Gates Jessica, Haris Faizan, Cefaloni Francesca, Khooshemehri Paniz, Green Linda, Fernandes Mariana, Thomson Louise, Roxas Cris, Lam Jodie, d'Ancona Grainne, Nanzer Alexandra M, Dhariwal Jaideep, Jackson David J
Guy's Severe Asthma Centre, Guy's and St Thomas' NHS Trust, London, UK.
School of Immunology and Microbial Sciences, King's College London, London, UK.
Allergy. 2025 Jun;80(6):1669-1676. doi: 10.1111/all.16590. Epub 2025 May 14.
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.
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).
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.
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.
tezepelumab是一种获批用于治疗重度哮喘的抗TSLP单克隆抗体。它具有广泛的下游抗T2效应，有望实现生物学缓解。目前缺乏关于tezepelumab临床缓解率的真实世界数据，且临床缓解与生物学缓解之间的关系尚不清楚。最后，tezepelumab在对现有生物疗法无反应的患者中的有效性尚不清楚。
分析了在真实世界中接受tezepelumab治疗的重度哮喘成人患者的临床和生物标志物数据。记录了包括临床缓解在内的临床结局指标以及生物学缓解率（定义为血液嗜酸性粒细胞计数<300个细胞/微升且呼出气一氧化氮<25 ppb）。
纳入了175例患者。98/175（56%）从另一种生物制剂转换而来。开始使用tezepelumab后，发作率从3.1（2.5）降至0.8（1.4），59%的患者在1年时无发作。54%的患者获得了<1.5的哮喘控制问卷（ACQ）评分。1年时观察到36%的患者实现临床缓解，T2高的患者缓解率为55%，而T2低的患者为19%。初治生物制剂患者和转换生物制剂患者的临床反应相似。呼出气一氧化氮从41 ppb（24 - 76）降至24 ppb（16 - 38），血液嗜酸性粒细胞计数从300个细胞/微升（60 - 610）降至180个细胞/微升（105 - 320）（两者p<0.001）。38%的患者实现生物学缓解。15%的患者实现了临床和生物学缓解。
tezepelumab使高达55%的重度哮喘T2高的患者实现了显著的临床改善和临床缓解。观察到临床缓解与生物学缓解之间存在脱节。残留T2炎症对tezepelumab的长期意义尚不清楚。
