PURPOSE OF THE STUDY.
The goal of this study was to report the real-life efficacy and safety of add-on treatment with omalizumab in a large group of children with severe allergic asthma. The primary aim of this observational study was to evaluate the effect of omalizumab on asthma control. Secondary aims were to evaluate outcomes, including asthma exacerbations, health care utilization, inhaled corticosteroid (ICS)-sparing effect, pulmonary function test results, and safety.
A total of 104 children <18 years of age with severe allergic asthma and long-term follow-up at participating tertiary care centers who started omalizumab between January 2006 and June 2009 were enrolled.
Baseline characteristics were collected from medical files. Data were collected prospectively during 3 separate visits, including at initial administration of omalizumab (V0), at 20 ± 4 weeks (V1), and 52 ± 4 weeks (V2). Data included the level of asthma control during the 4 weeks before each visit, exacerbations, health care utilization, pulmonary function test results, data on maintenance therapy and ICS dose, and adverse events.
Asthma control improved over the year of treatment with omalizumab. Rates of poor control were 82% at V0, 17% at V1, and 8% at V2, and rates of good control were 0% at V0, 53% at V1, and 67% at V2 (P < .0001). There was a 72% reduction in exacerbations and an 88.5% reduction in hospital admissions over the 1 year of treatment. There was a significant improvement in pulmonary function test results and a 30% reduction in ICS dose over the 1-year treatment. The only effect modifier observed for response to omalizumab was age (ie, age ≥12 years was associated with better control). Six patients discontinued omalizumab due to a serious adverse event.
Omalizumab improved asthma control, asthma exacerbations, hospital admissions, lung function, and steroid use in children with severe allergic asthma. This medication was generally well tolerated, but there was a fraction of patients who experienced serious adverse events.
This trial was an interesting real-life study which showed that omalizumab is an extremely effective drug for children with severe allergic asthma. This study reinforces the pediatric clinician’s knowledge and practice when using this medication for children who truly need it.
- Copyright © 2014 by the American Academy of Pediatrics