November 24, 2015
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Omalizumab reduces exacerbation rate in children with asthma

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Adding omalizumab to guide-line based care prior to the start of the school year reduced fall asthma exacerbation rates among inner-city children and adolescents, according to results of a multicenter clinical trial.

“Our study shows that an effective, preventative strategy for fall exacerbations can be achieved with targeted, seasonal treatment using omalizumab, suggesting a paradigm shift for managing high-risk patients,” Stephen J. Teach, MD, MPH, of Children’s National Health System in Washington, D.C., said in a press release.

Teach and colleagues conducted a double blind, double placebo-controlled study of 478 children with asthma aged 6 to 17 years old who lived in the inner city. Study participants — all of whom had a recent asthma exacerbation — were randomly assigned to omalizumab (Xolair; Genentech, Novartis), placebo or an inhaled corticosteroid boost.

Researchers found 11.3% of participants in the omalizumab group had exacerbations compared with 21% of patients in the placebo group (OR = 0.48; 95% CI, 0.25-0.92). However, there was no significant difference between the omalizumab and inhaled corticosteroid groups (OR = 0.73; 95% CI, 0.33-1.64).

Among study participants with an exacerbation during the 4-month to 9-month run-in phase of the trial, omalizumab was significantly more effective than placebo (6.4% vs. 36.3%; OR = 0.12; 95% CI, 0.02-0.64) or inhaled corticosteroid boost (2% vs 27.8%; OR = 0.05; 95% CI, 0-0.98), results of a prespecified subgroup analysis showed.

Rates of adverse events were comparable between study arms, researchers wrote. – by Jeff Craven

Disclosure: Teach reports grants from Novartis, PCORI, the Fight for Children Foundation, the Stewart Foundation, EJF Philanthropies, the NIH/National Institute of Allergy and Infectious Diseases and the NIH/National Heart, Lung, and Blood Institute. Please see the full study for a list of all other researchers’ relevant financial disclosures.