Head-to-Head Effectiveness Comparison of Biological Therapies in Patients With Mixed Eosinophilic and Allergic Severe Asthma

Abstract

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.

Keywords: Allergy; Asthma; Benralizumab; Biologic; Dupilumab; Eosinophilic; IgE; Mepolizumab; Omalizumab; Rhinosinusitis.