1600: Real-world clinical effectiveness of Benralizumab for Eosinophilic Granulomatosis with Polyangiitis: a National multicenter study

Background/Purpose: Benralizumab is approved for eosinophil-driven conditions, like eosinophilic asthma. Recently, the European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA) authorized its use for eosinophilic granulomatosis with polyangiitis (EGPA). However, real-world evidence remains limited. This study aims to evaluate the clinical effectiveness of benralizumab for EGPA in routine clinical practice on multiple centers.

Methods: We conducted an observational multicenter study with patients diagnosed with EGPA according to the 2022 EULAR/ACR classification criteria who received benralizumab treatment.

Effectiveness was assessed through clinical improvement, laboratory findings, pulmonary function, and corticosteroid-sparing effects. Clinical parameters were monitored throughout follow-up. Analytical outcomes included eosinophil count ( >500 cells/µL) and IgE level improvement ( >100 IU/L). Pulmonary function was evaluated using forced expiratory volume in the first second (FEV₁) and the FEV₁/FVC ratio.

Data were extracted from medical records up to April 30, 2025. Results were expressed as percentages, means ± standard deviation (SD), or medians [interquartile range, IQR]. Comparisons of continuous variables over time were conducted by Wilcoxon test.

Results: We included 23 patients (15 women/8 men); mean age of 58.5±13 years. Baseline clinical and laboratory characteristics before benralizumab initiation are summarized in Table 1. The most common manifestation was asthma (100%), followed by ENT involvement (91.3%), constitutional symptoms (76.1%), neurologic involvement (39.1%), cutaneous manifestations (21.7%), and renal (13% each).

Before treatment, all patients exhibited eosinophilia (median 865 [740-1100] eosinophils/mm³). Elevated serum IgE in 56.5%; (median 225 [57-360.5] IU/L), and ANCA positivity in 69.5%. Previous immunosuppressive therapies included azathioprine (22%), methotrexate (13.6%), mycophenolate mofetil (9%), and cyclophosphamide (9%). Prior biologic therapies were used in 43.4%. Most commonly were Mepolizumab (50%), Omalizumab (40%), and Reslizumab (10%).

Benralizumab was initiated a mean of 4.6±4 years post-EGPA diagnosis (30 mg subcutaneously every 4 weeks). Showed a rapid and sustained improvements over 60 months: a) FEV₁ increased from median 1935 [1545-2680] to 2270 [2192.5-2460] mL (p=0.0312), b) eosinophil counts dropped from 850 [740-1100]/mm³ to 0 [0-0] (p< 0.0001), c) serum IgE levels decreased from 225 [57-360] (IU/mL) to 158.5 [115-217] IU/mL; (p=0.125) and, d) prednisone dose from 5 mg/day [2.5-10] to 0 [0-0]; (p=< 0.0001)

After a mean follow-up of 42.4±20.7 months 78.2% of patients remained in remission. Disease relapse occurred in 3 (13%) (2 respiratory, 1 systemic), while 2 patients discontinued therapy due to inadequate clinical response.

Conclusion: Benralizumab demonstrated rapid and sustained effectiveness, even in patients with severe and refractory EGPA, consistent with findings from clinical trials. These preliminary real-world data highlight its therapeutic potential, but further validation in larger cohorts with extended follow-up is necessary to establish its role in routine clinical practice.