The Lancet Publishes Results from Phase 3 Induction and Maintenance Programs Eva… – Press Release

NORTH CHICAGO, Ill., May 27, 2022 /PRNewswire/ — AbbVie ABBV today announced The Lancet published results from three pivotal 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 publication 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.1 

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.  

About Ulcerative Colitis  

Ulcerative colitis is a chronic, idiopathic, immune-mediated inflammatory bowel disease (IBD) of the large intestine that causes continuous mucosal inflammation extending, to a variable extent, from the rectum to the more proximal colon.2,3 The hallmark signs and symptoms of ulcerative colitis include rectal bleeding, abdominal pain, bloody diarrhea, tenesmus (a sense of pressure), urgency and fecal incontinence.2,4 The severity of symptoms and unpredictability of disease course can lead to substantial burden and often disability among those living with the disease.5 The disease course of ulcerative colitis varies between patients and can range from quiescent disease to chronic refractory disease, which in some cases can lead to surgery or complications, including cancer or death.3,6 

About the U-ACHIEVE Induction, U-ACCOMPLISH and U-ACHIEVE Maintenance Studies6,7-10 

The three Phase 3 studies are multicenter, randomized, double-blind, placebo-controlled studies to evaluate the efficacy and…