Benralizumab

(Fasenra®)

Fasenra®

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Drug updated on 5/17/2024

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, exhibiting an eosinophilic phenotype. It effectively reduces the annualized exacerbation rate significantly, showing improvements in forced expiratory volume in 1 second (FEV1) and fractional exhaled nitric oxide (FeNO).
  • Ten systematic reviews/meta-analyses were reviewed to gather information about Fasenra's effectiveness.
  • Compared to other biologics like mepolizumab and reslizumab, benralizumab shows similar effect sizes in clinical outcomes. However, tezepelumab was favorably associated with numerically lower annualized asthma exacerbation rates.
  • Benralizumab has been shown to induce an oral corticosteroid-sparing effect, which overcomes OCS dependence issues seen in severe asthma cases. This finding is consistent across both randomized clinical trials and real-world studies.
  • For patients with a higher blood eosinophil count specifically, benralizumab demonstrated significant improvements compared with placebo by reducing exacerbation rates and providing an OCS-sparing effect.
  • While generally safe for use as evidenced by a lower risk of overall adverse events such as serious adverse events or bronchitis when compared to placebos, it does have increased risks for headaches and pyrexia that require monitoring during long-term treatment.

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