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Published on: August 7, 2017
The oral corticosteroid-sparing effect of omalizumab in children with severe asthma
Malcolm Brodlie1, Michael C McKean, Samantha Moss
1Institute of Cellular Medicine, Newcastle University, Newcastle upon Tyne, UK.
Insights
Omalizumab significantly reduced oral corticosteroid use in children with severe asthma, improving their quality of life and asthma control. Benefits were observed in both younger and older children, indicating its potential as a steroid-sparing therapy.
Area of Science:
- Pediatric Pulmonology
- Immunology
- Clinical Therapeutics
Background:
- Severe asthma in children often requires long-term oral corticosteroid therapy, associated with significant side effects.
- Omalizumab, a monoclonal antibody targeting IgE, has shown efficacy in adult asthma but its role in steroid reduction in children is less established.
Purpose of the Study:
- To evaluate the corticosteroid-sparing effect of omalizumab in children with severe asthma.
- To assess the impact of omalizumab on asthma control and quality of life in this pediatric population.
Main Methods:
- A 16-week therapeutic trial involving 34 children with severe asthma on oral prednisolone.
- Omalizumab was administered via subcutaneous injections, with dosage based on weight and IgE levels.
- Outcomes included reduction in prednisolone dose, mini-Asthma Quality of Life Questionnaire (AQLQ), Childhood Asthma Control Test (ACT), and FEV(1).
Main Results:
- The median daily prednisolone dose significantly decreased from 20 mg to 5 mg, with 7 children discontinuing steroids entirely.
- Significant improvements were noted in mini-AQLQ scores (3.5 to 5.9) and Childhood ACT scores (12 to 20).
- Improvements in steroid reduction and asthma control were consistent across age groups (<12 and ≥12 years).
Conclusions:
- Omalizumab demonstrated a significant steroid-sparing effect in children with severe asthma over 16 weeks.
- The treatment improved asthma control and quality of life, with benefits observed in both younger and older children.
- Further investigation via multicenter, randomized, placebo-controlled trials is warranted to confirm these encouraging findings.
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.
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