P0742 Real-world efficacy and safety of Upadacitinib in IBD patients. Preliminary data from the Apulian Network for Inflammatory Bowel Disease (AN-IBD)

Abstract Background Upadacitinib is a selective Jak-1 inhibitor approved for treating Inflammatory Bowel disease (IBD). Its efficacy and safety have been assessed in pivotal trials. Few real-world experiences of Upadacitinib in IBD patients have been published so far. We aimed to investigate the effectiveness and safety of Upadacitinib in a cohort of IBD patients in clinical practice. Methods This multicenter, observational study was performed among the Apulian Network for Inflammatory Bowel Disease (AN-IBD). All consecutive patients with IBD starting Upadacitinib from its introduction were included. Results We enrolled 68 patients with Ulcerative Colitis (UC) and 9 with Crohn’s Disease (CD. The mean age of the patients was 40.2 ± 14.2 (range 19 - 74) and 45.3 ± 11.8 (range 26 - 62) for UC and CD, respectively. Regarding gender, 51 patients were male (66.2%). The mean disease duration was 11.8 ± 8.4 (range 3 - 31) for UC patients and 11.4 ± 8.6 (range 2 - 26) for CD patients. As for disease extension, patients with UC were divided into three groups: pancolitis (n=31, 45.5%), distal colitis (n=33, 48.5%), and proctitis (n=4, 6%). In CD patients, 5 had ileitis (55.6%), 2 colitis (22%), 1 ileocolitis (11.2%) and 1 jejunoileitis (11.2%). The response and remission rates after 8 weeks were 39% and 52% in UC patients. The response and remission rates after 12 weeks were 66% and 16% in CD patients. The primary non-response rate was 9.5% and 16% in UC and CD, respectively. Regarding safety, two cases of herpes reactivation were observed (1 herpes zoster in a non-vaccinated patient, and 1 herpes simplex infection, both managed with antiviral therapy). One patient experienced mild anemia, rapidly corrected after switching to 15 mg/day. One non-responder underwent an urgent colectomy. Conclusion These preliminary data confirm the efficacy of upatacitinib in inducing responses in IBD patients (both UC and CD) with a very low rate of primary failure. No new safety issues were identified.