Belgian real-world data confirm the potential of benralizumab to induce clinical remission in patients with severe eosinophilic asthma

<bold>Background:</bold> The XALOC program is collecting real-world data to complement clinical trial results obtained with the anti-IL-5Rα antibody benralizumab in patients (pts) with severe eosinophilic asthma (SEA). <bold>Objective:</bold> To describe the clinical effects of benralizumab in a real-life cohort of Belgian pts with SEA and ≥2 severe exacerbation in the past year. <bold>Methods:</bold> Within the context of XALOC, the prospective, multicenter, single arm, BE-REAL study evaluated adult pts with uncontrolled SEA in Belgium treated with benralizumab over >56 weeks. The primary objective of BE-REAL was the change in patient-reported, asthma related symptoms (ACQ-6), with secondary endpoints including the exacerbations rate and changes in maintenance oral corticosteroids (mOCS) use. The clinical remission rate was assessed by combining these 3 endpoints (exacerbation-free, mOCS-free, ACQ-6 score <1.5). <bold>Results:</bold> 78 pts were enrolled in BE-REAL of whom 76 received benralizumab. The annualized exacerbation rate (AER) in these pts was reduced from 3.62 at baseline (BL) to 0.38 at week 56 (w56), representing a 90% reduction. In total, 77% of pts were exacerbation-free at w56 (<italic>vs</italic>. 1% at BL). At BL, 17 pts (22%) were on mOCS. The median reduction in the daily mOCS dose at w56 was 89%, with 7 pts (47%) who could stop mOCS and 87% of pts on a daily dose ≤5 mg at w56. At BL, 23% of pts had an ACQ-6 <1.5, increasing to 55% at w56. This translates into a clinical remission rate of 41% at w56. <bold>Conclusion:</bold> Real-world data confirm the clinical trial results with benralizumab in pts with SEA, with a strong reduction in AER and mOCS use and a clinical remission rate of 41% after 56 weeks.