Onset of effect and impact on health-related quality of life, exacerbation rate, lung function, and nasal polyposis symptoms for patients with severe eosinophilic asthma treated with benralizumab (ANDHI): a randomised, controlled, phase 3b trial.
| Autor: | Harrison TW; Respiratory Research Unit, Nottingham National Institute for Health Research Biomedical Research Centre, University of Nottingham; Nottingham City Hospital, Nottingham, UK. Electronic address: tim.harrison@nottingham.ac.uk., Chanez P; Department of Respiratory Diseases CIC Nord INSERM, INRAE, C2VN, Aix Marseille University, Marseille, France., Menzella F; Pneumology Unit, Santa Maria Nuova Hospital, Azienda USL di Reggio Emilia-IRCCS, Reggio Emilia, Italy., Canonica GW; Humanitas University & Research Hospital, IRCCS, Milano, Italy., Louis R; University and Centre Hospitalier Universitaire of Liège, Liège, Belgium., Cosio BG; Hospital Son Espases-IdISBa and Ciberes, Palma de Mallorca, Spain., Lugogo NL; University of Michigan Medical Center, Ann Arbor, MI, USA., Mohan A; East Carolina University Brody School of Medicine, Greenville, NC, USA., Burden A; AstraZeneca, Cambridge, UK., McDermott L; AstraZeneca, Gaithersburg, MD, USA., Garcia Gil E; AstraZeneca, Barcelona, Spain., Zangrilli JG; AstraZeneca, Gaithersburg, MD, USA. |
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| Jazyk: | angličtina |
| Zdroj: | The Lancet. Respiratory medicine [Lancet Respir Med] 2021 Mar; Vol. 9 (3), pp. 260-274. Date of Electronic Publication: 2020 Dec 22. |
| DOI: | 10.1016/S2213-2600(20)30414-8 |
| Abstrakt: | Background: ANDHI was done to assess the efficacy of benralizumab, including onset of effect and impact on health-related quality of life (HRQOL), exacerbation rate, lung function, and nasal polyposis symptoms. Methods: This phase 3b, randomised, double-blind, parallel-group, placebo-controlled ANDHI study was completed in adults (aged 18-75 years) with severe eosinophilic asthma with at least 2 exacerbations in the previous year, despite high-dose inhaled corticosteroid plus additional controllers, screening blood eosinophil counts of at least 150 cells per μL, and an Asthma Control Questionnaire 6 (ACQ-6) score of 1·5 or more. Patients who met eligibility criteria were randomly assigned (2:1; stratified by previous exacerbation count [two, or three or more], maintenance oral corticosteroid use, and region), using an integrated web-based response system, to receive benralizumab at 30 mg every 8 weeks (first three doses given 4 weeks apart) or matched placebo for 24 weeks. Primary efficacy measure was annualised asthma exacerbation rate, with rate ratio (RR) calculated over the approximate 24-week follow-up. Secondary efficacy measures included change from baseline to end of treatment (week 24) in St George's Respiratory Questionnaire (SGRQ) total score (key secondary endpoint), FEV Findings: Between July 7, 2017, and Sept 25, 2019, 656 patients received benralizumab (n=427) or placebo (n=229). Baseline characteristics were consistent with severe eosinophilic asthma. Benralizumab significantly reduced exacerbation risk by 49% compared with placebo (RR estimate 0·51, 95% CI 0·39-0·65; p<0·0001) over the 24-week treatment period and provided clinically meaningful and statistically significant improvement from baseline to week 24 in SGRQ total score versus placebo (least squares mean change from baseline -8·11 (95% CI -11·41 to -4·82; p<0·0001), with similar differences at earlier timepoints. Benralizumab improved FEV Interpretation: Our results extend the efficacy profile of benralizumab for patients with severe eosinophilic asthma, showing early clinical benefits in patient-reported outcomes, HRQOL, lung function, and nasal polyposis symptoms. Funding: AstraZeneca. (Copyright © 2021 Elsevier Ltd. All rights reserved.) |
| Databáze: | MEDLINE |
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