New Oral IBD Treatment Upadacitinib in Phase 3 Clinical Trials
Developed by biopharmaceutical company AbbVie, Upadacitinib (ABT-494) is a new oral treatment for IBD.
What is Upadacitinib?
Upadacitinib is an investigational oral treatment for rheumatoid arthritis, eczema, psoriatic arthritis, and inflammatory bowel disease (IBD)—both for Crohn’s disease and ulcerative colitis (UC).
Currently, this new IBD treatment is in Phase 3 trials for Crohn’s Disease and is also being investigated as a potential treatment for ulcerative colitis. Specifically, upadacitinib is being investigated for moderate to severe Crohn’s disease and in patients with inadequate response to an immunomodulator treatment or anti-TNF therapy.
What does Upadacitinib do?
Technically speaking, Upadacitinib is part of a class of drugs known as Janus kinase (JAK) inhibitors. JAK inhibitors interfere with the immune response by blocking the actions of a specific family of proteins, dampening the response of pro-inflammatory cytokines involved in IBD. This occurs when the JAK inhibitor molecules bind to the JAK receptor, blocking the intercellular signalling that would otherwise lead to immune cell proliferation and inflammation.
Upadacitinib is a JAK1-selective inhibitor, meaning that it selectively targets the JAK1 pathway, a signalling pathway that plays an important role in immune disorders. Several other IBD treatments being developed also target Janus kinases, including Filgotinib (also a JAK1 inhibitor) and Tofacitinib (a pan-JAK inhibitor).
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What condition do you have?Crohn's Disease Ulcerative Colitis
JAK inhibitors are believed to have certain advantages over other agents because of their oral delivery and small molecular size. Therefore, Upadacitinib is predicted to have lower production costs, coupled with the convenience of oral administration.
Studies on Upadacitinib
In February 2018, AbbVie announced results from an extension of a Phase 2 study called CELEST, which showed that patients who achieved clinical response after the 16-week induction phase maintained their response over the following 9 months.
Previous reports from the CELEST study observed that 27% of patients taking 6 mg of Upadacitinib daily achieved remission, compared to 11% in the placebo group. The patients in the study had moderate to severe Crohn’s disease, many of whom had already tried at least two other immune-modulating therapies without achieving remission.
Among other metrics, the current Phase 3 trials are examining the long-term efficacy and safety of this promising new IBD therapy.
What is Upadacitinib's Current Status?
Upadacitinib is currently in Phase 3 clinical trials as a Crohn’s disease treatment. This means that clinical researchers and physicians are testing the drug on patients with Crohn’s disease to assess its efficacy, safety, and dosing. Already having shown that the drug is safe and has an effect, the ultimate goal in phase III trials is to evaluate drug’s therapeutic effect (on anywhere between 300 and 3,000 patients) before making it available on the market.
How Can I Learn More About Upadacitinib?
Learn more about Upadacitinib and to check your eligibility, speak with the Discover Therapies Care Team about whether you can participate in an Upadacitinib clinical trial near you by taking a short quiz.
Lee, H. S., Park, S.-K., & Park, D. I. (2018). Novel treatments for inflammatory bowel disease. The Korean Journal of Internal Medicine, 33(1), 20–27. http://doi.org/10.3904/kjim.2017.393
Abbvie, Inc. (2018 February 16) AbbVie Announces New Phase 2 Data for Upadacitinib Showing Clinical and Endoscopic Outcomes in Crohn's Disease at 52 Weeks. [Press Relase]. Retrieved from https://news.abbvie.com/news/abbvie-announces-new-phase-2-data-for-upadacitinib-showing-clinical-and-endoscopic-outcomes-in-crohns-disease-at-52-weeks.htm
L.C.S. De Vries, M.E. Wildenberg, W.J. De Jonge, G.R. D’Haens; The Future of Janus Kinase Inhibitors in Inflammatory Bowel Disease, Journal of Crohn's and Colitis, 11(7), 885–893 1 July 2017,, https://doi.org/10.1093/ecco-jcc/jjx003
Atkinson, Helen Parker. 2018. Upadacitinib (ABT-494). IBD News Today. https://ibdnewstoday.com/upadacitinib-abt-494/