Duration of Benralizumab Maintenance Therapy
Benralizumab maintenance dosing should continue indefinitely for patients with severe eosinophilic asthma or hypereosinophilic syndrome who have responded well to treatment, as discontinuation leads to rapid disease relapse and loss of therapeutic benefit.
Evidence for Long-Term Continuous Therapy
The evidence strongly supports indefinite maintenance therapy without planned discontinuation:
Long-term safety data extending up to 5 years demonstrates that benralizumab maintains a favorable safety profile with no new safety signals emerging over time, with adverse event rates remaining stable at 28.5-32.4 per 100 patient-years and serious adverse event rates at 6.3-8.4 per 100 patient-years 1.
Extended treatment for up to 48 months in real-world settings confirms sustained effectiveness with consistent improvements in lung function, exacerbation reduction, and oral corticosteroid sparing throughout the entire treatment period 2.
The 2-year BORA extension trial showed that patients who continued benralizumab maintained their clinical benefits, with 75% or more patients experiencing zero exacerbations annually 3, 1.
Dosing Schedule for Maintenance
The standard maintenance regimen after initial loading is:
30 mg subcutaneously every 8 weeks (after the first three doses given every 4 weeks) 4, 3.
This dosing interval maintains near-complete eosinophil depletion and clinical efficacy throughout the maintenance phase 2.
Why Discontinuation Is Not Recommended
Unlike topical corticosteroids in eosinophilic esophagitis where maintenance therapy is debated, benralizumab for severe asthma requires continuous treatment:
For eosinophilic esophagitis treated with topical steroids, histological relapse rates are extremely high after withdrawal, with only 4.4% of patients maintaining remission on placebo versus 73.5-75% on continued treatment 5. This principle applies even more strongly to benralizumab, where the mechanism involves complete eosinophil depletion.
The mechanism of action—near-complete eosinophil depletion via IL-5 receptor alpha blockade—requires ongoing treatment to maintain therapeutic effect 2.
In hypereosinophilic disorders, 74% of patients maintained sustained response at 48 weeks with continued therapy, suggesting that ongoing treatment is necessary for disease control 4, 6.
Monitoring During Long-Term Therapy
While continuing indefinitely, appropriate monitoring includes:
The European Respiratory Society recommends therapeutic drug monitoring when using benralizumab 4, 7.
Regular assessment of exacerbation frequency, lung function, and oral corticosteroid requirements to confirm ongoing benefit 1, 8.
Surveillance for adverse events, though the safety profile remains stable over years of treatment with no increased risk from prolonged eosinophil depletion 2, 1.
Special Considerations
Near-complete eosinophil depletion does not increase long-term safety risks, as demonstrated by 5-year safety data showing no opportunistic infections or other complications related to sustained eosinophil suppression 2, 1.
Oral corticosteroid-sparing effects are maintained long-term, with median 67% reduction from baseline sustained through extended follow-up, resulting in cumulative steroid exposure reduction from 5.74 g to 2.98 g over 1.5 years 8.