P0633 Real World Outcomes of Upadacitinib Induction Therapy for Patient with Inflammatory Bowel Disease in Korea

Abstract Background Upadacitnib (UPA) has demonstrated efficacy and safety in both patients with Crohn’s disease (CD) and ulcerative colitis (UC) in pivotal clinical trials.1,2 Still, there is a lack of data on real-world effectiveness and safety of UPA for Asian patients with IBD. Methods We retrospectively analysed data of patients with IBD who received UPA induction therapy. Clinical effectiveness (excluding those in clinical remission at baseline), endoscopic outcomes (UC), biochemical outcomes and safety were evaluated (at week 12 in CD and at week 16 in UC). Clinical remission was defined as follows: clinical response together with Crohn’s disease activity index [CDAI] <150) (CD) and partial Mayo score ≤2 with combined rectal bleeding [RB] score and stool frequency score ≤1 (UC). Definitions for clinical response were a reduction of the CDAI score ≥100 from baseline in CD and a reduction of partial Mayo score ≥3 together with at least 30% from baseline and decrease in RB score ≥1 or absolute RB score ≤1 in UC. Endoscopic remission was defined as Mayo Endoscopic subscore [MES] =0 or Ulcerative Colitis Endoscopic Index of Severity [UCEIS] =0 and endoscopic response as a reduction of MES ≥1 or reduction of UCEIS ≥2. Results From September 2023 to October 2024, a total of 89 patients with IBD initiated UPA induction therapy. Among those patients, 53 patients (39 with CD and 14 with UC) completed induction therapy, while one patient with UC discontinued UPA three weeks after initiation of UPA due to worsening symptoms of UC. Median disease duration was 10 years, and 27 (50.0%) had been exposed to more than one advanced therapy. Of the CD patients, 27 (68.2%) exhibited either stricturing or penetrating behaviour. Among UC patients, 9 (60.0%) had extensive disease (Table 1). In patients with CD, clinical remission and clinical response were observed in 8/23 (34.8%) and 10/23 (43.5%), respectively. In patients with UC, clinical remission and clinical response were observed in 9/13 (69.2%) and in 9/13 (69.2%), respectively. Endoscopic remission and endoscopic response were observed in 5/15 (33.3%) and 10/14 (71.4%), respectively. In both CD and UC patients, disease activity scores and biomarker levels showed decreasing trends throughout the induction period (Figure 1). During the induction therapy, acne was reported in 12/54 patients (22.2%), without any other significant adverse events such as Herpes zoster, deep vein thrombosis, and major adverse cardiovascular events. Conclusion UPA induction therapy was effective for Korean patients with refractory IBD with an acceptable safety profile. Financial support This work was supported by the National Research Foundation of Korea (NRF) grant funded by the Korea government (MSIT) (NRF-2021R1A2C2095096). References 1.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. 2.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.