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Omalizumab in children with inadequately controlled severe allergic (IgE-mediated) asthma.

Abstract：

BACKGROUND:Many children with severe persistent allergic (IgE-mediated) asthma remain inadequately controlled despite treatment with high-dose inhaled corticosteroids (ICS) plus a long-acting beta(2)-agonist (LABA). RESEARCH AND DESIGN METHODS:This pre-specified analysis of a randomized, double-blind, placebo-controlled trial evaluated the efficacy and safety of omalizumab in children (6-<12 years) with perennial allergen sensitivity, and history of asthma exacerbations and symptoms despite treatment with ICS (fluticasone >or=500 microg x day(-1) or equivalent) plus a LABA. Patients received omalizumab (75-375 mg once or twice a month by subcutaneous injection, as determined from dosing tables) or placebo over 52 weeks (24-week fixed-steroid then 28-week adjustable-steroid phases). RESULTS:Out of 246 randomized patients (omalizumab, n = 166; placebo, n = 80), efficacy was analysed in 235 (omalizumab, n = 159; placebo, n = 76). 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 34% versus placebo (0.42 vs 0.63, rate ratio 0.662; P = 0.047). Over 52 weeks, the exacerbation rate was reduced by 50% (P < 0.001). Omalizumab had an acceptable safety profile, with no statistically significant (P < 0.05) differences in adverse events observed between omalizumab and placebo. CONCLUSION:Add-on omalizumab is well-tolerated and reduces exacerbations in children (6-<12 years) with severe persistent allergic asthma, inadequately controlled despite high-dose ICS plus a LABA. It should be noted that the sample size was not based on providing statistical power in the severe subgroup, and no corrections were made for multiple comparisons; however, outcomes consistently favoured omalizumab.

journal_name

Curr Med Res Opin

journal_title

Current medical research and opinion

authors

Kulus M,Hébert J,Garcia E,Fowler Taylor A,Fernandez Vidaurre C,Blogg M

doi

10.1185/03007991003771338

subject

Has Abstract

pub_date

2010-06-01 00:00:00

pages

1285-93

issue

eissn

0300-7995

issn

1473-4877

journal_volume

pub_type

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Omalizumab in children with inadequately controlled severe allergic (IgE-mediated) asthma.