AbbVie today announced new data on the investigational use of risankizumab (SKYRIZI®) in Crohn’s disease, upadacitinib (RINVOQ®) in ulcerative colitis and HUMIRA® (adalimumab) in inflammatory bowel disease (IBD) will be presented as live presentations and e-Posters at the United European Gastroenterology (UEG) Week Virtual 2021, to be held October 3-5. AbbVie is presenting a total of 13 abstracts, across a broad range of studies in IBD, including two late-breaking maintenance studies evaluating the efficacy and safety of risankizumab in Crohn’s disease and upadacitinib in ulcerative colitis at 52 weeks.
“Our long-term commitment to IBD has yielded favorable results, and the data we are presenting at UEG Week Virtual 2021 shows the potential of AbbVie’s pipeline to help transform the way IBD is treated,” said Chiedzo Mpofu, vice president, global medical affairs, immunology. “We continue to work to evolve the standards of care and improve symptom control and quality of life for people living with IBD.”
Four presentations will feature data from the pivotal Phase 3 U-ACHIEVE and U-ACCOMPLISH studies evaluating the efficacy, safety and rapidity of symptom control with upadacitinib in patients with moderate to severe ulcerative colitis. These studies evaluated improvements in abdominal pain, bowel urgency and fatigue. During UEG Week Virtual 2021, results of the pivotal Phase 3 maintenance study, in which the primary endpoint of clinical remission (per Adapted Mayo Score) was met, will be disclosed as a late-breaking presentation.3 Additionally, all secondary endpoints, including endoscopic improvement, histologic-endoscopic mucosal improvement and corticosteroid-free clinical remission at week 52 were met and will be presented.3 Clinical remission (per Adapted Mayo Score) is defined as Mayo score ≤2, with a stool frequency subscore (SFS) ≤1 and not greater than baseline, rectal bleeding subscore (RBS) of 0 and Mayo endoscopic subscore ≤1.3 New data highlighting the impact of upadacitinib on health-related quality of life will also be presented. Top-line induction results were previously announced in December 2020 and February 2021. Top-line maintenance results were announced in June 2021.
Other presentations will focus on risankizumab as an induction therapy in patients with moderate to severe Crohn’s disease. Analysis from two Phase 3 studies emphasizing early symptom relief will be shared, along with a pooled analysis evaluating clinical response after an additional 12 weeks of risankizumab treatment in subjects who failed to achieve clinical response initially. Additionally, results from the Phase 3 FORTIFY study will be presented as a late-breaker. This presentation will highlight the efficacy outcomes of continued treatment with risankizumab (360 mg), which met the co-primary endpoints of endoscopic response and clinical remission at week 52.4 Clinical remission was defined by Crohn’s Disease Activity Index (CDAI) in the U.S. analysis plan and by stool frequency and abdominal pain (SF/AP) in the OUS analysis plan.4 Top-line induction results were issued in January 2021.
“We are excited by the strong research AbbVie is producing in IBD, addressing the high unmet needs,” said Remo Panaccione, M.D., professor of medicine and director of the IBD unit, University of Calgary. “More treatment options are needed to help control symptoms and improve quality of life for patients suffering from moderate to severe ulcerative colitis and Crohn’s disease.”
AbbVie abstracts in the UEG Week Virtual 2021 program include: