Arch Dis Child. The oral corticosteroid-sparing effect of omalizumab in children with severe asthma

Institute of Cellular Medicine, Newcastle University, Newcastle upon Tyne, UK.
Archives of Disease in Childhood (Impact Factor: 2.9). 06/2012; 97(7):604-9. DOI: 10.1136/archdischild-2011-301570
Source: PubMed


To report the oral corticosteroid-sparing effect of omalizumab in children with severe asthma.
16-week therapeutic trial.
Tertiary paediatric asthma clinic.
34 children with severe asthma maintained on oral prednisolone (median age 12 years; 15 children <12 years and 19 children ≥12 years).
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.
Reduction in prednisolone dose; mini-Asthma Quality of Life Questionnaire (AQLQ); Childhood Asthma Control Test (ACT); forced expiratory volume in 1 s (FEV(1)).
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.
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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    • "Part of the reason for this relatively poor response on lung function could be the result of prior maximum bronchodilator and anti-inflammatory effects of corticosteroids and long-acting β2-agonists (LABAs) which all patients being selected for treatment with omalizumab will be receiving. However, what is most gratifying is the ability in both adults and children for oral and high dose inhaled corticosteroids to be reduced and, in some cases, stopped altogether with a reduction in corticosteroid comorbidities without loss of asthma control [18,19]. Also of importance is the marked effect of omalizumab in reducing emergency physician consultations, courses of oral corticosteroids and hospital admissions associated with severe exacerbations. "
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    • "Omalizumab has been shown to reduce asthma exacerbations and hospital visits, as well as corticosteroid use, in patients with allergic asthma [9-11]. Omalizumab has also been shown to have a direct OCS-sparing effect in a 32-week randomized, open-label study in adolescents and adults (12–75 years) with severe asthma [12], as well as in a 16-week uncontrolled therapeutic trial in children (median age 12 years) [13]. "
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