Children with persistent allergic asthma not well controlled with inhaled corticosteroids experience significant morbidity and are at risk for future exacerbations. Recently, the addition of omalizumab (OMA) to the treatment regimen of children 6–12 yrs with moderate-severe persistent allergic asthma was shown to reduce the frequency of asthma exacerbations and serum IgE. Here we present the effect of OMA on peripheral blood eosinophils (PBEs), a marker of inflammation in this population.
OMA or placebo (PBO) was administered to children 6–12 yrs with moderate-severe persistent allergic asthma who were receiving moderate-high dose inhaled corticosteroids (ICS) in 2 randomized double blind phase III trials. The change from baseline to end of the ICS stable phase in PBEs was analyzed using analysis of covariance.
910 children (609 OMA, 301 PBO) were in the intent-to-treat population for the pooled analysis. Baseline mean serum IgE was 434/416 IU/ml, PBEs were 0.508/0.536 x109/L or 7.43/7.58% of WBCs and daily ICS dose was 392/381ug fluticasone equivalent, OMA/PBO respectively. OMA was associated with a larger decrease in absolute PBE count and percent PBEs than PBO (least squares mean -0.149 x109/L OMA vs −0.018 x109/L PBO, mean difference −0.131 x109/L, 95% CI: −0.164, −0.098, p < 0.0001; least squares mean −1.76% OMA vs −0.10% PBO, mean difference −1.65%, 95% CI: −2.12, −1.18, p < 0.0001).
Addition of OMA significantly decreased peripheral blood eosinophils in children with moderate-severe allergic asthma not well controlled with moderate-high doses of inhaled corticosteroids.
Additional efforts should be undertaken to establish the relationship between reduction in PBEs and clinical benefit.
Bradley Chipps, Employee Employee of Novartis Pharmaceuticals; Product/procedure/technique that is considered research and is NOT yet approved for any purpose. Omalizumab not approved for use in children < 12yrs old