Methods: Here, we pooled data from ten published studies from 1999 with more of our unpublished data of patients with severe persistent asthma treated with omalizumab, an anti-immunoglobulin E (IgE) monoclonal antibody. Static analysis was used to find gender risk factors as the ratio of treatment effect (omalizumab : control) on the standardized exacerbation rate per year.
Results: The studies included 3270 patients (treated with omalizumab), whose had severe persistent asthma according to the Global Initiative for Asthma (GINA) classification. Analysis of two groups male vs female showed that the efficacy of omalizumab on asthma exacerbations was unaffected by patient age, gender, baseline serum IgE (split by median) or by 2- or 4-weekly dosing schedule, although a more large number of women were treated (1921/1349; 59 % women vs 41% men ; p< 0.001) and benefit in absolute terms appeared to be greatest in women patients which had a more severe asthma, defined by a lower value of percentage predicted forced expiratory volume in 1 s (FEV1) at baseline, this subgroup showed odds of being a responder (composite definition) 1.25 times higher (95% confidence interval, 1.18 to 3.01) than men.
Conclusions: These results suggest that in population of asthmatics treated with anti-IgE the number of women is shown higher than men, it confirms that asthma should be considered with different approach by the gender for being adequately controlled on current therapy.