{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,16]],"date-time":"2026-09-16T17:02:44Z","timestamp":1789578164950,"version":"build-2803163510"},"reference-count":26,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2025,7,24]],"date-time":"2025-07-24T00:00:00Z","timestamp":1753315200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2025,7,24]],"date-time":"2025-07-24T00:00:00Z","timestamp":1753315200000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"funder":[{"DOI":"10.13039\/100015502","name":"Dialysis Clinics","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100015502","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Transplantation"],"published-print":{"date-parts":[[2025,8]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>Belatacept (BELA) pharmacokinetic (PK) studies informed dosing strategies used in phase 3 studies, where fixed mg\/kg dosing compared a less intensive (LI) and more intensive (MI) regimen. The LI regimen was preferred due to a better risk\/benefit profile. We compared PK parameters observed in the BELA Early Steroid Withdrawal Trial (BEST) with previous reports. BELA trough samples were analyzed using a validated quantitative enzyme\u2010linked immunoassay. Clearance (CL) was estimated with Bayesian estimation using a published BELA population PK model. Significantly higher CL was observed in subjects &lt;60 years old and African American (AA) patients, leading to decreased BELA exposure. No differences in allometrically scaled CL were observed by BMI or sex; however, overall BELA exposure was greater in males. There were no differences in exposure in subjects with rejection; however, subjects with infection had significantly higher exposure. BELA PK was not different between alemtuzumab and rabbit\u2010antithymocyte globulin induction groups without steroids, but overall drug exposure was higher than previously reported in trials co\u2010administering with basiliximab and steroids. Future studies to optimize BELA dosing strategies are warranted as BELA exposure in this analysis exceeded Phase 3 target thresholds.<\/jats:p>\n                  <jats:p>\n                    <jats:bold>Trial Registration<\/jats:bold>\n                    : ClinicalTrials.gov identifier: NCT 01729494\n                  <\/jats:p>","DOI":"10.1111\/ctr.70172","type":"journal-article","created":{"date-parts":[[2025,7,24]],"date-time":"2025-07-24T10:35:50Z","timestamp":1753353350000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Belatacept Pharmacokinetic Analysis of Belatacept Early Steroid Withdrawal Trial (BEST) to Clinical Outcomes and Compared With Reported BENEFIT and BENEFIT\u2010EXT Pharmacokinetic Analysis"],"prefix":"10.1111","volume":"39","author":[{"ORCID":"https:\/\/orcid.org\/0009-0001-6523-5690","authenticated-orcid":false,"given":"Alexandra","family":"Pyatt","sequence":"first","affiliation":[{"name":"U Cincinnati  Cincinnati Ohio USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Melissa","family":"McGowan","sequence":"additional","affiliation":[{"name":"U Cincinnati  Cincinnati Ohio USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8452-7971","authenticated-orcid":false,"given":"Ryota","family":"Tanaka","sequence":"additional","affiliation":[{"name":"Division of Translational and Clinical Pharmacology Cincinnati Children's Hospital Medical Center  Cincinnati Ohio USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bradley","family":"Miyagawa","sequence":"additional","affiliation":[{"name":"Division of Translational and Clinical Pharmacology Cincinnati Children's Hospital Medical Center  Cincinnati Ohio USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8471-9826","authenticated-orcid":false,"given":"Tomoyuki","family":"Mizuno","sequence":"additional","affiliation":[{"name":"Division of Translational and Clinical Pharmacology Cincinnati Children's Hospital Medical Center  Cincinnati Ohio USA"},{"name":"Department of Pediatrics University of Cincinnati College of Medicine  Cincinnati Ohio USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1298-4150","authenticated-orcid":false,"given":"Adele Rike","family":"Shields","sequence":"additional","affiliation":[{"name":"U Cincinnati  Cincinnati Ohio USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Annette","family":"Christianson","sequence":"additional","affiliation":[{"name":"U Cincinnati  Cincinnati Ohio USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8288-5732","authenticated-orcid":false,"given":"Patricia","family":"West\u2010Thielke","sequence":"additional","affiliation":[{"name":"UIC  Chicago Illinois USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1575-748X","authenticated-orcid":false,"given":"John P.","family":"Leone","sequence":"additional","affiliation":[{"name":"Tampa General  Tampa Florida USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4280-0842","authenticated-orcid":false,"given":"E. Steve","family":"Woodle","sequence":"additional","affiliation":[{"name":"U Cincinnati  Cincinnati Ohio USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3615-0994","authenticated-orcid":false,"given":"Dixon","family":"Kaufman","sequence":"additional","affiliation":[{"name":"U Wisconsin  Madison Wisconsin USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2348-2359","authenticated-orcid":false,"given":"Alexander","family":"Wiseman","sequence":"additional","affiliation":[{"name":"AdventHealth Transplant Institute  Denver Colorado USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9957-639X","authenticated-orcid":false,"given":"Arthur J.","family":"Matas","sequence":"additional","affiliation":[{"name":"U Minnesota  Minneapolis Minnesota USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4224-2967","authenticated-orcid":false,"given":"Alexander A.","family":"Vinks","sequence":"additional","affiliation":[{"name":"Division of Translational and Clinical Pharmacology Cincinnati Children's Hospital Medical Center  Cincinnati Ohio USA"},{"name":"Department of Pediatrics University of Cincinnati College of Medicine  Cincinnati Ohio USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4835-9197","authenticated-orcid":false,"given":"Rita R.","family":"Alloway","sequence":"additional","affiliation":[{"name":"U Cincinnati  Cincinnati Ohio USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,7,24]]},"reference":[{"key":"e_1_2_11_2_1","unstructured":"X.Valencia An Open\u2010Label Pharmacokinetic Study in De Novo Renal Transplant Subjects Receiving a Belatacept\u2010Based Immunosuppressant Regimen(Bristol\u2010Myers Squibb 2009)."},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.1097\/TP.0b013e3181ff87cd"},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1600-6143.2009.03005.x"},{"key":"e_1_2_11_5_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1600-6143.2010.03016.x"},{"key":"e_1_2_11_6_1","doi-asserted-by":"publisher","DOI":"10.1038\/clpt.2012.84"},{"key":"e_1_2_11_7_1","unstructured":"Application Number: 125288Orig1s000.2011. Accessed September 9 2019 athttps:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/nda\/2011\/125288Orig1s000ClinPharmR.pdf). p.^pp."},{"key":"e_1_2_11_8_1","doi-asserted-by":"publisher","DOI":"10.1111\/ajt.15688"},{"key":"e_1_2_11_9_1","doi-asserted-by":"publisher","DOI":"10.2215\/CJN.13100820"},{"key":"e_1_2_11_10_1","unstructured":"Nulojix Package Insert(Bristol\u2010Myers Squibb Pharmaceuticals 2014)."},{"issue":"3","key":"e_1_2_11_11_1","article-title":"Belatacept Removal by Plasmapheresis: Kinetics, Dose Adjustments and Clinical Recommendations [Abstract]","volume":"20","author":"Tremblay S. W. N.","year":"2020","journal-title":"American Journal of Transplantation"},{"key":"e_1_2_11_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.kint.2023.06.021"},{"key":"e_1_2_11_13_1","doi-asserted-by":"publisher","DOI":"10.1111\/petr.12559"},{"key":"e_1_2_11_14_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.transproceed.2018.08.016"},{"key":"e_1_2_11_15_1","doi-asserted-by":"publisher","DOI":"10.3389\/fimmu.2022.1037566"},{"key":"e_1_2_11_16_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41598-022-20636-3"},{"key":"e_1_2_11_17_1","doi-asserted-by":"publisher","DOI":"10.1111\/bcp.14876"},{"key":"e_1_2_11_18_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40261-013-0153-2"},{"key":"e_1_2_11_19_1","doi-asserted-by":"publisher","DOI":"10.1111\/ajt.16538"},{"key":"e_1_2_11_20_1","doi-asserted-by":"publisher","DOI":"10.3389\/fimmu.2022.871372"},{"key":"e_1_2_11_21_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40262-020-00874-2"},{"key":"e_1_2_11_22_1","first-page":"69","article-title":"Pharmacogenetics of Anticancer Monoclonal Antibodies","volume":"2","author":"Shek D.","year":"2019","journal-title":"Cancer Drug Resistance"},{"key":"e_1_2_11_23_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ajt.2024.02.015"},{"key":"e_1_2_11_24_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12874-017-0363-z"},{"key":"e_1_2_11_25_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpt.28"},{"key":"e_1_2_11_26_1","doi-asserted-by":"publisher","DOI":"10.1111\/ajt.14452"},{"key":"e_1_2_11_27_1","doi-asserted-by":"publisher","DOI":"10.1097\/FTD.0000000000000179"}],"container-title":["Clinical Transplantation"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/ctr.70172","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/ctr.70172","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/ctr.70172","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,9,16]],"date-time":"2026-09-16T16:13:10Z","timestamp":1789575190000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/ctr.70172"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,7,24]]},"references-count":26,"journal-issue":{"issue":"8","published-print":{"date-parts":[[2025,8]]}},"alternative-id":["10.1111\/ctr.70172"],"URL":"https:\/\/doi.org\/10.1111\/ctr.70172","archive":["Portico"],"relation":{},"ISSN":["0902-0063","1399-0012"],"issn-type":[{"value":"0902-0063","type":"print"},{"value":"1399-0012","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,7,24]]},"assertion":[{"value":"2024-08-28","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-04-20","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-07-24","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e70172"}}