1. 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.
- Author
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William W. Busse, Marc Massanari, Farid Kianifard, and Gregory P. Geba
- Subjects
ASTHMA ,IMMUNOGLOBULIN E ,ALLERGENS ,RESPIRATORY allergy ,DRUG administration ,CLINICAL trials - Abstract
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 (⥠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 [0.48â0.66], 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 (GoodmanâKruskal gamma [95% CI]: 0.32 [0.26â0.38]) and patient (gamma [95% CI]: 0.29 [0.23â0.36]) 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. [ABSTRACT FROM AUTHOR]
- Published
- 2007
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