{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,28]],"date-time":"2026-10-28T09:32:49Z","timestamp":1793179969580,"version":"4.5.0"},"reference-count":32,"publisher":"Wiley","issue":"11","license":[{"start":{"date-parts":[[2026,7,6]],"date-time":"2026-07-06T00:00:00Z","timestamp":1783296000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2026,7,6]],"date-time":"2026-07-06T00:00:00Z","timestamp":1783296000000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"funder":[{"DOI":"10.13039\/100004325","name":"AstraZeneca","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004325","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100002429","name":"Amgen","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100002429","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Br J Clin Pharmacol"],"published-print":{"date-parts":[[2026,11]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Aim<\/jats:title>\n                    <jats:p>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\u2009days postdose in adolescents and children.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>The adolescent PK study (NCT02512900), in adolescents aged 12\u201317\u2009years with mild\u2010to\u2010moderate asthma, and TRAILHEAD (NCT04673630), in children aged 5\u201311\u2009years with mild, moderate or severe asthma, were both open\u2010label, single\u2010dose, Phase 1 studies.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      In the adolescent PK study, 21 adolescents (median age: 14\u2009years) received a single 140\u2010mg subcutaneous tezepelumab dose. The mean maximum concentration (\n                      <jats:italic>C<\/jats:italic>\n                      <jats:sub>max<\/jats:sub>\n                      ; 24.0 [SD: 6.6]\u00a0\u03bcg\/mL) was observed at a median time of 6 (range: 1\u201320)\u00a0days postdose, with a mean terminal half\u2010life of 25.3 (SD: 4.7)\u00a0days. The mean area under the concentration\u2013time curve (AUC\n                      <jats:sub>0\u2013infinity<\/jats:sub>\n                      ) was 952 (SD: 289)\u00a0\u03bcg*day\/mL. In TRAILHEAD, 18 children (median age: 8\u00a0years) received a single 70\u2010mg subcutaneous tezepelumab dose. The\n                      <jats:italic>C<\/jats:italic>\n                      <jats:sub>max<\/jats:sub>\n                      (27.1\u00a0\u03bcg\/mL [SD: 11.9]) was observed at a median time of 3.5 (range: 2\u201310)\u00a0days postdose, with a mean terminal half\u2010life of 25.7 (SD: 5.9) days. The mean AUC\n                      <jats:sub>0\u2013infinity<\/jats:sub>\n                      was 974 (SD: 320)\u00a0\u03bcg*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.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>These results were consistent with previous studies of tezepelumab in other groups, supporting development of tezepelumab for asthma in the paediatric population.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/bcp.70666","type":"journal-article","created":{"date-parts":[[2026,7,7]],"date-time":"2026-07-07T01:01:31Z","timestamp":1783386091000},"page":"3819-3830","source":"Crossref","is-referenced-by-count":0,"title":["Pharmacokinetics and safety of tezepelumab in children with mild, moderate or severe asthma and adolescents with mild\u2010to\u2010moderate asthma"],"prefix":"10.1002","volume":"92","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0272-3192","authenticated-orcid":false,"given":"Anna","family":"Lundahl","sequence":"first","affiliation":[{"name":"Clinical Pharmacology and Quantitative Pharmacology, Clinical Pharmacology and Safety Sciences, R&amp;D AstraZeneca  Gothenburg Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jonathan","family":"Grigg","sequence":"additional","affiliation":[{"name":"Centre for Genomics and Child Health, Blizard Institute Queen Mary University of London  London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lubna","family":"Abuqayyas","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology, Modeling and Simulation Amgen  Cambridge Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Piotr","family":"Kuna","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, Asthma and Allergy 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