New England Journal of Medicine publishes results from phase III induction and maintenance programs evaluating Rinvoq in Crohn's disease.- AbbVie.
AbbVie announced the New England Journal of Medicine (NEJM) published results from the pivotal Phase III 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.
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 III 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 the U-EXCEED and U-EXCEL Induction Studies, and the U-ENDURE Maintenance Study : The three Phase III 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).
See- "Upadacitinib Induction and Maintenance Therapy for Crohn’s Disease": Edward V. Loftus, Jr., M.D., Julian Panés, M.D., Ana P. Lacerda, M.D., Laurent Peyrin-Biroulet, M.D., Ph.D., Geert D’Haens, M.D., et al.- May 25, 2023. N Engl J Med 2023; 388:1966-1980. DOI: 10.1056/NEJMoa2212728.