Preseasonal treatment with either omalizumab or an inhaled corticosteroid boost to prevent fall asthma exacerbations.

Autor: Teach SJ; Division of Emergency Medicine and the Department of Pediatrics, Children's National Health System, Washington, DC. Electronic address: steach@childrensnational.org., Gill MA; Departments of Pediatrics and Immunology, University of Texas Southwestern Medical Center, Dallas, Tex., Togias A; National Institute of Allergy and Infectious Diseases, Bethesda, Md., Sorkness CA; University of Wisconsin School of Medicine and Public Health, Madison, Wis., Arbes SJ Jr; Rho Inc, Federal Systems Division, Chapel Hill, NC., Calatroni A; Rho Inc, Federal Systems Division, Chapel Hill, NC., Wildfire JJ; Rho Inc, Federal Systems Division, Chapel Hill, NC., Gergen PJ; National Institute of Allergy and Infectious Diseases, Bethesda, Md., Cohen RT; Boston University School of Medicine, Boston, Mass., Pongracic JA; Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago, Ill., Kercsmar CM; Cincinnati Children's Hospital, Cincinnati, Ohio., Khurana Hershey GK; Cincinnati Children's Hospital, Cincinnati, Ohio., Gruchalla RS; Departments of Pediatrics and Immunology, University of Texas Southwestern Medical Center, Dallas, Tex., Liu AH; National Jewish Health, Denver, Colo; Children's Hospital Colorado and University of Colorado School of Medicine, Aurora, Colo., Zoratti EM; Department of Internal Medicine, Division of Allergy and Immunology, Henry Ford Hospital, Detroit, Mich., Kattan M; College of Physicians and Surgeons, Columbia University, New York, NY., Grindle KA; University of Wisconsin School of Medicine and Public Health, Madison, Wis., Gern JE; University of Wisconsin School of Medicine and Public Health, Madison, Wis., Busse WW; University of Wisconsin School of Medicine and Public Health, Madison, Wis., Szefler SJ; Children's Hospital Colorado and University of Colorado School of Medicine, Aurora, Colo.
Jazyk: angličtina
Zdroj: The Journal of allergy and clinical immunology [J Allergy Clin Immunol] 2015 Dec; Vol. 136 (6), pp. 1476-1485. Date of Electronic Publication: 2015 Oct 27.
DOI: 10.1016/j.jaci.2015.09.008
Abstrakt: Background: Short-term targeted treatment can potentially prevent fall asthma exacerbations while limiting therapy exposure.
Objective: We 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.
Methods: A 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.
Results: Before 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.
Conclusions: Adding 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.)
Databáze: MEDLINE
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