Abstract

Introduction: PROXIMA study evaluated the effect of omalizumab in severe allergic asthma (SAA) patients. In the context of this study, a sub-study on proteomic analysis of asthma biomarkers was conducted on biological samples of SAA patients. Aim and objectives: The aim of this sub-study was to characterize patients with SAA, exploring asthma-related proteins in biologic samples as possible biomarkers and to assess whether these biomarkers correlated with the achievement and maintenance of disease control. Methods: Proteomic analysis was performed using chromatography and mass spectrometry applied on exosomes extracted from urine samples of patients at baseline (T0) and 12 months (T12) after omalizumab. Results: The protein profiles of samples from patients before treatment allowed a stratification of patients in two main groups characterized by a different clinical trend after treatment (Table). The same procedure was applied also to clinical parameters and the segregation of patients resulted in good agreement with that obtained by proteomics analysis. Finally, some proteins, such as Galectin 3-binding protein (Gal-3BP), resulted very consistent for predicting the patient behavior to omalizumab treatment. Conclusions: Overall the data suggest that molecular stratification correlates with those obtained by means of clinical parameters and thus proteomics profiles of urine samples from SAA patients could be useful for predicting clinical response to treatment.

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