The oral corticosteroid-sparing effect of omalizumab in children with severe asthma
- 1Institute of Cellular Medicine, Newcastle University, Newcastle upon Tyne, UK
- 2Department of Respiratory Paediatrics, Great North Children's Hospital, Newcastle upon Tyne, UK
- Correspondence to David Anthony Spencer, Department of Paediatric Respiratory Medicine, Great North Children's Hospital, Queen Victoria Rd, Newcastle upon Tyne NE1 4LP, UK;
Contributors MB analysed the data and drafted the manuscript. MCM was involved in the clinical management of the children and contributed to the final draft of the manuscript. SM was involved in the clinical management of the children and data collection, and contributed to the final draft of the manuscript. DAS conceived the study, was involved in the clinical management of the children and contributed to the final draft of the manuscript.
- Accepted 22 March 2012
- Published Online First 9 June 2012
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 (FEV1).
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). FEV1 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.
Competing interests SM and DAS have received support to attend the European Respiratory Society annual congress from Novartis, and DAS has received honoraria for lectures from Novartis.
Provenance and peer review Not commissioned; externally peer reviewed.