Intestinal Research

Ken Takeuchi

4 Articles

Conventional Versus Biological Therapy for Prevention of Postoperative Endoscopic Recurrence in Patients With Crohn's Disease: an International, Multicenter, and Observational Study: Paulo Gustavo Kotze, Antonino Spinelli, Rodolff Nunes da Silva, Ivan Folchini de Barcelos, Fábio Vieira Teixeira, Rogério Saad-Hossne, Idblan Carvalho de Albuquerque, Marcia Olandoski, Lorete Maria da Silva Kotze, Yasuo Suzuki, Akihiro Yamada, Ken Takeuchi, Matteo Sacchi, Takayuki Yamamoto; Intest Res 2015;13(3):259-265. Published online June 9, 2015; DOI: https://doi.org/10.5217/ir.2015.13.3.259

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

Postoperative endoscopic recurrence (PER) occurs in nearly 80% of patients 1 year after ileocecal resection in patients with Crohn's disease (CD). Biological agents were more effective in reducing the rates of PER in comparison with conventional therapy, in prospective trials. The aim of this study was to compare the PER rates of biological versus conventional therapy after ileocecal resections in patients with CD in real-world practice.

Methods

The MULTIPER (Multicenter International Postoperative Endoscopic Recurrence) database is a retrospective analysis of PER rates in CD patients after ileocecal resection, from 7 referral centers in 3 different countries. All consecutive patients who underwent ileocecal resections between 2008 and 2012 and in whom colonoscopies had been performed up to 12 months after surgery, were included. Recurrence was defined as Rutgeerts' score ≥i2. The patients were allocated to either biological or conventional therapy after surgery, and PER rates were compared between the groups.

Results

Initially, 231 patients were evaluated, and 63 were excluded. Of the 168 patients in the database, 96 received anti-tumor necrosis factor agents and 72 were treated with conventional therapy after resection. The groups were comparable regarding age, gender, and perianal disease. There was longer disease duration, more previous resections, and more open surgical procedures in patients on biologicals postoperatively. PER was identified in 25/96 (26%) patients on biological therapy and in 24/72 (33.3%) patients on conventional therapy (P=0.310).

Conclusions

In this retrospective observational analysis from an international database, no difference was observed between biological and conventional therapy in preventing PER after ileocecal resections in CD patients.

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Are the New Biologics Effective in the Management of Postoperative Crohn’s Disease?
Fadi H Mourad, Rami G Maalouf, Roni Aoun, Paulo Gustavo Kotze, Jana G Hashash
Inflammatory Bowel Diseases.2024; 30(3): 459. CrossRef
How Reliable Is Endoscopic Scoring of Postoperative Recurrence in Crohn Disease?: A Systematic Review and Meta-Analysis
Eline M. L. van der Does de Willebois, Vittoria Bellato, Marjolijn Duijvestein, Susan van Dieren, Silvio Danese, Pierpaolo Sileri, Christianne J. Buskens, Andrea Vignali, Willem A. Bemelman
Annals of Surgery Open.2024; 5(1): e397. CrossRef
Trends in Surgical Recurrence Among Pediatric Crohn’s Disease Patients Using Administrative Claims Data
Matthew D Egberg, Xian Zhang, Michael Phillips, Michael D Kappelman
Crohn's & Colitis 360.2023;[Epub] CrossRef
Optimal strategies to prevent recrudescent Crohn's disease after resection
Natália Sousa Freitas Queiroz, Takayuki Yamamoto, Paulo Gustavo Kotze
Seminars in Colon and Rectal Surgery.2020; 31(2): 100746. CrossRef
Profile of Consecutive Fecal Calprotectin Levels in the Perioperative Period and Its Predictive Capacity for Early Endoscopic Recurrence in Crohn’s Disease
Ruiqing Liu, Zhen Guo, Lei Cao, Zhiming Wang, Jianfeng Gong, Yi Li, Weiming Zhu
Diseases of the Colon & Rectum.2019; 62(3): 318. CrossRef
Efficacy of restarting anti-tumor necrosis factor α agents after surgery in patients with Crohn's disease
Sakiko Hiraoka, Shiho Takashima, Yoshitaka Kondo, Toshihiro Inokuchi, Yuusaku Sugihara, Masahiro Takahara, Seiji Kawano, Keita Harada, Jun Kato, Hiroyuki Okada
Intestinal Research.2018; 16(1): 75. CrossRef
Factors affecting the incidence of early endoscopic recurrence after ileocolonic resection for Crohn's disease: a multicentre observational study
I. F. de Barcelos, P. G. Kotze, A. Spinelli, Y. Suzuki, F. V. Teixeira, I. C. de Albuquerque, R. Saad‐Hossne, L. M. da Silva Kotze, T. Yamamoto
Colorectal Disease.2017;[Epub] CrossRef
Disease Phenotype, Activity and Clinical Course Prediction Based on C-Reactive Protein Levels at Diagnosis in Patients with Crohn’s Disease: Results from the CONNECT Study
Jee Hye Kwon, Jong Pil Im, Byong Duk Ye, Jae Hee Cheon, Hyun Joo Jang, Kang Moon Lee, You Sun Kim, Sang Wook Kim, Young Ho Kim, Geun Am Song, Dong Soo Han, Won Ho Kim, Joo Sung Kim
Gut and Liver.2016; 10(4): 595. CrossRef

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Factors affecting 1-year persistence with vedolizumab for ulcerative colitis: a multicenter, retrospective real-world study: Taku Kobayashi, Tadakazu Hisamatsu, Satoshi Motoya, Toshimitsu Fujii, Reiko Kunisaki, Tomoyoshi Shibuya, Minoru Matsuura, Ken Takeuchi, Sakiko Hiraoka, Hiroshi Yasuda, Kaoru Yokoyama, Noritaka Takatsu, Atsuo Maemoto, Toshiyuki Tahara, Keiichi Tominaga, Masaaki Shimada, Nobuaki Kuno, Jovelle L. Fernandez, Kaori Ishiguro, Mary Cavaliere, Hisato Deguchi, Toshifumi Hibi; Received May 1, 2024 Accepted October 5, 2024 Published online January 16, 2025; DOI: https://doi.org/10.5217/ir.2024.00063 [Epub ahead of print]

Abstract PDF Supplementary Material PubReader ePub

Background/Aims
The objectives of this real-world study were to determine 1-year persistence with vedolizumab in patients with ulcerative colitis and to evaluate factors contributing to loss of response.
Methods
In this multicenter, retrospective, observational chart review, patients with moderately to severely active ulcerative colitis who received ≥ 1 dose of vedolizumab in clinical practice at 16 tertiary hospitals in Japan (from December 2018 through February 2020) were enrolled.
Results
Persistence with vedolizumab was 64.5% (n = 370); the median follow-up time was 53.2 weeks. Discontinuation due to loss of response among initial clinical remitters was reported in 12.5% (35/281) of patients. Multivariate analysis showed that concomitant use of tacrolimus (odds ratio [OR], 2.76; 95% confidence interval [CI], 1.00–7.62; P= 0.050) and shorter disease duration (OR for median duration ≥ 7.8 years vs. < 7.8 years, 0.33; 95% CI, 0.13–0.82; P= 0.017) were associated with discontinuation due to loss of response. Loss of response was not associated with prior use of anti-tumor necrosis factor alpha therapy, age at the time of treatment, disease severity, or concomitant corticosteroids or immunomodulators. Of the 25 patients with disease duration < 1 year, 32.0% discontinued due to loss of response.
Conclusions
Persistence with vedolizumab was consistent with previous reports. Use of tacrolimus and shorter disease duration were the main predictors of decreased persistence.

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Real‐World Effectiveness and Safety of Vedolizumab in Patients ≥ 70 Versus < 70 Years With Ulcerative Colitis: Multicenter Retrospective Study
Tadakazu Hisamatsu, Taku Kobayashi, Satoshi Motoya, Toshimitsu Fujii, Reiko Kunisaki, Tomoyoshi Shibuya, Minoru Matsuura, Sakiko Hiraoka, Ken Takeuchi, Hiroshi Yasuda, Kaoru Yokoyama, Noritaka Takatsu, Atsuo Maemoto, Toshiyuki Tahara, Keiichi Tominaga, Ma
Journal of Gastroenterology and Hepatology.2025; 40(6): 1435. CrossRef

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Efficacy and safety of etrasimod in Japanese patients with ulcerative colitis: results from a phase 2 dose-ranging study: Ken Takeuchi, Hiroshi Nakase, Tadakazu Hisamatsu, Katsuyoshi Matsuoka, Shoko Arai, Hirotoshi Yuasa, Motoki Oe, Ryosuke Ono, Michael Keating, Guibao Gu, Krisztina Lazin, Aoibhinn McDonnell, Koki Fukuta, Toshifumi Hibi; Received December 17, 2024 Accepted March 4, 2025 Published online April 25, 2025; DOI: https://doi.org/10.5217/ir.2024.00213 [Epub ahead of print]

Abstract PDF Supplementary Material PubReader ePub: Background/Aims
Etrasimod is an oral, once-daily, selective sphingosine 1-phosphate1,4,5 receptor modulator for the treatment of moderately to severely active ulcerative colitis (UC). However, its efficacy, safety, and the appropriate dosage have not been extensively investigated in the Japanese population.
Methods
This phase 2, multicenter, randomized, double-blind, placebo-controlled dose-ranging, 12-week trial was carried out among Japanese patients with moderately to severely active UC. Patients were randomized 1:1:1 to receive etrasimod 1 mg once daily (QD), etrasimod 2 mg QD, or placebo. The primary efficacy endpoint was the proportion of patients achieving clinical remission at week 12. Secondary efficacy endpoints and treatmentemergent adverse events (TEAEs) were also investigated. Efficacy endpoints were presented as proportions of patients achieving each outcome.
Results
Overall, 17, 19, and 18 patients received etrasimod 1 mg QD, etrasimod 2 mg QD, and placebo, respectively. One patient receiving etrasimod 1 mg (6.7%), 5 patients receiving etrasimod 2 mg (26.3%), and no patients receiving placebo (0%) achieved clinical remission. More patients receiving etrasimod versus placebo achieved secondary endpoints, except endoscopic normalization, at week 12. TEAEs were experienced by 9 patients receiving etrasimod 1 mg (52.9%), 13 patients receiving etrasimod 2 mg (68.4%), and 10 patients receiving placebo (55.6%). None of the TEAEs were serious and none experienced by patients receiving etrasimod led to treatment discontinuation.
Conclusions
Overall, etrasimod 2 mg QD for up to 12 weeks appeared efficacious and safe in these Japanese patients with moderately to severely active UC. All TEAEs were mild to moderate in severity. (ClinicalTrials.gov: NCT05061446)

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The duration of prior anti-tumor necrosis factor agents is associated with the effectiveness of vedolizumab in patients with ulcerative colitis: a real-world multicenter retrospective study: Taku Kobayashi, Tadakazu Hisamatsu, Satoshi Motoya, Minoru Matsuura, Toshimitsu Fujii, Reiko Kunisaki, Tomoyoshi Shibuya, Ken Takeuchi, Sakiko Hiraoka, Hiroshi Yasuda, Kaoru Yokoyama, Noritaka Takatsu, Atsuo Maemoto, Toshiyuki Tahara, Keiichi Tominaga, Masaaki Shimada, Nobuaki Kuno, Mary Cavaliere, Kaori Ishiguro, Jovelle L Fernandez, Toshifumi Hibi; Received August 9, 2024 Accepted March 20, 2025 Published online June 4, 2025; DOI: https://doi.org/10.5217/ir.2024.00126 [Epub ahead of print]

Abstract PDF Supplementary Material PubReader ePub: Background/Aims
Previous literature suggests that the response of patients with ulcerative colitis to vedolizumab may be affected by previous biologic therapy exposure. This real-world study evaluated vedolizumab treatment effectiveness in biologicnon-naïve patients.
Methods
This was a multicenter, retrospective, observational chart review of records from 16 hospitals in Japan (December 1, 2018, to February 29, 2020). Included patients who had ulcerative colitis, were aged ≥ 20 years, and received at least 1 dose of vedolizumab. Outcomes included clinical remission rates from weeks 2 to 54 according to prior biologic exposure status and factors associated with clinical remission up to week 54.
Results
A total of 370 eligible patients were included. Clinical remission rates were significantly higher in biologic-naïve (n=197) than in biologic-non-naïve (n=173) patients for weeks 2 to 54 of vedolizumab treatment. Higher clinical remission rates up to week 54 were significantly associated with lower disease severity (partial Mayo score ≤ 4, P= 0.001; albumin ≥ 3.0, P= 0.019) and the duration of prior anti-tumor necrosis factor α (anti-TNFα) therapy (P= 0.026). Patients with anti-TNFα therapy durations of < 3 months, 3 to < 12 months, and ≥ 12 months had clinical remission rates of 28.1%, 32.7%, and 60.0%, respectively (P= 0.001 across groups).
Conclusions
The effectiveness of vedolizumab in biologic-non-naïve patients was significantly influenced by duration of prior anti-TNFα therapy. (Japanese Registry of Clinical Trials: jRCT-1080225363)

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