Drug updated on 7/26/2024
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
- Benralizumab (Fasenra) is indicated for the add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype.
- The information was derived from a total of 11 systematic reviews/meta-analyses documents.
- In patients with severe asthma and chronic rhinosinusitis with nasal polyps (CRSwNP), benralizumab showed significant improvements in lung function (FEV1) and quality of life after 24 weeks compared to other biologics like Dupilumab, Mepolizumab, Omalizumab, Reslizumab.
- Real-world studies indicate that benralizumab significantly reduces annual exacerbation rates and improves FEV1, showing similar effect sizes as observed in randomized controlled trials across various patient subgroups when compared to Mepolizumab and Reslizumab.
- Indirect comparisons among biologics such as Tezepelumab, Dupilumab, Mepolizumab, Reslizumab, and Omalizumab show no statistically significant differences in efficacy; however, Tezepelumab had numerically lower annual asthma exacerbation rates in subgroup analyses than benralizumab.
- For adults and children with severe chronic eosinophilic asthma, benralizumab was effective in reducing asthma exacerbations and improving HRQoL without excess serious adverse events, though some adverse events led to discontinuation compared to Mepolizumab and Reslizumab.
- Studies focusing on oral corticosteroid dependence found that real-world evidence supports the effectiveness of benralizumab in reducing or ceasing OCS usage, overcoming OCS dependence in severe asthma patients when compared to biologics like Dupilumab, Mepolizumab, Omalizumab, and Reslizumab.
- Among COPD patients with the eosinophilic phenotype, benralizumab and Mepolizumab reduced exacerbations and hospitalizations without an increased risk of serious adverse events.
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 |