Benralizumab

(Fasenra®)

Fasenra®

Drug updated on 9/4/2024

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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  • Fasenra (benralizumab) is indicated for the add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype.
  • This summary is based on the review of 11 systematic reviews or meta-analyses. [1-11]
  • Lung Function: Benralizumab significantly improved FEV1 in patients with severe asthma and CRSwNP, with real-world data showing an increase of 0.21L (95% CI 0.08, 0.34). In RCTs, FEV1 improvements ranged from 0.08L to 0.15L in eosinophilic participants. Mepolizumab also improved FEV1 by 0.17L (95% CI 0.11, 0.24).
  • Exacerbation Rates: Benralizumab reduced the annualized exacerbation rate by -3.79 (95% CI -4.53, -3.04) in real-world settings and decreased the rate of clinically significant asthma exacerbations by 41% (RR 0.59, 95% CI 0.52 to 0.66). Mepolizumab similarly reduced the exacerbation rate by -3.17 (95% CI -3.74, -2.59).
  • Quality of Life: Benralizumab led to significant improvements in quality of life, including a notable increase in Sino-Nasal Outcome Test scores and meeting the minimum clinically important difference (MCID) in the St. George's Respiratory Questionnaire (SGRQ). Other biologics like mepolizumab also improved HRQoL scores but did not reach the MCID for certain measures.
  • Oral Corticosteroid Usage: Benralizumab demonstrated significant OCS-sparing effects in severe asthmatic patients, leading to a reduction or suspension of OCS therapy. Mepolizumab and dupilumab also showed similar OCS-sparing benefits.
  • Benralizumab demonstrated a lower risk of overall adverse events (RR 0.94; 95% CI 0.90-0.98) and serious adverse events (RR 0.82; 95% CI 0.68-0.98), but there was a higher risk of headache (RR 1.42, 95% CI 1.07-1.87) and pyrexia (RR 2.26, 95% CI 1.32-3.87).
  • Benralizumab had a higher rate of discontinuation due to adverse events compared to placebo.
  • Benralizumab was associated with a reduced risk of asthma exacerbation, bronchitis, and sinusitis compared to placebo.
  • Eosinophilic Phenotype and Age Groups: Benralizumab and mepolizumab were more effective in patients with higher eosinophil counts, with most studies focusing on adults with severe eosinophilic asthma. Limited data was available for children aged 6 to 17 years.

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