Benralizumab

(Fasenra®)

Fasenra®

Drug updated on 12/11/2024

Dosage FormInjection (subcutaneous; 10 mg/0.5 mL, 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 aged 6 years and older with severe asthma, and with an eosinophilic phenotype
  • Indicated for treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA).

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Summary
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  • This summary is based on the review of 12 systematic review(s)/meta-analysis(es). [1-12]
  • Exacerbation Rates: Benralizumab significantly reduced exacerbation rates in patients with severe eosinophilic asthma (relative risk (RR) ~0.59) compared to placebo. However, it was less effective than dupilumab (RR ~0.32) and tezepelumab (RR ~0.63) but similar in efficacy to mepolizumab (RR ~0.53 to 0.59).
  • Lung Function (Forced Expiratory Volume in 1 Second (FEV₁) Improvements): Benralizumab demonstrated modest improvements in pre-bronchodilator FEV₁ (~0.08 to 0.15 L), smaller compared to dupilumab (~230 mL) and tezepelumab, though differences were not statistically significant. Both tezepelumab and dupilumab had a high probability (1.00) of improving FEV₁ by ≥100 mL above placebo.
  • Asthma Control and Quality of Life: Benralizumab improved Asthma Control Questionnaire (ACQ) and Asthma Quality of Life Questionnaire (AQLQ) scores, but these improvements did not meet the minimum clinically important difference (MCID). Mepolizumab showed the most ACQ improvement, but not significantly different from benralizumab or tezepelumab.
  • Subgroup Differences (Eosinophil Levels): In patients with higher blood eosinophil levels (≥300 cells/μL), dupilumab showed a more pronounced reduction in exacerbation rates compared to benralizumab. For lower eosinophil levels (<150 cells/μL), there was no significant difference between dupilumab and benralizumab.
  • Benralizumab: Generally well-tolerated, with no significant excess of serious adverse events compared to placebo. However, 2.1% of patients discontinued benralizumab due to adverse events, compared to 0.9% for placebo. Benralizumab showed a higher incidence of antidrug antibodies (8.35%) compared to other biologics.
  • Infectious Adverse Events: Benralizumab was associated with a higher incidence of infections, including pharyngitis and bronchitis, compared to mepolizumab and reslizumab. It also showed trends toward higher infection rates, particularly in suboptimal responders with concomitant infections and sputum neutrophilia.
  • Most studies focused on patients with severe eosinophilic asthma, and benralizumab was effective in reducing exacerbation rates in both eosinophilic and non-eosinophilic participants, with no significant reduction seen in non-eosinophilic participants with other anti-interleukin-5 (IL-5) treatments.

Product Monograph / Prescribing Information

Document TitleYearSource
Fasenra (benralizumab) Prescribing Information.2024AstraZeneca, Wilmington, DE

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Exploring the risk of infection events in patients with asthma receiving anti-IL-5 monoclonal antibodies: A rapid systematic review and a meta-analysis2024Heliyon
Incidence of Anti-Drug Antibodies to Monoclonal Antibodies in Asthma: A Systematic Review and Meta-Analysis2023The Journal of Allergy and Clinical Immunology
Comparative efficacy of tezepelumab to mepolizumab, benralizumab, and dupilumab in eosinophilic asthma: A Bayesian network meta-analysis2023The Journal of Allergy and Clinical Immunology
A bibliometric and scientific knowledge map study of the drug therapies for asthma-related study from 1982 to 20212022Frontiers in Pharmacology
Anti-IL-5 therapies for asthma2022The Cochrane Database of Systematic Reviews
Comparative efficacy of mepolizumab, benralizumab, and dupilumab in eosinophilic asthma: A Bayesian network meta-analysis2022The Journal of Allergy and Clinical Immunology
A systematic review and integrated analysis of biologics that target Type 2 inflammation to treat COPD with increased peripheral blood eosinophils2022Heliyon
Tezepelumab compared with other biologics for the treatment of severe asthma: a systematic review and indirect treatment comparison2022Journal of Medical Economics
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-Analysis2022Cells
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 asthma2020Allergy
Comparative Efficacy and Safety of Dupilumab and Benralizumab in Patients with Inadequately Controlled Asthma: A Systematic Review2020International Journal of Molecular Sciences
Matching-adjusted comparison of oral corticosteroid reduction in asthma: Systematic review of biologics2020Clinical and Experimental Allergy

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