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Omalizumab reduces exacerbations among pediatric patients

Adding omalizumab to ongoing guidelines-based care significantly reduced the number of asthma exacerbations for pediatric patients during the school year if initiated before school begins, according to results from a multicenter trial.

“Our findings that an effective preventative strategy for fall exacerbations can be achieved with targeted seasonal treatment suggest a paradigm shift for managing high-risk patients, although further research is needed to refine the subgroups of asthmatic patients most likely to benefit from seasonal treatment with omalizumab,” Stephen J. Teach, MD, MPH, from the division of emergency medicine and the department of pediatrics at Children’s National Health System in Washington, D.C., and colleagues.

In the randomized, double blind, placebo-controlled multicenter study, Teach and colleagues evaluated 478 children with asthma living in the inner city aged between 6 years and 17 years during the fall 2012 and fall 2013 school seasons, according to the abstract. Researchers assigned patients to either placebo, omalizumab with an inhaled corticosteroid, or omalizumab with placebo between 4 weeks to 6 weeks before the start of the school year.

Teach and colleagues observed a small subset of patients for the effects of interferon alpha on peripheral blood mononuclear cells and rhinovirus. They also initiated a 4-month to 9-month run-in phase of the study as well as a 4-month intervention phase.

The researchers observed a significantly lower exacerbation rate at the start of the school year for patients who received omalizumab (11.3%) compared with placebo (21.0%; OR = 0.48; 95% CI, 0.25-0.92), according to the abstract. However, they noted no significant difference between patients assigned omalizumab plus placebo (8.4%) and those assigned an inhaled corticosteroid boost in addition to omalizumab (11.1%; OR = 0.73; 95% CI, 0.33-1.64).

In the subgroup analysis, there was a significant reduction in exacerbation among patients who received omalizumab plus placebo compared with just placebo (6.4% vs. 36.3%; OR = 0.12; 95% CI, 0.02-0.64) or with inhaled corticosteroid boost (2% vs. 27.8%; OR = 0.05; 95% CI, 0.002-0.98).

Within the omalizumab group, Teach and colleagues noted improved interferon alpha responses to rhinovirus and that greater interferon alpha increases were associated with fewer exacerbations.

The researchers noted that adverse events were rare and similar among all arms. – by Jeff Craven

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