AbbVie announced results from three Phase 3 clinical trials – U-ACHIEVE (induction), U-ACCOMPLISH and U-ACHIEVE (maintenance) – evaluating upadacitinib (RINVOQ®) in patients with moderately to severely active ulcerative colitis who have had inadequate response, lost response or were intolerant to conventional or biologic therapy.
Data from the three studies formed the basis of the company's application for approval by regulatory agencies. The study, published in The Lancet, reports the efficacy and safety results of the two induction studies and a maintenance study evaluating clinical remission and endoscopic improvement with oral upadacitinib versus placebo over 8 weeks and 52 weeks, respectively.The use of upadacitinib for ulcerative colitis is not approved in the European Union and its safety and efficacy remain under review by the global health authorities.
Discovered and developed by AbbVie scientists, RINVOQ is a selective and reversible JAK inhibitor that is being studied in several immune-mediated inflammatory diseases.
RINVOQ is approved in the EU for rheumatoid arthritis, atopic dermatitis, axial spondyloarthritis and psoriatic arthritis. Phase 3 trials of RINVOQ in axial spondyloarthritis, Crohn's disease, giant cell arteritis and Takayasu arteritis are ongoing.