Omalizumab for the treatment of exacerbations in children with inadequately controlled allergic (IgE-mediated) asthma
Received 5 June 2009; received in revised form 9 September 2009; accepted 15 September 2009. published online 12 November 2009.
Background
Many children with asthma continue to experience symptoms despite available therapies.
Objective
This study evaluated the efficacy and safety of omalizumab, a humanized anti-IgE mAb, in children with moderate-to-severe persistent allergic (IgE-mediated) asthma that was inadequately controlled despite treatment with medium-dose or high-dose inhaled corticosteroids (ICSs) with or without other controller medications.
Methods
A randomized, double-blind, placebo-controlled trial enrolled children age 6 to <12 years with perennial allergen sensitivity and history of exacerbations and asthma symptoms despite at least medium-dose ICSs. Patients were randomized 2:1 to receive omalizumab (75-375 mg sc, q2 or q4 wk) or placebo over a period of 52 weeks (24-week fixed-steroid phase followed by a 28-week adjustable-steroid phase).
Results
A total of 627 patients (omalizumab, n = 421; placebo, n = 206) were randomized, with efficacy analyzed in 576 (omalizumab, n = 384; placebo, n = 192). Over the 24-week fixed-steroid phase, omalizumab reduced the rate of clinically significant asthma exacerbations (worsening symptoms requiring doubling of baseline ICS dose and/or systemic steroids) by 31% versus placebo (0.45 vs 0.64; rate ratio, 0.69; P = .007). Over a period of 52 weeks, the exacerbation rate was reduced by 43% versus placebo (P < .001). Omalizumab significantly reduced severe exacerbations. Over a period of 52 weeks, omalizumab had an acceptable safety profile, with no difference in overall incidence of adverse events compared with placebo.
Conclusion
Add-on omalizumab is effective and well tolerated as maintenance therapy in children (6 to <12 years) with moderate-to-severe persistent allergic (IgE-mediated) asthma whose symptoms are inadequately controlled despite medium to high doses of ICSs.
Reprint requests: Bob Lanier, MD, Department of Pediatrics, University of North Texas, 6407 Southwest Blvd, Fort Worth, TX 76132.
Supported by Novartis Pharma AG.
Disclosure of potential conflict of interest: B. Lanier has served as a consultant for Alcon Laboratories and has received research support from Alcon Laboratories, Genentech/Novartis, and AstraZeneca. T. Bridges has served on the speakers' bureau and has received research support from Novartis and Genentech. The rest of the authors have declared that they have no conflict of interest.
ABSTRACT