Cumulative IgE-levels specific for respiratory allergens as biomarker to predict efficacy of anti-IgE-based treatment of severe asthma

Abstract

Molecular therapies, including anti-IgE, biologicals and small molecules are increasingly used for treatment of asthma. The effectiveness of these therapies may be increased with biomarkers. Aim of this study was to assess the value of measuring cumulative IgE levels specific for respiratory allergens to increase the efficacy of anti-IgE therapy for severe bronchial asthma. One hundred and thirty seven patients with severe asthma were recruited from 2016 to 2022. Standard empirical allergy diagnosis (i.e., anamnesis, skin testing, allergen-specific IgE measurement), blood eosinophil counting, measurement of total IgE and of cumulative IgE-specific for respiratory allergens by Phadiatop™ were performed. Thirty four patients with severe allergic asthma, for whom all three diagnostic methods were performed, were then used to analyze the efficacy of anti-IgE treatment in patients stratified in two groups according to cumulative IgE levels specific for respiratory allergens determined by Phadiatop™. Group #1 patients (n = 8) had cumulative specific IgE values ≥ 0.35 and < 1.53 PAU/l while in group #2 patients (n = 26) they were ≥ 1.53 PAU/l. Treatment with Omalizumab was performed for at least 12 months. The level of asthma control (ACT questionnaire), the number of asthma exacerbations, the quality of life (AQLQ questionnaire), the need for systemic corticosteroids, and the respiratory function (FEV1) was determined by “before-after” analysis for each group, followed by a comparison of the dynamics between groups. In group 2 patients with an initial allergen-specific IgE level ≥ 1.53 kUA/L, the efficacy of Omalizumab treatment was better regarding asthma control, number of exacerbations, and quality of life than in group 1 patients. Our study provides evidence that measuring cumulative levels of IgE specific for respiratory allergens could be a useful screening method for detecting an allergic phenotype of severe asthma and may serve as biomarker to enhance the success of IgE-targeted therapy.

Association between pre-biologic T2-biomarker combinations and response to biologics in patients with severe asthma

“…We found no association between serum IgE concentrations and anti-IgE effectiveness. Consistent correlations between anti-IgE treatment response and baseline total serum IgE or antigen-specific IgE concentrations are lacking ( 52 , 53 ), although recently use of cumulative IgE levels has been suggested ( 54 ). When patients were stratified post-hoc by T2 biomarkers, exacerbations were reduced to a greater degree in those with the presence of both modestly elevated IgE and T2 biomarkers, despite similar IgE concentrations ( 55 ).…”

Mitochondria dysfunction in airway epithelial cells is associated with type 2-low asthma

“…Asthma is a chronic complicated airway disease, and presents a high prevalence throughout the world (Naumova et al, 2022). Airway inflammation in asthma can be subdivided in T2-high and T2-low subsets based on molecular mechanism (Halayko et al, 2021;Maggi et al, 2022).…”

Role of clinical biomarkers in predicting the effectiveness of omalizumab

“…In addition, Li et al 19 showed that the changes in total serum IgE levels may help evaluate responses to omalizumab treatment. Naumova et al 31 provided evidence that measuring cumulative levels of IgE specific for respiratory allergens serve as biomarker to enhance the success of IgE-targeted therapy. However, in our study, we did not find the baseline IgE level to predict the response to omalizumab; similar to the preliminary bioinformatics analysis results from a study by ourselves.…”