A Real-World Study of Upadacitinib in Anti-TNF Refractory Crohn’s Disease: Effectiveness, Persistence, and Safety

Purpose: Real-world evidence on the effectiveness of upadacitinib in Crohn's disease is increasing; however, data from Chinese populations remain limited. This study aimed to evaluate the real-world effectiveness, persistence, and safety of upadacitinib. Methods: This retrospective study included consecutive patients with Crohn's disease treated with upadacitinib at the First Affiliated Hospital of Anhui Medical University who had at least one follow-up visit. Clinical effectiveness was assessed using the Harvey-Bradshaw Index, and endoscopic effectiveness was evaluated using the Simple Endoscopic Score for Crohn's Disease. Logistic regression analysis was performed to identify factors associated with clinical remission at week 12. Kaplan-Meier analysis and Cox regression analysis were used to evaluate upadacitinib persistence. Results: = 0.012) was associated with an increased risk of discontinuation. A total of 22 (20.3%) patients experienced 23 adverse events. Conclusion: This real-world study demonstrates that upadacitinib is effective, with acceptable safety and favorable treatment persistence, in Chinese patients with moderate-to-severe anti-TNF-refractory Crohn's disease. Future studies with larger sample sizes should focus on long-term effectiveness and safety and provide more comprehensive pharmacokinetic characterization.