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Background: Safety and efficacy of benralizumab (BEN) for severe eosinophilic asthma (SEA) have been demonstrated in Phase III clinical trials. Obesity is a risk factor for SEA and might affect the beneficial effect of asthma medication. ANANKE is part of AstraZeneca’s global XALOC real-world evidence program for benralizumab. Aims: To explore whether benralizumab efficacy is affected by body mass index (BMI) in SEA patients. Methods: Post-hoc analysis of an observational, multicenter, retrospective Italian study of SEA patients with at least 12 weeks of BEN treatment. Patients were stratified according to BMI: normal/underweight (Nr) (BMI Results: 182 patients were included, Nr=70 (68.6% female, mean age 55±12.8, median BEN duration 9.2 months), OW=79 (48.1% female, mean age 56.6±12.9, median BEN duration 9.4 months), Ob=33 (75.8% female, mean age 56.5±14.7, median BEN duration 10.2 months). Any AER passed from 4.49 to 0.18 (-96%) in Nr (N=66), from 3.99 to 0.32 (-92%) in OW (N=76) and from 3.72 to 0.34 (-90.9%) in Ob (N=30). Severe AER changed from 1.32 to 0.04 (-97%) in Nr, from 1.12 to 0.10 (-91.1%) in OW and from 1.13 to 0.08 (-92.9%) in Ob. ACT increased from a median of 15 in Nr (N=57), 14 in OW (N=61) and 13 in Ob (N=25) to 22 in Nr (N=29) and Ob (N=11) and 23 in Ow (N=35) at week 48. Conclusions: In an Italian real-world setting, the efficacy of BEN in SEA patients seems not to be affected by obesity, leading to asthma control al >90% reduction of AER and severe AER regardless of BMI.

Introductions: Safety and efficacy of benralizumab for severe eosinophilic asthma (SEA) have been demonstrated in Phase III clinical trials. However real-word evidence in Italy is limited. ANANKE is part of AstraZeneca’s global XALOC RWE program for benralizumab. Objects: To describe the clinical impact of benralizumab on adult patients with SEA in a real-life setting. Methods: This is an ongoing observational, multicentre, retrospective study of the clinical characteristics and asthma exacerbations for SEA patients in Italy with at least 12 weeks of benralizumab treatment. Clinical (including comorbidities and atopic status) and laboratory (blood eosinophil count and total IgE) data have been collected. Annualized exacerbation rates (AER) before and after the first benralizumab injection (index date) were analysed. Results: 61 patients were included in this interim analysis [70.5% female, mean age 52.8 ± 13.9, median duration of disease 9.5 years (IQR 3.7-23.1), median eosinophil count (N=41) 410/mm3 (IQR 300-680/mm3), median total IgE (N=39) 215 IU/L (IQR 83-477 IU/L), atopic status 55.7%]. Comorbidities were frequent (44/61 patients, 72.1%), and 34.4% reported chronic rhinosinusitis with nasal polyps (CRSwNP) in the past year. Patients were treated with benralizumab for a median of 9.3 months (IQR 6.1-11.7).During the year prior to index date, AER was 4.98 for any exacerbation and 1.25 for severe exacerbations (N=52). After index date, AER was reduced to 0.38 for any exacerbation(92.4% reduction) and 0.08 for severe exacerbations (93.6% reduction). Conclusion: benralizumab has been prescribe to adult-onset SEA patients, with high prevalence of CRSwNP, indipendent of atopy. Benralizumab led to 93.6% reduction in severe AER