Pharmacokinetics, pharmacodynamics and safety of tezepelumab in children with asthma
Bibliographic record
Abstract
<bold>Background:</bold> Tezepelumab is approved for the treatment of patients aged ≥12 years with severe asthma. <bold>Objective:</bold> TRAILHEAD (<ext-link>NCT04673630</ext-link>) evaluated the pharmacokinetics (PK), pharmacodynamics (PD) and safety of tezepelumab in children with asthma. <bold>Methods:</bold> TRAILHEAD was a phase 1, multicentre, open-label study in children (5–11 years) with mild, moderate or severe asthma requiring daily controller medication use. PK (primary outcome), PD (exploratory outcome) and safety were evaluated for up to 85 days after a single subcutaneous dose of tezepelumab 70 mg. <bold>Results:</bold> Of 23 children enrolled, 18 received treatment and completed the study (median age, 8 years; 61% male). Max geometric mean serum concentration of tezepelumab (24.6 μg/mL) was observed at a median time of 3.5 days post dose, followed by exponential decline with a mean terminal half-life of 25.7 days (<bold>Figure</bold>). Mean area under the concentration–time curve was 974 μg*day/mL. Changes in biomarkers from baseline (blood eosinophil count, serum total IgE and FeNO) reflected the expected PD effects of tezepelumab. Seven patients (39%) reported adverse events; all were mild or moderate intensity and considered by the investigator to be unrelated to treatment. <bold>Conclusion:</bold> The PK, PD and safety after a single 70 mg dose of tezepelumab in children were as expected from previous studies in other age groups, supporting further development of tezepelumab for children with asthma. <fig><object-id>erj;64/suppl_68/PA3562/F1</object-id><object-id>F1</object-id><object-id>F1</object-id><graphic></graphic></fig>
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.000 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".