Arnaud Bourdin1, Dominick Shaw2, Andrew Menzies-Gow3, J Mark FitzGerald4, Eugene R Bleecker5, William W Busse6, Gary T Ferguson7, Laura Brooks8, Peter Barker8, Esther Garcia Gil9, Ubaldo J Martin8. 1. Department of Respiratory Diseases, Université de Montpellier, CHU Montpellier, PhyMedExp, INSERM, CNRS, Montpellier, France. 2. Division of Respiratory Medicine, University of Nottingham, Nottingham, UK. 3. Department of Respiratory Medicine, Royal Brompton Hospital, London, UK. 4. Centre for Heart and Lung Health, The Lung Centre Vancouver General Hospital, UBC Institute for Heart and Lung Health, Vancouver, Canada. 5. Divisions of Pharmacogenomics and Genetics, Genomics and Precision Medicine, University of Arizona College of Medicine, Tucson, AZ, USA. 6. Department of Medicine, Division of Allergy, Pulmonary and Critical Care Medicine, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA. 7. Pulmonary Medicine, Internal Medicine, Critical Care Medicine, Pulmonary Research Institute of Southeast Michigan, Farmington Hills, MI, USA. 8. Research and Development, AstraZeneca, Gaithersburg, MD, USA. 9. Global Medical Affairs, AstraZeneca, Barcelona, Spain.
Abstract
Objective: Treatment with benralizumab significantly reduces exacerbations and improves lung function after 1 year and decreases oral corticosteroid (OCS) use after 28 weeks for patients with severe, uncontrolled eosinophilic asthma. We assessed whether these effects on OCS reduction are sustained for up to an additional year of treatment while maintaining an acceptable safety profile. Methods: Data on OCS maintenance dosage were collected for adult patients with baseline blood eosinophil counts ≥150 cells/μL treated with add-on benralizumab 30 mg (every 4 [Q4W] or 8 weeks [Q8W; first three doses Q4W]) from the 28-week ZONDA study and were integrated with results from the predefined 56-week adult completion phase of the BORA extension study. Efficacy and safety were summarized descriptively. Results: For patients receiving benralizumab Q8W, the median daily OCS dosage reduction of 75% from baseline to end of treatment achieved in ZONDA was sustained at the end of the BORA extension period (median 67% reduction from baseline). This was estimated to result in a median cumulative OCS dosage of 2.98 g over the 1.5-year period for patients receiving benralizumab Q8W compared with 5.74 g if these patients had remained on their baseline OCS dosages prior to benralizumab initiation. All adverse event rates were similar between the BORA extension and ZONDA periods, with no new or unexpected safety findings. Conclusion: This benralizumab 1.5-year integrated analysis demonstrates that OCS reductions and safety were maintained with further follow up and supports long-term use of benralizumab for patients with severe, uncontrolled eosinophilic asthma.
Objective: Treatment with benralizumab significantly reduces exacerbations and improves lung function after 1 year and decreases oral corticosteroid (OCS) use after 28 weeks for patients with severe, uncontrolled eosinophilic asthma. We assessed whether these effects on OCS reduction are sustained for up to an additional year of treatment while maintaining an acceptable safety profile. Methods: Data on OCS maintenance dosage were collected for adult patients with baseline blood eosinophil counts ≥150 cells/μL treated with add-on benralizumab 30 mg (every 4 [Q4W] or 8 weeks [Q8W; first three doses Q4W]) from the 28-week ZONDA study and were integrated with results from the predefined 56-week adult completion phase of the BORA extension study. Efficacy and safety were summarized descriptively. Results: For patients receiving benralizumab Q8W, the median daily OCS dosage reduction of 75% from baseline to end of treatment achieved in ZONDA was sustained at the end of the BORA extension period (median 67% reduction from baseline). This was estimated to result in a median cumulative OCS dosage of 2.98 g over the 1.5-year period for patients receiving benralizumab Q8W compared with 5.74 g if these patients had remained on their baseline OCS dosages prior to benralizumab initiation. All adverse event rates were similar between the BORA extension and ZONDA periods, with no new or unexpected safety findings. Conclusion: This benralizumab 1.5-year integrated analysis demonstrates that OCS reductions and safety were maintained with further follow up and supports long-term use of benralizumab for patients with severe, uncontrolled eosinophilic asthma.
Authors: John Blakey; Li Ping Chung; Vanessa M McDonald; Laurence Ruane; John Gornall; Chris Barton; Sinthia Bosnic-Anticevich; John Harrington; Mark Hew; Anne E Holland; Trudy Hopkins; Lata Jayaram; Helen Reddel; John W Upham; Peter G Gibson; Philip Bardin Journal: Respirology Date: 2021-09-29 Impact factor: 6.175
Authors: Francesco Menzella; Elena Bargagli; Maria Aliani; Pietro Bracciale; Luisa Brussino; Maria Filomena Caiaffa; Cristiano Caruso; Stefano Centanni; Maria D'Amato; Stefano Del Giacco; Fausto De Michele; Fabiano Di Marco; Elide Anna Pastorello; Girolamo Pelaia; Paola Rogliani; Micaela Romagnoli; Pietro Schino; Gianenrico Senna; Alessandra Vultaggio; Lucia Simoni; Alessandra Ori; Silvia Boarino; Gianfranco Vitiello; Elena Altieri; Giorgio Walter Canonica Journal: Respir Res Date: 2022-02-19
Authors: Maria D'Amato; Francesco Menzella; Elena Altieri; Elena Bargagli; Pietro Bracciale; Luisa Brussino; Maria Filomena Caiaffa; Giorgio Walter Canonica; Cristiano Caruso; Stefano Centanni; Fausto De Michele; Fabiano Di Marco; Elide Anna Pastorello; Girolamo Pelaia; Paola Rogliani; Micaela Romagnoli; Pietro Schino; Gianenrico Senna; Alessandra Vultaggio; Alessandra Ori; Lucia Simoni; Silvia Boarino; Gianfranco Vitiello; Maria Aliani; Stefano Del Giacco Journal: Front Allergy Date: 2022-05-18
Authors: David J Jackson; Stephanie Korn; Sameer K Mathur; Peter Barker; Venkata G Meka; Ubaldo J Martin; James G Zangrilli Journal: Drug Saf Date: 2020-05 Impact factor: 5.606