PMID- 17711616
OWN - NLM
STAT- MEDLINE
DCOM- 20071214
LR  - 20151119
IS  - 1473-4877 (Electronic)
IS  - 0300-7995 (Linking)
VI  - 23
IP  - 10
DP  - 2007 Oct
TI  - Effect of omalizumab on the need for rescue systemic corticosteroid treatment in 
      patients with moderate-to-severe persistent IgE-mediated allergic asthma: a 
      pooled analysis.
PG  - 2379-86
AB  - BACKGROUND: Allergic asthma is an immunoglobulin E (IgE)-mediated disease 
      characterized by frequent exacerbations following exposure to relevant allergens 
      that leads to the development of chronic airway inflammation. Omalizumab, an 
      anti-IgE antibody, reduces asthma exacerbation and hospitalization rates in 
      patients with IgE-mediated allergic asthma. We investigated the effect of 
      omalizumab on asthma outcomes in a retrospective pooled analysis of data from 
      phase III clinical trials in patients (>or= 12 years) with moderate-to-severe 
      persistent IgE-mediated allergic asthma. METHODS: Systemic corticosteroid bursts 
      and physician and patient overall assessments of asthma control were assessed in 
      patients who received add-on omalizumab or current asthma therapy (control). The 
      association of physician and patient overall assessments with the number of 
      steroid bursts were also evaluated. RESULTS: The analysis encompassed 4308 
      patients with moderate-to-severe persistent IgE-mediated allergic asthma (93% met 
      GINA 2002 criteria for severe persistent asthma) from seven clinical trials. The 
      number of systemic corticosteroid bursts was significantly lower in 
      omalizumab-treated patients than in the control group (relative risk [95% CI]: 
      0.57 [0.48-0.66], p < 0.001). In addition, 58.5% of omalizumab recipients had 
      complete/marked improvement in asthma control according to the physician's 
      overall assessment (responders) vs. 36.9% in the control group (p < 0.001). 
      Similarly, 64.2% of omalizumab patients vs. 43.9% of control patients had 
      complete/marked improvement according to the patient's overall assessment (p < 
      0.001). There were statistically significant associations between systemic 
      corticosteroid bursts and physician (Goodman-Kruskal gamma [95% CI]: 0.32 
      [0.26-0.38]) and patient (gamma [95% CI]: 0.29 [0.23-0.36]) overall assessments. 
      This pooled analysis has limitations as it was not pre-specified. CONCLUSIONS: 
      Omalizumab therapy reduced the need for systemic corticosteroid bursts and 
      improved effectiveness of asthma treatment as judged by both physicians and 
      patients.
FAU - Busse, William W
AU  - Busse WW
AD  - University of Wisconsin, Madison, WI, USA.
FAU - Massanari, Marc
AU  - Massanari M
FAU - Kianifard, Farid
AU  - Kianifard F
FAU - Geba, Gregory P
AU  - Geba GP
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - Curr Med Res Opin
JT  - Current medical research and opinion
JID - 0351014
RN  - 0 (Adrenal Cortex Hormones)
RN  - 0 (Antibodies, Anti-Idiotypic)
RN  - 0 (Antibodies, Monoclonal)
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (Placebos)
RN  - 2P471X1Z11 (Omalizumab)
RN  - 37341-29-0 (Immunoglobulin E)
SB  - IM
MH  - Adolescent
MH  - Adrenal Cortex Hormones/*administration & dosage
MH  - Adult
MH  - Aged
MH  - Antibodies, Anti-Idiotypic
MH  - Antibodies, Monoclonal/*therapeutic use
MH  - Antibodies, Monoclonal, Humanized
MH  - Asthma/*drug therapy/etiology/immunology
MH  - Child
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Immunoglobulin E/*immunology
MH  - Male
MH  - Middle Aged
MH  - Omalizumab
MH  - Placebos
MH  - Retrospective Studies
MH  - Severity of Illness Index
MH  - Treatment Outcome
EDAT- 2007/08/23 09:00
MHDA- 2007/12/15 09:00
CRDT- 2007/08/23 09:00
PHST- 2007/08/23 09:00 [pubmed]
PHST- 2007/12/15 09:00 [medline]
PHST- 2007/08/23 09:00 [entrez]
AID - 10.1185/030079907X226258 [doi]
PST - ppublish
SO  - Curr Med Res Opin. 2007 Oct;23(10):2379-86. doi: 10.1185/030079907X226258.