Abstract

Background
Eosinophils play a pivotal role in severe asthma and have been the target of biologic treatments such as benralizumab, an anti-IL-5Ra mAb with eosinophil-depleting property. While benralizumab is effective in severe asthma, concerns about the consequences of long-term eosinophil-depleting therapies have been raised.
Aim
To perform a cumulative meta-analysis to assess the temporal trend of safety profile of benralizumab in severe asthma.
Methods
A cumulative meta-analysis was performed according to PRISMA-P to assess the temporal trend of benralizumab safety profile with specific focus on infections and infestations, neoplasms, and mortality by using the ClinicalTrials.gov database.
Results
Data from 3856 severe eosinophilic patients were extracted from the SOLANA, ANDHI, ZONDA, GRECO, GREGALE, SIROCCO, CALIMA, BORA, and MELTEMI studies. Patients were exposed to benralizumab up to 5 years. The cumulative frequency of infections and infestations detected for benralizumab was significantly (P<0.05) lower than that in placebo. No difference was detected between benralizumab and placebo with respect to the cumulative frequency of neoplasms and mortality. Detailed information is shown in Figure 1.
Conclusions
The long-term exposure to benralizumab is safe regardless of the regimen of administration. The reduction in infections and infestations may be due to the oral-glucocorticoid sparing effect of benrlizumab.