混合型嗜酸性粒细胞和过敏性重度哮喘患者中生物制剂的头对头有效性比较
2025/04/30
摘要
背景：目前一些疗法适用于过敏性哮喘，另一些适用于嗜酸性哮喘，比较重度哮喘生物疗法的研究通常存在选择偏差。重度混合性哮喘（SMA）被认为是同时患有过敏性和嗜酸性（混合）重度哮喘的患者。在SMA中，可以使用度普利尤单抗、奥马珠单抗、美泊利珠单抗和贝纳利珠单抗。目前还没有对这一组患者的生物疗法临床效果进行直接比较的研究。
目的：比较四种生物疗法治疗SMA的疗效。
方法：前瞻性研究，随访一年。招募了具有过敏性哮喘标志物（总IgE>100IU/L和sIgE对空气过敏原）和嗜酸性哮喘（嗜酸性粒细胞>150个细胞/ml）的重度哮喘患者。在基线时评估人口学和临床特征，以评估组间的显著差异。主要结局是哮喘控制测试（ACT）得分>20分的患者比例，作为次要结局，我们评估了每年哮喘严重恶化的次数和FEV1的变化。
结果：共有133名患者参与了这项研究（度普利尤单抗 n=43，奥马珠单抗=32，美泊利珠单抗 n=32，贝纳利珠单抗 n=26）。在基线时，各组在人口学或临床特征方面没有显著差异。经过一年的生物治疗，四组患者的临床结果显著改善，组间差异很小。四组的主要结局（ACT）没有差异。度普利尤单抗和美泊利珠单抗的FEV1间期改善率高于奥马珠单抗。与奥马珠单抗和贝纳利珠单抗相比，度普利尤单抗受试者FEV1改善200ml的患者比例最高。贝纳利珠单抗使用者的依从性最高。
结论：在SMA中，四种生物疗法根据ACT评分评估的症状控制方面表现相似，但根据FEV1和依从性存在一些差异。因此，SMA中这些疗法的选择必须基于每个患者的特定方面。
Head-to-head effectiveness comparison of biological therapies in patients with mixed eosinophilic and allergic severe asthma
Jorge Sánchez, Leidy Alvarez, Ana-Lorena Caraballo, Luis-Carlos Santamaria, Ana-Milena Acevedo, Ana Calle, Margarita Olivares
Abstract
Background: Studies comparing biological therapies for severe asthma usually have a selection bias considering that some of these therapies are indicated for allergic asthma and others for eosinophilic asthma. Severe mixed asthma (SMA) was considered in patients with both allergic and eosinophilic (mixed) severe asthma. In SMA, dupilumab, omalizumab, mepolizumab, and benralizumab, can be used. Currently there are no head-to-head studies comparing the clinical response of biological therapies in this group of patients.
Objective: To compare the effectiveness of four biological therapies in SMA.
Methods: Prospective study with one year of follow-up. Severe asthma patients with markers for allergic asthma (total IgE >100IU/L and sIgE to aeroallergens) and eosinophilic asthma (Eosinophils >150 cells/ml) were recruited. Sociodemographic and clinical characteristics were evaluated at baseline to assess significant differences between groups. The primary outcome was the proportion of patients achieving > 20 points in the Asthma Control Test (ACT), and as secondary outcomes we evaluated the number of severe exacerbations of asthma per year and change in FEV1.
Results: A total of 133 patients participated in the study (dupilumab n=43, omalizumab=32, mepolizumab=32, benralizumab=26). At baseline, the groups did not have significant differences in sociodemographic or clinical characteristics. After one year with biological therapies, the four groups presented a significant improvement in clinical outcomes with few between groups differences. There was no difference for the main outcome (ACT) in the four groups. Dupilumab and mepolizumab demonstrated a higher interval improvement in FEV1 than omalizumab. Dupilumab users had the highest proportion of patients who achieved a 200 ml improvement in FEV1 over omalizumab and benralizumab. The greatest adherence was observed among benralizumab users.
Conclusion: In SMA the four biological therapies offer similar symptom control according to ACT but there are some differences according to FEV1 and adherence. Therefore, the selection of these therapies in SMA must be based on particular aspects of each patient.
背景：目前一些疗法适用于过敏性哮喘，另一些适用于嗜酸性哮喘，比较重度哮喘生物疗法的研究通常存在选择偏差。重度混合性哮喘（SMA）被认为是同时患有过敏性和嗜酸性（混合）重度哮喘的患者。在SMA中，可以使用度普利尤单抗、奥马珠单抗、美泊利珠单抗和贝纳利珠单抗。目前还没有对这一组患者的生物疗法临床效果进行直接比较的研究。
目的：比较四种生物疗法治疗SMA的疗效。
方法：前瞻性研究，随访一年。招募了具有过敏性哮喘标志物（总IgE>100IU/L和sIgE对空气过敏原）和嗜酸性哮喘（嗜酸性粒细胞>150个细胞/ml）的重度哮喘患者。在基线时评估人口学和临床特征，以评估组间的显著差异。主要结局是哮喘控制测试（ACT）得分>20分的患者比例，作为次要结局，我们评估了每年哮喘严重恶化的次数和FEV1的变化。
结果：共有133名患者参与了这项研究（度普利尤单抗 n=43，奥马珠单抗=32，美泊利珠单抗 n=32，贝纳利珠单抗 n=26）。在基线时，各组在人口学或临床特征方面没有显著差异。经过一年的生物治疗，四组患者的临床结果显著改善，组间差异很小。四组的主要结局（ACT）没有差异。度普利尤单抗和美泊利珠单抗的FEV1间期改善率高于奥马珠单抗。与奥马珠单抗和贝纳利珠单抗相比，度普利尤单抗受试者FEV1改善200ml的患者比例最高。贝纳利珠单抗使用者的依从性最高。
结论：在SMA中，四种生物疗法根据ACT评分评估的症状控制方面表现相似，但根据FEV1和依从性存在一些差异。因此，SMA中这些疗法的选择必须基于每个患者的特定方面。
（中日友好医院呼吸与危重症医学科 李红雯 摘译 林江涛 审校）
（J Allergy Clin Immunol Pract. 2025 Apr 2:S2213-2198(25)00298-3. doi: 10.1016/j.jaip.2025.03.035.）
Head-to-head effectiveness comparison of biological therapies in patients with mixed eosinophilic and allergic severe asthma
Jorge Sánchez, Leidy Alvarez, Ana-Lorena Caraballo, Luis-Carlos Santamaria, Ana-Milena Acevedo, Ana Calle, Margarita Olivares
Abstract
Background: Studies comparing biological therapies for severe asthma usually have a selection bias considering that some of these therapies are indicated for allergic asthma and others for eosinophilic asthma. Severe mixed asthma (SMA) was considered in patients with both allergic and eosinophilic (mixed) severe asthma. In SMA, dupilumab, omalizumab, mepolizumab, and benralizumab, can be used. Currently there are no head-to-head studies comparing the clinical response of biological therapies in this group of patients.
Objective: To compare the effectiveness of four biological therapies in SMA.
Methods: Prospective study with one year of follow-up. Severe asthma patients with markers for allergic asthma (total IgE >100IU/L and sIgE to aeroallergens) and eosinophilic asthma (Eosinophils >150 cells/ml) were recruited. Sociodemographic and clinical characteristics were evaluated at baseline to assess significant differences between groups. The primary outcome was the proportion of patients achieving > 20 points in the Asthma Control Test (ACT), and as secondary outcomes we evaluated the number of severe exacerbations of asthma per year and change in FEV1.
Results: A total of 133 patients participated in the study (dupilumab n=43, omalizumab=32, mepolizumab=32, benralizumab=26). At baseline, the groups did not have significant differences in sociodemographic or clinical characteristics. After one year with biological therapies, the four groups presented a significant improvement in clinical outcomes with few between groups differences. There was no difference for the main outcome (ACT) in the four groups. Dupilumab and mepolizumab demonstrated a higher interval improvement in FEV1 than omalizumab. Dupilumab users had the highest proportion of patients who achieved a 200 ml improvement in FEV1 over omalizumab and benralizumab. The greatest adherence was observed among benralizumab users.
Conclusion: In SMA the four biological therapies offer similar symptom control according to ACT but there are some differences according to FEV1 and adherence. Therefore, the selection of these therapies in SMA must be based on particular aspects of each patient.
上一篇：
度普利尤单抗对比美泊利单抗与贝那利珠单抗治疗哮喘的有效性研究：一项多国回顾性队列分析
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呼吸功能障碍和抑郁是高2型重度哮喘的核心肺外和行为/危险因素特征
