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

Curr Med Res Opin. 2007 Oct;23(10):2379-86. doi: 10.1185/030079907X226258.


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.

Publication types

  • Clinical Trial, Phase III
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adrenal Cortex Hormones / administration & dosage*
  • Adult
  • Aged
  • Antibodies, Anti-Idiotypic
  • Antibodies, Monoclonal / therapeutic use*
  • Antibodies, Monoclonal, Humanized
  • Asthma / drug therapy*
  • Asthma / etiology
  • Asthma / immunology
  • Child
  • Double-Blind Method
  • Female
  • Humans
  • Immunoglobulin E / immunology*
  • Male
  • Middle Aged
  • Omalizumab
  • Placebos
  • Retrospective Studies
  • Severity of Illness Index
  • Treatment Outcome


  • Adrenal Cortex Hormones
  • Antibodies, Anti-Idiotypic
  • Antibodies, Monoclonal
  • Antibodies, Monoclonal, Humanized
  • Placebos
  • Omalizumab
  • Immunoglobulin E