Intestinal Research

IBD

Early resolution of bowel urgency by budesonide foam enema results in improved quality of life in patients with ulcerative colitis: a multicenter prospective observational study: Taku Kobayashi, Kei Moriya, Toshimitsu Fujii, Shigeki Bamba, Shinichiro Shinzaki, Akihiro Yamada, Takashi Hisabe, Shintaro Sagami, Shuji Hibiya, Takahiro Amano, Noritaka Takatsu, Katsutoshi Inagaki, Ken-ichi Iwayama, Toshifumi Hibi; Intest Res 2025;23(2):157-169. Published online July 15, 2024; DOI: https://doi.org/10.5217/ir.2024.00005

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Background/Aims
Bowel urgency is an important symptom for quality of life determination in patients with ulcerative colitis (UC). Few clinical studies have focused on bowel urgency as an efficacy endpoint. Budesonide foam enema has shown efficacy for clinical and endoscopic improvement in mild-to-moderate UC. We evaluated the improvement of clinical symptoms (bowel urgency), safety, and treatment impact of twice-daily budesonide foam enema on the quality of life in patients with UC.
Methods
This open-label, multicenter, prospective observational study comprised a 4-week observation period assessing the effectiveness and safety of twice-daily budesonide foam enema. Mild-to-moderate UC patients who had bowel urgency were included. Patients collected data daily in an electronic patient-reported outcome system or logbooks. The primary endpoint was the rate of resolution of bowel urgency at the end of the 4-week observation period. The rate of bowel incontinence was also assessed.
Results
Sixty-one patients were enrolled. Of patients with a final evaluation, the rate of resolution of bowel urgency was 58.5% (31/53; 95% confidence interval, 44.1%–71.9%). Bowel urgency decreased over time, with a significant difference observed on day 7 versus day 0. Bowel incontinence showed a decreasing trend from day 5, with a significant difference confirmed on day 12 versus day 0. The clinical remission rate was 64.4% (38/59; 95% confidence interval, 50.9%–76.4%). One adverse event not related to budesonide rectal foam occurred.
Conclusions
The findings suggest that bowel urgency can be improved early with twice-daily budesonide foam enema. No new safety signals were observed.

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The choice of treatment approach for mild and moderate ulcerative colitis: A review
Oleg V. Golovenko, Irina D. Loranskaia, Alexey M. Osadchuk
Consilium Medicum.2025; 27(12): 744. CrossRef

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IBD

Early change in serum leucine-rich α-2-glycoprotein predicts clinical and endoscopic response in ulcerative colitis: Ryo Karashima, Shintaro Sagami, Yoko Yamana, Masa Maeda, Aya Hojo, Yusuke Miyatani, Masaru Nakano, Takahisa Matsuda, Toshifumi Hibi, Taku Kobayashi; Intest Res 2024;22(4):473-483. Published online June 5, 2024; DOI: https://doi.org/10.5217/ir.2023.00135

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Background/Aims
Leucine-rich α-2-glycoprotein (LRG) is a new serum biomarker reflecting the disease activity of ulcerative colitis (UC), but its change during the acute phase has not been enough investigated.
Methods
Patients with UC who initiated the induction therapy with steroid or advanced therapy (biologics or Janus kinase inhibitors) were prospectively enrolled. Associations of LRG, C-reactive protein (CRP) and fecal calprotectin (FC) at baseline, week 1, and week 8 with clinical remission at week 8 and subsequent endoscopic improvement within 1 year (Mayo endoscopic subscore of 0 or 1) were assessed.
Results
A total of 143 patients with UC were included. LRG and CRP at week 1 were significantly lower in the clinical remission group than in the non-remission group (LRG, 20.6 μg/mL vs. 28.4 μg/mL, P< 0.001; CRP, 0.9 mg/dL vs. 2.3 mg/dL, P< 0.001) while FC demonstrated the difference between groups only at week 8. The area under the curves of week 1 LRG, CRP, and FC for week 8 clinical remission using the receiver operating characteristic curves analysis were 0.68, 0.71, and 0.57, respectively. Furthermore, LRG and CRP predicted subsequent endoscopic improvement as early as week 1, while FC was predictive only at week 8.
Conclusions
LRG can be an early-phase biomarker predicting subsequent clinical and endoscopic response to induction therapy.

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Role of leucine-rich α-2-glycoprotein in Taiwanese patients with inflammatory bowel disease as a predictive biomarker for endoscopic activity
Yun-Chu Chen, Meng-Tzu Weng, Feng-Pai Tsai, Zhi-Che Chen, Hsin-Yun Wu, Chien-Chih Tung, Chun-Ying Wang, Shu-Chen Wei
World Journal of Gastroenterology.2026;[Epub] CrossRef
The diagnostic accuracy of plasma and serum calprotectin is inferior to C-reactive protein in patients with suspected Crohn’s disease
M. H. Rasmussen, J. B. Brodersen, C. L. Brasen, J. S. Madsen, T. Knudsen, J. Kjeldsen, M. D. Jensen
Scandinavian Journal of Gastroenterology.2025; 60(3): 235. CrossRef
Changes of leucine-rich alpha 2 glycoprotein could be a marker of changes of endoscopic and histologic activity of ulcerative colitis
Yuki Aoyama, Sakiko Hiraoka, Eriko Yasutomi, Toshihiro Inokuchi, Takehiro Tanaka, Kensuke Takei, Shoko Igawa, Keiko Takeuchi, Masahiro Takahara, Junki Toyosawa, Yasushi Yamasaki, Hideaki Kinugasa, Jun Kato, Hiroyuki Okada, Motoyuki Otsuka
Scientific Reports.2025;[Epub] CrossRef
Real‐World Effectiveness and Safety of Mirikizumab Induction Therapy in Patients With Ulcerative Colitis: A Multicentre Retrospective Observational Study
Yasuhiro Takagi, Toshiyuki Sato, Takanori Nishiguchi, Akira Nogami, Masataka Igeta, Soichi Yagi, Maiko Ikenouchi, Mikio Kawai, Koji Kamikozuru, Yoko Yokoyama, Toshihiko Tomita, Hirokazu Fukui, Masayuki Fukata, Taku Kobayashi, Shinichiro Shinzaki
Alimentary Pharmacology & Therapeutics.2025; 61(12): 1923. CrossRef
Leucine-Rich Alpha-2 Glycoprotein 1 as a Biomarker for Evaluation of Inflammatory Bowel Disease Activity in Children
Betül Aksoy, Yeliz Çağan Appak, Murat Akşit, Serenay Çetinoğlu, Sinem Kahveci, Şenay Onbaşı Karabağ, Selen Güler, İlksen Demir, İnanç Karakoyun, Maşallah Baran
Journal of Clinical Medicine.2025; 14(8): 2803. CrossRef
Editorial: Real‐World Effectiveness of Mirikizumab in Ulcerative Colitis—A Valuable but Preliminary Glimpse. Authors' Reply
Shinichiro Shinzaki, Yasuhiro Takagi, Toshiyuki Sato
Alimentary Pharmacology & Therapeutics.2025; 61(12): 1967. CrossRef
Real-World Effectiveness of and Optimization Strategies for Mirikizumab in Pediatric Ulcerative Colitis: A Prospective, Observational Study
Keisuke Jimbo, Nobuyasu Arai, Mitsuyoshi Suzuki, Emiko Suzuki, Musashi Hibio, Masumi Nagata, Masamichi Sato, Eri Miyata, Eri Hoshino, Takahiro Kudo, Hiromichi Shoji
Inflammatory Bowel Diseases.2025;[Epub] CrossRef

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IBD

Individualized treatment based on CYP3A5 single-nucleotide polymorphisms with tacrolimus in ulcerative colitis: Shinji Okabayashi, Taku Kobayashi, Eiko Saito, Takahiko Toyonaga, Ryo Ozaki, Shintaro Sagami, Masaru Nakano, Junichi Tanaka, Keiji Yagisawa, Satoshi Kuronuma, Osamu Takeuchi, Toshifumi Hibi; Intest Res 2019;17(2):218-226. Published online February 7, 2019; DOI: https://doi.org/10.5217/ir.2018.00117

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Background/Aims
The pharmacokinetics of tacrolimus (TAC) is known to be largely influenced by single-nucleotide polymorphisms (SNPs) in CYP3A5. Patients starting TAC require careful dose adjustment, owing to the wide range of optimal dosages, depending on their CYP3A5 expression status. Here, we evaluated whether individualization of TAC dosages based on CYP3A5 SNPs would improve its therapeutic efficacy in ulcerative colitis.
Methods
Twenty-one patients were prospectively treated, with their initial dosage adjusted according to their CYP3A5 status (0.1, 0.15, and 0.2 mg/kg/day for CYP3A5*3/*3, CYP3A5*1/*3, and CYP3A5*1/*1, respectively). Their clinical outcomes were compared with those of patients treated with a fixed dose (0.1 mg/kg/day).
Results
The first blood trough level of CYP3A5 expressors, CYP3A5*1/*3 or CYP3A5*1/*1, and the overall rate in achieving the target blood trough level within a week in the individualized-dose group were significantly higher than those in the fixed-dose group (5.15±2.33 ng/mL vs. 9.63±0.79 ng/mL, P=0.035 and 12.5% vs. 66.7%, P=0.01). The remission rate at 2 weeks in the expressors was as high as that in the nonexpressors, CYP3A5*3/*3, in the individualized-dose group.
Conclusions
Individualized TAC treatment is effective against ulcerative colitis regardless of the CYP3A5 genotype.

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The impact of cytochrome P450 3A genetic polymorphisms on tacrolimus pharmacokinetics in ulcerative colitis patients
Maizumi Furuse, Shuhei Hosomi, Yu Nishida, Shigehiro Itani, Yuji Nadatani, Shusei Fukunaga, Koji Otani, Fumio Tanaka, Yasuaki Nagami, Koichi Taira, Noriko Kamata, Toshio Watanabe, Kenji Watanabe, Yasuhiro Fujiwara, Erika Cecchin
PLOS ONE.2021; 16(4): e0250597. CrossRef
Advances in research of tacrolimus for treatment of inflammatory bowel disease
Jing-Jing Wang, Yi-Hong Fan
World Chinese Journal of Digestology.2019; 27(13): 842. CrossRef

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