Influence of the diagnosis chronic rhinosinusitis on asthma response to omalizumab in severe, uncontrolled asthmatics

Abstract

Background: Omalizumab is a humanized anti-immunoglobulin E monoclonal antibody that has been approved as add-on therapy for the treatment of adults with moderate-to-severe (United States) or severe (Europe) allergic asthma, inadequately controlled after treatment with high-dose inhaled corticosteroids plus long-acting bagonists. The clinical efficacy of Omalizumab has not only been shown in the treatment of severe uncontrolled asthma, but also in the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) and comorbid asthma. The aim of this analysis was to examine whether the diagnosis of chronic rhinosinusitis (CRS) influenced the asthma response to Omalizumab treatment. Methods: This study retrospectively analysed data from 70 patients with severe, uncontrolled asthma treated with Omalizumab. In serum, specific Immunoglobulin E (IgE) to Staphylococcal enterotoxins (SE) and total IgE before the start of the treatment (basal total IgE) were measured by Immunocap. Asthma response was evaluated by physician's Global Evaluation of Treatment Effectiveness (GETE-score); GETE 0, 1 and 2 were considered as nonresponders, GETE 3 and 4 as responders. Results: The mean age of the patients was 54.4 years and 62% of them were female. 84.3% of the asthmatics responded to Omalizumab treatment. Within the total patient group, 55.7% had CRSwNP and 83.8% had antibodies to staphylococcal enterotoxins in their serum. Within the SEIgE positive group, 85.7% were responders compared to 14.3% non-responders (P < 0.001). A higher SE-IgE concentration was found in patients with CRSwNP and a strong correlation between SE-IgE and basal total IgE was observed (R = 0.612, P < 0.001). The proportion of responders tended to be higher in CRSwNP compared to CRS without nasal polyps (CRSsNP) and both higher compared to no CRS (89.7% vs 85.7% vs 81.8%); without reaching statistical significance. Conclusion: These results showed that a high proportion of severe uncontrolled asthma patients are sensitized to Staphylococcal enterotoxins and more than a half present comorbid CRS with nasal polyps. There is a trend towards a better asthma response in patients with antibodies to SE and in CRSwNP patients.