PURPOSE OF THE STUDY.
To evaluate the effectiveness of omalizumab in improving asthma control of inner-city children who are not adequately controlled on guideline-based therapy.
Inner-city children, adolescents, and young adults (N = 419) with persistent allergic asthma were included in this study. Eligible patients were required to have a physician's diagnosis of asthma or documentation of asthma symptoms for longer than 1 year before entry into the study and evidence of uncontrolled asthma. All patients had at least 1 positive skin-test result to a perennial allergen, weighed between 20 and 150 kg, and had a total serum immunoglobulin E (IgE) level between 30 and 1300 IU/mL.
Participants (n = 419) were randomly assigned to receive subcutaneous injections of omalizumab or placebo every 2 or 4 weeks for a 60-week treatment period. Omalizumab doses were calculated on the basis of patient weight and total serum IgE level; the minimum monthly dose was 0.016 mg/kg body weight/IU IgE/mL. Routine clinic visits were scheduled every 3 months. Asthma-control assessment was based on National Asthma Education and Prevention Program (NAEPP) guidelines. The primary outcome evaluated at each injection visit was the number of symptomatic days in the previous 2 weeks. Numerous secondary outcomes were evaluated.
Compared with placebo, omalizumab treatment significantly reduced the mean number of symptomatic days per 2-week interval from 1.96 to 1.48, which is a 24.5% difference (P < .001). Significantly fewer exacerbations occurred during the treatment period in the omalizumab group; 30.3% of patients had an exacerbation compared with 48.8% of patients in the placebo group (P < .001). Similarly, the percentage of hospitalizations caused by asthma was 1.51% vs 6.3% in the placebo group (P = .02). Asthma control in the omalizumab group required significantly lower doses of inhaled glucocorticoids (P < .001) and long-acting β2 agonists (P = .003). Finally, posthoc analysis revealed that omalizumab prevented the seasonal spikes in exacerbations seen in the placebo group. No differences in safety were seen.
Omalizumab improved asthma control in inner-city children, adolescents, and young adults when added to their previous guideline-based therapy.
Omalizumab is an effective treatment option for patients with asthma and allergies whose conditions are not adequately controlled on guideline-based therapy. In this study, the effectiveness of omalizumab was shown at all levels of asthma severity. According to NAEPP guidelines, omalizumab is indicated for patients older than 11 years as a step 5 or 6 treatment option. Further data on the long-term safety of omalizumab in children is needed before we can fully advocate adjusting these current recommendations. Overall, this study provides us with further proof that the allergic component of asthma plays a key role in controlling this population's asthma. Further research to investigate the potential use of omalizumab for preventing seasonal peaks would also be beneficial at this time.
- Copyright © 2011 by the American Academy of Pediatrics