Super-responder analysis and real-world one year effectiveness of benralizumab in severe eosinophilic asthma

Abstract

Benralizumab is an anti-IL5R monoclonal antibody licensed for patients with severe eosinophilic asthma (SEA). The phase 3 programme reported significant reductions in exacerbation rates and maintenance oral corticosteroid (mOCS) use. To date there is a paucity of real-world data to confirm its effectiveness or possible super-responder characteristics. Methods: We performed a retrospective review of patients in a regional Severe Asthma Centre who commenced benralizumab ≥48 weeks prior to analysis. Data collected included spirometry, asthma control questionnaire (ACQ6), mini-asthma quality of life questionnaire (mini-AQLQ), mOCS dose, exacerbation history and T2 biomarkers. Patients were categorized at 48 weeks as super-responders (exacerbation-free and not on mOCS), responders (≥50% reduction in mOCS or exacerbation rate), or non-responders. Results: 110 patients were included in the analysis. Annual exacerbation rate fell from 4.8 (SE 0.3) to 1.2 (SE 0.1), with a median reduction of 80% (IQR-100 to -33). 64 patients were on mOCS at baseline. Median dose reduction was 75% (IQR -100 to -36) and 28 (43.8%) patients were able to discontinue mOCS. Change in ACQ and mAQLQ was -0.81 (SE 0.13) and 0.99 (SE 0.14) respectively. At 48 weeks, 95 (86%) were categorised as responders of which 41 (37%) were ‘super-responders’. There were no significant differences in baseline characteristics between super-responders and non-responders. Conclusion: In a large real-world SEA cohort, benralizumab leads to substantial improvement in important clinical outcome measures in 86% of patients. There were no significant differences in baseline characteristics between super- and non-responders.