Drug updated on 12/11/2024
Dosage Form | Injection (subcutaneous; 10 mg/0.5 mL, 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 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).
Latest News
Summary
- 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 Title | Year | Source |
---|---|---|
Fasenra (benralizumab) Prescribing Information. | 2024 | AstraZeneca, 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 | Global Initiative for Asthma |