One-year effectiveness and safety of ustekinumab treatment in patients with ulcerative colitis: an Asan-Crohn’s and Colitis Association in Daegu-Gyeongbuk (CCAiD) multicenter real-world cohort study

Background/Aims: This study aimed to evaluate the 1-year effectiveness and safety of ustekinumab (UST) in Korean patients with ulcerative colitis (UC). Methods: We conducted a multicenter retrospective study of UC patients who received UST between January 2021 and October 2023. The primary endpoint was clinical remission at week (W) 8. Secondary endpoints included clinical remission at W16-20 and W52-56; corticosteroid-free clinical remission at W8, W16-20, and W52-56; clinical response at the same time points; endoscopic remission at W16-20 and W52-56; UST interval shortening and persistence through W52-56; and adverse events (AEs). Results: Sixty patients were included. After excluding one patient in clinical remission at baseline, 49.2% (29/59) achieved clinical remission at W8. Clinical remission rates were 59.3% (35/59) at W16-20 and 55.9% (33/59) at W52-56. Endoscopic remission was achieved in 15.3% (9/59) at W16-20 and 11.9% (7/59) at W52-56. The 12-month UST persistence rate was 84.9%. Multivariable analysis identified factors associated with clinical remission at W52-56: higher body mass index at baseline (adjusted odds ratio [aOR], 1.26; 95% confidence interval [CI], 1.00-1.57; P< 0.05), concomitant immunomodulator use (aOR, 4.69; 95% CI, 1.04-21.06; P= 0.04), and endoscopic improvement at W16-20 (aOR, 13.47; 95% CI, 2.87-63.30; P< 0.01), while prior exposure to advanced therapies was associated with lower remission (aOR, 0.20; 95% CI, 0.04-0.98; P< 0.05). AEs occurred in 24 patients (40.0%), with 1 serious AE (1.7%). Conclusions: UST showed favorable 1-year effectiveness and an acceptable safety profile in Korean patients with UC.