RCT Abstract - Treating eosinophilic exacerbations of asthma and COPD with benralizumab: a double-blind, double-dummy, active-placebo randomised controlled trial (ABRA)

<bold>Background:</bold> Eosinophilic inflammation is a treatable trait commonly found in acute exacerbations. We investigated if eosinophilic exacerbations could be treated acutely with benralizumab. <bold>Methods:</bold> ABRA was a multicentre RCT. At the time of an acute exacerbation of asthma or COPD, adults with blood eosinophil counts ≥300 cells/µL in a 1:1:1 ratio received prednisolone 30mg PO for 5 days+100mg benralizumab SC once; <bold><italic>or</italic></bold> placebo tablets PO for 5 days+100mg benralizumab SC once; <italic><bold>or</bold></italic> prednisolone 30mg PO for 5 days+placebo SC once. The co-primary outcomes were proportion of treatment failures over 90 days and total visual analogue scale (VAS) symptoms at day 28. Secondary endpoints included time to treatment failure and lung function. <bold>Findings:</bold> 158 patients were randomised at acute eosinophilic exacerbation of asthma and/or COPD. At 90 days, treatment failures occurred in 39/53 (73.6%) in the prednisolone only group and 47/105 (44.8%) in the pooled benralizumab group (OR 0.264, 95%CI 0.125-0.556, p<0.001). The 28-day total VAS mean (95%CI) difference was 49mm (14-84) favouring benralizumab (p=0.006). The time to treatment failure was longer with benralizumab compared to prednisolone (HR 0.393, 95%CI 0.252-0.612, p-value<0.001). Lung function was similar. <bold>Interpretation:</bold> Benralizumab is superior to prednisolone in the treatment of eosinophilic exacerbations. <fig><object-id>erj;64/suppl_68/RCT3716/F1</object-id><object-id>F1</object-id><object-id>F1</object-id><graphic></graphic></fig>