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Clinical Pharmacokinetics of Upadacitinib: Review of Data Relevant to the Rheumatoid Arthritis Indication

Author

Mohamed MF1, Klünder B2, Othman AA3. Clin Pharmacokinet. 2019 Dec 23. doi: 10.1007/s40262-019-00855-0. [Epub ahead of print]

Author Information

1 Clinical Pharmacology and Pharmacometrics, AbbVie Inc., N. Waukegan Road , North Chicago, IL, 60064, USA.

2 Clinical Pharmacology and Pharmacometrics, AbbVie Deutschland GmbH & Co. KG, Ludwigshafen am Rhein, Germany.

3 Clinical Pharmacology and Pharmacometrics, AbbVie Inc., N. Waukegan Road , North Chicago, IL, 60064, USA. ahmedaothman@gmail.com.

Abstract

Upadacitinib is a Janus kinase 1 inhibitor developed for treatment of moderate to severe rheumatoid arthritis (RA) and was recently approved by the US Food and Drug Administration for this indication in adults who have had an inadequate response or intolerance to methotrexate. Upadacitinib is currently under regulatory review by other agencies around the world. Ongoing trials are investigating the use of upadacitinib in other inflammatory autoimmune diseases. In this article, we review the clinical pharmacokinetic data available to date for upadacitinib that supported the clinical development program in RA and ultimately regulatory applications for upadacitinib in treatment of patients with moderate to severe RA.