Clinical Response Predictive Model for Omalizumab in Moderate-to-Severe Asthma Patients

Abstract

Objective. Our study aimed to develop a predictive model for evaluating the clinical response of omalizumab treatment in moderate-to-severe asthma patients. Methods. This single-center, prospective study collected patients who meet the diagnostic criteria for moderate-to-severe bronchial asthma set by the National Asthma Prevention and Treatment Group in 2016 in the first hospital affiliated with Soochow University. Patients recruited were treated with omalizumab once per four weeks; at the beginning of each injection, blood eosinophils and the level of total serum IgE (IU/mL) were tested. After four injections of omalizumab, asthma control test (ACT), the 15-item Mini Asthma Quality of Life Questionnaire (MiniAQLQ), global treatment effectiveness (GETE), and lung function of all patients were evaluated in the 16th week. We used the selection operator method to build a logistic model and evaluated the clinical response of omalizumab in these patients. Results. This study included 108 moderate-to-severe patients (aged 39.86 ± 14.59 years). Eighty-nine patients finished treatment for 16 weeks, and 74 patients (83.1%) had an excellent or good response. The serum level of total IgE increased significantly after injection of omalizumab, while blood eosinophils count decreased significantly from baseline. Using the GETE as a clinical outcome, several clinical variables were significant predictors of clinical response. The corrected AUC and Brier scores were 0.872 and 0.111, which showed good discrimination. Significant variables included age, weight, family allergic history, acute exacerbations, the ratio of total serum IgE level at the 4th week to the baseline level, forced expiratory volume in one second/forced vital capacity (FEV1/FVC), and commodities of rhinitis. Using the improvement in maximal expiratory flow 25% of the measured value to the predicted value (MEF25%pre) as clinical outcome, the significant variables included weight, duration of asthma, use of oral corticosteroids (OCS), total serum IgE level at the 4th week, and history of rhinitis. Its corrected AUC and Brier scores were 0.674 and 0.225 after internal validation. Conclusion. Omalizumab treatment remarkably improved asthma control and pulmonary function in Chinese patients with moderate-to-severe asthma. The response prediction model we developed provides convenient approaches to help identify better clinical response patients to omalizumab treatment.