Omalizumab in children with inadequately controlled severe allergic (IgE-mediated) asthma.
Curr Med Res Opin
; 26(6): 1285-93, 2010 Jun.
Article
en En
| MEDLINE
| ID: mdl-20377320
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 DESIGNMETHODS:
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.
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Asma
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Antialérgicos
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Anticuerpos Monoclonales
Tipo de estudio:
Clinical_trials
Límite:
Child
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Female
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Humans
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Male
Idioma:
En
Revista:
Curr Med Res Opin
Año:
2010
Tipo del documento:
Article
País de afiliación:
Polonia
Pais de publicación:
ENGLAND
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ESCOCIA
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GB
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GREAT BRITAIN
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INGLATERRA
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REINO UNIDO
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SCOTLAND
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UK
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UNITED KINGDOM