Benralizumab achieves sustained remission and glucocorticoid sparing in patients with eosinophilic granulomatosis with polyangiitis and asthma: a Spanish multicentre real-world cohort study

Eosinophilic granulomatosis with polyangiitis (EGPA) is a rare systemic inflammatory disease in which severe asthma frequently represents the predominant clinical manifestation. Although benralizumab has recently demonstrated efficacy in randomized clinical trials, long-term real-world evidence remains limited, particularly in patients with concomitant EGPA and severe asthma. We aimed to evaluate the effectiveness and safety of benralizumab in a Spanish multicentre real-world cohort. We conducted a retrospective multicentre observational study including 22 adults with EGPA and severe asthma from 14 Spanish tertiary hospitals treated with benralizumab according to the approved severe eosinophilic asthma regimen. The primary outcomes were EGPA remission, defined according to the MANDARA criteria, and oral glucocorticoid use. Secondary outcomes included asthma exacerbations, asthma control (ACT), lung function, clinical asthma remission, asthma super-response, biomarkers and safety. Patients were evaluated at baseline and after 4–6, 12 and 24 months. By the end of follow-up, 81.8% of patients achieved EGPA remission. Mean daily oral glucocorticoid dose decreased from 10.56 ± 12.26 to 0.36 ± 1.34 mg/day, while oral glucocorticoid dependence fell from 72.7% to 11.1%. Annual asthma exacerbations declined from 1.59 ± 1.30 to 0, ACT score improved from 15.6 ± 4.7 to 23.5 ± 1.0, and mean FEV₁ increased by 622 mL (from 2127 ± 795 to 2749 ± 781 mL). At 24 months, clinical asthma remission was achieved in 61.5% of evaluable patients and asthma super-response in 88.9%. Benralizumab induced complete depletion of peripheral blood eosinophils and was well tolerated, with no serious treatment-related adverse events. In this Spanish multicentre real-world cohort, benralizumab was associated with sustained EGPA remission, marked glucocorticoid sparing, substantial improvements in asthma control and lung function, and an excellent safety profile. Unlike previous real-world studies, this cohort simultaneously evaluated systemic EGPA remission together with clinically meaningful severe asthma outcomes, including clinical asthma remission and asthma super-response, over a two-year follow-up. These findings support benralizumab as an effective therapeutic option for patients with EGPA and severe asthma, particularly those with predominant respiratory disease managed in specialized severe asthma clinics.

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Journal
Respiratory Research
Published
2026-10-15
DOI
https://doi.org/10.1186/s12931-026-03946-2
Primary Topic
Asthma and respiratory diseases
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article
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article

Benralizumab achieves sustained remission and glucocorticoid sparing in patients with eosinophilic granulomatosis with polyangiitis and asthma: a Spanish multicentre real-world cohort study

Juan Carlos Miralles-López, Javier Díez‐Sierra, María Daniela Perez-Morales, Daniel Laorden et al.
Respiratory Research
Asthma and respiratory diseases
article

Benralizumab achieves sustained remission and glucocorticoid sparing in patients with eosinophilic granulomatosis with polyangiitis and asthma: a Spanish multicentre real-world cohort study

Juan Carlos Miralles-López, Javier Díez‐Sierra, María Daniela Perez-Morales, Daniel Laorden, F. Casas-Maldonado, E Arismendi, Alfredo de Diego-Damia, E. Martínez-Moragón, M. Blanco-Aparicio, A. Padilla-Galo, F. Sánchez-Toril-López, Á. Martínez-Mesa, A. Trisán-Alonso, A. Gómez-Bastero, C. Martínez-Rivera, C. Pinedo-Sierra
article en

Abstract

Eosinophilic granulomatosis with polyangiitis (EGPA) is a rare systemic inflammatory disease in which severe asthma frequently represents the predominant clinical manifestation. Although benralizumab has recently demonstrated efficacy in randomized clinical trials, long-term real-world evidence remains limited, particularly in patients with concomitant EGPA and severe asthma. We aimed to evaluate the effectiveness and safety of benralizumab in a Spanish multicentre real-world cohort. We conducted a retrospective multicentre observational study including 22 adults with EGPA and severe asthma from 14 Spanish tertiary hospitals treated with benralizumab according to the approved severe eosinophilic asthma regimen. The primary outcomes were EGPA remission, defined according to the MANDARA criteria, and oral glucocorticoid use. Secondary outcomes included asthma exacerbations, asthma control (ACT), lung function, clinical asthma remission, asthma super-response, biomarkers and safety. Patients were evaluated at baseline and after 4–6, 12 and 24 months. By the end of follow-up, 81.8% of patients achieved EGPA remission. Mean daily oral glucocorticoid dose decreased from 10.56 ± 12.26 to 0.36 ± 1.34 mg/day, while oral glucocorticoid dependence fell from 72.7% to 11.1%. Annual asthma exacerbations declined from 1.59 ± 1.30 to 0, ACT score improved from 15.6 ± 4.7 to 23.5 ± 1.0, and mean FEV₁ increased by 622 mL (from 2127 ± 795 to 2749 ± 781 mL). At 24 months, clinical asthma remission was achieved in 61.5% of evaluable patients and asthma super-response in 88.9%. Benralizumab induced complete depletion of peripheral blood eosinophils and was well tolerated, with no serious treatment-related adverse events. In this Spanish multicentre real-world cohort, benralizumab was associated with sustained EGPA remission, marked glucocorticoid sparing, substantial improvements in asthma control and lung function, and an excellent safety profile. Unlike previous real-world studies, this cohort simultaneously evaluated systemic EGPA remission together with clinically meaningful severe asthma outcomes, including clinical asthma remission and asthma super-response, over a two-year follow-up. These findings support benralizumab as an effective therapeutic option for patients with EGPA and severe asthma, particularly those with predominant respiratory disease managed in specialized severe asthma clinics.

Respiratory Research
Hospital Universitario La Paz (ES), Hospital Clínico San Carlos (ES), Hospital Universitari i Politècnic La Fe (ES), Hospital Costa del Sol (ES), Hospital Universitario Virgen Macarena (ES), Hospital Universitario Puerta de Hierro Majadahonda (ES), Hospital Clínic de Barcelona (ES), Hospital Arnau de Vilanova (ES), Hospital Universitario Doctor Peset (ES), Hospital Reina Sofía de Murcia (ES), Complexo Hospitalario Universitario A Coruña (ES), Hospital Universitari Germans Trias i Pujol (ES), Hospital Clínico Universitario Virgen de la Victoria (ES)
Good health and well-being
Openalex Percentile: Top 14%
Asthma and respiratory diseases
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