Two-year integrated steroid-sparing analysis and safety of benralizumab for severe asthma

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.

Keywords:

• Asthma
• benralizumab
• clinical features
• eosinophilic inflammation
• interleukin-5 receptor
• OCS
• oral corticosteroids
• treatment
• pharmacotherapy

Acknowledgements

Writing and editing support, including preparation of the draft manuscript under the direction and guidance of the authors, incorporating author feedback, and manuscript submission, was provided by Hayley Ellis, PhD, of JK Associates, Inc., and Michael A. Nissen, ELS, of AstraZeneca. This support was funded by AstraZeneca.

Declaration of interest

A. Bourdin has received personal fees from Actelion, AstraZeneca, Boehringer Ingelheim, Chiesi Pharmaceuticals, GSK, Novartis, Regeneron, Roche, and Teva; received grants from Boehringer Ingelheim and GSK; received non-financial support from Actelion, AstraZeneca, Biogen, Boehringer Ingelheim, Chiesi Pharmaceuticals, Galapagos, Novartis, Roche, and Vertex; and has been an advisory board member for Actelion, AstraZeneca, Boehringer Ingelheim, Chiesi Pharmaceuticals, Gilead, GSK, Novartis, Regeneron, and Teva. D. Shaw was an advisory board member for AstraZeneca, Boehringer Ingelheim, and GlaxoSmithKline and has received travel fees from Teva and Novartis. A. Menzies-Gow reports consultancy agreements with AstraZeneca, Sanofi, and Vectura; was an advisory board member for AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Novartis, Sanofi, and Teva; received speaker fees from AstraZeneca, Boehringer Ingelheim, Novartis, Teva, and Vectura; has received clinical funding from AstraZeneca; has participated in research that his institution has been remunerated from Boehringer Ingelheim, GlaxoSmithKline, AstraZeneca, and Hoffman La Roche; and has attended international conferences sponsored by Teva and Boehringer Ingelheim.

J.M. FitzGerald is an advisory board member for AstraZeneca, Boehringer Ingelheim, Novartis, Sanofi-Regeneron, and Teva, and has received honoraria for lectures from AstraZeneca, Boehringer Ingelheim, GSK, and Novartis. E.R. Bleecker has performed clinical trials through his former employer, the Wake Forest School of Medicine, and has served as a paid consultant for AstraZeneca, Boehringer Ingelheim, GSK, MedImmune, Novartis, Regeneron, and Sanofi-Aventis. W.W. Busse reports personal fees from AstraZeneca, Boston Scientific, Genentech, GSK, Novartis, Sanofi, and Teva. G.T. Ferguson reports grants and personal fees from AstraZeneca, Novartis, Pearl Therapeutics, and Sunovian, as well as grants from Forest and personal fees from GSK. L. Brooks, P. Barker, E. Garcia Gil, and U.J. Martin are employees of AstraZeneca.

Data-sharing statement

Data underlying the findings described in this manuscript may be requested in accordance with AstraZeneca’s data-sharing policy described at https://astrazenecagroup-dt.pharmacm.com/DT/Home.

Additional information

Funding

AstraZeneca and Kyowa Hakko Kirin funded the SIROCCO, CALIMA, ZONDA, and BORA studies.