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. 2025 Dec;57(1):2581812.
doi: 10.1080/07853890.2025.2581812. Epub 2025 Nov 3.

Long-term effectiveness and safety of benralizumab in EGPA: a 3-year single-center experience

Federica Davanzo  1 , Luca Iorio  1 , Marta Codirenzi  1 , Eleonora Fiorin  1 , Gabriella Guarnieri  2 , Alessia Achille  2 , Fulvia Chieco Bianchi  2 , Maria Rita Marchi  3 , Andrea Vianello  2 , Andrea Doria  1 , Roberto Padoan  1
Affiliations

Long-term effectiveness and safety of benralizumab in EGPA: a 3-year single-center experience

Federica Davanzo et al. Ann Med. 2025 Dec.

Abstract

Objectives: Benralizumab emerged as a promising treatment option for eosinophilic granulomatosis with polyangiitis (EGPA). This study assessed the long-term effectiveness and safety of benralizumab in patients with severe asthma and relapsing-refractory EGPA.

Methods: This retrospective, single-center study evaluated patients treated with benralizumab (30 mg/8 weeks), followed for up to 36 months. Primary outcome included disease remission (defined as Birmingham Vasculitis Activity Score version 3 = 0 and prednisone dose ≤4 mg/day). Secondary endpoints were corticosteroid tapering, lung function, relapses, treatment failure and drug retention rates.

Results: The study included 33 EGPA patients (17 [51.5%] male; median age at benralizumab initiation 56 years [IQR: 47-62]). Before starting benralizumab, most patients were on corticosteroids (90.9%), prior treatments included mepolizumab (24.2%). Benralizumab showed effectiveness, with clinical remission rates increasing from 39.4% (95% CI: 22.9-57.9) at 3 months to 65.0% (95% CI: 40.8-84.6) at 36 months (p < 0.001). Corticosteroid use declined from 90.9% to 15.4%, eosinophil counts dropped from 850 (515-1367) to 0 (0-0) cells/µL, and BVASv3 decreased from 2 (2-5) to 0 (0-0), showing significant improvements (p = 0.002 and p < 0.001, respectively). Proportion of patients experiencing asthma exacerbations reduced, alongside improved lung function. Retention rates were 81.8% at 1 year, 72.6% at 2 years, and 62.4% at 3 years, with secondary failure due to uncontrolled sinonasal symptoms. Mild adverse events were observed in 21.2% of patients.

Conclusions: These findings support the long-term effectiveness and safety of benralizumab for EGPA, highlighting its role in inducing clinical remission, reducing corticosteroid dependence, and controlling disease activity.

Keywords: Asthma; Benralizumab; Eosinophilic granulomatosis with polyangiitis; Vasculitis.

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Conflict of interest statement

RP reports being invited as a speaker or advisory board member by GSK, AstraZeneca, Sanofi, and CSL Vifor outside the current work. AV received research grants from CLS Behring, GSK, and AstraZeneca. All other authors declare they have no conflict of interest.

Figures

Figure 1.
Figure 1.
Remission rate and ongoing oral corticosteroids use following benralizumab treatment. Clinical remission was defined as Birmingham Vasculitis Activity Score version 3 of 0 and oral prednisone dose ≤4 mg/day. Clinical remission was achieved by a progressively increasing proportion of patients, starting 3 months after treatment initiation and peaking by 36 months (p < 0.001 compared with baseline across all timepoints). A significant progressive reduction in the proportion of patients using OCS was observed throughout the entire follow-up period (p < 0.001 compared with baseline across all timepoints).
Figure 2.
Figure 2.
Pulmonary function tests (PFT), asthma exacerbations, and patient-reported outcomes following benralizumab treatment. Pulmonary function tests, including FEV1%, FVC%, FEF 25–75%, and ACT scores showed significant improvement over the follow-up period (p < 0.001, p = 0.005, p < 0.001 and p = 0.010 respectively). FeNO levels and SNOT-22 scores did not show significant changes. The incidence of asthma exacerbations decreased significantly (p = 0.002) during follow-up.
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