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Benralizumab in children with severe eosinophilic asthma: Pharmacokinetics and long-term safety (TATE study).
- Source :
-
Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology [Pediatr Allergy Immunol] 2024 Mar; Vol. 35 (3), pp. e14092. - Publication Year :
- 2024
-
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.<br />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 <subscript>max</subscript> ), clearance, half-life (t <subscript>1/2</subscript> ), and blood eosinophil count. Clearance and t <subscript>1/2</subscript> were derived from a population PK (popPK) analysis. Safety and tolerability were also assessed.<br />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 <subscript>max</subscript> 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 <subscript>1/2</subscript> 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 <subscript>1</subscript> , 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.<br />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.<br />Trial Registration: ClinicalTrials.gov-ID: NCT04305405.<br /> (© 2024 European Academy of Allergy and Clinical Immunology and John Wiley & Sons Ltd.)
Details
- Language :
- English
- ISSN :
- 1399-3038
- Volume :
- 35
- Issue :
- 3
- Database :
- MEDLINE
- Journal :
- Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology
- Publication Type :
- Academic Journal
- Accession number :
- 38491795
- Full Text :
- https://doi.org/10.1111/pai.14092