替泽帕鲁单抗的临床与生物学缓解：真实世界中重症未控制哮喘的治疗应答
2025/06/27
摘要
引言：替泽帕鲁单抗是一种抗胸腺基质淋巴细胞生成素（TSLP）的单克隆抗体，已获批用于治疗重症哮喘。该药物具有广泛的下游抗2型炎症（anti-T2）效应，有望实现生物学生物学缓解。目前尚缺乏替泽帕鲁单抗在真实世界中临床缓解率的数据，且临床缓解与生物学缓解之间的关系尚未明确。此外，替泽帕鲁单抗对现有生物制剂治疗失败患者的疗效仍属未知。
方法：本研究分析了真实世界中接受替泽帕鲁单抗治疗的重症哮喘成人的临床及生物标志物数据。记录的临床结局指标包括临床缓解率，以及生物学缓解率（定义为血嗜酸性粒细胞计数<300个/μL且呼出气一氧化氮[FeNO]<25 ppb）。
结果：共纳入175例患者，其中98例（56%）曾换用其他生物制剂。启用替泽帕鲁单抗后，哮喘急性加重率从3.1（2.5）次/年降至0.8（1.4）次/年，59%的患者在1年内未发生急性加重。54%的患者哮喘控制问卷（ACQ）评分<1.5分。1年时临床缓解率为36%，其中高T2型患者达55%，而低T2型患者仅为19%。未接受过生物制剂治疗者与换用生物制剂者的临床应答率相似。FeNO中位数从41 ppb（24-76）降至24 ppb（16-38），血嗜酸性粒细胞计数从300个/μL（60-610）降至180个/μL（105-320）（均p<0.001）。38%的患者达到生物学缓解，15%同时实现临床与生物学缓解。
结论：替泽帕鲁单抗可显著改善临床结局，使高达55%的高T2型重症哮喘患者获得临床缓解。但观察到临床缓解与生物学缓解存在不一致性。替泽帕鲁单抗治疗后残留T2炎症的长期意义尚需进一步研究。
引言：替泽帕鲁单抗是一种抗胸腺基质淋巴细胞生成素（TSLP）的单克隆抗体，已获批用于治疗重症哮喘。该药物具有广泛的下游抗2型炎症（anti-T2）效应，有望实现生物学生物学缓解。目前尚缺乏替泽帕鲁单抗在真实世界中临床缓解率的数据，且临床缓解与生物学缓解之间的关系尚未明确。此外，替泽帕鲁单抗对现有生物制剂治疗失败患者的疗效仍属未知。
方法：本研究分析了真实世界中接受替泽帕鲁单抗治疗的重症哮喘成人的临床及生物标志物数据。记录的临床结局指标包括临床缓解率，以及生物学缓解率（定义为血嗜酸性粒细胞计数<300个/μL且呼出气一氧化氮[FeNO]<25 ppb）。
结果：共纳入175例患者，其中98例（56%）曾换用其他生物制剂。启用替泽帕鲁单抗后，哮喘急性加重率从3.1（2.5）次/年降至0.8（1.4）次/年，59%的患者在1年内未发生急性加重。54%的患者哮喘控制问卷（ACQ）评分<1.5分。1年时临床缓解率为36%，其中高T2型患者达55%，而低T2型患者仅为19%。未接受过生物制剂治疗者与换用生物制剂者的临床应答率相似。FeNO中位数从41 ppb（24-76）降至24 ppb（16-38），血嗜酸性粒细胞计数从300个/μL（60-610）降至180个/μL（105-320）（均p<0.001）。38%的患者达到生物学缓解，15%同时实现临床与生物学缓解。
结论：替泽帕鲁单抗可显著改善临床结局，使高达55%的高T2型重症哮喘患者获得临床缓解。但观察到临床缓解与生物学缓解存在不一致性。替泽帕鲁单抗治疗后残留T2炎症的长期意义尚需进一步研究。
(中日友好医院呼吸与危重症医学科 万静萱 摘译 林江涛 审校)
（Allergy 2025 May 14;0(0)DOI：10.1111/all.16590.IF: 8.706）
Clinical and Biological Remission With Tezepelumab: The Real-World Response in Severe Uncontrolled Asthma.
Jessica, Gates; Faizan, Haris;
Abstrast
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.
Jessica, Gates; Faizan, Haris;
Abstrast
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.
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