Efficacy and Safety of Omalizumab Combined with Allergen-Specific Immunotherapy in the Treatment of Moderate-to-Severe Allergic Asthma: A Prospective Cohort Study in a Chinese Population.

Background: Moderate-to-severe allergic asthma caused by dust mite sensitization is challenging to treat. Allergen-specific immunotherapy (AIT) is the only disease-modifying option but is limited by delayed effects, allergic side reactions, and poor adherence. Omalizumab, an anti-IgE antibody, may improve AIT's safety and effectiveness. Objective: To assess whether combining omalizumab with AIT is more effective and safer than AIT alone in patients with dust mite-induced moderate-to-severe asthma. Methods: This prospective study involved 37 patients divided into two groups: AIT alone (n=18) and omalizumab + AIT (n=19). Over 48 weeks, asthma control (ACT, ACQ), lung function (FEV₁%, PEF%, FEV₁/FVC), and airway inflammation (FeNO) were measured. Secondary outcomes included IgE levels, eosinophil counts, quality of life (AQLQ), and safety. Results: Both groups improved, but the combination group showed significantly better asthma control, lung function, and quality of life at week 48. Only the combination group had significant reductions in FeNO and eosinophils, suggesting stronger anti-inflammatory effects. IgE levels followed expected trends with no major group differences. Fewer adverse reactions occurred in the combination group; severe systemic events were reported only in the AIT-alone group. Conclusion: Adding omalizumab to AIT significantly enhances asthma control, lung function, and inflammation reduction while improving treatment safety. This supports its role as an effective adjunct in managing moderate-to-severe dust mite-allergic asthma in Chinese patients.