García-Moguel Ismael, Martínez-Mesa Álvaro, Andújar-Espinosa Rubén, Díaz-Campos Rocío, Velasco-Garrido José Luis, Sanchez-Trincado Jose Luis, Luzon Elisa, Nuevo Javier, Alconada Carlos, Gutiérrez Miguel Ángel, Niza Gabriel, Padilla-Galo Alicia
Hospital Universitario 12 de Octubre, Instituto de Investigación Sanitaria Hospital 12 de Octubre (Imas12), Madrid, Spain.
Hospital Universitario Virgen de la Victoria, Málaga, Spain.
Respir Med. 2025 Feb;237:107940. doi: 10.1016/j.rmed.2025.107940. Epub 2025 Jan 13.
The ORBE II study showed the real-world effectiveness of benralizumab in severe eosinophilic asthma (SEA). This subgroup analysis aimed to characterize patients and outcomes based on baseline blood eosinophil count (BEC) and/or fractional exhaled nitric oxide (FeNO) levels.
In this analysis of the ORBE II retrospective study, SEA patients receiving benralizumab were categorized into subgroups based on individual or combined BEC/FeNO levels, according to the following thresholds: high BEC (hiBEC): ≥300 cells/μL; low BEC (loBEC): <300 cells/μL; high FeNO (hiFeNO): ≥50 ppb; low FeNO (loFeNO): <50 ppb. Baseline and up to 1 year of follow-up data are described.
Most patients with available data were classified as hiBEC (72.6 %) and 38.3 % as hiFeNO. The distribution according to combined baseline BEC and FeNO levels revealed a heterogeneous patient population. Although common SEA features were shared among subgroups, some distinct characteristics were observed, including elevated allergic asthma prevalence in hiBEC/loFeNO patients, high obesity prevalence and fewer non-smokers in loBEC/loFeNO patients, remarkable severe exacerbation rates in loBEC/hiFeNO patients [5.5 SD (6.0)], and more severe symptoms in the hiBEC/loBEC subgroup. All subgroups showed benefits following benralizumab treatment, with super-responder rates ranging from 68.2 % to 83.3 % and clinical remission rates reaching 70.0 %. Particularly good responses were noted in hiBEC/hiFeNO patients.
This study shows the variability of T2 biomarkers in ORBE II SEA patients, emphasizing the prevalence of high BEC values. While benralizumab benefits were important regardless of BEC, high BEC predicted good outcomes and FeNO had less influence on treatment effectiveness.
ORBE II研究显示了贝那利珠单抗在重度嗜酸性粒细胞性哮喘（SEA）中的真实疗效。该亚组分析旨在根据基线血嗜酸性粒细胞计数（BEC）和/或呼出一氧化氮分数（FeNO）水平对患者和结局进行特征描述。
在这项对ORBE II回顾性研究的分析中，接受贝那利珠单抗治疗的SEA患者根据个体或联合的BEC/FeNO水平被分为亚组，具体阈值如下：高BEC（hiBEC）：≥300个细胞/μL；低BEC（loBEC）：<300个细胞/μL；高FeNO（hiFeNO）：≥50 ppb；低FeNO（loFeNO）：<50 ppb。描述了基线和长达1年的随访数据。
大多数有可用数据的患者被归类为hiBEC（72.6%），38.3%为hiFeNO。根据联合基线BEC和FeNO水平的分布显示患者群体具有异质性。虽然亚组之间共享SEA的常见特征，但也观察到一些不同的特征，包括hiBEC/loFeNO患者中过敏性哮喘患病率升高，loBEC/loFeNO患者中肥胖患病率高且非吸烟者较少，loBEC/hiFeNO患者中严重加重率显著[5.5标准差（6.0）]，以及hiBEC/loBEC亚组中症状更严重。所有亚组在接受贝那利珠单抗治疗后均显示出获益，超反应率在68.2%至83.3%之间，临床缓解率达到70.0%。在hiBEC/hiFeNO患者中观察到特别好的反应。
本研究显示了ORBE II SEA患者中T2生物标志物的变异性，强调了高BEC值的普遍性。虽然无论BEC如何，贝那利珠单抗的获益都很重要，但高BEC预示着良好的结局，而FeNO对治疗效果的影响较小。
