Omalizumab reduces exacerbations in children with poorly controlled asthma
MedWire News: Add-on therapy with omalizumab helps reduce asthma exacerbations in children with moderate-to-severe persistent allergic asthma who have poorly-controlled disease despite treatment with inhaled corticosteroids (ICSs), research shows.
Writing in the Journal of Allergy and Clinical Immunology, Bob Lanier (University of North Texas, Fort Worth, USA) and team explain: “ICSs are an effective controller therapy and recommended for the treatment of asthma in children. However, many have poor asthma control despite intensive treatment.”
To investigate whether add-on treatment with omalizumab may benefit such children, the researchers enrolled 576 patients, aged 6–12 years, with inadequately controlled, moderate-to-severe allergic asthma.
The children, who had a history of exacerbations and asthma symptoms despite treatment with at least medium-dose ICSs, were randomly assigned to treatment with omalizumab (75–375 mg once or twice a month, based on baseline serum total immunoglobulin E and body weight) or placebo for 52 weeks.
The participants also received a fixed ICS dose for the first 24-week period, unless adjustment was required for an exacerbation, followed by a 28-week adjustable-steroid phase.
Over the initial 24-week phase, children taking omalizumab suffered an average 0.45 exacerbations (worsening symptoms requiring a significant increased in ICS dose and/or systemic steroids) compared with an average of 0.64 exacerbations in those taking placebo. This equated to a 31% reduction in exacerbations with omalizumab compared with placebo.
Over the entire 52-week period, omalizumab treatment was associated with a 43% reduction in exacerbations, compared with placebo.
There were no significant differences between the two groups regarding the overall incidence of adverse events, the researchers note.
Lanier and team conclude: “This randomized, double-blind, placebo-controlled study in children with moderate-to-severe allergic (immunoglobulin E-mediated) asthma demonstrates that add-on omalizumab significantly reduces clinically significant asthma exacerbations.
“The study also demonstrated that omalizumab has an acceptable safety profile and is well tolerated.”
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By Mark Cowen