Document Detail

Omalizumab is effective in the long-term control of severe allergic asthma.
MedLine Citation:
PMID:  12952109     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: Previous reports show that addition of omalizumab to standard therapy reduces asthma exacerbations and simultaneously decreases use of inhaled corticosteroids (ICSs) and rescue medication in patients with allergic asthma.
OBJECTIVE: To determine the effect of omalizumab on long-term disease control in patients with severe allergic asthma.
METHODS: The present study concerns the 24-week, double-blind extension phase to a previous 28-week core study in which patients received subcutaneous omalizumab or matching placebo (at least 0.016 mg/kg/IgE [IU/mL] every 4 weeks) for 16 weeks in addition to their existing ICS therapy (beclomethasone dipropionate [BDP]; steroid-stable phase), followed by a 12-week phase in which controlled attempts were made to gradually reduce ICS therapy (steroid-reduction phase). During the extension phase patients were maintained on randomized treatment (omalizumab or placebo) and the lowest sustainable dose of BDP. The use of other asthma medications was permitted during the extension phase. Investigators were also allowed to switch patients from BDP to other ICS medications if considered necessary.
RESULTS: A total of 460 patients (omalizumab, n = 245; placebo, n = 215) entered the extension phase. Overall, omalizumab-treated patients experienced significantly fewer exacerbations vs placebo during the extension phase (0.60 and 0.83 exacerbations per patient, respectively; P = 0.023), despite a sustained significant reduction in their use of ICS (mean BDP equivalent dose: omalizumab, 227 microg/d; placebo, 335 microg/d; P < 0.001). Treatment with omalizumab was well tolerated and the incidence of adverse events was similar in both treatment groups.
CONCLUSIONS: These results indicate that omalizumab is effective in the long-term control of severe allergic asthma.
Bobby Quentin Lanier; Jonathan Corren; William Lumry; Jeen Liu; Angel Fowler-Taylor; Niroo Gupta
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Publication Detail:
Type:  Clinical Trial; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology     Volume:  91     ISSN:  1081-1206     ISO Abbreviation:  Ann. Allergy Asthma Immunol.     Publication Date:  2003 Aug 
Date Detail:
Created Date:  2003-09-03     Completed Date:  2003-09-30     Revised Date:  2013-01-18    
Medline Journal Info:
Nlm Unique ID:  9503580     Medline TA:  Ann Allergy Asthma Immunol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  154-9     Citation Subset:  IM    
Lanier Education and Research Network, Fort Worth, Texas, USA.
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MeSH Terms
Administration, Intranasal
Anti-Asthmatic Agents / administration & dosage*
Anti-Inflammatory Agents / administration & dosage
Antibodies, Anti-Idiotypic / administration & dosage*
Antibodies, Monoclonal / administration & dosage*
Antibodies, Monoclonal, Humanized
Beclomethasone / administration & dosage
Double-Blind Method
Drug Therapy, Combination
Forced Expiratory Volume / drug effects,  immunology
Glucocorticoids / administration & dosage
Injections, Subcutaneous
Longitudinal Studies
Middle Aged
Status Asthmaticus / drug therapy,  immunology,  prevention & control*
Reg. No./Substance:
0/Anti-Asthmatic Agents; 0/Anti-Inflammatory Agents; 0/Antibodies, Anti-Idiotypic; 0/Antibodies, Monoclonal; 0/Antibodies, Monoclonal, Humanized; 0/Glucocorticoids; 0/anti-IgE antibodies; 0/omalizumab; 4419-39-0/Beclomethasone
Comment In:
Ann Allergy Asthma Immunol. 2003 Aug;91(2):117-8   [PMID:  12952102 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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