{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,26]],"date-time":"2026-09-26T04:01:54Z","timestamp":1790395314261,"version":"4.1.0"},"reference-count":49,"publisher":"Wiley","license":[{"start":{"date-parts":[[2026,9,25]],"date-time":"2026-09-25T00:00:00Z","timestamp":1790294400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"},{"start":{"date-parts":[[2026,9,25]],"date-time":"2026-09-25T00:00:00Z","timestamp":1790294400000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"funder":[{"DOI":"10.13039\/501100001509","name":"Royal Society Te Ap\u0101rangi","doi-asserted-by":"publisher","award":["CSG\u2010UOA2209"],"award-info":[{"award-number":["CSG\u2010UOA2209"]}],"id":[{"id":"10.13039\/501100001509","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100000925","name":"National Health and Medical Research Council","doi-asserted-by":"publisher","award":["APP1175634"],"award-info":[{"award-number":["APP1175634"]}],"id":[{"id":"10.13039\/501100000925","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100000925","name":"National Health and Medical Research Council","doi-asserted-by":"publisher","award":["APP1173731"],"award-info":[{"award-number":["APP1173731"]}],"id":[{"id":"10.13039\/501100000925","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100000925","name":"National Health and Medical Research Council","doi-asserted-by":"publisher","award":["APP1173584"],"award-info":[{"award-number":["APP1173584"]}],"id":[{"id":"10.13039\/501100000925","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100000925","name":"National Health and Medical Research Council","doi-asserted-by":"publisher","award":["APP 2033196"],"award-info":[{"award-number":["APP 2033196"]}],"id":[{"id":"10.13039\/501100000925","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100001505","name":"Health Research Council of New Zealand","doi-asserted-by":"publisher","award":["22\/559"],"award-info":[{"award-number":["22\/559"]}],"id":[{"id":"10.13039\/501100001505","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100001562","name":"New Zealand Vice-Chancellors' Committee","doi-asserted-by":"publisher","award":["22\u2010UOA\u2010071\u2010CSG"],"award-info":[{"award-number":["22\u2010UOA\u2010071\u2010CSG"]}],"id":[{"id":"10.13039\/501100001562","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["ascpt.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clin Pharma and Therapeutics"],"abstract":"<jats:p>\n                    Anakinra, an interleukin\u20101 receptor antagonist, shows promise for reducing inflammatory complications of premature birth. However, the pharmacokinetics (PK) of anakinra in neonates has not been characterized, limiting evidence\u2010based dosing. This study aimed to develop a population PK model for anakinra to guide dosing in preterm neonates. Data from 25 preterm neonates (median gestational age: 26.3\u2009weeks) from a Phase I\/IIa trial of intravenous anakinra (Anakinra Pilot, NCT05280340) were analyzed, with 4\u20138 samples collected per neonate across 0\u201320\u2009days postnatal age (PNA). A population PK model was developed and dosing simulations were performed incorporating a pharmacodynamic (PD) direct effect model (I\n                    <jats:sub>max<\/jats:sub>\n                    , IC\n                    <jats:sub>50<\/jats:sub>\n                    ) and target exposure (AUC\n                    <jats:sub>0\u201024h<\/jats:sub>\n                    ). The data were best described by a one\u2010compartment model with linear elimination and a baseline component for endogenous IL\u20101Ra. Allometric scaling was applied to clearance (CL) and volume of distribution (V), with a maturation function using PNA on CL to account for early age\u2010related pharmacokinetic changes. Estimated CL and\n                    <jats:italic>V<\/jats:italic>\n                    were 3.97\u2009L\/h\/70\u2009kg (0.15\u2009L\/h\/0.9\u2009kg) and 28.9\u2009L\/70\u2009kg (0.37\u2009L\/h\/0.9\u2009kg). At birth, CL was ~45% of the maximal early postnatal value, achieving ~100% by day 10 PNA. Simulations suggest that an optimal intravenous dosing regimen of 0.6\u2009mg\/kg 12 hourly at birth, 0.8\u2009mg\/kg 12 hourly on PNA day 1, 1.0\u2009mg\/kg 12 hourly from PNA days 2\u20133 and 1.15\u2009mg\/kg 12 hourly day 4 onward. This model delivers the first critical understanding of small protein PK in premature neonates, establishing a foundation for evidence\u2010based dosing strategies to guide future prospective clinical trials.\n                  <\/jats:p>","DOI":"10.1002\/cpt.70491","type":"journal-article","created":{"date-parts":[[2026,9,26]],"date-time":"2026-09-26T03:40:19Z","timestamp":1790394019000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Model\u2010Informed Dose Optimization of Anakinra in Preterm Neonates Implications for Safe and Effective Dosing"],"prefix":"10.1002","author":[{"ORCID":"https:\/\/orcid.org\/0009-0009-8688-9878","authenticated-orcid":false,"given":"Jia","family":"Li","sequence":"first","affiliation":[{"name":"Monash Institute of Pharmaceutical Sciences Monash University  Melbourne Victoria Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4478-5308","authenticated-orcid":false,"given":"David K.","family":"Metz","sequence":"additional","affiliation":[{"name":"Department of Paediatrics Monash University  Melbourne Victoria Australia"},{"name":"Monash Children's Hospital  Melbourne Victoria Australia"},{"name":"Murdoch Children's Research Institute  Melbourne Victoria Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elys","family":"Green","sequence":"additional","affiliation":[{"name":"Department of Paediatrics Monash University  Melbourne Victoria Australia"},{"name":"Monash Children's Hospital  Melbourne Victoria Australia"},{"name":"Ritchie Centre Hudson Institute of Medical Research  Melbourne Victoria Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0178-1243","authenticated-orcid":false,"given":"Gergely","family":"Toldi","sequence":"additional","affiliation":[{"name":"Liggins Institute University of Auckland  Auckland New Zealand"},{"name":"Starship Child Health, Te Whatu Ora  Auckland New Zealand"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6374-9372","authenticated-orcid":false,"given":"Robert","family":"Galinsky","sequence":"additional","affiliation":[{"name":"Ritchie Centre Hudson Institute of Medical Research  Melbourne Victoria Australia"},{"name":"Department of Obstetrics and Gynaecology Monash University  Melbourne Victoria Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8391-1306","authenticated-orcid":false,"given":"Megan","family":"Clark","sequence":"additional","affiliation":[{"name":"Monash Institute of Pharmaceutical Sciences Monash University  Melbourne Victoria Australia"},{"name":"Monash Children's Hospital  Melbourne Victoria Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0009-2133-381X","authenticated-orcid":false,"given":"Rebecka","family":"Atkinson","sequence":"additional","affiliation":[{"name":"Monash Children's Hospital  Melbourne Victoria Australia"},{"name":"Ritchie Centre Hudson Institute of Medical Research  Melbourne Victoria Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7885-110X","authenticated-orcid":false,"given":"Ina","family":"Rudloff","sequence":"additional","affiliation":[{"name":"Department of Paediatrics Monash University  Melbourne Victoria Australia"},{"name":"Ritchie Centre Hudson Institute of Medical Research  Melbourne Victoria Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0002-7599-994X","authenticated-orcid":false,"given":"Josephine C.","family":"Owen","sequence":"additional","affiliation":[{"name":"Department of Paediatrics Monash University  Melbourne Victoria Australia"},{"name":"Ritchie Centre Hudson Institute of Medical Research  Melbourne Victoria Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sara K.","family":"DiSimone","sequence":"additional","affiliation":[{"name":"Department of Paediatrics Monash University  Melbourne Victoria Australia"},{"name":"Ritchie Centre Hudson Institute of Medical Research  Melbourne Victoria Australia"},{"name":"Centre for Innate Immunity and Infectious Disease Hudson Institute of Medical Research  Melbourne Victoria Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4144-2537","authenticated-orcid":false,"given":"Samuel C.","family":"Forster","sequence":"additional","affiliation":[{"name":"Centre for Innate Immunity and Infectious Disease Hudson Institute of Medical Research  Melbourne Victoria Australia"},{"name":"Department of Molecular and Translational Sciences Monash University  Melbourne Victoria Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4057-2092","authenticated-orcid":false,"given":"Steven X.","family":"Cho","sequence":"additional","affiliation":[{"name":"Department of Paediatrics Monash University  Melbourne Victoria Australia"},{"name":"Ritchie Centre Hudson Institute of Medical Research  Melbourne Victoria Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Atif","family":"Majid","sequence":"additional","affiliation":[{"name":"Liggins Institute University of Auckland  Auckland New Zealand"},{"name":"Starship Child Health, Te Whatu Ora  Auckland New Zealand"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8906-614X","authenticated-orcid":false,"given":"Graeme R.","family":"Polglase","sequence":"additional","affiliation":[{"name":"Department of Paediatrics Monash University  Melbourne Victoria Australia"},{"name":"Ritchie Centre Hudson Institute of Medical Research  Melbourne Victoria Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marcel","family":"Favilla","sequence":"additional","affiliation":[{"name":"Monash Children's Hospital  Melbourne Victoria Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3251-1417","authenticated-orcid":false,"given":"Pramod","family":"Pharande","sequence":"additional","affiliation":[{"name":"Department of Paediatrics Monash University  Melbourne Victoria Australia"},{"name":"Monash Children's Hospital  Melbourne Victoria 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H.","family":"Stansfield","sequence":"additional","affiliation":[{"name":"Monash Children's Hospital  Melbourne Victoria Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2600-7529","authenticated-orcid":false,"given":"Arvind","family":"Sehgal","sequence":"additional","affiliation":[{"name":"Department of Paediatrics Monash University  Melbourne Victoria Australia"},{"name":"Monash Children's Hospital  Melbourne Victoria Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1931-0549","authenticated-orcid":false,"given":"Kenneth","family":"Tan","sequence":"additional","affiliation":[{"name":"Department of Paediatrics Monash University  Melbourne Victoria Australia"},{"name":"Monash Children's Hospital  Melbourne Victoria 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Liebig University  Gie\u00dfen Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2446-1739","authenticated-orcid":false,"given":"Rod W.","family":"Hunt","sequence":"additional","affiliation":[{"name":"Department of Paediatrics Monash University  Melbourne Victoria Australia"},{"name":"Monash Children's Hospital  Melbourne Victoria Australia"},{"name":"Cerebral Palsy Alliance  Sydney New South Wales Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7439-3834","authenticated-orcid":false,"given":"Claudia A.","family":"Nold\u2010Petry","sequence":"additional","affiliation":[{"name":"Department of Paediatrics Monash University  Melbourne Victoria Australia"},{"name":"Ritchie Centre Hudson Institute of Medical Research  Melbourne Victoria Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9682-4618","authenticated-orcid":false,"given":"Marcel F.","family":"Nold","sequence":"additional","affiliation":[{"name":"Department of Paediatrics Monash University  Melbourne Victoria Australia"},{"name":"Monash Children's Hospital  Melbourne Victoria Australia"},{"name":"Ritchie Centre Hudson Institute of Medical Research  Melbourne Victoria Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5715-1534","authenticated-orcid":false,"given":"Carl M. J.","family":"Kirkpatrick","sequence":"additional","affiliation":[{"name":"Monash Institute of Pharmaceutical Sciences Monash University  Melbourne Victoria Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,9,25]]},"reference":[{"key":"e_1_2_9_1_1","doi-asserted-by":"crossref","first-page":"1261","DOI":"10.1016\/S0140-6736(23)00878-4","article-title":"National, regional, and global estimates of preterm birth in 2020, with trends from 2010: a systematic analysis","volume":"402","author":"Ohuma E.O.","year":"2023","journal-title":"Lancet"},{"key":"e_1_2_9_2_1","doi-asserted-by":"crossref","first-page":"106","DOI":"10.1016\/S2352-4642(21)00311-4","article-title":"Global, regional, and national causes of under\u20105 mortality in 2000\u201319: an updated systematic analysis with implications for the sustainable development goals","volume":"6","author":"Perin J.","year":"2022","journal-title":"Lancet Child Adolesc. Health."},{"key":"e_1_2_9_3_1","doi-asserted-by":"crossref","first-page":"1039","DOI":"10.1001\/jama.2015.10244","article-title":"Trends in care practices, morbidity, and mortality of extremely preterm neonates, 1993\u20102012","volume":"314","author":"Stoll B.J.","year":"2015","journal-title":"JAMA"},{"key":"e_1_2_9_4_1","doi-asserted-by":"crossref","first-page":"414","DOI":"10.1038\/jp.2016.250","article-title":"Bronchopulmonary dysplasia and pulmonary hypertension: a meta\u2010analysis","volume":"37","author":"Al\u2010Ghanem G.","year":"2017","journal-title":"J. Perinatol."},{"key":"e_1_2_9_5_1","doi-asserted-by":"crossref","first-page":"469","DOI":"10.1002\/ana.24132","article-title":"Brain injury in premature neonates: a primary cerebral dysmaturation disorder?","volume":"75","author":"Back S.A.","year":"2014","journal-title":"Ann. Neurol."},{"key":"e_1_2_9_6_1","doi-asserted-by":"crossref","first-page":"2795","DOI":"10.3390\/ijms24032795","article-title":"The role of the interleukin\u20101 family in complications of prematurity","volume":"24","author":"Green E.A.","year":"2023","journal-title":"Int. J. Mol. Sci."},{"key":"e_1_2_9_7_1","doi-asserted-by":"crossref","first-page":"189","DOI":"10.1186\/s12974-021-02238-4","article-title":"Interleukin\u20101 blockade attenuates white matter inflammation and oligodendrocyte loss after progressive systemic lipopolysaccharide exposure in near\u2010term fetal sheep","volume":"18","author":"Kelly S.B.","year":"2021","journal-title":"J. Neuroinflammation"},{"key":"e_1_2_9_8_1","doi-asserted-by":"crossref","first-page":"1128","DOI":"10.1111\/jcmm.13044","article-title":"Refining anti\u2010inflammatory therapy strategies for bronchopulmonary dysplasia","volume":"21","author":"Rudloff I.","year":"2017","journal-title":"J. Cell. Mol. Med."},{"key":"e_1_2_9_9_1","doi-asserted-by":"crossref","first-page":"14384","DOI":"10.1073\/pnas.1306859110","article-title":"Interleukin\u20101 receptor antagonist prevents murine bronchopulmonary dysplasia induced by perinatal inflammation and hyperoxia","volume":"110","author":"Nold M.F.","year":"2013","journal-title":"Proc. Natl. Acad. Sci. U.S.A."},{"key":"e_1_2_9_10_1","doi-asserted-by":"crossref","first-page":"448","DOI":"10.1038\/s41584-022-00797-1","article-title":"IL\u20101 and autoinflammatory disease: biology, pathogenesis and therapeutic targeting","volume":"18","author":"Broderick L.","year":"2022","journal-title":"Nat. Rev. Rheumatol."},{"key":"e_1_2_9_11_1","doi-asserted-by":"crossref","first-page":"12","DOI":"10.1186\/s41232-019-0101-5","article-title":"The role of interleukin\u20101 in general pathology","volume":"39","author":"Kaneko N.","year":"2019","journal-title":"Inflamm. Regen."},{"key":"e_1_2_9_12_1","doi-asserted-by":"crossref","first-page":"1480","DOI":"10.3389\/fimmu.2019.01480","article-title":"Interleukin\u20101 receptor antagonist protects newborn mice against pulmonary hypertension","volume":"10","author":"Bui C.B.","year":"2019","journal-title":"Front. Immunol."},{"key":"e_1_2_9_13_1","doi-asserted-by":"crossref","first-page":"371","DOI":"10.1111\/cts.12622","article-title":"Pharmacokinetics of anakinra in subjects of heavier vs. lighter body weights","volume":"12","author":"Yang B.B.","year":"2019","journal-title":"Clin. Transl. Sci."},{"key":"e_1_2_9_14_1","doi-asserted-by":"crossref","first-page":"85","DOI":"10.1016\/S0009-9236(03)00094-8","article-title":"Pharmacokinetics of anakinra in subjects with different levels of renal function","volume":"74","author":"Yang B.B.","year":"2003","journal-title":"Clin. Pharmacol. Ther."},{"key":"e_1_2_9_15_1","doi-asserted-by":"crossref","first-page":"575","DOI":"10.1002\/jps.2600840511","article-title":"Kidney as a major clearance organ for recombinant human interleukin\u2010I receptor antagonist","volume":"84","author":"Kim D.","year":"1995","journal-title":"J. Pharm. Sci."},{"key":"e_1_2_9_16_1","doi-asserted-by":"crossref","first-page":"173","DOI":"10.1016\/j.jpeds.2021.12.035","article-title":"Anakinra treatment in patients with acute Kawasaki disease with coronary artery aneurysms: a phase I\/IIa trial","volume":"243","author":"Yang J.","year":"2022","journal-title":"J. Pediatr."},{"key":"e_1_2_9_17_1","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1007\/s10928-015-9450-0","article-title":"Study design and population pharmacokinetic analysis of a phase II dose\u2010ranging study of interleukin\u20101 receptor antagonist","volume":"43","author":"Ogungbenro K.","year":"2016","journal-title":"J. Pharmacokinet. Pharmacodyn."},{"key":"e_1_2_9_18_1","doi-asserted-by":"crossref","first-page":"40","DOI":"10.1186\/2050-6511-14-40","article-title":"Anakinra pharmacokinetics in children and adolescents with systemic\u2010onset juvenile idiopathic arthritis and autoinflammatory syndromes","volume":"14","author":"Urien S.","year":"2013","journal-title":"BMC Pharmacol. Toxicol."},{"key":"e_1_2_9_19_1","doi-asserted-by":"crossref","first-page":"317","DOI":"10.1111\/j.1365-2125.2007.03026.x","article-title":"Pharmacokinetic modelling of interleukin\u20101 receptor antagonist in plasma and cerebrospinal fluid of patients following subarachnoid haemorrhage","volume":"65","author":"Gueorguieva I.","year":"2008","journal-title":"Br. J. Clin. Pharmacol."},{"key":"e_1_2_9_20_1","unstructured":"FDA.General clinical pharmacology considerations for neonatal studies for drugs and biological products<https:\/\/www.fda.gov\/media\/129532\/download>."},{"issue":"1","key":"e_1_2_9_21_1","first-page":"S141","article-title":"Considerations for drug dosing in premature infants","volume":"61","author":"Anker J.","year":"2021","journal-title":"J. Clin. Pharmacol."},{"key":"e_1_2_9_22_1","doi-asserted-by":"crossref","first-page":"2","DOI":"10.1038\/pr.2014.143","article-title":"Dosing in neonates: special considerations in physiology and trial design","volume":"77","author":"Ku L.C.","year":"2015","journal-title":"Pediatr. Res."},{"key":"e_1_2_9_23_1","doi-asserted-by":"crossref","first-page":"288","DOI":"10.1002\/cpt.166","article-title":"Neonatal drug therapy: the first frontier of therapeutics for children","volume":"98","author":"Allegaert K.","year":"2015","journal-title":"Clin. Pharmacol. 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Immunol."},{"key":"e_1_2_9_27_1","doi-asserted-by":"crossref","first-page":"293","DOI":"10.1007\/s40272-024-00679-x","article-title":"Off\u2010label use of anakinra in inflammatory conditions in neonates and infants up to 3 months of age: a case series and a review of the literature","volume":"27","author":"De Rose D.U.","year":"2025","journal-title":"Pediatr. Drugs"},{"key":"e_1_2_9_28_1","doi-asserted-by":"crossref","first-page":"303","DOI":"10.1146\/annurev.pharmtox.48.113006.094708","article-title":"Mechanism\u2010based concepts of size and maturity in pharmacokinetics","volume":"48","author":"Anderson B.J.","year":"2008","journal-title":"Annu. Rev. Pharmacol. Toxicol."},{"key":"e_1_2_9_29_1","doi-asserted-by":"crossref","first-page":"401","DOI":"10.1002\/psp4.12924","article-title":"Consistent methods for fat\u2010free mass, creatinine clearance, and glomerular filtration rate to describe renal function from neonates to adults","volume":"12","author":"O'Hanlon C.J.","year":"2023","journal-title":"CPT Pharmacometrics Syst. Pharmacol."},{"key":"e_1_2_9_30_1","doi-asserted-by":"crossref","first-page":"1066","DOI":"10.1111\/bcp.15978","article-title":"A physiological approach to renal clearance: from premature neonates to adults","volume":"90","author":"Holford N.","year":"2024","journal-title":"Br. J. Clin. Pharmacol."},{"key":"e_1_2_9_31_1","doi-asserted-by":"crossref","first-page":"695","DOI":"10.1007\/s40262-024-01372-5","article-title":"Time\u2010varying clearance in milrinone pharmacokinetics from premature neonates to adolescents","volume":"63","author":"O'Hanlon C.J.","year":"2024","journal-title":"Clin. 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