{"title":"嗜酸性粒细胞混合性和过敏性严重哮喘患者生物治疗的正面疗效比较。","authors":"Jorge Sánchez MD, MSc, EAC, PhD , Leidy Alvarez MD, MSc, PhD(c) , Ana-Lorena Caraballo MD , Luis-Carlos Santamaria MD , Ana-Milena Acevedo MD , Ana Calle MD , Margarita Olivares MD","doi":"10.1016/j.jaip.2025.03.035","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><div>Studies comparing biologic 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 biologic therapies in this group of patients.</div></div><div><h3>Objective</h3><div>To compare the effectiveness of four biologic therapies in SMA.</div></div><div><h3>Methods</h3><div>This was a prospective study with 1 year of follow-up. Patients with severe asthma with markers for allergic asthma (total IgE greater than 100 IU/L and specific IgE to aeroallergens) and eosinophilic asthma (eosinophils greater than 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 greater than 20 points on the Asthma Control Test (ACT). As a secondary outcomes, we evaluated the number of severe exacerbations of asthma per year and changes in FEV<sub>1</sub>.</div></div><div><h3>Results</h3><div>A total of 133 patients participated in the study (dupilumab, n = 43; omalizumab, n = 32; mepolizumab, n = 32; and benralizumab, n = 26). At baseline, the groups did not have significant differences in sociodemographic or clinical characteristics. After 1 year with biologic therapies, the four groups had significant improvement in clinical outcomes with few between-group differences. There was no difference for the main outcome (ACT) in the four groups. Dupilumab and mepolizumab demonstrated a higher interval improvement in FEV<sub>1</sub> compared with omalizumab. Dupilumab users had the highest proportion of patients who achieved a 200-mL improvement in FEV<sub>1</sub> over omalizumab and benralizumab. The greatest adherence was observed among benralizumab users.</div></div><div><h3>Conclusions</h3><div>In SMA the four biologic therapies offer similar symptom control according to the ACT, but there are some differences according to FEV<sub>1</sub> and adherence. Therefore, the selection of these therapies in SMA must be based on the particular aspects of each patient.</div></div>","PeriodicalId":51323,"journal":{"name":"Journal of Allergy and Clinical Immunology-In Practice","volume":"13 7","pages":"Pages 1776-1785"},"PeriodicalIF":6.6000,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Head-to-Head Effectiveness Comparison of Biological Therapies in Patients With Mixed Eosinophilic and Allergic Severe Asthma\",\"authors\":\"Jorge Sánchez MD, MSc, EAC, PhD , Leidy Alvarez MD, MSc, PhD(c) , Ana-Lorena Caraballo MD , Luis-Carlos Santamaria MD , Ana-Milena Acevedo MD , Ana Calle MD , Margarita Olivares MD\",\"doi\":\"10.1016/j.jaip.2025.03.035\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background</h3><div>Studies comparing biologic 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 biologic therapies in this group of patients.</div></div><div><h3>Objective</h3><div>To compare the effectiveness of four biologic therapies in SMA.</div></div><div><h3>Methods</h3><div>This was a prospective study with 1 year of follow-up. Patients with severe asthma with markers for allergic asthma (total IgE greater than 100 IU/L and specific IgE to aeroallergens) and eosinophilic asthma (eosinophils greater than 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 greater than 20 points on the Asthma Control Test (ACT). As a secondary outcomes, we evaluated the number of severe exacerbations of asthma per year and changes in FEV<sub>1</sub>.</div></div><div><h3>Results</h3><div>A total of 133 patients participated in the study (dupilumab, n = 43; omalizumab, n = 32; mepolizumab, n = 32; and benralizumab, n = 26). At baseline, the groups did not have significant differences in sociodemographic or clinical characteristics. After 1 year with biologic therapies, the four groups had significant improvement in clinical outcomes with few between-group differences. There was no difference for the main outcome (ACT) in the four groups. Dupilumab and mepolizumab demonstrated a higher interval improvement in FEV<sub>1</sub> compared with omalizumab. Dupilumab users had the highest proportion of patients who achieved a 200-mL improvement in FEV<sub>1</sub> over omalizumab and benralizumab. The greatest adherence was observed among benralizumab users.</div></div><div><h3>Conclusions</h3><div>In SMA the four biologic therapies offer similar symptom control according to the ACT, but there are some differences according to FEV<sub>1</sub> and adherence. 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引用次数: 0
摘要
背景：比较重度哮喘生物疗法的研究通常存在选择偏倚，因为其中一些疗法适用于过敏性哮喘，而另一些适用于嗜酸性哮喘。严重混合性哮喘（SMA）被认为是过敏性和嗜酸性粒细胞（混合性）严重哮喘患者。在SMA中，可以使用dupilumab， omalizumab， mepolizumab和benralizumab。目前还没有对这组患者的生物治疗的临床反应进行正面比较的研究。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1年。研究招募具有过敏性哮喘标志物（总IgE >100IU/L和对空气过敏原的sIgE）和嗜酸性哮喘标志物（嗜酸性粒细胞>150细胞/ml）的重度哮喘患者。在基线时评估社会人口学和临床特征，以评估组间的显著差异。主要结局是哮喘控制测试（ACT）达到bbb20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133例患者参与研究（dupilumab =43, omalizumab=32, mepolizumab=32, benralizumab=26）。在基线时，两组在社会人口学或临床特征上没有显著差异。经过一年的生物治疗，四组的临床结果均有显著改善，组间差异不大。四组的主要结局（ACT）没有差异。Dupilumab和mepolizumab在FEV1的间期改善比omalizumab更高。与omalizumab和benralizumab相比，Dupilumab使用者获得200 ml FEV1改善的患者比例最高。在贝纳利珠单抗使用者中观察到最大的依从性。结论：在SMA中，四种生物疗法的症状控制与ACT相似，但在FEV1和依从性方面存在一定差异。因此，SMA的治疗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
Background
Studies comparing biologic 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 biologic therapies in this group of patients.
Objective
To compare the effectiveness of four biologic therapies in SMA.
Methods
This was a prospective study with 1 year of follow-up. Patients with severe asthma with markers for allergic asthma (total IgE greater than 100 IU/L and specific IgE to aeroallergens) and eosinophilic asthma (eosinophils greater than 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 greater than 20 points on the Asthma Control Test (ACT). As a secondary outcomes, we evaluated the number of severe exacerbations of asthma per year and changes in FEV1.
Results
A total of 133 patients participated in the study (dupilumab, n = 43; omalizumab, n = 32; mepolizumab, n = 32; and benralizumab, n = 26). At baseline, the groups did not have significant differences in sociodemographic or clinical characteristics. After 1 year with biologic therapies, the four groups had significant improvement in clinical outcomes with few between-group differences. There was no difference for the main outcome (ACT) in the four groups. Dupilumab and mepolizumab demonstrated a higher interval improvement in FEV1 compared with 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.
Conclusions
In SMA the four biologic therapies offer similar symptom control according to the ACT, but there are some differences according to FEV1 and adherence. Therefore, the selection of these therapies in SMA must be based on the particular aspects of each patient.
期刊介绍：
JACI: In Practice is an official publication of the American Academy of Allergy, Asthma & Immunology (AAAAI). It is a companion title to The Journal of Allergy and Clinical Immunology, and it aims to provide timely clinical papers, case reports, and management recommendations to clinical allergists and other physicians dealing with allergic and immunologic diseases in their practice. The mission of JACI: In Practice is to offer valid and impactful information that supports evidence-based clinical decisions in the diagnosis and management of asthma, allergies, immunologic conditions, and related diseases.
This journal publishes articles on various conditions treated by allergist-immunologists, including food allergy, respiratory disorders (such as asthma, rhinitis, nasal polyps, sinusitis, cough, ABPA, and hypersensitivity pneumonitis), drug allergy, insect sting allergy, anaphylaxis, dermatologic disorders (such as atopic dermatitis, contact dermatitis, urticaria, angioedema, and HAE), immunodeficiency, autoinflammatory syndromes, eosinophilic disorders, and mast cell disorders.
The focus of the journal is on providing cutting-edge clinical information that practitioners can use in their everyday practice or to acquire new knowledge and skills for the benefit of their patients. However, mechanistic or translational studies without immediate or near future clinical relevance, as well as animal studies, are not within the scope of the journal.
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