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Title: Omalizumab Improves Symptoms and Pulmonary Function in Adolescents With Asthma: Presented at ACAAI

"Omalizumab Improves Symptoms and Pulmonary Function in Adolescents With Asthma: Presented at ACAAI"

By Corinna S. Bowser, MD PHILADELPHIA, PA -- November 15, 2006 -- The benefit of omalizumab in patients with moderate to severe IgE-mediated asthma may be most pronounced among adolescents, according to data presented here at 2006 Annual Meeting of the American College of Allergy, Asthma and Immunology (ACAAI). Pooled data from 5 randomized, double-blind, placebo-controlled trials show that adolescents had greater improvement in forced expiratory volume in 1 second (FEV[₁) compared with the general population. In addition, improvement in total asthma symptom scores was somewhat greater in the adolescent population, investigators reported.

The pronounced efficacy of omalizumab in adolescents is likely due to the fact that "their disease is homogeneous and better defined," said investigator Henry Milgrom, MD, director, Ambulatory Pediatric Allergy Program, National Jewish Medical and Research Center, Denver, Colorado.

"Adults may have more morbidities and more complicating features -- such as smoking or interstitial lung disease -- that make them not as likely to respond. And in children, we are more likely to be dealing with less complicated asthma," he said.

Out of 2,236 subjects randomized in these trials, there were 146 adolescents (mean age, 14.2 years) who had received omalizumab at a dose of 0.016 mg/kg or greater for every IU/mL of total IgE or placebo. All subjects also remained on their previous asthma treatment.

Omalizumab improved mean FEV₁ versus placebo in both adolescents and the overall population. However, the improvement tended to be greater in the adolescent subset. For omalizumab- and placebo-treated adolescents, the mean change was 268.2 and 98.3 mL, respectively; in overall population the mean change was 111.5 and 30.7 mL, respectively, for omalizumab and placebo.

Change in asthma symptom scores at the end of the study tended to be higher among adolescents, with a decrease from baseline (least squares mean difference) of 1.96 in adolescents and 1.13 in adults.

In a related presentation of data from this meta-analysis, researchers found that adding omalizumab to baseline controller therapy significantly reduced the need for rescue bursts of oral steroids among adolescents. Nearly 90% of adolescent subjects who responded to omalizumab reported no asthma exacerbations.

[Presentation title: Effect of Omalizumab on Pulmonary Function and Symptom Scores in Adolescents With Moderate-Severe Persistent IgE-Mediated Asthma. Abstract P169. Presentation title. Effect of Omalizumab on Need for Rescue Steroid Bursts in Adolescent Asthmatics - a Pooled Analysis. Abstract P170]

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