Annals of medicine · 2025
Long-term effectiveness and safety of benralizumab in EGPA: a 3-year single-center experience.
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Davanzo Federica, Iorio Luca, Codirenzi Marta, Fiorin Eleonora, Guarnieri Gabriella, Achille Alessia, Chieco Bianchi Fulvia, Marchi Maria Rita, Vianello Andrea, Doria Andrea, Padoan Roberto
Аннотация
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.
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.