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

Background and aims: Although Upadacitinib (UPA) has proven successful in inflammatory bowel disease (IBD), there are limited data on its efficacy and safety in Asian patients with refractory IBD. This multicenter study aimed to evaluate the real-world effectiveness and safety of UPA in patients with refractory IBD. Methods This multicenter retrospective cohort analysis included adult patients with refractory IBD who received UPA therapy at three tertiary hospitals between January 2023 and March 2025. Clinical, endoscopic, and laboratory outcomes were the effectiveness goals. Safety measures included adverse events (AEs) and discontinuation rates. Results Eighty patients were studied: 52 with Crohn’s Disease (CD) and 28 with Ulcerative Colitis (UC). Steroid-free clinical remission was 59.6%, clinical response was 61.5%, endoscopic remission was 30.8%, and endoscopic response was 57.7% at the time of induction. In UC patients, steroid-free clinical remission, clinical response was 71.4%, endoscopic remission was 46.4%, and endoscopic response were 67.9%, 71.4%, 46.4%, and 60.7%, respectively. In the maintenance phase, 78.8% of CD patients had steroid-free clinical remission and 75.0% had endoscopic remission. UC patients had 85.0% steroid-free clinical remission and 78.6% endoscopic remission. Inflammatory indicators and nutritional parameters were significantly improved. No severe thromboembolic events, malignancies, or treatment-related fatalities occurred at an adverse event rate of 20.0%. Conclusions The UPA demonstrated robust real-world effectiveness and an acceptable safety profile in Asian patients with refractory IBD.