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Randomized Controlled Trial
. 2021 Apr;58(4):514-522.
doi: 10.1080/02770903.2019.1705333. Epub 2019 Dec 26.

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

Arnaud Bourdin  1 , Dominick Shaw  2 , Andrew Menzies-Gow  3 , J Mark FitzGerald  4 , Eugene R Bleecker  5 , William W Busse  6 , Gary T Ferguson  7 , Laura Brooks  8 , Peter Barker  8 , Esther Garcia Gil  9 , Ubaldo J Martin  8
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Free article
Randomized Controlled Trial

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

Arnaud Bourdin et al. J Asthma. 2021 Apr.
Free article

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; OCS; benralizumab; clinical features; eosinophilic inflammation; interleukin-5 receptor; oral corticosteroids; pharmacotherapy; treatment.

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