{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,30]],"date-time":"2026-06-30T15:13:06Z","timestamp":1782832386246,"version":"3.54.5"},"reference-count":45,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2020,9,22]],"date-time":"2020-09-22T00:00:00Z","timestamp":1600732800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"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":[[2021,3]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Elevated cytokine levels in inflammatory diseases are associated with downregulation of certain cytochrome P450 (CYP) enzymes. Upon treatment with some cytokine\u2010targeting therapeutic proteins, the CYP enzymes levels may be restored resulting in therapeutic protein\u2013mediated drug interactions (TP\u2010DI). These analyses characterized the worst\u2010case scenario for CYP1A2, 2C9, and 3A\u2010based TP\u2010DI potential in patients with psoriasis by comparing the pharmacokinetics of probe substrates between healthy volunteers and subjects with moderate to severe psoriasis. Data for the CYP probe substrates midazolam (CYP3A), caffeine (CYP1A2), and S\u2010warfarin (CYP2C9) from 7 drug interaction studies (1 in patients with psoriasis and 6 in healthy subjects) were pooled to develop a population pharmacokinetics model for each substrate. A 2\u2010compartment model with absorption lag time for midazolam, a 1\u2010compartment model with 5 transit absorption compartments for caffeine, and a 3\u2010compartment model with absorption lag time for S\u2010warfarin best described the observed data. Apparent oral clearance and relative bioavailability for caffeine and S\u2010warfarin were not significantly different between the subject populations. Psoriasis patients were estimated to have 17% lower midazolam oral bioavailability than healthy volunteers. Compounded with other covariate effects, the ratio of median post hoc area under the plasma concentration\u2013time estimates in subjects with psoriasis relative to healthy subjects was 0.96, 1.13, and 0.65 for midazolam, caffeine, and S\u2010warfarin, respectively. Therefore, inflammation in psoriasis had no relevant effect on reducing CYP1A2, 2C9, and 3A activities in vivo and no significant TP\u2010DIs mediated through these enzymes are expected in patients with psoriasis. This approach can potentially be used in lieu of dedicated TP\u2010DI studies to identify TP\u2010DI risks within a disease area.<\/jats:p>","DOI":"10.1002\/jcph.1744","type":"journal-article","created":{"date-parts":[[2020,9,23]],"date-time":"2020-09-23T00:44:42Z","timestamp":1600821882000},"page":"307-318","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":8,"title":["Therapeutic Protein Drug Interaction Potential in Subjects With Psoriasis: An Assessment Based on Population Pharmacokinetic Analyses of Sensitive Cytochrome P450 Probe Substrates"],"prefix":"10.1002","volume":"61","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7348-4208","authenticated-orcid":false,"given":"Abhishek G.","family":"Sathe","sequence":"first","affiliation":[{"name":"Clinical Pharmacology and Pharmacometrics, Abbvie  North Chicago Illinois USA"},{"name":"Department of Experimental and Clinical Pharmacology, College of Pharmacy University of Minnesota  Twin Cities Minnesota 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  North Chicago Illinois USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0959-2025","authenticated-orcid":false,"given":"Mohamed\u2010Eslam F.","family":"Mohamed","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology and Pharmacometrics, Abbvie  North Chicago Illinois USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2020,9,22]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1155\/MI.2005.273"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1038\/nri2094"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cyto.2015.10.008"},{"issue":"4","key":"e_1_2_9_5_1","first-page":"707","article-title":"Cytokines down\u2010regulate expression of major cytochrome P\u2010450 enzymes in adult human hepatocytes in primary culture","volume":"44","author":"Abdel\u2010Razzak Z","year":"1993","journal-title":"Mol Pharmacol"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1002\/hep.1840220420"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.1124\/dmd.32.3.359"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.1002\/1520-6017(200105)90:5<638::AID-JPS1020>3.0.CO;2-L"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.1124\/dmd.111.038679"},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40262-016-0462-8"},{"key":"e_1_2_9_11_1","doi-asserted-by":"publisher","DOI":"10.1038\/clpt.2011.35"},{"key":"e_1_2_9_12_1","doi-asserted-by":"publisher","DOI":"10.1002\/jcph.1093"},{"key":"e_1_2_9_13_1","doi-asserted-by":"publisher","DOI":"10.1080\/17425255.2016.1211109"},{"key":"e_1_2_9_14_1","article-title":"Drug\u2010drug interaction assessment for therapeutic proteins","journal-title":"Guidance for Industry"},{"key":"e_1_2_9_15_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40262-018-0730-x"},{"key":"e_1_2_9_16_1","doi-asserted-by":"publisher","DOI":"10.1111\/bcp.12936"},{"key":"e_1_2_9_17_1","unstructured":"Eli Lilly and Company. A study of mirikizumab in participants with plaque psoriasis [ClinicalTrials.gov identifier NCT03718884].https:\/\/www.clinicaltrials.gov. Published 2018\u20132019. Accessed February 29 2020."},{"key":"e_1_2_9_18_1","unstructured":"Eli Lilly and Company. A study of ixekizumab in participants with plaque psoriasis [ClinicalTrials.gov identifier NCT02993471]https:\/\/www.clinicaltrials.gov. Published 2016\u20132019. Accessed February 29 2020."},{"key":"e_1_2_9_19_1","unstructured":"Abbott. Open label single dose non\u2010randomized study to assess the drug drug interaction of briakinumab on CYP substrates [ClinicalTrials.gov identifier NCT01260844].https:\/\/www.clinicaltrials.gov. Published 2010\u20132011. Accessed February 29 2020."},{"key":"e_1_2_9_20_1","unstructured":"Janssen Research and Development LLC. 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