Rapid & sustained benefit of benralizumab in severe eosinophilic asthma: the BE-REAL study

BACKGROUND: Benralizumab is an anti-IL-5Rα antibody used as add-on maintenance therapy in patients with severe eosinophilic asthma (SEA). MATERIALS AND METHODS: The prospective, observational BE-REAL study evaluated the outcomes in SEA patients treated with benralizumab in a Belgian real-world setting. The primary objective of the study was to assess within-patient improvement of a minimum clinically important difference (MCID) in Asthma Control Questionnaire-6 (ACQ-6) (i.e., ≥0.5 units) up to 6 months (or 24 weeks). Secondary objectives include the change in ACQ-6 at weeks 56 and 112, the change in the daily oral corticosteroid (OCS) use, changes in asthma status and disease severity, healthcare resource utilization, treatment satisfaction, exacerbation rate and safety. Clinical remission rate was determined by combining the effect on asthma control, OCS use and exacerbation rate. RESULTS: 78 patients were screened, 2 were screening failures and 76 received at least one dose of benralizumab. At week 24, 71% of patients achieves an ACQ-6 response. Reductions in ACQ-6 scores were seen within 1 week of therapy. Over 112 weeks, the mean ACQ-6 score was reduced by 1.60 points (>3-fold MCID), the Annualized Exacerbation Rate (AER) was reduced by 82%, and the mean daily dose of OCS was reduced by 90%. 44% of patients in BE-REAL fulfilled the definition of clinical remission at week 56. Benralizumab was well-tolerated and associated with an improved perception of disease severity and a reduced healthcare utilization. CONCLUSION: BE-REAL provide a real-world confirmation of the clinical trial data obtained with benralizumab showing both favourable short and long-term outcomes.