AbbVieAbbVie (NYSE: ABBV) announced the New England Journal of Medicine (NEJM) published results from the pivotal Phase 3 clinical trials - U-EXCEL, U-EXCEED and U-ENDURE - evaluating upadacitinib (RINVOQ®) in adult patients with moderately to severely active Crohn's disease who have had an inadequate response, lost response or were intolerant to conventional therapy or a biologic agent. (1-4)

The publication reports the safety and efficacy results of oral upadacitinib versus placebo in two induction studies (U-EXCEL and U-EXCEED) and one maintenance study (U-ENDURE), evaluating the co-primary endpoints of clinical remission and endoscopic response. Data from this Phase 3 program formed the basis of the company's application for approval by regulatory agencies. Use of upadacitinib in Crohn's disease is approved in Great Britain, Russia, United Arab Emirates, the European Union, and most recently in the United States as of May 2023.

About Crohn's Disease

Crohn's disease is a chronic, systemic disease that manifests as inflammation within the gastrointestinal (or digestive) tract, causing persistent diarrhea, abdominal pain and fatigue.(5-7) It is a progressive disease, meaning it gets worse over time.(5,7) Because the signs and symptoms of Crohn's disease are unpredictable, it causes a significant burden on people living with the disease - not only physically, but also emotionally and economically.(8)

About the U-EXCEED and U-EXCEL Induction Studies, and the U-ENDURE Maintenance Study

The three Phase 3 studies are multicenter, randomized, double-blind, placebo-controlled studies to evaluate the efficacy and safety of upadacitinib 45 mg as induction therapy and upadacitinib 15 mg and 30 mg as maintenance therapy in patients with moderately to severely active Crohn's disease. Topline results of the U-EXCEED and U-EXCEL induction studies were announced in December 2021 and February 2022. Topline results of the U-ENDURE maintenance study were announced in May 2022. Results from all three of these studies have also been presented at recent congresses. More information can be found on www.clinicaltrials.gov (U-EXCEED: NCT03345836, U-EXCEL: NCT03345849, U-ENDURE: NCT03345823).

About RINVOQ® (upadacitinib)

Discovered and developed by AbbVie scientists, RINVOQ is a selective JAK inhibitor that is being studied in several immune-mediated inflammatory diseases. Based on enzymatic and cellular assays, RINVOQ demonstrated greater inhibitory potency for JAK-1 vs JAK-2, JAK-3, and TYK-2.9 The relevance of inhibition of specific JAK enzymes to therapeutic effectiveness and safety is not currently known.

Phase 3 trials of RINVOQ in rheumatoid arthritis, atopic dermatitis, psoriatic arthritis, axial spondyloarthritis, Crohn's disease, ulcerative colitis, giant cell arteritis and Takayasu arteritis are ongoing.(10-17)

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across our Allergan Aesthetics portfolio.

1. Abbvie, Ltd. RINVOQ (upadacitinib) [summary of product characteristics]. Available at: https://www.ema.europa.eu/en/documents/product-information/rinvoq-epar-product-information_en.pdf. Accessed on December 7, 2022.
2. Colombel, J.F., Panes, J., Lacerda, A.P., et al. Efficacy and Safety of Upadacitinib Induction Therapy in Patients with Moderately to Severely Active Crohn's Disease Who Failed Prior Biologics: Results from a Randomized Phase 3 U-EXCEED Study. UEG Journal. 2022;S-1934. Accessed on December 12, 2022.
3. Loftus, E., Colombel, L.F., Lacerda, A.P., et al. Efficacy and Safety of Upadacitinib Induction Therapy in Patients with Moderately to Severely Active Crohn's Disease: Results from a Randomized Phase 3 U-EXCEL Study. UEG Journal. 2022; 10(8): 103-104. doi/10.1002/ueg2.12293. Accessed on December 12, 2022.
4. Panes, J., Loftus, E., Lacerda, A.P., et al. Efficacy and Safety of Upadacitinib Maintenance Therapy in Patients with Moderately to Severely Active Crohn's Disease: Results from a Randomized Phase 3 U-ENDURE Maintenance Study. American College of Gastroenterology. 2022: 1-14. Accessed on December 12, 2022.
5. The Facts about Inflammatory Bowel Diseases. Crohn's & Colitis Foundation of America. 2014. Available at: https://www.crohnscolitisfoundation.org/sites/default/files/2019-02/Updated%20IBD%20Factbook.pdf. Accessed on February 13, 2023.
6. Kaplan, G. The global burden of IBD: from 2015 to 2025. Nat Rev Gastroenterol Hepatol. 2015 Dec;12(12):720-7. doi: 10.1038/nrgastro.2015.150.
7. Crohn's disease. Symptoms and Causes. Mayo Clinic. 2022. Available at: https://www.mayoclinic.org/diseases-conditions/crohns-disease/symptoms-causes/syc-20353304. Accessed on February 13, 2023.
8. Mehta F. Report: economic implications of inflammatory bowel disease and its management. Am J Manag Care. 2016 Mar;22(3 Suppl):s51-60
9. RINVOQ® (upadacitinib) [Package Insert]. North Chicago, Ill.: AbbVie Inc.
10. A study comparing upadacitinib (ABT-494) to placebo and to adalimumab in adults with rheumatoid arthritis who are on a stable dose of methotrexate and who have an inadequate response to methotrexate (SELECT-COMPARE). ClinicalTrials.gov identifier: NCT02629159. Accessed February 14, 2023. https://www.clinicaltrials.gov/ct2/show/NCT02629159.
11. A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Immunomodulators or Anti-TNF Therapy. ClinicalTrials.gov. Available at: https://clinicaltrials.gov/ct2/show/NCT02365649. Accessed on February 14, 2023.
12. A Study to Evaluate the Safety and Efficacy of Upadacitinib in Participants With Giant Cell Arteritis (SELECT-GCA). ClinicalTrials.gov. Available at: https://clinicaltrials.gov/ct2/show/NCT03725202. Accessed on February 14, 2023.
13. A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Participants With Psoriatic Arthritis Who Have an Inadequate Response to at Least One Non-Biologic Disease Modifying Anti-Rheumatic Drug (SELECT - PsA 1). ClinicalTrials.gov. Available at: https://clinicaltrials.gov/ct2/show/NCT03104400. Accessed on February 14, 2023.
14. A Study to Compare Safety and Efficacy of Upadacitinib to Dupilumab in Adult Participants With Moderate to Severe Atopic Dermatitis (Heads Up). ClinicalTrials.gov. Available at: https://clinicaltrials.gov/ct2/show/NCT03738397. Accessed on February 14, 2023.
15. Study to Evaluate the Efficacy and Safety of Upadacitinib in Subjects With Takayasu Arteritis (SELECT-TAK). ClinicalTrials.gov. Available at https://clinicaltrials.gov/ct2/show/record/NCT04161898. Accessed on November 8, 2022.
16. A Study to Evaluate Efficacy and Safety of Upadacitinib in Adult Participants With Axial Spondyloarthritis (SELECT AXIS 2). ClinicalTrials.gov. Available at: https://clinicaltrials.gov/ct2/show/NCT04169373. Accessed on February 14, 2023.
17. SKYRIZI [Summary of Product Characteristics]. AbbVie Ltd. Available at: https://www.ema.europa.eu/en/documents/product-information/skyrizi-epar-product-information_en.pdf. Accessed on February 14, 2023.