(Boston) – Researchers from Boston University School of Medicine (BUSM), in collaboration with researchers from the Inner City Asthma Consortium, have found that among inner-city children, the drug omalizumab improved asthma control, nearly eliminated seasonal exacerbations and reduced the need for controller medication. These findings appear in the March 17th issue of the New England Journal of Medicine.

Guidelines-based treatment of persistent asthma follows a step-wise approach designed to achieve control. in allergic patients with asthma who fail to achieve control on higher steps of treatment, omalizumab, a humanized monoclonal anti-IgE antibody, is recommended based on available clinical trial data for children with severe asthma. Anti-IgE treatment reduces the allergic airway response to inhaled antigen, symptoms, exacerbations, and, in some patients, the dose of inhaled corticosteroids (ICS) needed to maintain disease control.

“There is a high prevalence of allergic sensitization and ongoing allergen exposure in inner-city environments,” said study coauthor Suzanne Steinbach, MD, an associate professor of pediatrics at BUSM. “Therefore we hypothesized that the addition of anti-IgE would improve disease control by reducing symptoms and exacerbations in inner-city children and adolescents with asthma and persistent symptoms despite guidelines-based treatment,” she added.

Inner city children and adolescents with persistent asthma were enrolled in a randomized, double-blind, placebo-controlled, parallel-group, multi-center trial comparing omalizumab versus placebo added to guidelines-based therapy for 60 weeks. Among the 419 randomized participants, omalizumab treatment reduced asthma symptoms by 25 percent and exacerbations by 30 percent. while the control group experienced more than a 100 percent increase in exacerbations from summer to fall, a small, non-significant, increase in this outcome occurred in the omalizumab group. These improvements occurred with omalizumab despite significant reductions in both inhaled corticosteroids and long-acting beta agonists.

“We found omalizumab to be equally effective at all levels of asthma severity and all ages evaluated. secondly, the addition of omalizumab significantly reduced asthma symptoms within one month rather than three as previously reported. Third, and most striking, was the profound reduction in fall exacerbations associated with omalizumab treatment,” added Steinbach.