P4A046: Effect of Omalizumab on Asthma Outcomes in Pediatric Patients with Asthma and Food Allergy

Background: Food allergy (FA) is often comorbid in patients with allergic asthma. In the IA05 trial, omalizumab (OMA) treatment reduced asthma exacerbations in pediatric patients (6 to < 12 years) with allergic asthma. In this analysis, we use the IA05 trial results to examine baseline characteristics and assess whether OMA treatment influenced asthma exacerbations and healthcare resource use in pediatric patients with allergic asthma regardless of their FA status.

Methods: This post-hoc analysis examined data from the IA05 randomized, double-blind, placebo-controlled trial (NCT00079937). Patients aged 6 to < 12 years with moderate-to-severe allergic asthma (N=628), who have inadequate asthma control with inhaled corticosteroids (ICS), were randomized to OMA or placebo and followed for 52 weeks. Patients with asthma were categorized by whether or not they had physician-reported FA. Poisson regression analysis examined the rates of asthma exacerbations and healthcare resource use (hospital admissions, emergency room (ER) visits, and unscheduled doctor visits related to asthma, and total emergency visits).

Results: Baseline demographic characteristics (Table) were similar and balanced between patients with FA (asthma+FA) and patients without FA (asthma-FA), and patients on placebo or OMA. For asthma exacerbations and healthcare resource use, response to OMA versus placebo appeared to be similar for patients with and without FA at both 24 weeks (end of fixed-steroid phase, interaction p-values between 0.47-0.98) and 52 weeks (end of adjustable-steroid phase, interaction p-values between 0.21-0.84). Overall safety results for this study are available in Lanier JACI 2009;124:1210-6.

Conclusion: Patients 6 to < 12 years with moderate-to-severe allergic asthma appeared to have improvements in asthma exacerbations and healthcare resource use (asthma-related and all-cause) with OMA, versus placebo, regardless of their FA status. These findings add to the growing evidence that anti-IgE therapy with OMA is efficacious across atopic conditions and ages.