Abstract Background / Rationale Asthma is a chronic inflammatory disease characterized by variable airflow obstruction triggered by diverse stimuli and often associated with elevated serum IgE levels. “Difficult-to-treat” asthma refers to patients who remain uncontrolled despite optimized standard asthma therapy. Omalizumab (anti-IgE monoclonal antibody) neutralizes circulating IgE to reduce airway inflammation and improve lung function. Current Global Initiative for Asthma (GINA) guidelines recommend Omalizumab use in patients with serum IgE 1500 IU/mL. There is a dearth of studies related to Omalizumab efficacy and safety in Serun IgE values1500 Methods A retrospective review was conducted among patients with severe asthma uncontrolled on high-dose inhaled corticosteroids (ICS), long-acting β2-agonists (LABA), and inhaled Tiotropium between 2023 and 2025. Baseline Modified Medical Research Council (MMRC) dyspnea scores and Asthma Control Questionnaire (ACQ-5) results were collected. Patients with serum IgE 1500 IU/mL were screened for Allergic Bronchopulmonary Aspergillosis (ABPA) using modified ISHAM criteria. Eligible patients received Omalizumab 300 mg subcutaneously every month for six months. Post-treatment assessments included MMRC, ACQ-5, spirometry (FEV₁), and serum IgE levels. Adverse events were also recorded. Results Thirteen patients (mean age 38.5 years; 7 females, 6 males) received Omalizumab therapy. Following six months of treatment: Both MMRC and ACQ-5 scores showed symptomatic improvement. Mean FEV₁ improved from 0.83 L to 1.04 L (mean change: 210 mL, p = 0.005, paired t-test). Mean serum IgE levels reduced from 5701 IU/mL to 4127 IU/mL (mean change: 1574 IU/mL, p = 0.022). No adverse reactions were reported. Conclusions Omalizumab is safe and effective in severe asthma patients with high IgE levels (1500 IU/mL). It enhances symptom control, significantly improves lung function and reduces serum IgE levels. Limitations Non-randomized design, small sample size, and use of a fixed dose of Omalizumab (300 mg monthly). Omalizumab available in 150mg/vial makes its use limitation to 300 mg to avoid wastage. References: 1. Maselli DJ, Singh H, Diaz J, Peters JI. Efficacy of omalizumab in asthmatic patients with IgE levels above 700 IU/mL: a retrospective study. Ann Allergy Asthma Immunol. 2013;110(6):457-461. 2. Casale TB, Luskin AT, Busse W, Zeiger RS, Trzaskoma B, Yang M, et al. Omalizumab effectiveness in asthma patients with IgE levels above the dosing table range and high body weight. Br J Clin Pharmacol. 2014;77(3):431-438. 3. Matucci A, Bormioli S, Vivarelli E, Maggi E, Vultaggio A. Omalizumab for the treatment of patients with severe allergic asthma with immunoglobulin E levels above 1500 IU/mL. Front Pharmacol. 2023;14:1194895. This abstract is funded by: None
Nair et al. (Fri,) studied this question.