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The approvals of upadacitinib for the treatment of AS and nr\u2010axSpA were based on the safety and efficacy data for upadacitinib 15\u2009mg once\u2010daily compared to placebo from the SELECT\u2010AXIS 1 and SELECT\u2010AXIS 2 studies. Population pharmacokinetic analyses based on data from 244 patients with axSpA showed that the pharmacokinetics of upadacitinib were comparable in subjects with AS and nr\u2010axSpA. Exposure\u2010response relationships were characterized for key efficacy and safety end points using data from 482 patients with axSpA. The exposure\u2010response analyses for efficacy based on Assessment of SpondyloArthritis International Society (ASAS)20 and ASAS40 responses at week 14, showed a clear differentiation from placebo with no evidence of increased responses with increasing upadacitinib plasma exposures. There were no clear exposure\u2010response trends observed for safety end points that included serious infections, herpes zoster, pneumonia, lymphopenia (grade \u22653), neutropenia (grade \u22653), or a greater than 2\u2009g\/dL decrease in hemoglobin from baseline through week 14. The exposure\u2010response analyses for efficacy and safety presented here supported the favorable benefit\u2013risk profile with the use of upadacitinib 15\u2009mg once\u2010daily for the treatment of axSpA.<\/jats:p>","DOI":"10.1111\/cts.13733","type":"journal-article","created":{"date-parts":[[2024,2,12]],"date-time":"2024-02-12T10:12:43Z","timestamp":1707732763000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["Population pharmacokinetics and exposure\u2010response analyses for efficacy and safety of upadacitinib in patients with axial spondyloarthritis"],"prefix":"10.1111","volume":"17","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4410-8131","authenticated-orcid":false,"given":"Sumit","family":"Bhatnagar","sequence":"first","affiliation":[{"name":"Clinical Pharmacology AbbVie  North Chicago Illinois USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0007-5946-2364","authenticated-orcid":false,"given":"Doerthe","family":"Eckert","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology AbbVie Deutschland GmbH &amp; Co. 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