Background Allergic asthma is the most prevalent phenotype of severe asthma in which treatment with omalizumab has been proven to be beneficial.

Purpose Analyse the effectiveness, efficiency and safety of omalizumab in patients with uncontrolled moderate-to-severe asthma.

Material and methods Retrospective observational study of all patients with uncontrolled persistent asthma who received omalizumab for at least 52 weeks from March 2007 until September 2018. Variables: age, sex, diagnosis, baseline IgE levels, FEV1 (baseline and at 52 weeks after omalizumab); number of exacerbations (NEX), corticosteroid cycles (CC) and emergency visits (EV) 12 months prior to omalizumab and at 12 months after, duration, discontinuation and side effects; and ACT quality of life questionnaire after last administration. The main variable was the reduction in NEX and as secondary variables reduction in CC and EV. Efficiency was estimated by the reduction in EV/patient cost.

Results Thirty-six patients were included, 67% females, mean age 44.2 years (SD=16.9). Sixteen patients were diagnosed with asthma moderate-severe and 20 severe. Mean IgE level was 590.7 IU/ml (SD=1210.2). Seventy per cent of patients had FEV1 <80%. In the 12 months prior to omalizumab the mean NEX, CC and EV was 4.5 (SD=3), 4.4 (SD=3) and 2.2 (SD=1.8), respectively. NEX at 52 weeks was 0.6 (SD=0.9), a significant difference compared to the baseline. CC was reduced to 0.7 (SD=0.9) and mean/patient EV to 0.3 (SD=0.6). Average treatment duration was 52 months (SD=30) and treatment was discontinued in 20 patients, three of those because of efficacy, 12 for inefficacy, one after poor tolerance (diarrhoea, myalgias and tremors) and four for hospital change. Except for one patient, the rest showed good tolerance to omalizumab. Fifty per cent of patients with decreased lung function reached FEV1 >80% at 52 weeks. After the last administration of omalizumab, 72% of patients were under control or reasonably well controlled and 28% not well controlled. The mean cost of asthma EV/patient prior to omalizumab was €422.9 (SD=356.8) and after omalizumab €97.2 (SD=247.4).

Conclusion This analysis shows that omalizumab decreases NEX and CC, achieving a substantial improvement in patients with uncontrolled moderate-to-severe asthma, as well as a reduction in the direct costs of EV. Interruption of treatment in three patients suggests that the effects of omalizumab may persist over time.

References and/or acknowledgements No conflict of interest.