North Chicago, Illinois, USA, October 11, 2026
AbbVie has announced new clinical and real-world evidence supporting SKYRIZI® (risankizumab-rzaa) and RINVOQ® (upadacitinib) for the management of inflammatory bowel disease (IBD), including Crohn’s disease and ulcerative colitis. The findings are being presented at the American College of Gastroenterology (ACG) 2026 Annual Scientific Meeting, held in Nashville, Tennessee, from October 9 to 14. The announcement highlights results from the Phase 3 AFFIRM study, long-term analyses of SKYRIZI treatment and real-world evidence evaluating RINVOQ in patients with difficult-to-treat Crohn’s disease. These data address important treatment challenges in IBD, a group of chronic inflammatory conditions that can cause abdominal pain, diarrhea, intestinal damage and complications requiring surgery. The latest findings demonstrate clinical and endoscopic improvements with SKYRIZI and disease control among selected patients receiving RINVOQ, including individuals with complex disease characteristics and previous treatment exposure. AbbVie reported that it is presenting 22 scientific abstracts at the meeting, reflecting its continued research into long-term disease management and treatment options for patients with inflammatory bowel conditions.
Phase 3 AFFIRM Study Highlights SKYRIZI Efficacy
The Phase 3 AFFIRM study evaluated subcutaneous risankizumab as induction and maintenance treatment in patients with moderately to severely active Crohn’s disease. According to AbbVie, the study demonstrated significantly higher rates of clinical remission and endoscopic response at Week 12 compared with placebo. Clinical remission generally reflects substantial control of disease symptoms, while endoscopic response measures improvement in visible intestinal inflammation. Among clinical responders, rates across efficacy endpoints remained numerically higher through Week 24. These findings support further evaluation of subcutaneous SKYRIZI as an induction treatment option for patients with active Crohn’s disease. The company also presented comparative analyses examining risankizumab against guselkumab using an anchored matching-adjusted indirect comparison. The analysis reported significantly higher endoscopic response rates with subcutaneous risankizumab during induction. However, indirect comparisons are not the same as head-to-head randomized clinical trials, and their findings must be interpreted in light of methodological limitations. AbbVie has previously submitted an application to the U.S. Food and Drug Administration seeking approval for subcutaneous induction treatment with SKYRIZI in adults with moderately to severely active Crohn’s disease. The new findings contribute to the evidence supporting this development program, although regulatory decisions depend on the complete submitted data.
Long-Term SKYRIZI Data Show Sustained Disease Control
Additional analyses from the Phase 3 FORTIFY and SEQUENCE studies examined the durability of risankizumab treatment over several years. In the FORTIFY open-label extension, clinical and endoscopic outcomes were generally maintained or improved through 144 weeks across patients with ileal, colonic and ileocolonic Crohn’s disease. Another analysis of patients with fistulizing Crohn’s disease reported that 74.5% had no draining fistulas after five years of treatment. Fistulas are abnormal connections that can develop between the intestine and other tissues, sometimes causing substantial complications and requiring specialized treatment. The SEQUENCE open-label extension also showed sustained clinical and endoscopic outcomes through 148 weeks among patients with moderately to severely active Crohn’s disease who had previously experienced anti-TNF treatment failure. Endoscopic outcomes among patients with ileal disease continued to improve over time. In ulcerative colitis, analyses from the COMMAND open-label extension demonstrated sustained clinical and endoscopic improvements through three years of SKYRIZI maintenance treatment, including among patients previously exposed to multiple advanced therapies. These long-term findings provide additional evidence about the durability of treatment responses, although open-label extension studies may be affected by participant retention and should not be interpreted as equivalent to new placebo-controlled trials.
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RINVOQ Real-World Evidence Addresses Complex Crohn’s Disease
AbbVie also presented real-world evidence for RINVOQ (upadacitinib) in patients with advanced and difficult-to-treat Crohn’s disease. Analyses using Veterans Affairs healthcare data examined patients with fistulizing and stricturing disease, two complications associated with more complex disease management. Among patients who remained on treatment, 93.3% of those with fistulizing disease and 76.9% of those with stricturing disease achieved clinical remission and corticosteroid-free remission, according to the company’s report. A separate analysis using Department of Defense healthcare data evaluated patients with isolated ileal Crohn’s disease. At six months, 57% achieved clinical remission, 58% achieved endoscopic response and 53.6% achieved endoscopic remission. These findings provide practical evidence about outcomes in clinical settings outside tightly controlled randomized trials. Nevertheless, real-world analyses can be influenced by patient selection, treatment persistence and differences in clinical practice, so the reported percentages should not be generalized to all patients. Together, the SKYRIZI and RINVOQ findings underscore AbbVie’s efforts to address different aspects of IBD management, including induction response, long-term intestinal healing and complex disease complications. Further research will help clarify which treatment strategies are most appropriate for individual patients.
Source: AbbVie press release
