Intestinal Research

IBD

Real-world effectiveness and safety of carotegrast methyl in patients with ulcerative colitis: a multicenter retrospective cohort study: Ryoji Koshiba, Kazuki Kakimoto, Takuya Inoue, Makoto Sanomura, Mitsuyuki Murano, Hiroaki Ito, Yoshihiko Nakanishi, Ken Kawakami, Noboru Mizuta, Keijiro Numa, Naohiko Kinoshita, Kei Nakazawa, Azusa Hara, Yuki Hirata, Naokuni Sakiyama, Shoko Arimitsu, Takako Miyazaki, Shiro Nakamura, Hiroki Nishikawa; Intest Res 2026;24(2):316-328. Published online August 12, 2025; DOI: https://doi.org/10.5217/ir.2025.00066

Background/Aims
Carotegrast methyl is a novel small-molecule drug that inhibits α4 integrin. It is prescribed for up to 6 months in patients with moderate ulcerative colitis who have demonstrated an inadequate response to or intolerance of 5-aminosalicylic acid. However, only a few clinical trials have been conducted to assess its effectiveness. This study aimed to evaluate the efficacy and safety of carotegrast methyl in patients with ulcerative colitis.
Methods
This multicenter retrospective study included patients with active ulcerative colitis treated with carotegrast methyl between March 2022 and October 2024. The primary outcome was the clinical remission rate following treatment with carotegrast methyl. Secondary outcomes included the clinical response rate, predictors of clinical remission, ulcerative colitis relapse rate after discontinuing carotegrast methyl, and incidence of adverse events.
Results
This study included 62 patients who received carotegrast methyl treatment. The median duration of administration was 84 days, with 48.4% of patients achieving clinical remission at the time of carotegrast methyl discontinuation. In 42 patients with corticosteroid/advanced therapies-naive disease, the clinical remission rate was 54.8%. Multivariate analysis identified the baseline partial Mayo score as an independent predictor of clinical remission. Among those who achieved clinical remission, 34.8% experienced a relapse with a median time to relapse of 152 days. Adverse events occurred in 8 patients, but none were serious.
Conclusions
Carotegrast methyl demonstrated good efficacy and safety, potentially benefiting patients with low baseline disease activity. This drug may be a useful treatment option to consider before systemic corticosteroid therapy for ulcerative colitis.

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Small Molecules as Advanced Therapy for the Treatment of Inflammatory Bowel Disease, Particularly Regarding Ulcerative Colitis
Toshiyuki Sakurai, Masayuki Saruta
Internal Medicine.2026;[Epub] CrossRef
Integrin Inhibitors for Ulcerative Colitis Treatment
Takanao Tanaka, Keiichi Tominaga, Shunsuke Kojimahara, Mimari Kanazawa, Akira Yamamiya, Takeshi Sugaya, Atsushi Irisawa
Digestion.2025; : 1. CrossRef

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IBD

Depressed lesion detected during surveillance colonoscopy in a patient with ulcerative colitis: Keijiro Numa, Kazuki Kakimoto, Noboru Mizuta, Naohiko Kinoshita, Kei Nakazawa, Ryoji Koshiba, Yuki Hirata, Ken Kawakami, Takako Miyazaki, Shiro Nakamura, Hiroki Nishikawa; Intest Res 2026;24(1):189-191. Published online July 23, 2025; DOI: https://doi.org/10.5217/ir.2025.00051

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IBD

Usefulness of fecal calprotectin by monoclonal antibody testing in adult Japanese with inflammatory bowel diseases: a prospective multicenter study: Shiro Nakamura, Hirotsugu Imaeda, Hiroki Nishikawa, Masaki Iimuro, Minoru Matsuura, Hideo Oka, Junsuke Oku, Takako Miyazaki, Hirohito Honda, Kenji Watanabe, Hiroshi Nakase, Akira Andoh; Intest Res 2018;16(4):554-562. Published online October 10, 2018; DOI: https://doi.org/10.5217/ir.2018.00027

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Background/Aims
Noninvasive objective monitoring is advantageous for optimizing treatment strategies in patients inflammatory bowel disease (IBD). Fecal calprotectin (FCP) is superior to traditional biomarkers in terms of assessing the activity in patients with IBD. However, there are the differences among several FCP assays in the dynamics of FCP. In this prospective multicenter trial, we investigated the usefulness of fecal FCP measurements in adult Japanese patients with IBD by reliable enzyme immunoassay using a monoclonal antibody.
Methods
We assessed the relationship between FCP levels and disease or endoscopic activity in patients with ulcerative colitis (UC, n=64) or Crohn’s disease (CD, n=46) compared with healthy controls (HCs, n=64).
Results
FCP levels in UC patients strongly correlated with the Disease Activity Index (rs=0.676, P<0.0001) and Mayo endoscopic subscore (MES; rs=0.677, P<0.0001). FCP levels were significantly higher even in patients with inactive UC or CD compared with HCs (P=0.0068, P<0.0001). The optimal cutoff value between MES 1 and 2 exhibited higher sensitivity (94.1%). FCP levels were significantly higher in active UC patients than in inactive patients (P<0.001), except those with proctitis. The Crohn’s Disease Activity Index tended to correlate with the FCP level (rs=0.283, P=0.0565).
Conclusions
Our testing method using a monoclonal antibody for FCP was well-validated and differentiated IBD patients from HCs. FCP may be a useful biomarker for objective assessment of disease activity in adult Japanese IBD patients, especially those with UC.

Citations

Citations to this article as recorded by

Combining mechanistic modeling with machine learning as a strategy to predict inflammatory bowel disease clinical scores
Jaehee V. Shim, Markus Rehberg, Britta Wagenhuber, Piet H. van der Graaf, Douglas W. Chung
Frontiers in Pharmacology.2025;[Epub] CrossRef
Treatment escalation and de-escalation decisions in Crohn’s disease: Delphi consensus recommendations from Japan, 2021
Hiroshi Nakase, Motohiro Esaki, Fumihito Hirai, Taku Kobayashi, Katsuyoshi Matsuoka, Minoru Matsuura, Makoto Naganuma, Masayuki Saruta, Kiichiro Tsuchiya, Motoi Uchino, Kenji Watanabe, Tadakazu Hisamatsu, Akira Andoh, Shigeki Bamba, Motohiro Esaki, Mikihi
Journal of Gastroenterology.2023; 58(4): 313. CrossRef
Mucosal concentrations of N‐acetyl‐5‐aminosalicylic acid related to endoscopic activity in ulcerative colitis patients with mesalamine
Tomohiro Fukuda, Makoto Naganuma, Kaoru Takabayashi, Yuya Hagihara, Shun Tanemoto, Ena Nomura, Yusuke Yoshimatsu, Shinya Sugimoto, Kosaku Nanki, Shinta Mizuno, Yohei Mikami, Kayoko Fukuhara, Tomohisa Sujino, Makoto Mutaguchi, Nagamu Inoue, Haruhiko Ogata,
Journal of Gastroenterology and Hepatology.2020; 35(11): 1878. CrossRef
Clinical management for small bowel of Crohn’s disease in the treat-to-target era: now is the time to optimize treatment based on the dominant lesion
Kenji Watanabe
Intestinal Research.2020; 18(4): 347. CrossRef

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