Omalizumab reduces frequency of asthma exacerbations in children

Article Outline

• Question
• Design
• Setting
• Participants
• Intervention
• Outcomes
• Main Results
• Conclusions
• Commentary
• Reference
• Copyright

Busse WW, Morgan WJ, Gergen PJ, Mitchell HE, Gern JE, Liu AH, et al. Randomized trial of omalizumab (anti-IgE) for asthma in inner-city children. N Engl J Med 2011;364:1005-15.

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Question 

Among children and adolescents with asthma, does omalizumab decrease asthma exacerbations and symptoms, compared with placebo?

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Design 

Randomized, double-blind, placebo-controlled, parallel-group trial.

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Setting 

Multiple centers in the United States.

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Participants 

419 children, adolescents, and young adults (6-20 years old) with persistent asthma. At randomization, 73% had moderate or severe disease.

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Intervention 

Participants were randomized to subcutaneous injections of omalizumab (75 to 375 mg based on weight) or placebo every 2 or 4 weeks for a total of 60 weeks (15 or 30 injections).

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Outcomes 

The primary outcome was severity of asthma symptoms. Secondary outcomes included asthma exacerbations and other validated measures of asthma control.

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Main Results 

Omalizumab significantly reduced the number of days with asthma symptoms, from 1.96 to 1.48 days per 2-week interval, a 24.5% decrease (P < .001). Similarly, omalizumab significantly reduced the proportion of participants who had one or more exacerbations from 48.8 to 30.3% (P < .001, number needed to treat = 6). Improvements occurred with omalizumab despite reductions in the use of inhaled glucocorticoids and long-acting beta-agonists.

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Conclusions 

When added to a regimen of guidelines-based therapy for inner-city children, adolescents, and young adults, omalizumab further improved asthma control, nearly eliminated seasonal peaks in exacerbations, and reduced the need for other medications to control asthma.

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Commentary 

Omalizumab, a humanized monoclonal anti-IgE antibody, is clinically effective, although cost-effectiveness has not been conclusively demonstrated. Some of the difficulties with establishing the cost-effectiveness of omalizumab are related to the fact that improvements in quality of life and reductions in exacerbations are not accompanied by changes in lung function on which many costs-effectiveness models are based.¹ Responses to omalizumab are variable and, although cost-effectiveness appears to be greater in those with severe disease, to date there is no reliable way of identifying those people prior to starting treatment. This study shows that omalizumab has a significant impact on asthma control and exacerbations in an inner-city population of children and young adults with severe asthma. It also suggests that it is more effective in those who are both sensitized and exposed to cockroach allergen. Compared with those who were neither sensitized nor exposed to cockroach allergen, people receiving omalizumab had bigger reductions in inhaled corticosteroid dose (P = .03), asthma exacerbations (P = .06), and increased odds of not having an asthma exacerbation (P = .06). This may represent the beginning of a different approach to selecting patients for treatment with omalizumab, which allows prior identification of likely responders. Importantly, however, it is clear from neither the paper nor the supplementary appendices how many people in this study were both sensitized and exposed to cockroach allergen. Further validation of this approach is required before it can be used to reliably to identify responders to omalizumab.

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Reference 

1. Sullivan SD, Turk F. An evaluation of the cost-effectiveness of omalizumab for the treatment of severe allergic asthma. Allergy. 2008;63:670–684
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