PMID- 15266491
OWN - NLM
STAT- MEDLINE
DCOM- 20041130
LR  - 20181221
IS  - 1469-493X (Electronic)
IS  - 1361-6137 (Linking)
IP  - 3
DP  - 2004
TI  - Anti-IgE for chronic asthma in adults and children.
PG  - CD003559
AB  - BACKGROUND: Omalizumab is a recombinant humanised monoclonal antibody directed 
      against immunoglobulin E (IgE) to inhibit the immune system's response to 
      allergen exposure. Omalizumab is directed against the binding site of IgE for its 
      high affinity Fc receptor. It prevents free serum IgE from attaching to mast 
      cells and other effector cells and prevents IgE mediated inflammatory changes. 
      OBJECTIVES: To determine the efficacy of anti-IgE in patients with allergic 
      asthma SEARCH STRATEGY: We searched the Cochrane Airways Group Asthma trials 
      register (February 2003) for potentially relevant studies. SELECTION CRITERIA: 
      Randomised controlled trials examining anti-IgE administered in any manner for 
      any duration. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed 
      study quality and extracted and entered data. Three modes of administration were 
      identified from the published literature (inhaled, intravenous and subcutaneous 
      injection). Subgroup analysis was performed by asthma severity. Data were 
      extracted from published and unpublished sources. MAIN RESULTS: Eight trials were 
      included in the review, contributing a total of 2037 mild to severe allergic 
      asthmatic participants with high levels of IgE. Treatment with intravenous and 
      subcutaneous Omalizumab significantly reduced free IgE compared with placebo. 
      Omalizumab led to a significant reduction in inhaled steroid consumption compared 
      with placebo: -114 mcg/day (95% CI -150 to -78.13, two trials). There were 
      significant increases in the number of participants who were able to reduce 
      steroids by over 50%: odds ratio (OR) 2.50, 95% confidence interval (CI) 2.02 to 
      3.10 (four trials); or completely withdraw their daily steroid intake: OR 2.50, 
      95%CI 2.00 to 3.13 (four trials). Participants treated with Omalizumab were less 
      likely to suffer an asthma exacerbation with treatment as an adjunct to steroids 
      (OR 0.49, 95%CI 0.38 to 0.64, four trials), or as a steroid tapering agent (OR 
      0.47, 95% CI 0.37 to 0.60, four trials). REVIEWERS' CONCLUSIONS: Omalizumab was 
      significantly more effective than placebo at increasing the numbers of patients 
      who were able to reduce or withdraw their inhaled steroids, but the mean 
      difference in steroid consumption achieved with Omalizumab was of debatable 
      clinical value. The impressive effects observed in control groups bring into 
      question the true effect of Omalizumab. Omalizumab was effective in reducing 
      asthma exacerbations as an adjunctive therapy to inhaled steroids. Omalizumab was 
      well tolerated, although the safety profile requires longer term assessment. 
      Patient and physician assessment of the drug was positive. Further assessment in 
      paediatric and severe adult populations is necessary, as is double-dummy 
      comparison with inhaled corticosteroids.
FAU - Walker, S
AU  - Walker S
AD  - National Respiratory Training Centre, The Athenaeum, 10 Church Street, Warwick, 
      UK, CV34 4AB.
FAU - Monteil, M
AU  - Monteil M
FAU - Phelan, K
AU  - Phelan K
FAU - Lasserson, T J
AU  - Lasserson TJ
FAU - Walters, E H
AU  - Walters EH
LA  - eng
PT  - Journal Article
PT  - Meta-Analysis
PT  - Review
PT  - Systematic Review
PL  - England
TA  - Cochrane Database Syst Rev
JT  - The Cochrane database of systematic reviews
JID - 100909747
RN  - 0 (Anti-Asthmatic Agents)
RN  - 0 (Antibodies, Anti-Idiotypic)
RN  - 0 (Antibodies, Monoclonal)
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 2P471X1Z11 (Omalizumab)
RN  - 37341-29-0 (Immunoglobulin E)
SB  - IM
UOF - Cochrane Database Syst Rev. 2003;(3):CD003559. PMID: 12917972
UIN - Cochrane Database Syst Rev. 2006;(2):CD003559. PMID: 16625585
MH  - Adult
MH  - Anti-Asthmatic Agents/therapeutic use
MH  - Antibodies, Anti-Idiotypic/*therapeutic use
MH  - Antibodies, Monoclonal/*therapeutic use
MH  - Antibodies, Monoclonal, Humanized
MH  - Asthma/*drug therapy/immunology
MH  - Child
MH  - Chronic Disease
MH  - Humans
MH  - Immunoglobulin E/blood/immunology
MH  - Omalizumab
MH  - Randomized Controlled Trials as Topic
RF  - 42
EDAT- 2004/07/22 05:00
MHDA- 2004/12/16 09:00
CRDT- 2004/07/22 05:00
PHST- 2004/07/22 05:00 [pubmed]
PHST- 2004/12/16 09:00 [medline]
PHST- 2004/07/22 05:00 [entrez]
AID - 10.1002/14651858.CD003559.pub2 [doi]
PST - ppublish
SO  - Cochrane Database Syst Rev. 2004;(3):CD003559. doi: 
      10.1002/14651858.CD003559.pub2.