Abstract Background Upadacitinib (UPA) has demonstrated efficacy and safety for Crohn’s disease (CD) and ulcerative colitis (UC) in pivotal trials.1,2 However, real-world data in Asian patients remain limited. Methods We conducted a retrospective multicentre study including patients with CD or UC who initiated UPA across six referral hospitals in Korea between September 2023 and January 2025. Clinical remission/response, endoscopic outcomes (UC), biochemical outcomes, and safety were evaluated (week 12/24/52 in CD; week 16/52 in UC). Clinical remission was defined as CDAI 150 together with clinical response (CD) and partial Mayo score ≤2 with combined rectal bleeding RB and stool frequency scores ≤1 (UC). Clinical response was defined as CDAI reduction ≥100 (CD) and reduction in partial Mayo score ≥3 with ≥30% decrease and RB score decrease ≥1 or absolute RB score ≤1 (UC). Endoscopic remission was defined as MES = 0 or UCEIS = 0; endoscopic response as ≥ 1-point MES reduction or ≥ 2-point UCEIS reduction. Biochemical remission (CRP remission and Faecal calprotectinFC remission) were defined as CRP 0.6 mg/dL (for those with baseline ≥0.6) and FC 250 µg/g (for those with baseline ≥250), respectively. Results A total of 187 patients (119 CD, 68 UC) were included. Among patients with CD, the median disease duration was 127 months and 87.4% had prior biologic exposure. Clinical remission was achieved in 50.0% (43/86), 49.4% (42/85), and 29.0% (9/31) at weeks 12, 24, and 52, while clinical response was achieved in 53.5% (46/86), 55.3% (47/85), and 32.3% (10/31), respectively (Figure 1). CRP remission was observed in 63.3% (38/60), 55.0% (33/60), and 37.0% (10/27), and FC remission in 26.2% (28/107), 26.2% (27/103), and 8.8% (3/34) at the corresponding time points. Among patients with UC, 76.5% had prior biologic exposure. Clinical remission was achieved in 83.1% (54/65) and 59.3% (16/27) at weeks 16 and 52, while clinical response was achieved in 83.1% (54/65) and 63.0% (17/27), respectively (Figure 1). Endoscopic remission was observed in 33.8% (23/68) and 31.0% (9/29), and endoscopic response in 69.1% (47/68) and 48.3% (14/29) at weeks 16 and 52. CRP remission achieved in 75.0% (33/44) and 50.0% (9/18), and FC remission in 28.8% (19/66) and 37.0% (10/27) at each time point. In UC, higher baseline serum albumin was associated with week 16 endoscopic remission (OR 4.95; 95% CI 1.59–20.8), and prior biologic exposure was negatively associated (OR 0.23; 95% CI 0.05–0.83). Acne was the most common adverse event (27.3%, 55.25/100 person-years), whereas serious adverse events were rare (Table 1). Conclusion UPA demonstrated favourable effectiveness and safety in Korean patients with IBD, with outcomes comparable to Western real-world data. 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. Conflict of interest: Ye, Byong Duk: Byong Duk Ye reports consulting fees from AbbVie Korea, BMS Pharmaceutical Korea Ltd., Celltrion, Chong Kun Dang Pharm, CJ Red BIO, Curacle, Daewoong Pharm, Dong-A ST, Ferring Korea, Hanmi Pharmaceutical, Imscout, IQVIA, Johnson & Johnson, Johnson & Johnson Korea, Jeil Pharmaceutical Co., Kangstem Biotech, Korea Otsuka Pharm, Korea United Pharm, Lilly Korea, Medtronic Korea, NanoEntek, ORGANOIDSCIENCES Ltd., Pfizer Korea, Samsung Bioepis, Takeda, Takeda Korea and Yuhan speaker fees from AbbVie Korea, BMS Pharmaceutical Korea Ltd., Celltrion, Cornerstones Health, Curacle, Daewoong Pharm, Eisai Korea, Ferring Korea, IQVIA, Johnson & Johnson Korea, Pfizer Korea, Samsung Bioepis, and Takeda Korea and research support from Celltrion and Pfizer Korea. Kim, Min Kyu: No conflicts Kim, Eun Soo: Personal Fees: I have served as a speaker or an advisory board member for AbbVie, Eli Lilly, J & J, Takeda Pharmaceutical, Bristol-Myers Squibb, Samsung Bioepis, Pfizer, Celltrion and Ferring Pharmaceuticals. Lee, Seung Bum: No conflicts Kang, Sang-Bum: “No conflicts” Seong-Joon, Koh: I have no conflict of interest Hwang, Sung Wook: no conflicts Park, Sang Hyoung: No conflicts Yoon, Hyuk: Consultancy and/or advisory roles for AbbVie Korea, BMS Pharmaceutical Korea Ltd., Celltrion, Daewoong Pharm, Eisai Korea, Ferring Korea, Janssen Korea, Pfizer Korea, Samsung Bioepis, Takeda Korea and Yuhan. Honoraria from AbbVie Korea, BMS Pharmaceutical Korea Ltd., Celltrion, Daewoong Pharm, Eisai Korea, Ferring Korea, Janssen Korea, Pfizer Korea, Samsung Bioepis, and Takeda Korea Byeon, Jeong-Sik: - Clinical study grants from Olympus Co, GC genome, Pharmbio Korea Inc, and Taejoon Pharm. Clinical studies related to the grants include artificial intelligence endoscopy for colon polyp detection/diagnosis, cfDNA for colorectal cancer screening, and colonoscopy bowel preparation. - I am a medical advisor of AINEX corporation, Korea, which is an AI endoscopy company.
Ye et al. (Thu,) studied this question.