PURPOSE: Poorly-controlled asthma in school-age children can negatively affect school attendance and performance. Adding omalizumab (OMA) to inhaled corticosteroids in patients with moderate-severe persistent IgE-mediated asthma improves symptoms and reduces exacerbations. We evaluated the impact of the addition of OMA on treatment effectiveness and school absenteeism in children and adolescents with moderate-severe persistent IgE-mediated asthma.
METHODS: Data were combined from 4 randomized, double-blind, placebo (PBO)-controlled OMA 28-32 week trials. Asthma control at study end was determined using investigator's global assessment of treatment effectiveness (IGETE). IGETE was analyzed using the Cochran-Mantel-Haenszel test, for the distribution of responses categorized as excellent/good, moderate and poor/worse. The number of missed school days was analyzed using Poisson regression.
RESULTS: The children/adolescent subgroup (OMA, n=275; PBO, n=156) had a mean age of 10.5 yrs, mean serum IgE level of 332.6 IU/mL and were receiving a mean baseline inhaled corticosteroid dose of 431.8 μg/day (beclomethasone equivalent). The mean duration of asthma at baseline was 6.9 yrs and in the year prior to study entry, patients missed a mean of 4.9 school days. Addition of OMA was associated with a significant improvement in IGETE vs PBO (excellent/good 75% vs 49%, poor/worse 4% vs 21%) p < 0.001. OMA significantly reduced the number of missed school days (relative risk=0.47; 95% confidence interval: 0.29, 0.76; p=0.002).
CONCLUSION: OMA was associated with a significant improvement in investigator assessed treatment effectiveness and decreased the number of missed school days in children and adolescents with moderate-severe persistent IgE mediated asthma.
CLINICAL IMPLICATIONS: Addition of omalizumab to children and adolescents with moderate-severe persistent IgE mediated asthma improves treatment effectiveness and reduces school absenteeism.
DISCLOSURE: Henry Milgrom, Employee Novartis Pharmaceuticals; Product/procedure/technique that is considered research and is NOT yet approved for any purpose. Off label use of omalizumab in children