Benralizumab

(Fasenra®)

Fasenra®

Drug updated on 7/26/2024

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.

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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, and with an eosinophilic phenotype.
  • The information was derived from a total of 11 systematic reviews/meta-analyses documents.
  • In patients with severe asthma and chronic rhinosinusitis with nasal polyps (CRSwNP), benralizumab showed significant improvements in lung function (FEV1) and quality of life after 24 weeks compared to other biologics like Dupilumab, Mepolizumab, Omalizumab, Reslizumab.
  • Real-world studies indicate that benralizumab significantly reduces annual exacerbation rates and improves FEV1, showing similar effect sizes as observed in randomized controlled trials across various patient subgroups when compared to Mepolizumab and Reslizumab.
  • Indirect comparisons among biologics such as Tezepelumab, Dupilumab, Mepolizumab, Reslizumab, and Omalizumab show no statistically significant differences in efficacy; however, Tezepelumab had numerically lower annual asthma exacerbation rates in subgroup analyses than benralizumab.
  • For adults and children with severe chronic eosinophilic asthma, benralizumab was effective in reducing asthma exacerbations and improving HRQoL without excess serious adverse events, though some adverse events led to discontinuation compared to Mepolizumab and Reslizumab.
  • Studies focusing on oral corticosteroid dependence found that real-world evidence supports the effectiveness of benralizumab in reducing or ceasing OCS usage, overcoming OCS dependence in severe asthma patients when compared to biologics like Dupilumab, Mepolizumab, Omalizumab, and Reslizumab.
  • Among COPD patients with the eosinophilic phenotype, benralizumab and Mepolizumab reduced exacerbations and hospitalizations without an increased risk of serious adverse events.

Product Monograph / Prescribing Information

Document TitleYearSource
Fasenra (benralizumab) Prescribing Information.2021AstraZeneca Pharmaceuticals LP., Wilmington, DE

Systematic Reviews / Meta-Analyses

Document TitleYearSource
The effect of biologics in lung function and quality of life of patients with united airways disease: a systematic review.2023Journal of Allergy and Clinical Immunology
Real-world efficacy of treatment with benralizumab, dupilumab, mepolizumab and reslizumab for severe asthma: A systematic review and meta-analysis. 2022Clinical and Experimental Allergy
Tezepelumab compared with other biologics for the treatment of severe asthma: a systematic review and indirect treatment comparison.2022Journal of Medical Economics
Anti‐IL‐5 therapies for asthma.2022The Cochrane 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
Oral corticosteroids dependence and biologic drugs in severe asthma: myths or facts? a systematic review of real-world evidence.2021International Journal of Molecular Sciences
Comparative efficacy and safety of dupilumab and benralizumab in patients with inadequately controlled asthma: a systematic review.2020International Journal of Molecular Sciences
Anti‐IL‐5 therapies for chronic obstructive pulmonary disease.2020The Cochrane Database of Systematic Reviews
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
Adverse events of benralizumab in moderate to severe eosinophilic asthma: a meta-analysis. 2019Medicine Open
Monoclonal antibodies in type 2 asthma: a systematic review and network meta-analysis.2019BMC Respiratory Journal

Clinical Practice Guidelines