Lee Ji Ho, Lee Hyun Young, Jung Chang Gyu, Ban Ga Young, Shin Yoo Seob, Ye Young Min, Nahm Dong Ho, Park Hae Sim
Department of Allergy and Clinical Immunology, Ajou University School of Medicine, Suwon, Korea.
Department of Statistics, Clinical Trial Center, Ajou University Medical Center, Suwon, Korea.
Allergy Asthma Immunol Res. 2018 Mar;10(2):121-130. doi: 10.4168/aair.2018.10.2.121.
Omalizumab, an anti-immunoglobulin E (IgE) monoclonal antibody, has proved to be effective for the treatment of severe asthma. However, there is no direct evidence of effectiveness of omalizumab in Korean patients with severe asthma. We sought to evaluate the real-world effectiveness of omalizumab in Korean adult patients suffering from severe asthma and to identify predictors of favorable response.
A retrospective analysis of electrical medical records was performed on severe allergic asthmatic patients with omalizumab treatment group (OT group) for more than 6 months between March 2008 and February 2016. Propensity score matching was applied to define the standardized treatment control group (STC group) treated without omalizumab. Asthma-related outcomes were compared between the 2 groups, and analyzed before and after omalizumab use in the OT group. Responders to treatment were defined as patients showing >50% reduction in asthma exacerbations and/or systemic steroid requirement during the outcome period.
One hundred twenty-four patients with severe asthma (62 in the OT group; 62 in the STC group) were enrolled in the study. Proportion of patients having the reduction of asthma exacerbation (53.2% vs 35.5%, P=0.015) and the rate of responders (67.7% vs 41.9%, P=0.007) were significantly higher in the OT group than in the STC group. Significant reductions were noted in asthma exacerbation (P=0.006), hospitalization (P=0.009), hospitalization days (P=0.006), systemic corticosteroid requirements (P=0.027), and sputum eosinophil count (P=0.031) in OT group compared with STC group. There were no significant differences in changes of forced expiratory volume in the 1 second (FEV1) levels between the 2 groups. No predictors of responders were found for omalizumab treatment.
Omalizumab can reduce exacerbations/hospitalization/systemic steroid burst in Korean adult patients with severe asthma.
奥马珠单抗，一种抗免疫球蛋白E（IgE）单克隆抗体，已被证明对重度哮喘治疗有效。然而，在韩国重度哮喘患者中，尚无奥马珠单抗有效性的直接证据。我们旨在评估奥马珠单抗在韩国成年重度哮喘患者中的实际疗效，并确定良好反应的预测因素。
对2008年3月至2016年2月间接受奥马珠单抗治疗超过6个月的重度过敏性哮喘患者进行电子病历回顾性分析。应用倾向评分匹配法确定未使用奥马珠单抗治疗的标准化治疗对照组（STC组）。比较两组间与哮喘相关的结局，并对奥马珠单抗治疗组使用奥马珠单抗前后进行分析。治疗反应者定义为在观察期内哮喘发作和/或全身类固醇需求减少>50%的患者。
124例重度哮喘患者（奥马珠单抗治疗组62例；标准化治疗对照组62例）纳入研究。奥马珠单抗治疗组哮喘发作减少的患者比例（53.2%对35.5%，P=0.015）和治疗反应者比例（67.7%对41.9%，P=0.007）显著高于标准化治疗对照组。与标准化治疗对照组相比，奥马珠单抗治疗组哮喘发作（P=0.006）、住院（P=0.009）、住院天数（P=0.006）、全身皮质类固醇需求（P=0.027）和痰液嗜酸性粒细胞计数（P=0.031）均显著降低。两组间一秒用力呼气容积（FEV1）水平变化无显著差异。未发现奥马珠单抗治疗反应者的预测因素。
奥马珠单抗可减少韩国成年重度哮喘患者的发作/住院/全身类固醇冲击。
