{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,25]],"date-time":"2026-08-25T00:25:16Z","timestamp":1787617516917,"version":"build-2736575974"},"reference-count":16,"publisher":"Wiley","issue":"12","license":[{"start":{"date-parts":[[2019,6,30]],"date-time":"2019-06-30T00:00:00Z","timestamp":1561852800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100001003","name":"Boehringer Ingelheim","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100001003","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100006483","name":"AbbVie","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100006483","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["accp1.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["The Journal of Clinical Pharma"],"published-print":{"date-parts":[[2019,12]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>Risankizumab, a humanized monoclonal antibody that targets interleukin\u201023 p19 subunit, was developed for the treatment of psoriasis. This work characterizes risankizumab pharmacokinetics in Japanese and Chinese healthy subjects compared with white healthy subjects and in Japanese patients with moderate to severe plaque psoriasis, generalized pustular psoriasis, or erythrodermic psoriasis. A phase 1, single\u2010dose study evaluated risankizumab pharmacokinetics and safety\/tolerability in healthy white (18 and 300\u00a0mg subcutaneous [SC]), Japanese (18, 90, and 300\u00a0mg SC and 200, 600, and 1200\u00a0mg intravenous [IV]), and Chinese (18, 90, and 300\u00a0mg SC) subjects; pharmacokinetic data were analyzed using noncompartmental methods. Risankizumab pharmacokinetic data from phase 2\/3 studies in Japanese patients with plaque psoriasis, generalized pustular psoriasis, or erythrodermic psoriasis following multiple SC doses of 75\u00a0mg or 150\u00a0mg were analyzed using a population pharmacokinetic approach along with data from the phase 1 and global phase 1 to 3 studies. Risankizumab plasma exposures (peak plasma concentration and area under the concentration\u2010time curve) were approximately dose\u2010proportional across 18\u2010 to 300\u2010mg SC or 200\u2010 to 1200\u2010mg IV doses. Risankizumab terminal elimination half\u2010life (harmonic mean 27\u201334 days) was comparable across doses and ethnicities. Risankizumab exposures were approximately 20% to 30% higher in Japanese and Chinese healthy subjects compared with white healthy subjects or in Japanese patients compared with non\u2010Japanese patients. After accounting for body\u2010weight differences, risankizumab exposures were comparable across ethnicities. Overall, there was no ethnic impact on risankizumab pharmacokinetics, and the small difference in exposure due to body weight has no clinical relevance.<\/jats:p>","DOI":"10.1002\/jcph.1473","type":"journal-article","created":{"date-parts":[[2019,7,1]],"date-time":"2019-07-01T02:28:18Z","timestamp":1561948098000},"page":"1656-1668","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":32,"title":["Pharmacokinetics of Risankizumab in Asian Healthy Subjects and Patients With Moderate to Severe Plaque Psoriasis, Generalized Pustular Psoriasis, and Erythrodermic Psoriasis"],"prefix":"10.1002","volume":"59","author":[{"given":"Amit","family":"Khatri","sequence":"first","affiliation":[{"name":"Clinical Pharmacology and Pharmacometrics, AbbVie Inc.  North Chicago IL USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Doerthe","family":"Eckert","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology and Pharmacometrics AbbVie Deutschland GmbH &amp; Co KG  Ludwigshafen am Rhein Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rajneet","family":"Oberoi","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology and Pharmacometrics, AbbVie Inc.  North Chicago IL USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ahmed","family":"Suleiman","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology and Pharmacometrics AbbVie Deutschland GmbH &amp; Co KG  Ludwigshafen am Rhein Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yinuo","family":"Pang","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology and Pharmacometrics, AbbVie Inc.  North Chicago IL USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ling","family":"Cheng","sequence":"additional","affiliation":[{"name":"Discovery and Exploratory Statistics, AbbVie Inc  North Chicago IL USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4937-2775","authenticated-orcid":false,"given":"Ahmed A.","family":"Othman","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology and Pharmacometrics, AbbVie Inc.  North Chicago IL USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2019,6,30]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1007\/s12016-018-8668-1"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/jdv.14949"},{"key":"e_1_2_10_4_1","first-page":"93","article-title":"Erythrodermic psoriasis: pathophysiology and current treatment perspectives","volume":"6","author":"Singh RK","year":"2016","journal-title":"Psoriasis (Auckl)"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1038\/nri3707"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1080\/19420862.2015.1032491"},{"key":"e_1_2_10_7_1","unstructured":"AbbVie.Press release: Risankizumab Meets All Co\u2010Primary and Ranked Secondary Endpoints Achieving Significantly Greater Efficacy Versus Standard Biologic Therapies in Three Pivotal Phase 3 Psoriasis Studies.https:\/\/news.abbvie.com\/news\/risankizumab-meets-all-co-primary-and-ranked-secondary-endpoints-achieving-significantly-greater-efficacy-versus-standard-biologic-therapies-in-three-pivotal-phase-3-psoriasis-studies.htm. Accessed June 4 2018."},{"key":"e_1_2_10_8_1","unstructured":"AbbVie.Press release: Risankizumab Meets All Primary Endpoints Reporting Positive Results in Fourth Pivotal Phase 3 Psoriasis Study.https:\/\/news.abbvie.com\/news\/risankizumab-meets-all-primary-endpoints-reporting-positive-results-in-fourth-pivotal-phase-3-psoriasis-study.htm. Accessed June 4 2018."},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(18)31713-6"},{"key":"e_1_2_10_10_1","article-title":"Efficacy and safety of risankizumab in Japanese patients with moderate to severe plaque psoriasis: results from the SustaIMM phase 2\/3 trial","author":"Ohtsuki M","journal-title":"J Dermatol"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40262-018-0704-z"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1607017"},{"key":"e_1_2_10_13_1","article-title":"Population pharmacokinetics of risankizumab in healthy volunteers and subjects with moderate to severe plaque psoriasis: integrated analyses of phase I\u2010III clinical trials","author":"Suleiman AA","year":"2019","journal-title":"Clin Pharmacokinet"},{"key":"e_1_2_10_14_1","doi-asserted-by":"publisher","DOI":"10.2165\/11530560-000000000-00000"},{"key":"e_1_2_10_15_1","doi-asserted-by":"publisher","DOI":"10.2165\/11531280-000000000-00000"},{"key":"e_1_2_10_16_1","doi-asserted-by":"publisher","DOI":"10.1002\/jcph.231"},{"key":"e_1_2_10_17_1","unstructured":"KhatriA Suleiman AA Polepally AR Othman AA.Exposure\u2010 response relationships for efficacy and safety of risankizumab in patients with moderate to severe plaque psoriasis: integrated analyses of phase 2 and 3 clinical trials. American Academy of Dermatology Annual Meeting March 1\u20105 2019; Washington DC."}],"container-title":["The Journal of Clinical Pharmacology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1002%2Fjcph.1473","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/jcph.1473","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/jcph.1473","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/jcph.1473","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,8]],"date-time":"2023-09-08T16:05:42Z","timestamp":1694189142000},"score":1,"resource":{"primary":{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/10.1002\/jcph.1473"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2019,6,30]]},"references-count":16,"journal-issue":{"issue":"12","published-print":{"date-parts":[[2019,12]]}},"alternative-id":["10.1002\/jcph.1473"],"URL":"https:\/\/doi.org\/10.1002\/jcph.1473","archive":["Portico"],"relation":{},"ISSN":["0091-2700","1552-4604"],"issn-type":[{"value":"0091-2700","type":"print"},{"value":"1552-4604","type":"electronic"}],"subject":[],"published":{"date-parts":[[2019,6,30]]},"assertion":[{"value":"2019-04-03","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2019-06-04","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2019-06-30","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}