Intestinal Research

Original Articles

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; Received April 25, 2025 Accepted June 30, 2025 Published online August 12, 2025; DOI: https://doi.org/10.5217/ir.2025.00066 [Epub ahead of print]

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

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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

Understanding fatigue among Japanese patients with inflammatory bowel disease: insights from international comparisons and meta-analysis: Makoto Tanaka, Momoko Takai, Sayaka Wakai, Kayoko Sakagami, Hiroaki Ito; Intest Res 2025;23(3):372-381. Published online January 22, 2025; DOI: https://doi.org/10.5217/ir.2024.00145

Abstract PDF Supplementary Material PubReader ePub

Background/Aims
Fatigue is a common symptom in patients with inflammatory bowel disease (IBD). The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale has demonstrated reliability and validity in assessing fatigue in patients with IBD and is used worldwide. This study aimed to examine the current state of fatigue among Japanese patients with IBD using the FACIT-F scale and to compare these findings with data from global studies through a systematic review.
Methods
Data from 488 patients with IBD treated at a specialized IBD clinic were analyzed. Patient characteristics, such as sex, age, disease duration, disease activity, FACIT-F scores, and sleep duration, were collected. A literature search identified 8 studies that met our inclusion criteria for an international comparison. A meta-analysis was performed on the Fatigue Subscale (FS) scores of FACIT-F to estimate the pooled mean.
Results
The mean FACIT-F (FS) score in this study was 39.9 ± 8.6. Four variables were significantly associated with fatigue: low Emotional Well-Being subscale scores, sleep duration < 6 hours, albumin level below the reference value, and being unmarried. The meta-analysis revealed that the pooled mean score was 40.2 (95% confidence interval, 39.5–40.9), and between-study heterogeneity was moderate (I² = 41%).
Conclusions
The FACIT-F (FS) scores and related factors in Japanese patients with IBD demonstrated a similar trend to those in other countries. These findings can be used to identify patients in need of support and to consider interventions for modifiable factors. This study will help promote international collaborative research.

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Sexual satisfaction and associated factors among patients with inflammatory bowel disease in Japan
Sayaka Wakai, Makoto Tanaka, Momoko Takai, Kayoko Sakagami, Hiroaki Ito
Japan Journal of Nursing Science.2025;[Epub] CrossRef

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Inflammatory Bowel Diseases

Efficacy and safety of a new vedolizumab subcutaneous formulation in Japanese patients with moderately to severely active ulcerative colitis: Taku Kobayashi, Hiroaki Ito, Toshifumi Ashida, Tadashi Yokoyama, Masakazu Nagahori, Tomoki Inaba, Mitsuhiro Shikamura, Takayoshi Yamaguchi, Tetsuharu Hori, Philippe Pinton, Mamoru Watanabe, Toshifumi Hibi; Intest Res 2021;19(4):448-460. Published online August 18, 2020; DOI: https://doi.org/10.5217/ir.2020.00026

Abstract PDF Supplementary Material PubReader ePub

Background/Aims
A subgroup analysis was conducted in Japanese patients with moderate to severe ulcerative colitis (UC) enrolled in the phase 3 VISIBLE 1 study, which evaluated the safety and efficacy of a new vedolizumab subcutaneous (SC) formulation.
Methods
Eligible patients received open-label infusions of vedolizumab 300 mg intravenous (IV) at weeks 0 and 2 in the induction phase. Patients with clinical response by complete Mayo score at week 6 entered the double-blind maintenance phase and were randomized to vedolizumab 108 mg SC every 2 weeks, placebo, or vedolizumab 300 mg IV every 8 weeks. The primary endpoint was clinical remission (complete Mayo score ≤ 2 points; no individual subscore > 1 point) at week 52.
Results
Of 49 patients who entered the induction phase, 22 out of 49 patients (45%) had clinical response at week 6 and were randomized to vedolizumab 108 mg SC (n = 10), placebo (n = 10), or vedolizumab 300 mg IV (n = 2). At week 52, 4 out of 10 patients (40%) who received vedolizumab SC had clinical remission versus 2 out of 10 patients (20%) who received placebo (difference: 20% [95% confidence interval, –27.9 to 61.8]). Two patients (2/10, 20%) who received vedolizumab SC experienced an injection-site reaction versus none who received placebo.
Conclusions
Our results indicate that the efficacy of vedolizumab SC in a subgroup of Japanese patients with UC are similar with those in the overall VISIBLE 1 study population, and with those established with vedolizumab IV. The safety and tolerability of vedolizumab SC were generally similar to that established for vedolizumab IV. (ClinicalTrials.gov ID NCT02611830; EudraCT 2015-000480-14)

Citations

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Valoración de la transición de vedolizumab intravenoso a subcutáneo en pacientes con enfermedad inflamatoria intestinal
Carmen Amor Costa, Cristina Suárez Ferrer, Laura García Ramírez, Eduardo Martín-Arranz, Joaquín Poza Cordón, José Luis Rueda García, María Sánchez Azofra, Irene González Diaz, Clara Amiama Roig, María Dolores Martín-Arranz
Gastroenterología y Hepatología.2025; 48(3): 502201. CrossRef
Evaluation of the transition from intravenous to subcutaneous vedolizumab in patients with inflammatory bowel disease
Carmen Amor Costa, Cristina Suárez Ferrer, Laura García Ramírez, Eduardo Martín-Arranz, Joaquín Poza Cordón, José Luis Rueda García, María Sánchez Azofra, Irene González Diaz, Clara Amiama Roig, María Dolores Martín-Arranz
Gastroenterología y Hepatología (English Edition).2025; 48(3): 502201. CrossRef
Treatment discontinuation rates due to lack of efficacy through 1 year of maintenance treatment with vedolizumab or subcutaneous infliximab in patients with inflammatory bowel disease: a systematic literature review and meta-analysis
Marc Ferrante, Laurent Peyrin-Biroulet, Perttu Arkkila, Alessandro Armuzzi, Jean-Frédéric Colombel, Silvio Danese, Roberto Faggiani, Jordi Guardiola, Stephen B. Hanauer, Jorgen Jahnsen, Walter Reinisch, Xavier Roblin, Philip J. Smith, Taek Sang Kwon, Seun
Therapeutic Advances in Gastroenterology.2025;[Epub] CrossRef
Vedolizumab subcutaneous formulation maintenance therapy for patients with IBD: a systematic review and meta-analysis
Qiong Hu, Xing-zhou Tang, Fang Liu, De-wu Liu, Bo Cao
Therapeutic Advances in Gastroenterology.2023;[Epub] CrossRef
Network meta-analysis on efficacy and safety of different biologics for ulcerative colitis
Xinqiao Chu, Yaning Biao, Chengjiang Liu, Yixin Zhang, Chenxu Liu, Ji-zheng Ma, Yufeng Guo, Yaru Gu
BMC Gastroenterology.2023;[Epub] CrossRef
Vedolizumab as the first line of biologic therapy for ulcerative colitis and Crohn's disease – a systematic review with meta-analysis
Mohamed Attauabi, Gorm Roager Madsen, Flemming Bendtsen, Jakob Benedict Seidelin, Johan Burisch
Digestive and Liver Disease.2022; 54(9): 1168. CrossRef
AJM300 (carotegrast methyl), an oral antagonist of α4-integrin, as induction therapy for patients with moderately active ulcerative colitis: a multicentre, randomised, double-blind, placebo-controlled, phase 3 study
Katsuyoshi Matsuoka, Mamoru Watanabe, Toshihide Ohmori, Koichi Nakajima, Tetsuya Ishida, Yoh Ishiguro, Kazunari Kanke, Kiyonori Kobayashi, Fumihito Hirai, Kenji Watanabe, Hidehiro Mizusawa, Shuji Kishida, Yoshiharu Miura, Akira Ohta, Toshifumi Kajioka, To
The Lancet Gastroenterology & Hepatology.2022; 7(7): 648. CrossRef
Microbial changes in stool, saliva, serum, and urine before and after anti-TNF-α therapy in patients with inflammatory bowel diseases
Yong Eun Park, Hye Su Moon, Dongeun Yong, Hochan Seo, Jinho Yang, Tae-Seop Shin, Yoon-Keun Kim, Jin Ran Kim, Yoo Na Lee, Young-Ho Kim, Joo Sung Kim, Jae Hee Cheon
Scientific Reports.2022;[Epub] CrossRef
Effectiveness and Safety of Golimumab in Patients with Ulcerative Colitis: A Multicenter, Prospective, Postmarketing Surveillance Study
Jongwook Yu, Soo Jung Park, Hyung Wook Kim, Yun Jeong Lim, Jihye Park, Jae Myung Cha, Byong Duk Ye, Tae Oh Kim, Hyun-Soo Kim, Hyun Seok Lee, Su Young Jung, Youngdoe Kim, Chang Hwan Choi
Gut and Liver.2022; 16(5): 764. CrossRef
Inflammatory Bowel Disease Patients’ Acceptance for Switching from Intravenous Infliximab or Vedolizumab to Subcutaneous Formulation: The Nancy Experience
Clotilde Remy, Bénédicte Caron, Celia Gouynou, Vincent Haghnejad, Elodie Jeanbert, Patrick Netter, Silvio Danese, Laurent Peyrin-Biroulet
Journal of Clinical Medicine.2022; 11(24): 7296. CrossRef
Targeting Immune Cell Trafficking – Insights From Research Models and Implications for Future IBD Therapy
Maximilian Wiendl, Emily Becker, Tanja M. Müller, Caroline J. Voskens, Markus F. Neurath, Sebastian Zundler
Frontiers in Immunology.2021;[Epub] CrossRef
Subcutaneous vedolizumab in moderately to severely active ulcerative colitis or Crohn’s disease: a profile of its use
Sheridan M. Hoy
Drugs & Therapy Perspectives.2021; 37(12): 563. CrossRef
AJM300 (Carotegrast Methyl), an Oral Antagonist of α4-Integrin, as Induction Therapy for Patients with Moderately Active Ulcerative Colitis: A Multicentre, Randomised, Double-Blind, Placebo-Controlled Phase 3 Study
Katsuyoshi Matsuoka, Mamoru Watanabe, Toshihide Ohmori, Kouichi Nakajima, Tetsuya Ishida, Yoh Ishiguro, Kazunari Kanke, Kiyonori Kobayashi, Fumihito Hirai, Kenji Watanabe, Hidehiro Mizusawa, Shuji Kishida, Yoshiharu Miura, Akira Ohta, Toshifumi Kajioka, T
SSRN Electronic Journal .2021;[Epub] CrossRef

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Efficacy and safety of two pH-dependent-release mesalamine doses in moderately active ulcerative colitis: a multicenter, randomized, double-blind, parallel-group study: Yasuo Suzuki, Mitsuo Iida, Hiroaki Ito, Isamu Saida, Toshifumi Hibi; Intest Res 2016;14(1):50-59. Published online January 26, 2016; DOI: https://doi.org/10.5217/ir.2016.14.1.50

Abstract PDF PubReader ePub

<b>Background/Aims</b><br/>

The therapeutic effect of mesalamine is considered to be dose-dependent; however, no consensus has been reached regarding the optimal doses for individual patients. This study aimed to provide new insight for dose optimization using two doses of pH-dependent release mesalamine for induction of remission of moderately active ulcerative colitis (UC).

Methods

In a multicenter, double-blind, randomized study, 110 patients with moderately active UC were assigned to two groups after treatment with a constant dose of mesalamine. Fifty-five patients were treated with a pH-dependent release formulation of 3.6 or 4.8 g/day for 8 weeks. The primary endpoint was a decrease in the UC disease activity index (UCDAI) adjusted by covariates.

Results

In the full analysis set (n=110), the mean decrease in UCDAI was 3.1 in the 3.6 g/day group and 3.4 in the 4.8 g/day group (P>0.05). In a subgroup analysis, the effectiveness of the 4.8 g/day dose was greater in particular populations, such as those who had been previously treated with a lower dose of mesalamine and those with more severe disease. The safety was comparable between the two groups.

Conclusions

The results suggest that treatment with pH-dependent release mesalamine at either 3.6 or 4.8 g/day was effective and safe for the induction of remission in patients with moderately active UC. However, the patients receiving mesalamine at 2.4 g/day but in whom the therapeutic effect is not sufficient and having more severe symptoms (UCDAI 9-10), benefit from higher doses of mesalamine compared to others.

Citations

Citations to this article as recorded by

Colitis and Crohn’s Foundation (India) consensus statements on use of 5-aminosalicylic acid in inflammatory bowel disease
Ajit Sood, Vineet Ahuja, Vandana Midha, Saroj Kant Sinha, C. Ganesh Pai, Saurabh Kedia, Varun Mehta, Sawan Bopanna, Philip Abraham, Rupa Banerjee, Shobna Bhatia, Karmabir Chakravartty, Sunil Dadhich, Devendra Desai, Manisha Dwivedi, Bhabhadev Goswami, Kir
Intestinal Research.2020; 18(4): 355. CrossRef
Nonimmunity against hepatitis B virus infection in patients newly diagnosed with inflammatory bowel disease
Seong Jae Yeo, Hyun Seok Lee, Byung Ik Jang, Eun Soo Kim, Seong Woo Jeon, Sung Kook Kim, Kyeong Ok Kim, Yoo Jin Lee, Hyun Jik Lee, Kyung Sik Park, Yun Jin Jung, Eun Young Kim, Chang Heon Yang
Intestinal Research.2018; 16(3): 400. CrossRef
Comparison of efficacy of multimatrix mesalazine 4.8 g/day once-daily with other high-dose mesalazine in active ulcerative colitis: a randomized, double-blind study
Haruhiko Ogata, Nobuo Aoyama, Seiichi Mizushima, Atsushi Hagino, Toshifumi Hibi
Intestinal Research.2017; 15(3): 368. CrossRef
Remission endpoints in ulcerative colitis: A systematic review
Maki Jitsumura, Rory Frederick Kokelaar, Dean Anthony Harris
World Journal of Meta-Analysis.2017; 5(4): 85. CrossRef
Potential Benefits of Dietary Fibre Intervention in Inflammatory Bowel Disease
Celestine Wong, Philip Harris, Lynnette Ferguson
International Journal of Molecular Sciences.2016; 17(6): 919. CrossRef
What is the real-life maintenance mesalazine dose in ulcerative colitis?
Alicia Algaba, Iván Guerra, Ana García García de Paredes, María Hernández Tejero, Carlos Ferre, Daniel Bonillo, Lara Aguilera, Antonio López-Sanromán, Fernando Bermejo
Revista Española de Enfermedades Digestivas.2016;[Epub] CrossRef

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