OBJECTIVE: To report the oral corticosteroid-sparing effect of omalizumab in children with severe asthma. DESIGN: 16-week therapeutic trial. SETTING:Tertiary paediatric asthma clinic. PATIENTS: 34 children with severe asthma maintained onoral prednisolone (median age 12 years; 15 children <12 years and 19 children ≥12 years). INTERVENTIONS: Fortnightly or monthly subcutaneous injections of omalizumab; the dose was calculated as per manufacturer's instructions based on body weight and serum immunoglobulin E concentration. MAIN OUTCOME MEASURES: Reduction in prednisolone dose; mini-Asthma Quality of Life Questionnaire (AQLQ); Childhood Asthma Control Test (ACT); forced expiratory volume in 1 s (FEV(1)). RESULTS: Median daily prednisolone dose reduced from 20 mg to 5 mg (n=34, p<0.0001), including seven children who stopped prednisolone completely. Mini-AQLQ score increased from 3.5 to 5.9 (n=24, p<0.0001). Childhood ACT score increased from 12 to 20 (n=23, p=0.0001). FEV(1) increased from 2.10 to 2.25 litres (n=31, non-significant). The reduction in prednisolone dose and improvements in mini-AQLQ and childhood ACT were significant in children both under and over 12 years of age, with no differences in outcome detected between these two groups. CONCLUSIONS: A 16-week therapeutic trial of omalizumab allowed a significant reduction in daily prednisolone dose and was associated with improvements in asthma control and quality of life in 34 children with severe asthma. Similar benefits were seen in children both above and below 12 years of age. These uncontrolled data are very encouraging. There is an urgent requirement for a multicentre randomised placebo-controlled trial of omalizumab in children with severe asthma, with reduction in oral corticosteroid dose as the primary outcome measure.
RCT Entities:
OBJECTIVE: To report the oral corticosteroid-sparing effect of omalizumab in children with severe asthma. DESIGN: 16-week therapeutic trial. SETTING: Tertiary paediatric asthma clinic. PATIENTS: 34 children with severe asthma maintained on oral prednisolone (median age 12 years; 15 children <12 years and 19 children ≥12 years). INTERVENTIONS: Fortnightly or monthly subcutaneous injections of omalizumab; the dose was calculated as per manufacturer's instructions based on body weight and serum immunoglobulin E concentration. MAIN OUTCOME MEASURES: Reduction in prednisolone dose; mini-Asthma Quality of Life Questionnaire (AQLQ); Childhood Asthma Control Test (ACT); forced expiratory volume in 1 s (FEV(1)). RESULTS: Median daily prednisolone dose reduced from 20 mg to 5 mg (n=34, p<0.0001), including seven children who stopped prednisolone completely. Mini-AQLQ score increased from 3.5 to 5.9 (n=24, p<0.0001). Childhood ACT score increased from 12 to 20 (n=23, p=0.0001). FEV(1) increased from 2.10 to 2.25 litres (n=31, non-significant). The reduction in prednisolone dose and improvements in mini-AQLQ and childhood ACT were significant in children both under and over 12 years of age, with no differences in outcome detected between these two groups. CONCLUSIONS: A 16-week therapeutic trial of omalizumab allowed a significant reduction in daily prednisolone dose and was associated with improvements in asthma control and quality of life in 34 children with severe asthma. Similar benefits were seen in children both above and below 12 years of age. These uncontrolled data are very encouraging. There is an urgent requirement for a multicentre randomised placebo-controlled trial of omalizumab in children with severe asthma, with reduction in oral corticosteroid dose as the primary outcome measure.