P0615 Effectiveness and Safety Analysis of Upadacitinib in the Treatment of Inflammatory Bowel Disease: A Multicenter Real-World Study
Authors: Wu H , Su T , Wu L , Zhi M , Yao J 
Published: January 2025

Abstract

Background
Inflammatory bowel disease (IBD) requires effective treatment options. Upadacitinib, a Janus kinase 1 (JAK1) inhibitor, has shown effectiveness in trials for Crohn’s disease (CD) and ulcerative colitis (UC). This study evaluates its real-world effectiveness and safety.

Methods
We conducted a multicenter retrospective cohort study in tertiary care centers, involving patients treated with upadacitinib from January 2023 to September 2024. The study included adult patients aged 18 years or older, diagnosed with UC or CD, who received at least 8 weeks of upadacitinib therapy. Treatment outcomes were evaluated using established clinical, endoscopic, imaging, histological, and laboratory parameters.

Results
A total of 236 IBD patients received upadacitinib treatment. In 80 UC patients at 8 weeks, 64.0% achieved steroid-free remission (P=0.250), 57.6% clinical remission (P=0.063), and 81.8% response. Endoscopic remission was 35.8% (P=0.039), with 63.3% response and 35.8% mucosal healing (P=0.219). Histological remission reached 29.2% (P=0.009). Mean albumin increased from 37.0 to 40.3 g/L (P&lt;0.001). Normal hemoglobin rates improved from 63.9% to 91.0% (P&lt;0.001), and normal CRP rates from 51.4% to 77.8% (P&lt;0.001).For 156 CD patients at 12 weeks, 76.8% achieved steroid-free remission (P&lt;0.001), 77.8% clinical remission (P&lt;0.001), and 81.0% response. Mean CDAI decreased from 214.9 to 117.5 (P&lt;0.001). Endoscopic remission was 19.4%, with 48.9% response and 4.9% mucosal healing. Radiological remission was 9.1% with 85.7% response. Intestinal ultrasound showed 5.7% remission and 56.7% response. Mean albumin increased from 37.3 to 41.4 g/L (P&lt;0.001). Median CRP decreased from 12.3 to 2.3 mg/L (P&lt;0.001), and ESR from 15.0 to 5.0 mm/h (P=0.025). Normal CRP rates improved from 60.0% to 82.7% (P&lt;0.001).

Conclusion
Upadacitinib demonstrates significant real-world effectiveness and safety in IBD, suggesting its potential as a treatment for biologic-resistant cases. These results support its use in IBD management, with further research needed to fully define its therapeutic role.

References
1.Khor B, Gardet A, Xavier RJ. Genetics and pathogenesis of inflammatory bowel disease. Nature. 2011;474(7351):307-317.
2.Ma C, Battat R, Dulai PS, et al. Innovations in Oral Therapies for Inflammatory Bowel Disease. Drugs. 2019;79(12):1321-1335.
3.Dunleavy KA, Pardi DS. Biologics: how far can they go in Crohn’s disease? Gastroenterol Rep (Oxf). 2022;10:goac049.
4.Danese S, Argollo M, Le Berre C, Peyrin-Biroulet L. JAK selectivity for inflammatory bowel disease treatment: does it clinically matter? Gut. 2019;68(10):1893-1899.
5.Sandborn WJ, Feagan BG, Loftus EV, Jr., et al. Efficacy and Safety of Upadacitinib in a Randomized Trial of Patients With Crohn’s Disease. Gastroenterology. 2020;158(8):2123-2138 e2128.
6.Sandborn WJ, Ghosh S, Panes J, et al. Efficacy of Upadacitinib in a Randomized Trial of Patients With Active Ulcerative Colitis. Gastroenterology. 2020;158(8):2139-2149 e2114.
7.HCP R. Dosing & Monitoring | Crohn’s Disease. 2023; https://www.rinvoqhcp.com/crohns-disease/dosing-and-monitoring.
8.HCP R. Ulcerative Colitis Treatment Information. 2023; https://www.rinvoqhcp.com/ulcerative-colitis. Accessed 2024/4/12.
9.Turner D, Ricciuto A, Lewis A, et al. STRIDE-II: An Update on the Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE) Initiative of the International Organization for the Study of IBD (IOIBD): Determining Therapeutic Goals for Treat-to-Target strategies in IBD. Gastroenterology. 2021;160(5):1570-1583.