{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2024,4,22]],"date-time":"2024-04-22T11:49:30Z","timestamp":1713786570175},"reference-count":18,"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"}],"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>Mogamulizumab is a humanized monoclonal antibody against C\u2010C chemokine receptor 4 approved in the United States for the treatment of patients with relapsed\/refractory mycosis fungoides or S\u00e9zary syndrome, the most common forms of cutaneous T\u2010cell lymphoma (CTCL). The exposure\u2010response relationships for efficacy (progression\u2010free survival [PFS] and overall response rate [ORR]) and safety (the 5 most common treatment\u2010related adverse events by <jats:italic>Medical Dictionary for Regulatory Activities<\/jats:italic> [<jats:italic>MedDRA<\/jats:italic>] System Organ Class) for 184 patients with CTCL treated with mogamulizumab in a large, registrational clinical trial. Exposure metrics were area under the serum mogamulizumab concentration\u2010time curve over the dose interval at steady state (AUC<jats:sub>ss<\/jats:sub>) and minimum serum mogamulizumab concentration after the first dose (C<jats:sub>min,1st<\/jats:sub>). PFS by investigator assessment, the primary efficacy objective, and PFS and ORR by independent review were not correlated with exposure metrics; however, there was a statistically significant positive relationship between a secondary objective, ORR by investigator assessment, and AUC<jats:sub>ss<\/jats:sub> (<jats:italic>P<\/jats:italic> = .0168). The frequency of treatment\u2010related adverse events was not related to exposure metrics (C<jats:sub>min,1st<\/jats:sub> or AUC<jats:sub>ss<\/jats:sub>) for any of the <jats:italic>MedDRA<\/jats:italic> System Organ Classes examined. Of the covariates that were found to have a statistically significantly effect on the population PK model (ie, albumin, aspartate aminotransferase, body surface area, mild to moderate hepatic impairment, and sex), none was found to impact efficacy or safety, indicating that there is no need to modify dose on the basis of these parameters.<\/jats:p>","DOI":"10.1002\/jcph.1548","type":"journal-article","created":{"date-parts":[[2019,12,16]],"date-time":"2019-12-16T11:30:35Z","timestamp":1576495835000},"page":"50-57","update-policy":"http:\/\/dx.doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Exposure\u2010Response Analysis for Mogamulizumab in Adults With Cutaneous 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.  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