Benralizumab

(Fasenra®)

Benralizumab

Drug updated on 3/28/2024

Dosage FormInjection (subcutaneous; 30 mg/mL)
Drug ClassInterleukin-5 receptor alpha-directed cytolytic monoclonal antibodies
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype.

Summary
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  • Benralizumab (Fasenra) is indicated for the add-on maintenance treatment of patients with severe asthma aged 12 years and older, specifically those with an eosinophilic phenotype.
  • A total of 10 systematic reviews/meta-analyses were reviewed to gather information about Fasenra's efficacy and safety in treating severe asthma.
  • In a comparison study involving tezepelumab, dupilumab, benralizumab, and mepolizumab for the treatment of eosinophilic asthma, it was found that tezepelumab had significantly lower exacerbation rates than benralizumab but similar improvements in FEV1.
  • Another network meta-analysis comparing five treatments, including tezepelumab, dupilumab, benralizumab, mepolizumab, and a placebo, showed that there was a significant difference in efficacy between tezepelumab and the other treatments across all participants, as well as patient subgroups based on peripheral blood eosinophil count (PBEC).
  • An indirect comparison between licensed dosage administrations of dupilumab and benralizumab for inadequately controlled asthma showed no significant difference in the annual exacerbation rate (AER). However, dupilumab was superior to benralizumab in patients with higher blood eosinophil counts.
  • Despite its effectiveness at reducing exacerbations compared to placebo by up to 52%, some studies have raised concerns over adverse events associated with Fasenra use such as headache and pyrexia; more data on long-term safety are needed together with more efficacy data in pediatric population according to one review article.

Product Monograph / Prescribing Information

Document TitleYearSource
Fasenra (benralizumab) Prescribing Information .2021AstraZeneca

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Comparative efficacy of tezepelumab to mepolizumab, benralizumab, and dupilumab in eosinophilic asthma: A Bayesian network meta-analysis.2023The Journal of allergy and clinical immunology.
Anti‐IL‐5 therapies for asthma. 2022Cochrane Database of Systematic Reviews
Comparative efficacy and safety of tezepelumab and other biologics in patients with inadequately controlled asthma according to thresholds of type 2 inflammatory biomarkers: a systematic review and network meta-analysis.2022Cells
Real-world efficacy of treatment with benralizumab, dupilumab, mepolizumab and reslizumab for severe asthma: A systematic review and meta-analysis. 2022Clinical and experimental allergy
Comparative efficacy of mepolizumab, benralizumab, and dupilumab in eosinophilic asthma: A Bayesian network meta-analysis. 2022The Journal of allergy and clinical immunology
Comparative efficacy and safety of dupilumab and benralizumab in patients with inadequately controlled asthma: a systematic review. 2020International Journal of Molecular Sciences
Effect of monoclonal antibody drug therapy on mucosal biomarkers in airway disease: a systematic review. 2020Clinical and Experimental Allergy
Efficacy and safety of treatment with biologicals (benralizumab, dupilumab, mepolizumab, omalizumab and reslizumab) for severe eosinophilic asthma. A systematic review for the EAACI Guidelines ‐ recommendations on the use of biologicals in severe asthma. 2020Allergy
Clinical review report: benralizumab (Fasenra). 2019CADTH
Adverse events of benralizumab in moderate to severe eosinophilic asthma: a meta-analysis. 2019Medicine
Monoclonal antibodies in type 2 asthma: a systematic review and network meta-analysis. 2019BMC Respiratory Journal
Australian public assessment report for benralizumab. 2019Australian Government: Department of Health
Biologic therapies for treatment of asthma associated with type 2 inflammation: effectiveness, value, and value-based price benchmarks. 2018ICER
Matching-adjusted indirect comparison of benralizumab versus interleukin-5 inhibitors for the treatment of severe asthma: a systematic review. 2018European Respiratory Journal

Clinical Practice Guidelines