Benralizumab in children with severe eosinophilic asthma: Pharmacokinetics and long‐term safety ( TATE study)

Abstract Background Benralizumab is an anti‐interleukin‐5 receptor α monoclonal antibody approved as an add‐on maintenance treatment for patients with uncontrolled severe asthma. Prior Phase 3 studies have evaluated benralizumab in patients aged ≥12 years with severe uncontrolled asthma. The TATE study evaluated the pharmacokinetics (PK), pharmacodynamics (PD), and safety of benralizumab treatment in children. Methods TATE was an open‐label, Phase 3 study of benralizumab in children aged 6–11 years from the United States and Japan (plus participants aged 12–14 years from Japan) with severe eosinophilic asthma. Participants received benralizumab 10/30 mg according to weight (<35/≥35 kg). Primary endpoints included maximum serum concentration ( C max ), clearance, half‐life ( t 1/2 ), and blood eosinophil count. Clearance and t 1/2 were derived from a population PK (popPK) analysis. Safety and tolerability were also assessed. Results Twenty‐eight children aged 6–11 years were included, with an additional two participants from Japan aged 12–14 years also included in the popPK analysis. Mean C max was 1901.2 and 3118.7 ng/mL in the 10 mg/<35 kg and 30 mg/≥35 kg groups, respectively. Clearance was 0.257, and mean t 1/2 was 14.5 days. Near‐complete depletion of blood eosinophils was shown across dose/weight groups. Exploratory efficacy analyses found numerical improvements in mean FEV 1 , mean ACQ‐IA, patient/clinician global impression of change, and exacerbation rates. Adverse events occurred in 22/28 (78.6%) of participants; none led to discontinuation/death. Conclusion PK, PD, and safety data support long‐term benralizumab in children with severe eosinophilic asthma, and were similar to findings in adolescents and adults. Trial Registration ClinicalTrials.gov ‐ID: NCT04305405.