Adding omalizumab to guidelines-directed asthma therapy reduces seasonal exacerbations and the need for controller medication among inner-city children, regardless of asthma severity, results from the Inner City Anti-IgE Therapy for Asthma (ICATA) Trial indicated.
“We found omalizumab (Xolair, Novartis) to be equally effective at all levels of asthma severity and all ages evaluated,” study researcher Suzanne Steinbach, MD, an associate professor of pediatrics at Boston University School of Medicine, said in a press release.
She and colleagues enrolled 419 inner-city patients, aged 6 years to 20 years, who had persistent asthma and randomly assigned patients to receive either subcutaneous omalizumab (n=208; 75-375 mg) injections or placebo injections (n=211) every two or four weeks for 60 weeks, in addition to existing asthma therapy.
At baseline 72% of participants did not have well-controlled asthma and 30% had poorly controlled asthma, as designated by the National Asthma Education and Prevention Program Expert Panel Report 3 (NAEPP EPR-3).
A blinded study staff conducted asthma evaluation and management visits every three months, during which asthma therapy was adjusted based on patient symptoms determined by questionnaires and NAEPP EPR-3 guidelines.
The researchers found that omalizumab reduced asthma symptoms by 25% (0.48 day reduction per two weeks) and asthma exacerbations by 30% (37.2% vs. 53.6%; P=.001) compared with placebo.
Data indicated that children in the treatment group achieved these improvements with significantly lower doses of inhaled corticosteroids and long-acting beta-agonist bronchodilators — 15% of children in the control group were treated according to NAEPP severe guidelines vs. 25% in the placebo group.
Furthermore, children in the omalizumab group experienced fewer exacerbations between September and November, the peak asthma season. Whereas exacerbations increased more than 100% in the placebo group from summer to fall and inhaled-corticosteroid use went up, rates stayed static in the treatment group.
“Because omalizumab targets a specific immunologic pathway of major importance in asthma, patients with asthma and allergic sensitizations are obviously the candidates for this treatment,” the researchers wrote, adding that the specificity of omalizumab for IgE may lead to a greater understanding into the underlying mechanisms in asthma exacerbations.
For example, children in omalizumab treatment group who were sensitized and exposed to German cockroach allergen — previously associated with high asthma morbidity in inner-city children — experienced the greatest reductions in asthma symptoms, exacerbations and inhaled-corticosteroid use.
“Although our observations will help in the selection of patients for omalizumab, asthma treatments for individual patients will eventually need to consider many aspects of disease management, including cost,” the researchers wrote.
Results were published online in the March 17 issue of the New England Journal of Medicine.