Intestinal Research

Original Articles

Efficacy and safety of mirikizumab in maintenance therapy for ulcerative colitis in difficult-to-treat inflammatory bowel disease: a single-center retrospective study in Japan: Ichiro Mizushima, Yusuke Yoshimatsu, Hiroki Kiyohara, Shinya Sugimoto, Tomohisa Sujino, Kaoru Takabayashi, Yohei Mikami, Takanori Kanai; Received August 13, 2025 Accepted November 19, 2025 Published online February 11, 2026; DOI: https://doi.org/10.5217/ir.2025.00176 [Epub ahead of print]

Abstract PDF Supplementary Material PubReader ePub: Background/Aims
Randomized controlled trials have confirmed the efficacy and safety of mirikizumab, an anti-interleukin-23p19 monoclonal antibody, for moderate-to-severe active ulcerative colitis (UC). However, there are no real-world data on the efficacy and safety of mirikizumab for UC as maintenance therapy, especially in difficult-to-treat inflammatory bowel disease (DTT-IBD). This study aimed to evaluate the long-term efficacy and safety of mirikizumab in patients with UC of DTT-IBD.
Methods
This was a single-center retrospective observational study involving adult patients with UC who received mirikizumab between January 2023 and April 2025 and met the criteria for DTT-IBD (e.g., failure of biologics and advanced small molecule drugs with at least 2 different mechanisms of action). The primary outcome was the clinical response at week 52. Secondary outcomes included steroid-free clinical remission within 52 weeks and the persistency of mirikizumab use. Adverse events were also recorded.
Results
Thirty-two patients were included in this study. The median 2-item patient-reported outcome score at baseline was 3 (interquartile range, 2–4). The proportion of patients with a clinical response at week 52 was 33.3% (95% confidence interval, 14.6%–57.0%). Steroid-free clinical remission was achieved in 26.7% (95% confidence interval, 12.3%–45.9%) of the patients. The cumulative continuous rate of mirikizumab use at week 52 was approximately 60%. Only 1 patient developed a serious adverse event requiring hospitalization (pneumonia), and mirikizumab was successfully resumed after recovery.
Conclusions
The present study demonstrated real-world data regarding maintenance therapy with mirikizumab for UC among patients with DTT-IBD.

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IBD

Ulcerative colitis-associated neoplasms often harbor poor prognostic histologic components with low detection by biopsy: Ryoya Sakakibara, Shinya Sugimoto, Kaoru Takabayashi, Hiroki Kiyohara, Yusuke Wakisaka, Yuta Kaieda, Miho Kawaida, Yusuke Yoshimatsu, Tomohisa Sujino, Naoki Hosoe, Motohiko Kato, Masayuki Shimoda, Yohei Mikami, Yasushi Iwao, Takanori Kanai; Intest Res 2024;22(4):428-438. Published online May 7, 2024; DOI: https://doi.org/10.5217/ir.2024.00006

Abstract PDF PubReader ePub

Background/Aims
Poorly differentiated adenocarcinoma, signet-ring cell carcinoma, and mucinous adenocarcinoma (por/sig/muc), which are considered to be histologic subtypes with a poor prognosis, occur more frequently with colitis-associated cancer than with sporadic tumors. However, their invasiveness and manifestations are unclear. This study aimed to determine the prevalence of the por/sig/muc component in ulcerative colitis-associated neoplasms (UCANs) and its association with invasiveness and to clarify its clinicohistologic and endoscopic features.
Methods
This retrospective observational study included patients diagnosed with ulcerative colitis-associated high-grade dysplasia or adenocarcinoma from 1997 to 2022 who were divided according to the presence or absence of a por/sig/muc component.
Results
Thirty-five patients had UCAN with a por/sig/muc component and 66 had UCAN without this component. The 5-year survival rate was significantly lower in the por/sig/muc group than in the tub group (67% vs. 96%, P= 0.001), which was attributed to disease above stage III and depth to below the subserosa. Biopsy-based diagnosis before resection detected a por/sig/muc component in only 40% of lesions (14/35). Lesions with a por/sig/muc component were prevalent even in the early stages: stage 0 (4/36, 11%), I (8/20, 40%), II (7/12, 58%), III (10/14, 71%), and IV (6/8, 75%).
Conclusions
This is the first investigation that shows UCANs with a por/sig/muc component tended to be deeply invasive and were often not recognized preoperatively. Endoscopists should be aware that UCAN often has a por/sig/muc component that is not always recognized on biopsy, and the optimal treatment strategy needs to be carefully considered.

Citations

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Underestimation of the horizontal extent of ulcerative colitis-associated neoplasia may lead to incomplete endoscopic resection and subsequent recurrence
Soichiro Murakami, Shinya Sugimoto, Yasushi Iwao, Kaoru Takabayashi, Hiroki Kiyohara, Yusuke Yoshimatsu, Ryoya Sakakibara, Yuta Kaieda, Arina Shigehara, Naoki Hosoe, Motohiko Kato, Yohei Mikami, Takanori Kanai
Therapeutic Advances in Gastroenterology.2026;[Epub] CrossRef
Adjustment of Surveillance Intervals for Ulcerative Colitis‐Associated Neoplasia Based on Disease Duration
Ryoya Sakakibara, Shinya Sugimoto, Yuta Kaieda, Hiroki Kiyohara, Yusuke Yoshimatsu, Kaoru Takabayashi, Soichiro Murakami, Miho Kawaida, Tomohisa Sujino, Naoki Hosoe, Motohiko Kato, Yasushi Iwao, Yohei Mikami, Takanori Kanai
Digestive Endoscopy.2025; 37(10): 1068. CrossRef
Characterization of Computed Tomography Colonography Findings of Ulcerative Colitis-Associated Neoplasia
Yuta Kaieda, Shinya Sugimoto, Tatsuya Suzuki, Shunsuke Matsumoto, Hiroki Kiyohara, Kaoru Takabayashi, Yusuke Yoshimatsu, Koji Okabayashi, Kohei Shigeta, Ryoya Sakakibara, Yusuke Wakisaka, Soichiro Murakami, Masahiro Jinzaki, Yasushi Iwao, Yohei Mikami, Ta
Inflammatory Bowel Diseases.2025;[Epub] CrossRef

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IBD

Risk of venous thromboembolism with a central venous catheter in hospitalized Japanese patients with inflammatory bowel disease: a propensity score-matched cohort study: Yasuhiro Aoki, Hiroki Kiyohara, Yohei Mikami, Kosaku Nanki, Takaaki Kawaguchi, Yusuke Yoshimatsu, Shinya Sugimoto, Tomohisa Sujino, Kaoru Takabayashi, Naoki Hosoe, Haruhiko Ogata, Yasushi Iwao, Takanori Kanai; Intest Res 2023;21(3):318-327. Published online February 10, 2023; DOI: https://doi.org/10.5217/ir.2022.00116

Abstract PDF Supplementary Material PubReader ePub

Background/Aims
Thromboprophylaxis is recommended for hospitalized patients with inflammatory bowel disease (IBD) in Western countries, although it is selectively administered to high-risk patients in East Asia. A central venous catheter (CVC) is commonly placed in patients with IBD. Although CVC placement is considered a risk factor for venous thromboembolism (VTE), the degree of increased risk in patients with IBD is uncertain. This study aimed to identify the risk of VTE with CVC placement in hospitalized Japanese patients with IBD without thromboprophylaxis.
Methods
This retrospective cohort study included patients with ulcerative colitis or Crohn’s disease who were admitted for disease flares at Keio University Hospital between January 2016 and December 2020. Patients who already had thrombosis or were administered any antithrombotic treatment on admission were excluded. VTE development during the hospitalization was surveyed, and VTE risk associated with CVC indwelling was estimated using propensity score matching and inverse probability of treatment weighting analyses.
Results
Altogether, 497 hospitalized patients with IBD (ulcerative colitis, 327; Crohn’s disease, 170) were enrolled. VTE developed in 9.30% (12/129) of catheterized patients and in 0.82% (3/368) of non-catheterized patients. The propensity score matching yielded 127 matched pairs of patients. The catheterized group demonstrated higher odds for VTE than the non-catheterized group (odds ratio, 13.15; 95% confidence interval, 1.68–102.70). A similar result was obtained in the inverse probability of treatment weighting analysis (odds ratio, 11.02; 95% confidence interval, 2.64–46.10).
Conclusions
CVC placement is a major risk factor for VTE among hospitalized Japanese patients with IBD without thromboprophylaxis.

Citations

Citations to this article as recorded by

Incidence of Venous Thromboembolism in Asian Patients With Inflammatory Bowel Disease: A Systematic Review and Meta‐Analysis
Joo Hye Song, Sung Ryul Shim, Dae Sung Kim, Hoon Sup Koo, Kyu Chan Huh
Journal of Gastroenterology and Hepatology.2025; 40(4): 774. CrossRef
Metabolic Disorders and Inflammatory Bowel Diseases
Hye Kyung Hyun, Jae Hee Cheon
Gut and Liver.2025; 19(3): 307. CrossRef
Coagulopathy and platelet abnormalities in patients with inflammatory bowel disease
Dae Sung Kim, Won Moon
The Korean Journal of Internal Medicine.2025; 40(6): 866. CrossRef
Safety and effectiveness of tofacitinib in Korean adult patients with ulcerative colitis: post-marketing surveillance study
Hyuk Yoon, Byong Duk Ye, Sang-Bum Kang, Kang-Moon Lee, Chang Hwan Choi, Joo-young Jo, Juwon Woo, Jae Hee Cheon
BMC Gastroenterology.2024;[Epub] CrossRef

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Inflammatory bowel diseases

5-Aminosalicylic acid intolerance is associated with a risk of adverse clinical outcomes and dysbiosis in patients with ulcerative colitis: Shinta Mizuno, Keiko Ono, Yohei Mikami, Makoto Naganuma, Tomohiro Fukuda, Kazuhiro Minami, Tatsuhiro Masaoka, Soichiro Terada, Takeshi Yoshida, Keiichiro Saigusa, Norimichi Hirahara, Hiroaki Miyata, Wataru Suda, Masahira Hattori, Takanori Kanai; Intest Res 2020;18(1):69-78. Published online January 30, 2020; DOI: https://doi.org/10.5217/ir.2019.00084

Abstract PDF Supplementary Material PubReader ePub

Background/Aims
5-Aminosalicylic acid (ASA) causes intolerance reactions in some patients. This study was performed to examine the prognosis of patients with ulcerative colitis (UC) and 5-ASA intolerance, and to evaluate the potential interaction between 5-ASA intolerance and the intestinal microbiota.
Methods
We performed a retrospective cohort study of patients with UC who visited participating hospitals. The primary endpoint was to compare the incidence of hospitalization within 12 months between the 5-ASA intolerance group and the 5-ASA tolerance group. The secondary endpoint was to compare the risk of adverse clinical outcomes after the start of biologics between the 2 groups. We also assessed the correlation between 5-ASA intolerance and microbial change in an independently recruited cohort of patients with UC.
Results
Of 793 patients, 59 (7.4%) were assigned to the 5-ASA intolerance group and 734 (92.5%) were assigned to the 5-ASA tolerance group. The admission rate and incidence of corticosteroid use were significantly higher in the intolerance than tolerance group (P< 0.001). In 108 patients undergoing treatment with anti-tumor necrosis factor biologics, 5-ASA intolerance increased the incidence of additional induction therapy after starting biologics (P< 0.001). The 5-ASA intolerance group had a greater abundance of bacteria in the genera Faecalibacterium, Streptococcus, and Clostridium than the 5-ASA tolerance group (P< 0.05).
Conclusions
In patients with UC, 5-ASA intolerance is associated with a risk of adverse clinical outcomes and dysbiosis. Bacterial therapeutic optimization of 5-ASA administration may be important for improving the prognosis of patients with UC.

Citations

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Ayumi Ito, Shun Murasugi, Miki Koroku, Maria Yonezawa, Teppei Omori, Shinichi Nakamura, Katsutoshi Tokushige, Yousuke Nakai
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Association of Proton Pump Inhibitor and Potassium‐Competitive Acid Blocker Use With Discontinuation and Intolerance of Oral 5‐Aminosalicylic Acid in Patients With Ulcerative Colitis
Shinsuke Otagiri, Takahiro Ito, Keiji Yagisawa, Ayumu Sugitani, Atsuo Maemoto
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Review

Immunological Abnormalities in the Pathogenesis of Inflammatory Bowel Disease: Tadakazu Hisamatsu, Yohei Mikami, Katsuyoshi Matsuoka, Takanori Kanai, Toshifumi Hibi; Intest Res 2012;10(4):317-323. Published online October 31, 2012; DOI: https://doi.org/10.5217/ir.2012.10.4.317

Abstract PDF

Crohn's disease and ulcerative colitis represent two distinct forms of inflammatory bowel diseases (IBD). In this paper, we discuss how immunological mechanisms contribute to the pathogenesis of IBD. Intestinal homeostasis is sustained by various kinds of cells, such as epithelial cells, lymphocytes, antigen presenting cells, and other innate immune cells. We pay special attention to intestinal CD14+ macrophages. Intestinal macrophages play a central role in the regulation of immune responses against commensal bacteria. In the physiological condition, intestinal macrophages lack the expression of innate-immune receptor CD14 and do not produce proinfl ammatory cytokines. We identified a unique macrophage subset of IBD in the human intestine, which expressed both macrophage (CD14, CD33, CD68) and dendritic cell (DC) markers (CD205, CD209) and produced larger amounts of proinflammatory cytokines, such as interleukin (IL)-23 and tumor necrosis factor (TNF)-Ձ. In addition, the CD14+ macrophages contributed to interferon (IFN)-Ճ production rather than IL-17 production by lamina propria mononuclear cells dependent on IL-23. We discuss herein this IL-23/IFN-Ճ-positive feedback loop in IBD patients. We also discuss IFN-Ճ and IL-17 production from mucosal T cells and natural killer (NK) cells. Here, we show our recent findings about the plasticity of T helper cells in colitis. Th 17 cells express T-bet, and finally lose the expression of retinoic acid-related orphan receptor (ROR)Ճt, the master regulator of Th 17 cells, and are differentiated 'alternative Th 1 cells.' In addition to Th 1 cells, mucosal NK cells are also important sources of IFN-Ճ. Some of our ideas may be provocative, but we hope this review paper will provide new and firm understanding of the pathogenesis of IBD. (Intest Res 2012;10:317-323)

Citations

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