Addition of Omalizumab to Guideline-based Therapy May Improve Asthma Control in Inner-city Children and Adolescents with Allergic Asthma
DynaMed Weekly Update - Volume 6, Issue 11
Guidelines from the National Heart Lung and Blood Institute (NHLBI) recommend omalizumab, an anti-IgE monoclonal antibody, as an option for patients over 12 years old with severe persistent asthma and elevated IgE levels (J Allergy Clin Immunol 2007 Nov;120(5 Suppl):S94). The Inner-City Anti-IgE Therapy for Asthma (ICATA) trial evaluated the addition of omalizumab to guideline-based therapy for inner-city children and adolescents 6-20 years old with any level of persistent asthma and with elevated IgE levels. Following a 4-week run-in period, 419 patients with persistent uncontrolled asthma for > 1 year (mean age 11 years, 73% with moderate-severe disease) were randomized to omalizumab subcutaneous injections (75-375 mg every 2-4 weeks for 60 weeks) vs. placebo. All patients were assessed to determine appropriate guideline-based therapy based on symptoms, FEV1 and current treatment during the run-in period. Dosing for the omalizumab was determined by weight and IgE level.
In an analysis of 92% of the randomized patients, the omalizumab group had fewer asthma exacerbations (30.3% vs. 48.4%, p< 0.001, NNT 6) and less use of long-acting beta-2 agonists (55.4% vs. 65.5%, p = 0.003, NNT 10) (level 2 [mid-level] evidence). Omalizumab was also associated with a reduction in mean number of days per 2-week period with asthma symptoms (24.5% decrease, p < 0.001) and mean dose of inhaled glucocorticoids (p < 0.001). The reduction in days with symptoms was greatest (48.5%) in a subgroup of children who were both allergic to and exposed to cockroaches. There were no significant differences in lung function. Omalizumab was associated with a higher rate of gastrointestinal adverse events and a nonsignificant reduction in infections (N Engl J Med 2011 Mar 17;364(11):1005).