Case series study on efficacy and safety of Omalizumab in the treatment of moderate-to-severe allergic asthma in children / 中华实用儿科临床杂志

ABSTRACT

Objective:To explore the clinical efficacy and safety of the new targeted anti-immunoglobulin E (IgE) drug Omalizumab in the treatment of children with moderate and severe allergic bronchial asthma in China.Methods:The clinical data of children with moderate and severe allergic asthma who were treated in the Department of Pediatrics of Peking University First Hospital from July 2018 to January 2020 and treated with Omalizumab were retrospectively analyzed.A comparison was performed on the changes of questionnaires, including childhood asthma control test (C-ACT), pediatric asthma quality of life questionnaire (PAQLQ), mini-asthma quality of life questionnaire (Mini-AQLQ) and global evaluation of asthma treatment effectiveness (GETE), pulmonary function test, including forced expiratory volume in the first second (FEV 1), percentage to predicted value (FEV 1% pred) and small airway function, fractional concentration of exhaled nitric oxide (FeNO) and so on, before and after treating with Omalizumab. Results:A total of 15 pediatric patients completed 16 weeks of treatment follow-up.After 16 weeks of Omazumab treatment, the score of C-ACT increased from (16.001.66) scores to (25.38±0.64) scores ( F=11.969, P<0.001), PAQLQ increased from (118.08 ± 23.78) scores to (141.00 ± 11.91) scores ( F=9.289, P=0.001), Mini-AQLQ increased from (78.93±7.43) scores to (97.92±3.12) scores ( F=4.145, P=0.042), and GETE decreased from (2.47±0.27) scores to (1.60±0.19) scores ( t=2.982, P=0.010). The actual value of FEV 1, FEV 1% pred, the maximum expiratory flow percentage of the predicted value (PEF% pred), forced expiratory flow at 25% (MEF 75), forced expiratory flow at 50% (MEF 50) and maximum midexpiratory flow (MMEF 75/25), increased from (1.96±0.12) L to (2.17±0.21) L ( F=0.425, P=0.789), (81.46±2.85)% to (82.64±1.55)% ( F=0.926, P=0.465), (82.05±3.58)% to (91.10±4.67)% ( F=1.909, P=0.128), (60.36±7.43)% to (76.94±4.65)% ( F=2.120, P=0.096), (52.72±3.75)% to (73.80±8.34)% ( F=3.140, P=0.047) and (60.05±8.47)% to (74.86±10.85)% ( F=7.860, P=0.010), respectively.FeNO decreased from 25.0 (14.5, 35.5) μg/L to 20.0 (18.5, 30.0) μg/L ( Z=-0.206, P=0.840). Transient headache was observed in 1 case and evanescent eruption in 2 cases during the treatment, respectively. Conclusions:Omalizumab can significantly improve the clinical manifestations, lung function indicators and quality of life of children with moderate and severe allergic asthma, and has good safety.Thus, it is expected to play an important role in the treatment of children with moderate-to-severe allergic asthma.