Abstract
While up to 50% of severe asthma patients have no evidence of allergy, IgE has been linked to asthma in epidemiological and immunopathological studies, irrespective of atopic status. Omalizumab (OMA), an anti-IgE monoclonal antibody, is reported to significantly benefit a subset of patients with poorly controlled severe persistent allergic asthma. Therefore biological and clinical effects of OMA were investigated in patients with refractory nonatopic asthma.
Methods: 41 patients with severe nonatopic asthma uncontrolled despite daily high-dose inhaled corticosteroids (with or without maintenance oral corticosteroids) plus a long-acting β2-agonist were randomized to receive OMA or placebo in a 1:1 ratio. Primary end-point was change in expression of high-affinity IgE receptor FceRI on blood basophils and plasmacytoid dendritic cells (pDC2) after 16 weeks. The impact on lung function and clinical parameters was also assessed.
Results: When compared to placebo, OMA treatment resulted in a statistically significant reduction in FcεRI expression on blood basophils and pDC2 (p<0.001). The OMA group also showed an overall increase in placebo-adjusted predicted FEV1 compared to baseline (+9.9%; p=0.029). The placebo-adjusted absolute change in FEV1 with OMA was +250 ml (p=0.032). A trend toward improvement in global evaluation of treatment effectiveness scale and asthma exacerbations rate was also observed.
Conclusion: Omalizumab treatment may have a therapeutic role in severe nonatopic asthma. These findings support further investigation to assess the clinical efficacy of omalizumab in severe persistent nonatopic asthma.
Funded by: Novartis Pharma SAS.
- © 2012 ERS