276 A 4-Year Follow-up in Children With Moderate/Severe Asthma after Withdrawal 1 Year Omalizumab Treatment

BACKGROUND: Asthma guidelines include omalizumab in the step up management in those patients with severe non-controlled asthma despite the use of the inhaled corticosteroids (ICS) at the highest dose recommended and/or oral corticosteroids (OCS) courses. This communication describes the 4 year follow up of children with moderate/severe allergic asthma treated for 1 year with add-on omalizumab after discontinuation. METHODS: 7 children (6 to <12 years) with moderate/severe uncontrolled asthma following strict inclusion/exclusion criteria. The patients completed a 1 year treatment with omalizumab according to the DBPC CIGE025 clinical study protocol. Four years follow up after discontinuation of the study medication was performed. It included clinical assessment, different asthma-related outcomes and lung function in outpatient hospital office RESULTS: All patients that received xolair during the study period achieved good asthma control and high dose ICS (mean dose fluticasone 500 mcg) were could be discontinued. Surprisingly, the 7 patients that received Xolair for one year were completely free of asthma symptoms during the first 3 years of follow up. They did not use any additional asthma medication. After the third year of follow up, only 2 out of 7 (28%) patients begun with persistent asthma symptoms and exacerbations. These patients have required rescue medication and then regular controller medication (budesonide 400 mcg). We could not identified any risk factor helping in predicting those who had symptoms relapsing. Lung function, number of exacerbation, number of hospitalization, eosinophilia, IgE levels or previous treatments with OCS CONCLUSIONS: Most of these patients 5 out of 7 still remain asymptomatic 4 years after discontinuation Xolair without regular ICS treatment. They are still not using any controller medication only 2 patients had exacerbations and at present show persistent mild asthma controlled with medium ICS therapy. This follow up would generate the hypothesis that omalizumab could have a potential as a modifier of the natural history of asthma beyond the improvement of symptoms control in children with moderate/severe uncontrolled asthma. Further studies are needed to test this hypothesis.