Pharmacokinetics and safety of tezepelumab in children with mild, moderate or severe asthma and adolescents with mild-to-moderate asthma.
Anna Lundahl, Jonathan Grigg, Lubna Abuqayyas et al.
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In 30 seconds
Two open-label, single-dose Phase 1 studies assessed tezepelumab pharmacokinetics, pharmacodynamics and safety in adolescents aged 12–17 years with mild-to-moderate asthma and children aged 5–11 years with mild, moderate or severe asthma. Twenty-one adolescents received 140 mg and 18 children received 70 mg subcutaneously. Mean terminal half-life was 25.3 (SD: 4.7) days in adolescents and 25.7 (SD: 5.9) days in children. Biomarker changes were consistent with expected pharmacodynamic effects, and no new safety signals were identified.
Key findings
- In adolescents, mean terminal half-life was 25.3 (SD: 4.7) days after a single 140-mg subcutaneous dose.
- In children, mean terminal half-life was 25.7 (SD: 5.9) days after a single 70-mg subcutaneous dose.
- Changes in blood eosinophil count, fractional exhaled nitric oxide and serum IgE reflected expected pharmacodynamic effects.
- No new safety signals were identified in either study.
Why it matters
These early paediatric data describe tezepelumab exposure and biomarker responses across the studied age and asthma-severity groups. The broadly similar terminal half-lives and absence of new safety signals are relevant to further evaluation of the drug in children and adolescents, while the single-dose design does not establish longer-term safety or clinical benefit.
What to keep in mind
Both studies were open-label, single-dose Phase 1 studies with small participant groups and pharmacokinetic and pharmacodynamic follow-up up to 85 days postdose; they do not establish long-term safety or efficacy.