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Original Article
- 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
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Abstract
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ePub - 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. -
Citations
Citations to this article as recorded by
- 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
- Small Molecules as Advanced Therapy for the Treatment of Inflammatory Bowel Disease, Particularly Regarding Ulcerative Colitis
- 4,847 View
- 473 Download
- 2 Web of Science
- 2 Crossref
Images of the Issue
- 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
- 2,654 View
- 209 Download
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