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Subjects in CELEST received either placebo or upadacitinib (3, 6, 12, 24\u00a0mg b.i.d. or 24\u00a0mg q.d.). Exposure\u2013response models were developed and utilized to simulate efficacy of induction doses of the immediate\u2010release (IR) and extended\u2010release (ER) formulations. Upadacitinib exposures associated with 18\u201324\u00a0mg b.i.d. (IR formulation) or 45\u201360\u00a0mg q.d. (ER formulation) are estimated to have greater efficacy during 12\u2010week induction in patients with CD compared with lower doses. No exposure\u2013response relations were observed with decreases in hemoglobin or lymphocytes at week 16 or with herpes zoster infections, pneumonia, or serious infections during 16\u00a0weeks of treatment in this study. These analyses informed the selection of upadacitinib induction dose for phase III studies in CD.<\/jats:p>","DOI":"10.1002\/cpt.1668","type":"journal-article","created":{"date-parts":[[2019,10,8]],"date-time":"2019-10-08T21:29:18Z","timestamp":1570570158000},"page":"639-649","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":19,"title":["Exposure\u2013Response Analyses for Upadacitinib Efficacy and Safety in the Crohn's Disease CELEST Study and Bridging to the Extended\u2010Release Formulation"],"prefix":"10.1111","volume":"107","author":[{"given":"Mohamed\u2010Eslam F.","family":"Mohamed","sequence":"first","affiliation":[{"name":"Clinical Pharmacology and Pharmacometrics AbbVie Inc. North Chicago Illinois USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ben","family":"Kl\u00fcnder","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology and Pharmacometrics AbbVie Inc. 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