Intestinal Research

Original Article

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: Ji Eun Baek, Min Kyu Kim, Eun Soo Kim, Kyeong Ok Kim, Hyeong Ho Jo, Sung Wook Hwang, Sang Hyoung Park, Byung Ik Jang, Eun Young Kim, Sung Kook Kim, Suk-Kyun Yang, Byong Duk Ye; Received October 12, 2025 Accepted December 30, 2025 Published online April 20, 2026; DOI: https://doi.org/10.5217/ir.2025.00258 [Epub ahead of print]

Abstract PDF Supplementary Material PubReader ePub: 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.

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Review

Microbiota

Gut microbiome on immune checkpoint inhibitor therapy and consequent immune-related colitis: a review: Sung Wook Hwang, Min Kyu Kim, Mi-Na Kweon; Intest Res 2023;21(4):433-442. Published online August 29, 2023; DOI: https://doi.org/10.5217/ir.2023.00019

Abstract PDF PubReader ePub

Immune checkpoint inhibitors have dramatically revolutionized the therapeutic landscape for patients with advanced malignancies. Recently, convincing evidence has shown meaningful influence of gut microbiome on human immune system. With the complex link between gut microbiome, host immunity and cancer, the variations in the gut microbiota may influence the efficacy of immune checkpoint inhibitors. Indeed, some bacterial species have been reported to be predictive for cancer outcome in patients treated with immune checkpoint inhibitors. Although immune checkpoint inhibitors are currently proven to be an effective anti-tumor treatment, they can induce a distinct form of toxicity, termed immune-related adverse events. Immune-related colitis is one of the common toxicities from immune checkpoint inhibitors, and it might preclude the cancer therapy in severe or refractory cases. The manipulation of gut microbiome by fecal microbiota transplantation or probiotics administration has been suggested as one of the methods to enhance anti-tumor effects and decrease the risk of immune-related colitis. Here we review the role of gut microbiome on immune checkpoint inhibitor therapy and consequent immune-related colitis to provide a new insight for better anti-cancer therapy.

Citations

Citations to this article as recorded by

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