 ppb).
Results: One hundred seventy-five patients were included. 98/175 (56%) had switched from another biologic. Following tezepelumab initiation, the exacerbation rate decreased from 3.1 (2.5) to 0.8 (1.4), with 59% of patients remaining exacerbation-free at 1 year. 54% achieved an ACQ score < 1.5. Clinical remission at 1 year was observed in 36%, with a rate of 55% in T2-high patients versus 19% in T2 low patients. The clinical response in biologic-naïve and biologic switch patients was similar. FeNO declined from 41 ppb (24-76) to 24 ppb (16-38) and BEC fell from 300 cells/μL (60-610) to 180 cells/μL (105-320) (both p < 0.001). 38% achieved biological remission. 15% attained both clinical and biological remission.
Conclusion: Tezepelumab led to substantial clinical improvements and clinical remission in up to 55% of T2-high patients with severe asthma. A disconnect between clinical and biological remission was observed. The long-term significance of residual T2 inflammation on tezepelumab is unknown.
Keywords: asthma; asthma treatment; biologics.
介绍:特泽利尤单抗（Tezepelumab ）是一种获批用于治疗重度哮喘的抗TSLP单克隆抗体。该药具有广泛的下游抗T2型炎症效应，有望实现生物缓解。目前尚缺乏真实世界中Tezepelumab的临床缓解率数据，且临床缓解与生物缓解之间的关系尚不明确。此外，Tezepelumab对现有生物制剂治疗失败患者的有效性尚未可知。
方法:本研究对真实世界中接受Tezepelumab治疗的成人重度哮喘患者的临床及生物标志物数据进行分析。记录包括临床缓解在内的临床结局指标，以及生物缓解率（定义为：外周血嗜酸性粒细胞计数< 300个/μL且FeNO < 25 ppb）。
结果:研究共纳入175例患者，其中98例（56%）患者由其他生物制剂治疗转换而来。在开始Tezepelumab治疗后，哮喘年化急性加重率由3.1±2.5 (均值 ± 标准差)次显著降低至0.8±1.4 次 (p < 0.001)，59%的患者在1年内无急性发作。54%的患者达到哮喘控制问卷（ACQ）评分< 1.5。1年内观察到36%的患者达到临床缓解，其中高T2型重度哮喘患者的缓解率为55%，而低T2型重度患者仅为19%。初次使用生物制剂患者与转换生物制剂使用患者的临床应答率相似。FeNO从41 ppb（IQR24-76）降至24 ppb（IQR16-38），血嗜酸性粒细胞计数（BEC）从300个/μL（IQR60-610）降至180个/μL（IQR105-320）（两者p值均<0.001）。38%的患者达到生物学缓解，15%的患者同时达到临床和生物缓解。
结论：Tezepelumab 治疗显著改善了重度哮喘患者的临床结局，高达55% 的高T2型重度哮喘患者中实现临床缓解。研究中观察到临床缓解与生物缓解之间存在脱节现象。目前，对于残留的T2型炎症在Tezepelumab治疗下的长期意义尚不清楚。
关键词：哮喘；哮喘治疗；生物制剂；Tezepelumab；临床缓解；生物缓解；真实世界研究；T2 炎症。
文献来源：（Gates J, Haris F, et, al. Clinical and Biological Remission With Tezepelumab: The Real-World Response in Severe Uncontrolled Asthma. Allergy. 2025 May 14. doi: 10.1111/all.16590. Epub ahead of print. PMID: 40365686.）
（南方医科大学南方医院 樊可可 朱邦 赵海金）
Abstract
Introduction: Tezepelumab is an anti-TSLP monoclonal antibody approved for the treatment of severe asthma. It has broad downstream anti-T2 effects, offering the prospect of biological remission. Real-world data on clinical remission rates with tezepelumab is lacking, and the relationship between clinical and biological remission is unclear. Finally, the effectiveness of tezepelumab in patients who have failed to respond to existing biologic therapies is unknown.
Methods: Clinical and biomarker data from adults with severe asthma treated with tezepelumab in a real-world setting was analyzed. Clinical outcome measures including clinical remission were recorded along with rates of biological remission (defined as blood eosinophil count < 300 cells/mcL and FeNO < 25 ppb).
Results: One hundred seventy-five patients were included. 98/175 (56%) had switched from another biologic. Following tezepelumab initiation, the exacerbation rate decreased from 3.1 (2.5) to 0.8 (1.4), with 59% of patients remaining exacerbation-free at 1 year. 54% achieved an ACQ score < 1.5. Clinical remission at 1 year was observed in 36%, with a rate of 55% in T2-high patients versus 19% in T2 low patients. The clinical response in biologic-naïve and biologic switch patients was similar. FeNO declined from 41 ppb (24-76) to 24 ppb (16-38) and BEC fell from 300 cells/μL (60-610) to 180 cells/μL (105-320) (both p < 0.001). 38% achieved biological remission. 15% attained both clinical and biological remission.
Conclusion: Tezepelumab led to substantial clinical improvements and clinical remission in up to 55% of T2-high patients with severe asthma. A disconnect between clinical and biological remission was observed. The long-term significance of residual T2 inflammation on tezepelumab is unknown.
Keywords: asthma; asthma treatment; biologics.
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