The characteristics of treatment failure with omalizumab in patients with severe asthma: The impact of eosinophilic complication

Abstract

Introduction: Omalizumab has been widely used in Japan. Although some cases cannot achieve good control, the reason for treatment failure with omalizumab has not been fully elucidated. Therefore, in this study, we aimed to evaluate the characteristics of patients who had failed to achieve disease control by omalizumab treatment in a real world setting. Method: We retrospectively reviewed medical record between March 2009 and May 2016 (only omalizumab available in this period in Japan). We evaluated the patient characteristics including age, sex, treatment duration, complication, smoking status, eosinophil counts, total IgE, BMI, FeNO, and OCS use. Treatment failure was judged by physician’s decision based on the exacerbation rate, ER visit, and symptoms. We also evaluated alternative treatment after discontinuation of omalizumab. Results: Total 65 patients were included in this study. Compared to the omalizumab-effective group, the omalizumab-ineffective group contained significantly higher number of patients who had eosinophilic complication (otitis media and sinusitis) and OCS use. Multivariate analysis showed that eosinophilic otitis media was associated with treatment failure with omalizumab (odds ratio 17.35, 95%CI (1.535-196.3), p=0.021). Most of the omalizumab-ineffective group with eosinophilic complication received mepolizumab or benralizumab as an alternative therapy. Conclusion: Eosinophilic complication may affect treatment failure with omalizumab. Anti-IL-5 or anti-IL-5Rα antibodies rather than anti-IgE antibody, omalizumab, should be considered as an additional therapy for severe asthma patients who have eosinophilic complication.