Benralizumab in severe eosinophilic asthma by previous biologic use and key clinical subgroups: real-world XALOC-1 programme.


Journal

The European respiratory journal
ISSN: 1399-3003
Titre abrégé: Eur Respir J
Pays: England
ID NLM: 8803460

Informations de publication

Date de publication:
04 Apr 2024
Historique:
received: 08 09 2023
accepted: 20 03 2024
medline: 5 4 2024
pubmed: 5 4 2024
entrez: 4 4 2024
Statut: aheadofprint

Résumé

Pivotal Phase 3 trials and real-world studies have demonstrated benralizumab's overall efficacy and safety in severe eosinophilic asthma (SEA). Additional large-cohort data are needed to confirm its real-world effectiveness in SEA according to previous biologic use and key baseline characteristics important for treatment selection. XALOC-1 is a large, multinational, retrospective, observational, real-world study programme of benralizumab in adults with SEA. This 48-week integrated analysis assessed annualised exacerbation rate (AER), maintenance oral corticosteroid (mOCS) use, asthma symptom control and lung function during a 12-month baseline period and up to 48 weeks after benralizumab initiation. Subgroup analyses were based on previous biologic use and key baseline clinical characteristics (mOCS use, blood eosinophil count, exacerbation history, age at asthma diagnosis, fractional exhaled nitric oxide level and presence of atopy and chronic rhinosinusitis with nasal polyps). Of 1002 patients analysed, 380 were biologic-experienced. At Week 48, 71.3% were exacerbation-free ( In this large, real-world programme, SEA patients treated with benralizumab had substantial improvements in clinical outcomes irrespective of previous biologic use and key clinical characteristics important to therapeutic decision-making in clinical practice.

Sections du résumé

BACKGROUND BACKGROUND
Pivotal Phase 3 trials and real-world studies have demonstrated benralizumab's overall efficacy and safety in severe eosinophilic asthma (SEA). Additional large-cohort data are needed to confirm its real-world effectiveness in SEA according to previous biologic use and key baseline characteristics important for treatment selection.
METHODS METHODS
XALOC-1 is a large, multinational, retrospective, observational, real-world study programme of benralizumab in adults with SEA. This 48-week integrated analysis assessed annualised exacerbation rate (AER), maintenance oral corticosteroid (mOCS) use, asthma symptom control and lung function during a 12-month baseline period and up to 48 weeks after benralizumab initiation. Subgroup analyses were based on previous biologic use and key baseline clinical characteristics (mOCS use, blood eosinophil count, exacerbation history, age at asthma diagnosis, fractional exhaled nitric oxide level and presence of atopy and chronic rhinosinusitis with nasal polyps).
RESULTS RESULTS
Of 1002 patients analysed, 380 were biologic-experienced. At Week 48, 71.3% were exacerbation-free (
CONCLUSION CONCLUSIONS
In this large, real-world programme, SEA patients treated with benralizumab had substantial improvements in clinical outcomes irrespective of previous biologic use and key clinical characteristics important to therapeutic decision-making in clinical practice.

Identifiants

pubmed: 38575162
pii: 13993003.01521-2023
doi: 10.1183/13993003.01521-2023
pii:
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Informations de copyright

Copyright ©The authors 2024. For reproduction rights and permissions contact permissions@ersnet.org.

Auteurs

David J Jackson (DJ)

Guy's Severe Asthma Centre, School of Immunology & Microbial Sciences, King's College London, London, UK david.jackson@gstt.nhs.uk.
School of Immunology & Microbial Sciences, King's College London, London, UK.

Girolamo Pelaia (G)

Department of Health Sciences, "Magna Graecia" University of Catanzaro, Catanzaro, Italy.

Benjamin Emmanuel (B)

AstraZeneca, Gaithersburg, MD, USA.

Trung N Tran (TN)

AstraZeneca, Gaithersburg, MD, USA.

David Cohen (D)

AstraZeneca, Gaithersburg, MD, USA.

Vivian H Shih (VH)

AstraZeneca, Gaithersburg, MD, USA.

Anat Shavit (A)

AstraZeneca, Cambridge, UK.

Douglas Arbetter (D)

AstraZeneca, Boston, MA, USA.

Rohit Katial (R)

National Jewish Health and University of Colorado Denver, Denver, CO, USA.
AstraZeneca, Denver, CO, USA, at the time of the programme.

Adrian Paul J Rabe (APJ)

AstraZeneca, Cambridge, UK.
Imperial College London, London, UK.

Esther Garcia Gil (E)

Almirall, Barcelona, Spain.
AstraZeneca, Barcelona, Spain, at the time of the programme.

Marisa Pardal (M)

AstraZeneca, Lisbon, Portugal.

Javier Nuevo (J)

AstraZeneca, Madrid, Spain.

Michael Watt (M)

AstraZeneca, London, UK.

Silvia Boarino (S)

AstraZeneca, Milan, Italy.

Sheena Kayaniyil (S)

AstraZeneca, Mississauga, Canada.

Cláudia Chaves Loureiro (C)

Pneumology Unit, Hospitais da Universidade de Coimbra, Centro Hospitalar e Universitário de Coimbra, Coimbra, Portugal; Centre of Pneumology, Faculty of Medicine, University of Coimbra, Coimbra, Portugal.

Alicia Padilla-Galo (A)

Hospital Costa del Sol, Marbella, Málaga, Spain.

Parameswaran Nair (P)

McMaster University, Hamilton, Canada; McGill University, Montreal, Canada; St Joseph's Healthcare Hamilton, Hamilton, Canada.

Classifications MeSH