[Clinical efficacy of omalizumab for treatment of moderate or severe allergic asthma in children with serum immunoglobulin E levels >1 500 IU/mL: a prospective study].

OBJECTIVES

To evaluate the clinical efficacy of omalizumab in the treatment of moderate or severe allergic asthma in children with serum total immunoglobulin E (IgE) levels >1 500 IU/mL.

METHODS

A total of 95 children with moderate or severe allergic asthma, who were treated at the Department of Respiratory Medicine in Anhui Provincial Children's Hospital from December 2020 to May 2022, were enrolled. Based on their serum total IgE levels and whether they received omalizumab treatment, they were divided into a control group (IgE >1 500 IU/mL, no omalizumab treatment), a normal treatment group (IgE levels between 30 and 1 500 IU/mL, omalizumab treatment), and an ultra-high IgE treatment group (IgE >1 500 IU/mL, omalizumab treatment). The differences in clinical characteristics, Childhood Asthma Control Test (C-ACT) scores before and after treatment, the proportion of acute attacks, IgE levels, pulmonary function indicators, and fractional exhaled nitric oxide (FeNO) concentrations were analyzed among the three groups.

RESULTS

At the 8th week of treatment, the normal treatment group and the ultra-high IgE treatment group had higher C-ACT scores, forced expiratory volume in first second (FEV) as a percentage of predicted value (FEV%pred), FEV/forced vital capacity (FVC) ratio (FEV/FVC), and peak expiratory flow (PEF) as a percentage of predicted value (PEF%pred), as well as a lower proportion of acute attacks and FeNO concentration compared to the control group (<0.05). There were no statistically significant differences in the comparison of various indicators between the ultra-high IgE treatment group and the normal treatment group (>0.05). At the 16th week of treatment, the normal treatment group and the ultra-high IgE treatment group had higher C-ACT scores and pulmonary function indicators including FEV%pred, FEV/FVC, PEF%pred, and forced expiratory flow at 25% vital capacity (FEF) as a percentage of predicted value (FEF%pred) compared to the control group (<0.05). The proportion of acute attacks and FeNO concentration in the ultra-high IgE treatment group were lower than those in the control group (<0.05). There were no statistically significant differences in the comparison of various indicators between the ultra-high IgE treatment group and the normal treatment group (>0.05).

CONCLUSIONS

Omalizumab therapy has a certain clinical efficacy in children with moderate or severe allergic asthma and serum total IgE levels >1 500 IU/mL, with no significant difference in efficacy compared to children with serum total IgE levels between 30 and 1 500 IU/mL.