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Population pharmacokinetic (PK) models were developed in a phase 3 trial to characterize PK in pediatric patients with JIA and identify weight\u2010based dosing regimens. The phase 3, randomized, double\u2010blind, placebo\u2010controlled withdrawal, efficacy and safety trial, JUVE\u2010BASIS, enrolled patients (aged 2 to &lt;18\u2009years) with polyarticular course JIA. During a safety\/PK period, baricitinib concentration data from age\u2010based dose cohorts were compared to concentrations from adult patients receiving 4\u2010mg QD. PK data were used to develop a population PK model with allometric scaling to determine a weight\u2010based posology in pediatric patients with JIA that matched the adult 4\u2010mg exposure. Baricitinib plasma concentrations from 217 pediatric patients were used to characterize PK. Based on the adult model, pediatric PK was best described using a 2\u2010compartment model with allometric scaling on clearance and volume of distribution and renal function (estimated with glomerular filtration rate [GFR], a known covariate affecting PK of baricitinib) on clearance. The PK modeling suggested the optimal dosing regimen based on weight for pediatric patients as: 2\u2010mg QD for patients 10 to &lt;30\u2009kg and 4\u2010mg QD for patients \u226530\u2009kg. The use of a population PK model of baricitinib treatment in adult patients with RA, with the addition of allometric scaling for weight on clearance and volume terms, was useful to predict exposures and identify weight\u2010based dosing in pediatric patients with JIA.<\/jats:p>","DOI":"10.1002\/psp4.13131","type":"journal-article","created":{"date-parts":[[2024,3,27]],"date-time":"2024-03-27T04:40:22Z","timestamp":1711514422000},"page":"970-981","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":10,"title":["A population pharmacokinetic model using allometric scaling for baricitinib in patients with juvenile idiopathic arthritis"],"prefix":"10.1002","volume":"13","author":[{"given":"Rodney L.","family":"Decker","sequence":"first","affiliation":[{"name":"Eli Lilly and Company  Indianapolis Indiana USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"suffix":"II","given":"C.","family":"Steven Ernest","sequence":"additional","affiliation":[{"name":"Metrum Research Group  Tariffville Connecticut USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David B.","family":"Radtke","sequence":"additional","affiliation":[{"name":"Eli Lilly and Company  Indianapolis Indiana USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rona","family":"Wang","sequence":"additional","affiliation":[{"name":"Eli Lilly and Company  Indianapolis Indiana USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joana","family":"Ara\u00fajo","sequence":"additional","affiliation":[{"name":"Eli Lilly and Company  Indianapolis Indiana USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0890-1562","authenticated-orcid":false,"given":"Stuart Y.","family":"Keller","sequence":"additional","affiliation":[{"name":"Eli Lilly and Company  Indianapolis Indiana USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xin","family":"Zhang","sequence":"additional","affiliation":[{"name":"Eli Lilly and Company  Indianapolis Indiana USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2024,3,26]]},"reference":[{"key":"e_1_2_11_2_1","doi-asserted-by":"publisher","DOI":"10.4049\/jimmunol.0902819"},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41572-021-00332-8"},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(07)60363-8"},{"key":"e_1_2_11_5_1","doi-asserted-by":"publisher","DOI":"10.1093\/rheumatology\/kep125"},{"key":"e_1_2_11_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(11)60244-4"},{"key":"e_1_2_11_7_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1608345"},{"key":"e_1_2_11_8_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1507247"},{"key":"e_1_2_11_9_1","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2016-210094"},{"key":"e_1_2_11_10_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.39953"},{"key":"e_1_2_11_11_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40265-018-0908-4"},{"key":"e_1_2_11_12_1","doi-asserted-by":"publisher","DOI":"10.1002\/psp4.12251"},{"key":"e_1_2_11_13_1","doi-asserted-by":"publisher","DOI":"10.3390\/jcm12134527"},{"key":"e_1_2_11_14_1","doi-asserted-by":"publisher","DOI":"10.1542\/peds.2004-1133"},{"key":"e_1_2_11_15_1","doi-asserted-by":"publisher","DOI":"10.1002\/jcph.354"},{"key":"e_1_2_11_16_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(23)00921-2"},{"key":"e_1_2_11_17_1","unstructured":"European Commission Public Health \u2013 Union of Register of medicinal products.https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/olumiant. 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