Literature DB >> 31642025

Upadacitinib: First Approval.

Sean Duggan1, Susan J Keam2.   

Abstract

Upadacitinib (Rinvoq™), an orally-administered Janus kinase 1 (JAK-1) inhibitor, is being developed by AbbVie for the treatment of rheumatoid arthritis. In August 2019, based on positive results from multinational phase III trials conducted in patients with rheumatoid arthritis, upadacitinib received marketing approval in the USA for the treatment of moderately to severely active rheumatoid arthritis and an inadequate response or intolerance to methotrexate. This article summarizes the milestones in the development of upadacitinib leading to this first approval for the treatment of rheumatoid arthritis.

Entities:  

Year:  2019        PMID： 31642025     DOI： 10.1007/s40265-019-01211-z

Source DB:  PubMed          Journal:  Drugs        ISSN： 0012-6667            Impact factor:   9.546


  17 in total

1.  Assessment of effect of CYP3A inhibition, CYP induction, OATP1B inhibition, and high-fat meal on pharmacokinetics of the JAK1 inhibitor upadacitinib.

Authors:  Mohamed-Eslam F Mohamed; Steven Jungerwirth; Armen Asatryan; Ping Jiang; Ahmed A Othman
Journal:  Br J Clin Pharmacol       Date:  2017-06-19       Impact factor: 4.335

2.  Upadacitinib Versus Placebo or Adalimumab in Patients With Rheumatoid Arthritis and an Inadequate Response to Methotrexate: Results of a Phase III, Double-Blind, Randomized Controlled Trial.

Authors:  Roy Fleischmann; Aileen L Pangan; In-Ho Song; Eduardo Mysler; Louis Bessette; Charles Peterfy; Patrick Durez; Andrew J Ostor; Yihan Li; Yijie Zhou; Ahmed A Othman; Mark C Genovese
Journal:  Arthritis Rheumatol       Date:  2019-08-28       Impact factor: 10.995

3.  Safety and efficacy of upadacitinib in patients with rheumatoid arthritis and inadequate response to conventional synthetic disease-modifying anti-rheumatic drugs (SELECT-NEXT): a randomised, double-blind, placebo-controlled phase 3 trial.

Authors:  Gerd R Burmester; Joel M Kremer; Filip Van den Bosch; Alan Kivitz; Louis Bessette; Yihan Li; Yijie Zhou; Ahmed A Othman; Aileen L Pangan; Heidi S Camp
Journal:  Lancet       Date:  2018-06-18       Impact factor: 79.321

4.  Safety and efficacy of upadacitinib in patients with active rheumatoid arthritis refractory to biologic disease-modifying anti-rheumatic drugs (SELECT-BEYOND): a double-blind, randomised controlled phase 3 trial.

Authors:  Mark C Genovese; Roy Fleischmann; Bernard Combe; Stephen Hall; Andrea Rubbert-Roth; Ying Zhang; Yijie Zhou; Mohamed-Eslam F Mohamed; Sebastian Meerwein; Aileen L Pangan
Journal:  Lancet       Date:  2018-06-18       Impact factor: 79.321

5.  Efficacy and Safety of ABT-494, a Selective JAK-1 Inhibitor, in a Phase IIb Study in Patients With Rheumatoid Arthritis and an Inadequate Response to Methotrexate.

Authors:  Mark C Genovese; Josef S Smolen; Michael E Weinblatt; Gerd R Burmester; Sebastian Meerwein; Heidi S Camp; Li Wang; Ahmed A Othman; Nasser Khan; Aileen L Pangan; Steven Jungerwirth
Journal:  Arthritis Rheumatol       Date:  2016-12       Impact factor: 10.995

6.  Pharmacokinetics of Upadacitinib With the Clinical Regimens of the Extended-Release Formulation Utilized in Rheumatoid Arthritis Phase 3 Trials.

Authors:  Mohamed-Eslam F Mohamed; Jiewei Zeng; Patrick J Marroum; In-Ho Song; Ahmed A Othman
Journal:  Clin Pharmacol Drug Dev       Date:  2018-04-24

7.  Characterization of the Effect of Hepatic Impairment on Upadacitinib Pharmacokinetics.

Authors:  Sheryl Trueman; Mohamed-Eslam F Mohamed; Tian Feng; Ana Paula Lacerda; Thomas Marbury; Ahmed A Othman
Journal:  J Clin Pharmacol       Date:  2019-04-11       Impact factor: 3.126

8.  In vitro and in vivo characterization of the JAK1 selectivity of upadacitinib (ABT-494).

Authors:  Julie M Parmentier; Jeff Voss; Candace Graff; Annette Schwartz; Maria Argiriadi; Michael Friedman; Heidi S Camp; Robert J Padley; Jonathan S George; Deborah Hyland; Matthew Rosebraugh; Neil Wishart; Lisa Olson; Andrew J Long
Journal:  BMC Rheumatol       Date:  2018-08-28

9.  Characterization of the Effect of Renal Impairment on Upadacitinib Pharmacokinetics.

Authors:  Mohamed-Eslam F Mohamed; Sheryl Trueman; Tian Feng; Jaclyn Anderson; Thomas C Marbury; Ahmed A Othman
Journal:  J Clin Pharmacol       Date:  2019-01-11       Impact factor: 3.126

Review 10.  Population Pharmacokinetics of Upadacitinib in Healthy Subjects and Subjects with Rheumatoid Arthritis: Analyses of Phase I and II Clinical Trials.

Authors:  Ben Klünder; Mohamed-Eslam F Mohamed; Ahmed A Othman
Journal:  Clin Pharmacokinet       Date:  2018-08       Impact factor: 6.447
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  16 in total

Review 1.  The JAK/STAT signaling pathway: from bench to clinic.

Authors:  Xiaoyi Hu; Jing Li; Maorong Fu; Xia Zhao; Wei Wang
Journal:  Signal Transduct Target Ther       Date:  2021-11-26

Review 2.  Management of Axial Spondyloarthritis - Insights into Upadacitinib.

Authors:  Jürgen Braun; Uta Kiltz; Xenofon Baraliakos
Journal:  Drug Des Devel Ther       Date:  2022-10-19       Impact factor: 4.319

3.  Generation of a chemical genetic model for JAK3.

Authors:  Judit Remenyi; Rangeetha Jayaprakash Naik; Jinhua Wang; Momchil Razsolkov; Alyssa Verano; Quan Cai; Li Tan; Rachel Toth; Samantha Raggett; Carla Baillie; Ryan Traynor; C James Hastie; Nathanael S Gray; J Simon C Arthur
Journal:  Sci Rep       Date:  2021-05-12       Impact factor: 4.379

4.  Comparative Efficacy and Safety of Peficitinib Versus Tofacitinib and Baricitinib for Treatment of Rheumatoid Arthritis: A Systematic Review and Network Meta-Analysis.

Authors:  Yoshiya Tanaka; Hiroyuki Okumura; Soyoung Kim; Julie Dorey; Piotr Wojciechowski; Justyna Chorąży; Daisuke Kato; Neil M Schultz
Journal:  Rheumatol Ther       Date:  2021-03-16

Review 5.  Clinical translation of immunomodulatory therapeutics.

Authors:  Amanda Nash; Samira Aghlara-Fotovat; Andrea Hernandez; Christopher Scull; Omid Veiseh
Journal:  Adv Drug Deliv Rev       Date:  2021-07-27       Impact factor: 17.873

Review 6.  Inside Perspective of the Synthetic and Computational Toolbox of JAK Inhibitors: Recent Updates.

Authors:  Adriana Coricello; Francesco Mesiti; Antonio Lupia; Annalisa Maruca; Stefano Alcaro
Journal:  Molecules       Date:  2020-07-22       Impact factor: 4.411

Review 7.  Differential regulation of JAK/STAT-signaling in patients with ulcerative colitis and Crohn's disease.

Authors:  Friederike Cordes; Dirk Foell; John Nik Ding; Georg Varga; Dominik Bettenworth
Journal:  World J Gastroenterol       Date:  2020-07-28       Impact factor: 5.742

8.  The JAK-STAT pathway: an emerging target for cardiovascular disease in rheumatoid arthritis and myeloproliferative neoplasms.

Authors:  Chiara Baldini; Francesca Romana Moriconi; Sara Galimberti; Peter Libby; Raffaele De Caterina
Journal:  Eur Heart J       Date:  2021-11-07       Impact factor: 35.855

Review 9.  Molecular Structure and Function of Janus Kinases: Implications for the Development of Inhibitors.

Authors:  Alba Garrido-Trigo; Azucena Salas
Journal:  J Crohns Colitis       Date:  2020-08-01       Impact factor: 9.071

Review 10.  Efficacy of JAK inhibitors in Crohn's Disease.

Authors:  Gerhard Rogler
Journal:  J Crohns Colitis       Date:  2020-08-01       Impact factor: 9.071
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