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Peer-reviewedCC BY-NC 4.0British Journal of Clinical Pharmacology

Pharmacokinetics and safety of tezepelumab in children with mild, moderate or severe asthma and adolescents with mild‐to‐moderate asthma

  • Anna Lundahl1
  • Jonathan Grigg2
  • Lubna Abuqayyas3
  • Piotr Kuna4
  • Gillian Hunter5
  • Beata Pawlikowska6
  • Jacob Leander1
  • Michael Levin7
  • Atul Gupta8,9
  • James Paton10
  • Katharine C. Pike11
  • Jane R. Parnes12
3 more authors
  • Gun Almqvist13
  • Stephanie L. Roseti14
  • the study investigators
14 affiliations
  1. 1Clinical Pharmacology and Quantitative Pharmacology, Clinical Pharmacology and Safety Sciences, R&D AstraZeneca Gothenburg Sweden
  2. 2Centre for Genomics and Child Health, Blizard Institute Queen Mary University of London London UK
  3. 3Clinical Pharmacology, Modeling and Simulation Amgen Cambridge Massachusetts USA
  4. 4Department of Internal Medicine, Asthma and Allergy Medical University of Łódź Łódź Poland
  5. 5Biometrics, Respiratory and Immunology, BioPharmaceuticals R&D AstraZeneca Cambridge UK
  6. 6Biometrics, Respiratory and Immunology, BioPharmaceuticals R&D AstraZeneca Warsaw Poland
  7. 7Division of Paediatric Allergology University of Cape Town Cape Town South Africa
  8. 8Department of Paediatric Respiratory Medicine King's College Hospital London UK
  9. 9Faculty of Life Sciences and Medicine King's College London London UK
  10. 10School of Medicine, College of Medical, Veterinary & Life Sciences University of Glasgow Glasgow UK
  11. 11Department of Paediatric Respiratory Medicine Bristol Royal Hospital for Children Bristol UK
  12. 12Early Development Amgen Thousand Oaks California USA
  13. 13Respiratory and Immunology, BioPharmaceuticals R&D AstraZeneca Gothenburg Sweden
  14. 14Respiratory and Immunology, BioPharmaceuticals R&D AstraZeneca Gaithersburg Maryland USA
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Abstract

Aim: Tezepelumab is a human monoclonal antibody that blocks the activity of thymic stromal lymphopoietin and is approved for adolescents and adults with severe asthma. This analysis assessed pharmacokinetics (PK), pharmacodynamics and safety of tezepelumab up to 85 days postdose in adolescents and children.

Methods: The adolescent PK study (NCT02512900), in adolescents aged 12–17 years with mild‐to‐moderate asthma, and TRAILHEAD (NCT04673630), in children aged 5–11 years with mild, moderate or severe asthma, were both open‐label, single‐dose, Phase 1 studies.

Results: In the adolescent PK study, 21 adolescents (median age: 14 years) received a single 140‐mg subcutaneous tezepelumab dose. The mean maximum concentration (C max; 24.0 [SD: 6.6] μg/mL) was observed at a median time of 6 (range: 1–20) days postdose, with a mean terminal half‐life of 25.3 (SD: 4.7) days. The mean area under the concentration–time curve (AUC0–infinity) was 952 (SD: 289) μg*day/mL. In TRAILHEAD, 18 children (median age: 8 years) received a single 70‐mg subcutaneous tezepelumab dose. The C max (27.1 μg/mL [SD: 11.9]) was observed at a median time of 3.5 (range: 2–10) days postdose, with a mean terminal half‐life of 25.7 (SD: 5.9) days. The mean AUC0–infinity was 974 (SD: 320) μg*day/mL. Changes from baseline in blood eosinophil count, fractional exhaled nitric oxide and serum immunoglobulin E (IgE) reflected expected pharmacodynamic effects of tezepelumab. No new safety signals were identified.

Conclusions: These results were consistent with previous studies of tezepelumab in other groups, supporting development of tezepelumab for asthma in the paediatric population.

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Cite

BibTeXRIS
BibTeX
@article{lundahl2026pharmacokinetics,
  title = {{Pharmacokinetics and safety of tezepelumab in children with mild, moderate or severe asthma and adolescents with mild‐to‐moderate asthma}},
  author = {Anna Lundahl and Jonathan Grigg and Lubna Abuqayyas and Piotr Kuna and Gillian Hunter and Beata Pawlikowska and Jacob Leander and Michael Levin and Atul Gupta and James Paton and Katharine C. Pike and Jane R. Parnes and Gun Almqvist and Stephanie L. Roseti and the study investigators},
  journal = {British Journal of Clinical Pharmacology},
  year = {2026},
  month = jul,
  doi = {10.1002/bcp.70666},
  url = {https://doi.org/10.1002/bcp.70666},
  note = {CC BY-NC 4.0},
}
RIS
TY  - JOUR
TI  - Pharmacokinetics and safety of tezepelumab in children with mild, moderate or severe asthma and adolescents with mild‐to‐moderate asthma
AU  - Anna Lundahl
AU  - Jonathan Grigg
AU  - Lubna Abuqayyas
AU  - Piotr Kuna
AU  - Gillian Hunter
AU  - Beata Pawlikowska
AU  - Jacob Leander
AU  - Michael Levin
AU  - Atul Gupta
AU  - James Paton
AU  - Katharine C. Pike
AU  - Jane R. Parnes
AU  - Gun Almqvist
AU  - Stephanie L. Roseti
AU  - the study investigators
PY  - 2026
DA  - 2026/07/06
JO  - British Journal of Clinical Pharmacology
DO  - 10.1002/bcp.70666
UR  - https://doi.org/10.1002/bcp.70666
AB  - Aim: Tezepelumab is a human monoclonal antibody that blocks the activity of thymic stromal lymphopoietin and is approved for adolescents and adults with severe asthma. This analysis assessed pharmacokinetics (PK), pharmacodynamics and safety of tezepelumab up to 85 days postdose in adolescents and children.  Methods: The adolescent PK study (NCT02512900), in adolescents aged 12–17 years with mild‐to‐moderate asthma, and TRAILHEAD (NCT04673630), in children aged 5–11 years with mild, moderate or severe asthma, were both open‐label, single‐dose, Phase 1 studies.  Results: In the adolescent PK study, 21 adolescents (median age: 14 years) received a single 140‐mg subcutaneous tezepelumab dose. The mean maximum concentration (C max; 24.0 [SD: 6.6] μg/mL) was observed at a median time of 6 (range: 1–20) days postdose, with a mean terminal half‐life of 25.3 (SD: 4.7) days. The mean area under the concentration–time curve (AUC0–infinity) was 952 (SD: 289) μg*day/mL. In TRAILHEAD, 18 children (median age: 8 years) received a single 70‐mg subcutaneous tezepelumab dose. The C max (27.1 μg/mL [SD: 11.9]) was observed at a median time of 3.5 (range: 2–10) days postdose, with a mean terminal half‐life of 25.7 (SD: 5.9) days. The mean AUC0–infinity was 974 (SD: 320) μg*day/mL. Changes from baseline in blood eosinophil count, fractional exhaled nitric oxide and serum immunoglobulin E (IgE) reflected expected pharmacodynamic effects of tezepelumab. No new safety signals were identified.  Conclusions: These results were consistent with previous studies of tezepelumab in other groups, supporting development of tezepelumab for asthma in the paediatric population.
SN  - 0306-5251
SN  - 1365-2125
ER  -