Efficacy And Safety Of Anti-IgE Monoclonal Antibody Combination With Dust Mite Subcutaneous Immunotherapy For Children With Bronchial Asthma

Objective We retrospectively analyzed the efficacy and safety of anti-Ig E monoclonal antibody（Omazumab）combined with dust mite subcutaneous immunotherapy（SCIT）for children with bronchial asthma.Methods Eighty-three asthmatic children were enrolled in the Department of Allergy,Affiliated Hospital of Qingdao University from January 2019 to February 2020.According to the severity of disease and different treatment plans,the patients were divided into control group,SCIT group and omalizumab combined with SCIT group（combination group）.All the children in the three groups were treated with basic medicines for asthma,while the control group was treated with only standard basic medicines for asthma,the SCIT group was added with dust mite SCIT on the basis of drug therapy,and the combination group was combination with dust mite SCIT after adding omalizumab on the basis of drug therapy.The changes of Asthma Control Questionnaire（ACQ）,Visual Analogue Scale（VAS）and lung function in the three groups were compared at pre-baseline,baseline,24and 48 weeks of treatment.The changes of asthma drug scores in the three groups after 24and 48 weeks of treatment were compared with baseline,and the changes of total Ig E（t Ig E）and dust mite specific Ig E（s Ig E）in the three groups at baseline and 48 weeks of treatment were compared,respectively.The adverse reactions of SCIT group and combination group were observed and recorded.Among them,the pre-baseline refers to the children in the three groups who were treated for the first time without standardized drug therapy,and the baseline refers to the children in the three groups who were treated for 16 weeks without acute asthma attack,with FEV1≥70%of lung function,and can start SCIT treatment.Results 83 children with asthma were included:There were 33 cases in SCIT group,18 cases in combination group and 32 cases in control group.1.Pre-baseline:There was a statistically significant difference in ACQ scores among the three groups of children（F=6.997,P=0.002）,with the combination group having a higher ACQ score than the control group and SCIT group,the difference was statistically significant(t=3.84,P_adj<0.05;t=3.59,P_adj<0.05);There was no significant difference in VAS score among the three groups（F=0.96,P<0.05）.There was a significant difference in FEV1 among the three groups（F=10.21,P<0.05）,with the combination group having lower FEV1 values than the control group and SCIT group,the difference was statistically significant(t=3.84,P_adj<0.05;t=3.59,P_adj<0.05).2.Baseline:There was no significant difference in ACQ score among the three groups（F=0.19,P=0.83）,and the ACQ score was lower than that in the pre-baseline,with statistically significant difference(t=15.58,P_adj<0.05;t=21.45,P_adj<0.05;t=68.05,P_adj<0.05);There was no significant difference in VAS score among the three groups（F=0.42,P=0.66）,and VAS score among the three groups decreased compared with the pre-baseline,and the difference was statistically significant(t=47.44,P_adj<0.05;t=28.87,P_adj<0.05;t=11.48,P_adj<0.05);There was no significant difference in FEV1among the three groups（F=0.47,P=0.63）,and FEV1 in the three groups decreased from the pre-baseline,with statistical significance(t=4.69,P_adj<0.05;t=3.16,P_adj<0.05;t=11.22,P_adj<0.05).3.After 24 weeks of treatment:The ACQ score in the combination group was lower than in the control group and SCIT group,and the differences were statistically significant(t=6.81,P_adj<0.05;t=4.60,P_adj<0.05).The VAS score in SCIT group was lower than that in the control group and in combination group,the difference was not statistically significant(t=1.17,P_adj>0.05;t=1.26,P_adj>0.05),the VAS score in combination group was lower than in control group,but the difference was not statistically significant(t=0.11,P_adj>0.05).FEV1 in combination group was higher than the control group and SCIT group,and the difference was not statistically significant(t=1.89,P_adj>0.05;t=0.44,P_adj>0.05);FEF50 in the combination group was higher than in the control group and SCIT group,but the difference between the combination group and the control group was statistically significant(t=2.03,P_adj<0.05).FEF50 in the SCIT group was higher than in the control group,and the difference was statistically significant only between the combination group and the control group.(t=0.36,P_adj>0.05).The drug score of the combination group decreased from baseline and the change value was greater than the control group and SCIT group.Only the difference between the combination group and the control group was statistically significant(t=3.70,P_adj<0.01).The drug score in the SCIT group decreased from baseline and the change value was greater than in the control group,but the difference was not statistically significant(t=1.44,P_adj>0.05).4.After 48 weeks of treatment:The ACQ score in the combination group was lower than the control group and SCIT group,and the differences were statistically significant(t=5.94,P_adj<0.05;t=4.60,P_adj<0.05),the ACQ score in SCIT group was lower than in the control group,but the difference was not statistically significant(t=0.36,P_adj>0.05).The VAS scores of SCIT group and combination group were lower than the control group,the difference between SCIT group and control group was statistically significant(t=2.61,P_adj<0.05).FEV1 in the combination group was higher than the other two groups,and the difference was statistically significant only between the combination group and the control group(t=2.52,P_adj<0.05).FEV1 in the SCIT group was higher than the control group,but the difference was not statistically significant(t=0.82,P_adj<0.05).FEF50 in the combination group was higher than that in the other two groups,but the difference between the combination group and the control group was statistically significant(t=2.13,P_adj<0.05).FEF50 in the SCIT group was higher than the control group,but the difference was not statistically significant(t=0.80,P_adj>0.05).Compared with baseline,the drug score of the combination group decreased and the change value was greater than the control group and the SCIT group.Only the difference between the combination group and the control group was statistically significant(t=3.78,P_adj<0.01).The drug score of the SCIT group decreased and the change value was greater than the control group,but the difference was not statistically significant(t=0.62,P_adj>0.05);t Ig E at 48 weeks of treatment in the combination group was significantly higher than that at baseline,with statistical significance（Z=-3.51,P<0.05）.s Ig E at 48 weeks of treatment in the combination group was significantly higher than that at baseline（Z=-3.75,P<0.05）.s Ig E of house dust mites in SCIT group at 48 weeks of treatment was significantly lower than that at baseline（Z=-3.66,P<0.05）.51 patients received 1347 subcutaneous injections of allergen,18 patients received 106 subcutaneous injections of Omalizumab,and the incidence of local adverse reactions was 9.56%in the SCIT group and 2.24%in the combination group,the difference was statistically significant（χ²=26.35,P<0.01）.The incidence of systemic adverse reactions was 3.70%in the SCIT group,all of which were gradeⅠ,while no systemic adverse reactions occurred in the combination group.Conclusions1.Compared with basic drugs and SCIT alone,omalizumab combined with SCIT can achieve complete control of asthma faster,reduce the dosage of basic drugs for asthma,and improve lung function better.2.Compared with SCIT alone,omalizumab combined with SCIT has a lower incidence of adverse reactions,indicating a safe and effective etiological treatment.