Efficacy and Safety of Upadacitinib for Refractory Inflammatory Bowel Disease: A Multicenter Real-World Observational Study

Yuqing Mao,1,* Yibo Hu,1,* Shaopeng Sun,1 Yan Chen,2 Wen Lyu,3 Bin Lv,4 Yihong Fan4 1Department of Gastroenterology, The First Clinical Medical College, Zhejiang Chinese Medical University, Hangzhou, 310000, People’s Republic of China; 2Department of Gastroenterology, The Second Affiliated Hospital of Zhejiang University, Hangzhou, 310000, People’s Republic of China; 3Department of Gastroenterology, Hangzhou First People’s Hospital, Hangzhou, 310000, People’s Republic of China; 4Department of Gastroenterology, the First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Traditional Chinese Medicine), Hangzhou, 310000, People’s Republic of China*These authors contributed equally to this workCorrespondence: Yihong Fan, Email [email protected] Bin Lv, Email [email protected]: Although Upadacitinib has proven success in inflammatory bowel diseases (IBD), there is less data on its efficacy and safety in Asian patients with refractory IBD.Methods: This multicenter study evaluated the real-world effectiveness and safety of UPA in patients with refractory IBD. This multicenter retrospective cohort analysis included adult refractory IBD patients who received UPA therapy at three tertiary hospitals from January 2023 to March 2025. Clinical, endoscopic, and laboratory outcomes were effectiveness goals. Safety measures included AEs and and rates of discontinuation.Results: A total of 80 eligible patients were enrolled, including 52 with CD and 28 with UC. During the induction period, for CD: steroid-free clinical remission: 59.6%; clinical response: 61.5%; endoscopic remission: 30.8%; endoscopic response: 57.7%. For UC, steroid-free clinical remission: 67.9%; clinical response: 71.4%; endoscopic remission: 46.4%; endoscopic response: 60.7%. In the maintenance phase (12 months), CD had 78.8% steroid-free clinical remission and 75.0% endoscopic remission. UC had 85.7% steroid-free clinical remission and 78.6% endoscopic remission. Inflammatory indicators and nutritional parameters improved significantly. The incidence of adverse events in CD and UC was 23.1% and 14.3%, respectively, and the discontinuation rates during the 12-month maintenance treatment period were 7.1% and 21.5%, respectively. The most common adverse reaction is acne (8.75%).Conclusion: UPA demonstrated robust real-world effectiveness and an acceptable safety profile in Asian patients with refractory IBD.Keywords: upadacitinib, inflammatory bowel disease, Crohn’s disease, ulcerative colitis, difficult-to-treat, real-world evidence