P0943Real-World Effectiveness and Safety of Upadacitinib in Korean Patients with Inflammatory Bowel Disease: A Single-Center Retrospective Study

Abstract Background Upadacitinib, a selective Janus kinase 1 inhibitor, has demonstrated efficacy in clinical trials for inflammatory bowel disease (IBD); however, real-world data from Asian populations remain limited. Methods We conducted a retrospective study to evaluate the real-world effectiveness and safety of upadacitinib in Korean patients with ulcerative colitis (UC) or Crohn’s disease (CD). Adult patients who initiated upadacitinib between July 2021 and November 2024 were included. Symptom-based clinical activity was assessed using patient-reported outcomes (PRO2) at baseline and six months. Adverse events (AEs) and surgical interventions were also documented. Results Forty patients (28 CD, 12 UC) were analyzed. At six months, symptom-based clinical remission was achieved in 82.4% of CD and 81.8% of UC patients, with clinical response rates of 88.2% and 90.9%, respectively. No clinical or treatment-related factors were significantly associated with remission in univariate analyses. AEs occurred in 57.5% of patients, all grade 1, and no treatment discontinuations were required. Conclusion Upadacitinib was effective and well tolerated over six months in Korean patients with moderate-to-severe IBD, including those with prior biologic experienced. These findings support its use in routine clinical practice, while highlighting the need for prospective studies to confirm its long-term safety and efficacy in Asian populations. References: 1.Chovatiya R, Paller AS. JAK inhibitors in the treatment of atopic dermatitis. J Allergy Clin Immunol 2021;148:927–940. 2.Fayand A, Hentgen V, Posseme C, et al. Successful treatment of JAK1-associated inflammatory disease. J Allergy Clin Immunol 2023;152:972–983. 3. Ahn SH, Lee YJ, Lim DS, et al. Upadacitinib counteracts hepatic lipid deposition via the repression of JAK1/STAT3 signaling and AMPK/autophagy-mediated suppression of ER stress. Biochem Biophys Res Commun 2024;735:150829. 4. Parmentier JM, Voss J, Graff C, et al. In vitro and in vivo characterization of the JAK1 selectivity of upadacitinib (ABT-494). BMC Rheumatol 2018;2:23. 5.Harris C, Cummings JRF. JAK1 inhibition and inflammatory bowel disease. Rheumatology (Oxford) 2021;60:ii45–ii51. 6. Sandborn WJ, Ghosh S, Panes J, et al. Efficacy of Upadacitinib in a Randomized Trial of Patients With Active Ulcerative Colitis. Gastroenterology 2020;158:2139–2149.e2114. 7. Danese S, Vermeire S, Zhou W, et al. Upadacitinib as induction and maintenance therapy for moderately to severely active ulcerative colitis: results from three phase 3, multicentre, double-blind, randomised trials. Lancet 2022;399:2113–2128. 8.Loftus EV, Jr., Panés J, Lacerda AP, et al. Upadacitinib Induction and Maintenance Therapy for Crohn’s Disease. N Engl J Med 2023;388:1966–1980. 9.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;158:2123–2138.e2128. 10. Runde J, Ryan K, Hirst J, et al. Upadacitinib is associated with clinical response and steroid-free remission for children and adolescents with inflammatory bowel disease. J Pediatr Gastroenterol Nutr 2025;80:133–140. 11. Friedberg S, Choi D, Hunold T, et al. Upadacitinib Is Effective and Safe in Both Ulcerative Colitis and Crohn’s Disease: Prospective Real-World Experience. Clin Gastroenterol Hepatol 2023;21:1913–1923.e1912. 12. Treuer T, Richards M, Mert C, et al. Dose Escalation Patterns and Associated Costs of Advanced Therapies for Ulcerative Colitis in France and the United Kingdom: A Retrospective Database Analysis. Clinicoecon Outcomes Res 2025;17:129–146. 13. A Special Meeting Review Edition: Highlights in Inflammatory Bowel Disease From the 14th Congress of ECCO. Gastroenterol Hepatol (N Y) 2019;15:1–24. 14. Nogami A, Asonuma K, Okabayashi S, et al. Real-World Comparative Effectiveness and Safety of Filgotinib and Upadacitinib for Ulcerative Colitis: A Multicentre Cohort Study. United European Gastroenterol J 2024;12:1357–1366. 15. Zheng DY, Wang YN, Huang YH, Jiang M, Dai C. Effectiveness and safety of upadacitinib for inflammatory bowel disease: A systematic review and meta-analysis of RCT and real-world observational studies. Int Immunopharmacol 2024;126:111229. 16. Puca P, Del Gaudio A, Iaccarino J, et al. Cancer Risk in IBD Patients Treated with JAK Inhibitors: Reassuring Evidence from Trials and Real-World Data. Cancers (Basel) 2025;17:735. 17.Winthrop KL, Nash P, Yamaoka K, et al. Incidence and risk factors for herpes zoster in patients with rheumatoid arthritis receiving upadacitinib: a pooled analysis of six phase III clinical trials. Ann Rheum Dis 2022;81:206–213. 18.Beckman JD, DaSilva A, Aronovich E, et al. JAK-STAT inhibition reduces endothelial prothrombotic activation and leukocyte-endothelial proadhesive interactions. J Thromb Haemost 2023;21:1366–1380. 19.Solitano V, Fiorino G, D’Amico F, Peyrin-Biroulet L, Danese S. Thrombosis in IBD in the Era of JAK Inhibition. Curr Drug Targets 2021;22:126–136. 20.Wu CY, Wang Q, Shi J, et al. Safety and Effectiveness of Baricitinib in Chinese Patients with Moderate-to-Severe Rheumatoid Arthritis: 24-Week Results from a Post-Marketing Safety Study. Rheumatol Ther 2023;10:1609–1622. 21.Hilley P, Con D, Choy MC, Srinivasan A, De Cruz P. Upadacitinib in end stage renal disease: A case of acute severe ulcerative colitis. JGH Open 2023;7:1012–1015. 22.Ytterberg SR, Bhatt DL, Mikuls TR, et al. Cardiovascular and Cancer Risk with Tofacitinib in Rheumatoid Arthritis. N Engl J Med 2022;386:316–326. 23.colitis in patients with and without prior exposure to anti-tumor necrosis factor α antibody. Intest Res 2025. 24.López-Sanromán A, Esplugues JV, Domènech E. Pharmacology and safety of tofacitinib in ulcerative colitis. Gastroenterol Hepatol 2021;44:39–48. 25. Harrington R, Harkins P, Conway R. Janus Kinase Inhibitors in Rheumatoid Arthritis: An Update on the Efficacy and Safety of Tofacitinib, Baricitinib and Upadacitinib. J Clin Med 2023;12:6690. Conflict of interest: Prof. Kim, Ji Eun: Nothing to declare Lee, Yeong Chan: Nothing to declare Kim, Minjee: Nothing to declare Kim, Eun Ran: Nothing to declare Chang, Dong Kyung: Nothing to declare Kim, Young-Ho: Nothing to declare Hong, Sung Noh: No conflict of interest