{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,7]],"date-time":"2026-06-07T12:46:35Z","timestamp":1780836395281,"version":"3.54.1"},"reference-count":34,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2018,12,11]],"date-time":"2018-12-11T00:00:00Z","timestamp":1544486400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["accp1.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["The Journal of Clinical Pharma"],"published-print":{"date-parts":[[2019,4]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Population pharmacokinetics (PK) and exposure\u2010response (E\u2010R) analyses were conducted to compare the PK and E\u2010R relationships of golimumab between children and adults with ulcerative colitis. PK data following subcutaneous golimumab administration to children with ulcerative colitis (6\u201017\u00a0years) in the PURSUIT\u2010PEDS\u2010PK study, adults with ulcerative colitis in the PURSUIT study, and children with pediatric polyarticular juvenile idiopathic arthritis (2\u201017\u00a0years) in the GO\u2010KIDS study, were included in the population PK analysis. E\u2010R analysis was conducted using logistic regression to link serum golimumab concentration and Mayo score\u2013based efficacy outcomes in pediatric and adult ulcerative colitis. Golimumab PK was adequately described by a 1\u2010compartment model with first\u2010order absorption and elimination. Golimumab apparent clearance and volume of distribution increased with body weight. Golimumab apparent clearance was higher in patients with lower serum albumin, no methotrexate use, and positive antibodies to golimumab; age was not an influential factor after accounting for body weight. Model\u2010estimated terminal half\u2010life (9.2 days in children; 9.5 days in adults) and other PK parameters suggest that golimumab PK properties are generally comparable between children and adults with ulcerative colitis. Simulations suggest that a higher induction dose than that tested in PURSUIT\u2010PEDS\u2010PK may be needed for children \u226445\u00a0kg to achieve exposures comparable to adults. Comparable E\u2010R relationships between children and adults with ulcerative colitis were observed, although children appeared to be more responsive for the more stringent remission end point. The overall comparable PK and E\u2010R relationships between children and adults support the extrapolation of golimumab efficacy from the adult to the pediatric ulcerative colitis population.<\/jats:p>","DOI":"10.1002\/jcph.1353","type":"journal-article","created":{"date-parts":[[2018,12,11]],"date-time":"2018-12-11T16:46:04Z","timestamp":1544546764000},"page":"590-604","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":24,"title":["Population Pharmacokinetics and Exposure\u2010Response Modeling Analyses of Golimumab in Children With Moderately to Severely Active Ulcerative Colitis"],"prefix":"10.1002","volume":"59","author":[{"given":"Yan","family":"Xu","sequence":"first","affiliation":[{"name":"Global Clinical Pharmacology Janssen Research &amp; Development, LLC  Spring House PA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Omoniyi J.","family":"Adedokun","sequence":"additional","affiliation":[{"name":"Global Clinical Pharmacology Janssen Research &amp; Development, LLC  Spring House PA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daphne","family":"Chan","sequence":"additional","affiliation":[{"name":"Immunology Clinical Development Janssen Research &amp; Development, LLC  Spring House PA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chuanpu","family":"Hu","sequence":"additional","affiliation":[{"name":"Global Clinical Pharmacology Janssen Research &amp; Development, LLC  Spring House PA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zhenhua","family":"Xu","sequence":"additional","affiliation":[{"name":"Global Clinical Pharmacology Janssen Research &amp; Development, LLC  Spring House PA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Richard S.","family":"Strauss","sequence":"additional","affiliation":[{"name":"Immunology Clinical Development Janssen Research &amp; Development, LLC  Spring House PA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeffrey S.","family":"Hyams","sequence":"additional","affiliation":[{"name":"Department of Pediatrics University of Connecticut School of Medicine and Division of Digestive Diseases, Hepatology and Nutrition, Connecticut Children's Medical Center  Hartford CT USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dan","family":"Turner","sequence":"additional","affiliation":[{"name":"Juliet Keidan Institute of Pediatric Gastroenterology Shaare Zedek Medical Center The Hebrew University of Jerusalem  Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Honghui","family":"Zhou","sequence":"additional","affiliation":[{"name":"Global Clinical Pharmacology Janssen Research &amp; Development, LLC  Spring House PA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2018,12,11]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(16)32126-2"},{"key":"e_1_2_10_3_1","doi-asserted-by":"crossref","first-page":"684","DOI":"10.1097\/MPG.0000000000000322","article-title":"Steps toward harmonization for clinical development of medicines in pediatric ulcerative colitis\u2014a global scientific discussion, part 2: data extrapolation, trial design, and pharmacokinetics","volume":"58","author":"Sun H","year":"2014","journal-title":"J\u00a0Pediatr Gastroenterol Nutr"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cgh.2006.04.008"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1038\/ajg.2011.67"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1097\/MPG.0b013e31826ac41a"},{"key":"e_1_2_10_7_1","first-page":"CD000478","article-title":"Azathioprine and 6\u2010mercaptopurine for maintenance of remission in ulcerative colitis","volume":"5","author":"Timmer A","year":"2016","journal-title":"Cochrane Database Syst Rev"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1097\/01.MIB.0000435438.84365.f7"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.crohns.2013.10.006"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1038\/nrgastro.2013.158"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1080\/1744666X.2016.1177459"},{"key":"e_1_2_10_12_1","unstructured":"Golimumab US Package Insert.https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2018\/125289s139lbl.pdfAccessed September 25 2018."},{"key":"e_1_2_10_13_1","doi-asserted-by":"publisher","DOI":"10.1097\/MIB.0000000000001262"},{"key":"e_1_2_10_14_1","doi-asserted-by":"publisher","DOI":"10.1002\/jcph.744"},{"key":"e_1_2_10_15_1","unstructured":"US Food and Drug Administration (USFDA).General clinical pharmacology considerations for pediatric studies for drugs and biological products guidance for industry. 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