• Stephen J Teach, Michelle A Gill, Alkis Togias, Christine A Sorkness, Samuel J Arbes, Agustin Calatroni, Jeremy J Wildfire, Peter J Gergen, Robyn T Cohen, Jacqueline A Pongracic, Carolyn M Kercsmar, Gurjit K Khurana Hershey, Rebecca S Gruchalla, Andrew H Liu, Edward M Zoratti, Meyer Kattan, Kristine A Grindle, James E Gern, William W Busse, and Stanley J Szefler.
• Division of Emergency Medicine and the Department of Pediatrics, Children's National Health System, Washington, DC. Electronic address: steach@childrensnational.org.
• J. Allergy Clin. Immunol. 2015 Dec 1; 136 (6): 1476-1485.

BackgroundShort-term targeted treatment can potentially prevent fall asthma exacerbations while limiting therapy exposure.ObjectiveWe sought to compare (1) omalizumab with placebo and (2) omalizumab with an inhaled corticosteroid (ICS) boost with regard to fall exacerbation rates when initiated 4 to 6 weeks before return to school.MethodsA 3-arm, randomized, double-blind, double placebo-controlled, multicenter clinical trial was conducted among inner-city asthmatic children aged 6 to 17 years with 1 or more recent exacerbations (clincaltrials.gov #NCT01430403). Guidelines-based therapy was continued over a 4- to 9-month run-in phase and a 4-month intervention phase. In a subset the effects of omalizumab on IFN-α responses to rhinovirus in PBMCs were examined.ResultsBefore the falls of 2012 and 2013, 727 children were enrolled, 513 were randomized, and 478 were analyzed. The fall exacerbation rate was significantly lower in the omalizumab versus placebo arms (11.3% vs 21.0%; odds ratio [OR], 0.48; 95% CI, 0.25-0.92), but there was no significant difference between omalizumab and ICS boost (8.4% vs 11.1%; OR, 0.73; 95% CI, 0.33-1.64). In a prespecified subgroup analysis, among participants with an exacerbation during the run-in phase, omalizumab was significantly more efficacious than both placebo (6.4% vs 36.3%; OR, 0.12; 95% CI, 0.02-0.64) and ICS boost (2.0% vs 27.8%; OR, 0.05; 95% CI, 0.002-0.98). Omalizumab improved IFN-α responses to rhinovirus, and within the omalizumab group, greater IFN-α increases were associated with fewer exacerbations (OR, 0.14; 95% CI, 0.01-0.88). Adverse events were rare and similar among arms.ConclusionsAdding omalizumab before return to school to ongoing guidelines-based care among inner-city youth reduces fall asthma exacerbations, particularly among those with a recent exacerbation.Copyright © 2015 American Academy of Allergy, Asthma & Immunology. All rights reserved.

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