Severe Asthma Standard-of-Care Background Medication Reduction With Benralizumab: ANDHI in Practice Substudy

[en] Background: The phase IIIb, randomized, parallel-group, placebo-controlled ANDHI double-blind (DB) study extended understanding of the efficacy of benralizumab for patients with severe eosinophilic asthma. Patients from ANDHI DB could join the 56-week ANDHI in Practice (IP) single-arm, open-label extension substudy. Objective: Assess potential for standard-of-care background medication reductions while maintaining asthma control with benralizumab. Methods: Following ANDHI DB completion, eligible adults were enrolled in ANDHI IP. After an 8-week run-in with benralizumab, there were 5 visits to potentially reduce background asthma medications for patients achieving and maintaining protocol-defined asthma control with benralizumab. Main outcome measures for non–oral corticosteroid (OCS)-dependent patients were the proportions with at least 1 background medication reduction (ie, lower inhaled corticosteroid dose, background medication discontinuation) and the number of adapted Global Initiative for Asthma (GINA) step reductions at end of treatment (EOT). Main outcomes for OCS-dependent patients were reductions in daily OCS dosage and proportion achieving OCS dosage of 5 mg or lower at EOT. Results: For non–OCS-dependent patients, 53.3% (n = 208 of 390) achieved at least 1 background medication reduction, increasing to 72.6% (n = 130 of 179) for patients who maintained protocol-defined asthma control at EOT. A total of 41.9% (n = 163 of 389) achieved at least 1 adapted GINA step reduction, increasing to 61.8% (n = 110 of 178) for patients with protocol-defined EOT asthma control. At ANDHI IP baseline, OCS dosages were 5 mg or lower for 40.4% (n = 40 of 99) of OCS-dependent patients. Of OCS-dependent patients, 50.5% (n = 50 of 99) eliminated OCS and 74.7% (n = 74 of 99) achieved dosages of 5 mg or lower at EOT. Conclusions: These findings demonstrate benralizumab's ability to improve asthma control, thereby allowing background medication reduction. © 2023

Disciplines :

Cardiovascular & respiratory systems

Author, co-author :

Louis, Renaud ; Centre Hospitalier Universitaire de Liège - CHU > > Service de pneumologie - allergologie

Harrison, T.W.; Respiratory Research Unit, Nottingham Respiratory NIHR BRC, University of Nottingham, Nottingham, United Kingdom, BioPharmaceuticals R&D Digital, AstraZeneca, Cambridge, United Kingdom

Chanez, P.; Department of Respiratory CIC Nord INSERMINRAE C2VN, Aix Marseille University, Marseille, France

Menzella, F.; Pulmonology Unit, S. Valentino Hospital, Montebelluna (TV), Marca Trevigiana, Italy

Philteos, G.; Royal University Hospital, University of Saskatchewan, Saskatoon, Sask, Canada

Cosio, B.G.; Hospital Son Espases-IdISBa and Ciberes, Palma de Mallorca, Spain

Lugogo, N.L.; University of Michigan, Ann Arbor, Mich, United States

de Luiz, G.; Hospital Vithas Xanit Internacional, Málaga, Benalmádena, Spain

Burden, A.; Biometrics, Late-stage Development, Respiratory & Immunology, BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom

Adlington, T.; Biometrics, Late-stage Development, Respiratory & Immunology, BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom

More authors (163 more)

Language :

English

Title :

Severe Asthma Standard-of-Care Background Medication Reduction With Benralizumab: ANDHI in Practice Substudy

Publication date :

2023

Journal title :

Journal of Allergy and Clinical Immunology: In Practice

ISSN :

2213-2198

eISSN :

2213-2201

Publisher :

American Academy of Allergy, Asthma and Immunology

Peer reviewed :

Peer Reviewed verified by ORBi

Funding text :

This study was funded by AstraZeneca.

Data Set :

10.1016/j.jaip.2023.03.009

Available on ORBi :

since 19 May 2023

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