Drug updated on 9/4/2024
Dosage Form | Injection (subcutaneous; 30 mg/mL) |
Drug Class | Interleukin-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
- 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 Title | Year | Source |
---|---|---|
Fasenra (benralizumab) Prescribing Information. | 2021 | AstraZeneca Pharmaceuticals LP., Wilmington, DE |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
Benralizumab (Fasenra®) protocol for the treatment of Severe refractory eosinophilic asthma. | 2023 | National Clinical Programme for Respiratory Medicine |
Severe asthma: adding new evidence –Latin American Thoracic Society. | 2021 | ERJ Open Research |
EAACI biologicals guidelines—recommendations for severe asthma. | 2021 | Allergy |
Global strategy for asthma management and prevention. | 2020 | GINA |