Clinical remission in patients with severe eosinophilic asthma treated with benralizumab who were randomised to reduce their inhaled corticosteroid/formoterol dose: SHAMAL post-hoc analysis

In SHAMAL, the first study to prospectively investigate clinical remission (CR) in severe eosinophilic asthma (SEA) as a prespecified endpoint, patients (pts) with SEA controlled on benralizumab were randomised to reduce high-dose inhaled corticosteroid (ICS)/formoterol (to medium dose, low dose or anti-inflammatory reliever [AIR] only [reduction arm]) over 32 weeks, or maintain their dose (reference arm). >90% of pts in the reduction arm were able to reduce their ICS/formoterol dose, maintain asthma control and remain exacerbation-free. SHAMAL was an open-label, parallel-group, multicentre, Phase 4 study. Pts receiving oral corticosteroids (OCS) were excluded. In this post-hoc analysis, we assessed CR at Week (W)32 by ICS/formoterol dose attained at W32 (definitions of CR-3 and CR-4 are in the <bold>Figure</bold> footnote). Of pts in the reduction arm with data available, CR-3 and CR-4 at W32 were achieved in 62.5% and 71.4% of pts (high dose), 72.2% and 40.0% (medium dose), 66.7% and 53.8% (low dose) and 95.8% and 58.8% (AIR only; <bold>Figure</bold>). In the reference arm, 91.4% and 75.0% of pts achieved CR-3 and CR-4 at W32, respectively. Overall, the majority of pts in the reduction and reference arms achieved CR-3 and CR-4 at W32, although CR-4 was achieved less frequently than CR-3, particularly with ICS/formoterol step down. <fig><object-id>erj;64/suppl_68/PA1194/F1</object-id><object-id>F1</object-id><object-id>F1</object-id><graphic></graphic></fig>