Abstract

Introduction
In randomized controlled trials (RCT), benralizumab, a cytolytic anti-interleukin-5 receptor ? monoclonal antibody, was well tolerated, significantly reduced asthma exacerbations and oral corticosteroid dosages, and improved lung function as well as asthma control in patients with severe eosinophilic asthma (SEA). Data on asthma control after biologic therapy initiation in real-world practice are limited.

Objective
To evaluate the change in patient-reported asthma control as measured by Asthma Control Questionnaire (ACQ-5) after up to 56 weeks of benralizumab treatment.

Methods
BEEPS (NCT03907137) is a multi-center, single-arm, non-interventional, observational, prospective study in Switzerland that has recruited 77 SEA patients treated with benralizumab over 56 weeks according to the Swiss label (week 8: primary endpoint).

Results
73 patients were included; 66 completed the ACQ-5 at week 8. The mean change (95% CI) from baseline ACQ-5 score was ?0.34 (?0.58; ?0.09) at week 1, ?0.58 (?0.86; ?0.29) at week 2, ?0.68 (?0.99; ?0.38) at week 4, ?0.95 (?1.25; ?0.66) at week 8, ?1.22 (?1.58; ?0.86) at week 16 and ?1.58 (?1.96; ?1.21) at week 56 after treatment initiation (p<0.01 for all timepoints). At week 8, 39 patients (59.1%) achieved a score improvement of ?0.5 (MCID). Moreover, 34 (51.5%) and 18 (27.3%) patients achieved an ACQ-5 score of ?1.5 (baseline: 13 [17.8%]) and ?0.75 (baseline: 3 [4.1%]), respectively.

Conclusion
SEA patients reported significant and clinically meaningful differences in asthma control as early as 2 weeks after initiation of benralizumab treatment in a non-randomised pragmatic real-world Swiss setting, thus complementing the data obtained from RCT.