{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,30]],"date-time":"2026-07-30T23:56:36Z","timestamp":1785455796771,"version":"3.56.0"},"reference-count":23,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2019,12,16]],"date-time":"2019-12-16T00:00:00Z","timestamp":1576454400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"name":"Kyowa Kirin Pharmaceutical Development, Inc., Princeton, New Jersey"}],"content-domain":{"domain":["accp1.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["The Journal of Clinical Pharma"],"published-print":{"date-parts":[[2020,1]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Cutaneous T\u2010cell lymphoma (CTCL) and adult T\u2010cell leukemia\/lymphoma (ATL) are rare non\u2010Hodgkin lymphomas commonly expressing C\u2010C chemokine receptor 4 (CCR4). Mogamulizumab is a humanized monoclonal antibody against CCR4 approved in the United States for the treatment of patients with relapsed\/refractory mycosis fungoides or S\u00e9zary syndrome, the most common forms of CTCL. Pharmacokinetic (PK) and clinical study data from 444 adult patients with ATL or CTCL collected during 6 clinical trials of mogamulizumab were used to construct a population PK model, which was best described by a 2\u2010compartment model with linear clearance. Albumin, aspartate aminotransferase, mild\u2010to\u2010moderate hepatic impairment, and sex were statistically significant predictors of clearance; albumin was also a statistically significant predictor of peripheral volume of distribution; and body surface area was a statistically significant predictor for central volume of distribution. None of the other covariates\u2014for example, age, body weight, body mass index, bilirubin, creatinine clearance, disease type (ATL and CTCL), ATL subtype (acute, lymphoma, and chronic), CTCL subtype (mycosis fungoides and S\u00e9zary syndrome), CCR4 expression (status or degree), race (Japanese and non\u2010Japanese), renal impairment (normal, mild, moderate, and severe), or performance status\u2014had a statistically significant impact. Performance of the final population PK model was acceptable. This model will be valuable for guiding further studies of mogamulizumab.<\/jats:p>","DOI":"10.1002\/jcph.1564","type":"journal-article","created":{"date-parts":[[2019,12,16]],"date-time":"2019-12-16T11:33:18Z","timestamp":1576495998000},"page":"58-66","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["Population Pharmacokinetic Modeling of Mogamulizumab in Adults With Cutaneous T\u2010Cell Lymphoma or Adult T\u2010Cell Lymphoma"],"prefix":"10.1002","volume":"60","author":[{"given":"Mayumi","family":"Mukai","sequence":"first","affiliation":[{"name":"Kyowa Kirin Pharmaceutical Development, Inc.  Princeton New Jersey USA"},{"name":"Kyowa Kirin Co., Ltd.  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hiroshi","family":"Maeda","sequence":"additional","affiliation":[{"name":"Kyowa Kirin Co., Ltd.  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kazuya","family":"Narushima","sequence":"additional","affiliation":[{"name":"Kyowa Kirin Co., Ltd.  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Diane R.","family":"Mould","sequence":"additional","affiliation":[{"name":"Projections Research Inc.  Phoenixville Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Douglas","family":"Greene","sequence":"additional","affiliation":[{"name":"Kyowa Kirin Pharmaceutical Development, Inc.  Princeton New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2019,12,16]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2016-01-643569"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2007-03-055749"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1523-1747.2002.19610.x"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood.V99.5.1505"},{"key":"e_1_2_10_6_1","first-page":"3625","article-title":"Clinical significance of CCR4 expression in adult T\u2010cell leukemia\/lymphoma: its close association with skin involvement and unfavorable outcome","volume":"9","author":"Ishida T","year":"2003","journal-title":"Clin Cancer Res"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1158\/1078-0432.CCR-04-0371"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1158\/1078-0432.CCR-09-2697"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2009.25.3575"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2011.37.3472"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1111\/bjh.13338"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2013.52.0924"},{"key":"e_1_2_10_13_1","first-page":"993","article-title":"Mogamulizumab versus investigator choice of chemotherapy regimen in relapsed\/refractory adult T\u2010cell leukemia\/lymphoma","volume":"104","author":"Phillips AA","year":"2019","journal-title":"Blood"},{"key":"e_1_2_10_14_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(18)30379-6"},{"key":"e_1_2_10_15_1","doi-asserted-by":"publisher","DOI":"10.1007\/BF02353487"},{"key":"e_1_2_10_16_1","first-page":"225","volume-title":"Primer of Applied Regression and Analysis of Variance","author":"Glantz SA","year":"1990"},{"key":"e_1_2_10_17_1","doi-asserted-by":"publisher","DOI":"10.1038\/sj.clpt.6100241"},{"key":"e_1_2_10_18_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10928-009-9143-7"},{"key":"e_1_2_10_19_1","doi-asserted-by":"publisher","DOI":"10.1007\/BF01060893"},{"key":"e_1_2_10_20_1","doi-asserted-by":"publisher","DOI":"10.1023\/A:1012299115260"},{"key":"e_1_2_10_21_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1365-2125.2000.00231.x"},{"key":"e_1_2_10_22_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10928-007-9081-1"},{"key":"e_1_2_10_23_1","doi-asserted-by":"publisher","DOI":"10.1002\/(SICI)1097-0258(19990315)18:5<581::AID-SIM47>3.0.CO;2-1"},{"key":"e_1_2_10_24_1","first-page":"60","article-title":"Exposure\u2010response analysis for mogamulizumab in adults with cutaneous T\u2010cell lymphoma","author":"Mukai M","year":"2019","journal-title":"J Clin Pharmacol"}],"container-title":["The Journal of Clinical Pharmacology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1002%2Fjcph.1564","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/jcph.1564","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/jcph.1564","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/jcph.1564","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,9]],"date-time":"2023-09-09T10:18:31Z","timestamp":1694254711000},"score":1,"resource":{"primary":{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/10.1002\/jcph.1564"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2019,12,16]]},"references-count":23,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2020,1]]}},"alternative-id":["10.1002\/jcph.1564"],"URL":"https:\/\/doi.org\/10.1002\/jcph.1564","archive":["Portico"],"relation":{},"ISSN":["0091-2700","1552-4604"],"issn-type":[{"value":"0091-2700","type":"print"},{"value":"1552-4604","type":"electronic"}],"subject":[],"published":{"date-parts":[[2019,12,16]]},"assertion":[{"value":"2019-08-20","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2019-11-08","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2019-12-16","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}