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  • Title: Relationship Between Benralizumab Exposure and Efficacy for Patients With Severe Eosinophilic Asthma.
    Author: Chia YL, Yan L, Yu B, Wang B, Barker P, Goldman M, Roskos L.
    Journal: Clin Pharmacol Ther; 2019 Aug; 106(2):383-390. PubMed ID: 30661249.
    Abstract:
    We evaluated the relationship between benralizumab (30 mg every 4 and 8 weeks (Q4W, Q8W)) pharmacokinetic (PK) exposure and end points of asthma exacerbation rates (AERs) and change from baseline in prebronchodilator forced expiratory volume in 1 second (FEV1 ) for patients with severe, uncontrolled eosinophilic asthma in the SIROCCO/CALIMA phase III trials. In empirical assessment, AER ratios in SIROCCO were similar across PK quartiles. However, the lowest PK quartile in CALIMA had reduced efficacy; low CALIMA placebo AER possibly confounded this result. In population modeling, estimated benralizumab 90% effective concentration for AER reduction was 927 ng/mL, below the Q8W dosage steady-state average PK concentration (1,066 ng/mL). Benralizumab treatment resulted in more rapid FEV1 improvement vs. placebo (estimated half-maximum time: 7.6 vs. 18 days); this response was greater for patients with greater baseline eosinophil counts. These results confirmed 30 mg Q8W is the optimal benralizumab dosage for patients with severe eosinophilic asthma.
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