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Toshimitsu Fujii 8 Articles
IBD
Long-term efficacy and safety of tofacitinib in patients with ulcerative colitis: 3-year results from a real-world study
Hiromichi Shimizu, Yuko Aonuma, Shuji Hibiya, Ami Kawamoto, Kento Takenaka, Toshimitsu Fujii, Eiko Saito, Masakazu Nagahori, Kazuo Ohtsuka, Ryuichi Okamoto
Intest Res 2024;22(3):369-377.   Published online July 16, 2024
DOI: https://doi.org/10.5217/ir.2023.00194
AbstractAbstract PDFSupplementary MaterialPubReaderePub
Background/Aims
The efficacy and safety of tofacitinib for the treatment of refractory ulcerative colitis (UC) has been demonstrated in clinical trials. Although, a series of reports with real-world evidence of its short-term efficacy and safety profiles have already been published, reports of long-term real-world data have been limited. We aimed to show our 3-year evidence on the clinical use of tofacitinib for the treatment of UC, focusing on its efficacy and safety profiles.
Methods
A retrospective observational study was conducted on patients who started tofacitinib for active refractory UC at our hospital. The primary outcome was the retention rate until 156 weeks after initiating tofacitinib. The secondary outcomes were short-term efficacy at 4, 8, and 12 weeks; long-term efficacy at 52, 104, and 156 weeks; prognostic factors related to the cumulative retention rate; loss of response; and safety profile, including adverse events.
Results
Forty-six patients who were able to be monitored for up to 156 weeks after tofacitinib initiation, were enrolled in this study. Continuation of tofacitinib was possible until 156 weeks in 54.3%, with > 50% response rates and > 40% remission rates. Among patients in whom response or remission was achieved and tofacitinib was deescalated after 8 weeks of induction treatment, 54.3% experienced relapse but were successfully rescued by and retained on reinduction treatment, except for 1 patient. No serious AEs were observed in the study.
Conclusions
Tofacitinib is effective and safe as long-term treatment in a refractory cohort of UC patients in real-world clinical practice.

Citations

Citations to this article as recorded by  
  • In which patients with ulcerative colitis would filgotinib be effective?
    Jihye Park
    Intestinal Research.2025; 23(1): 1.     CrossRef
  • 2,231 View
  • 163 Download
  • 1 Crossref
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IBD
Combination of leucine-rich alpha-2 glycoprotein and fecal markers detect Crohn’s disease activity confirmed by balloon-assisted enteroscopy
Ami Kawamoto, Kento Takenaka, Shuji Hibiya, Yoshio Kitazume, Hiromichi Shimizu, Toshimitsu Fujii, Eiko Saito, Kazuo Ohtsuka, Ryuichi Okamoto
Intest Res 2024;22(1):65-74.   Published online November 9, 2023
DOI: https://doi.org/10.5217/ir.2023.00092
AbstractAbstract PDFSupplementary MaterialPubReaderePub
Background/Aims
Endoscopic activity confirmed by enteroscopy is associated with poor clinical outcome in Crohn’s disease (CD). We investigated which of the existing biomarkers best reflects endoscopic activity in CD patients including the small bowel, and whether their combined use can improve accuracy.
Methods
One hundred and four consecutive patients with ileal and ileocolonic type CD who underwent balloon-assisted enteroscopy (BAE) from October 2021 to August 2022 were enrolled, with clinical and laboratory data prospectively collected and analyzed.
Results
Hemoglobin, platelet count, C-reactive protein, leucine-rich alpha-2 glycoprotein (LRG), fecal calprotectin, and fecal hemoglobin all showed significant difference in those with ulcers found on BAE. LRG and fecal calprotectin showed the highest areas under the curve (0.841 and 0.853) for detecting ulcers. LRG showed a sensitivity of 78% and specificity of 80% at a cutoff value of 13 μg/mL, whereas fecal calprotectin showed a sensitivity of 91% and specificity of 67% at a cutoff value of 151 μg/g. Dual positivity for LRG and fecal calprotectin, as well as LRG and fecal hemoglobin, both predicted ulcers with an improved specificity of 92% and 100%. A positive LRG or fecal calprotectin/hemoglobin showed an improved sensitivity of 96% and 91%. Positivity for LRG and either of the fecal biomarkers was associated with increased risk of hospitalization, surgery, and relapse.
Conclusions
The biomarkers LRG, fecal calprotectin, and fecal hemoglobin can serve as noninvasive and accurate tools for assessing activity in CD patients confirmed by BAE, especially when used in combination.

Citations

Citations to this article as recorded by  
  • Leucine-rich alpha-2 glycoprotein in combination with C-reactive protein for predicting endoscopic activity in Crohn’s disease: a single-centre, cross-sectional study
    Yoshiaki Takada, Hiroki Kiyohara, Yohei Mikami, Masataka Taguri, Ryoya Sakakibara, Yasuhiro Aoki, Kosaku Nanki, Takaaki Kawaguchi, Yusuke Yoshimatsu, Shinya Sugimoto, Tomohisa Sujino, Kaoru Takabayashi, Naoki Hosoe, Haruhiko Ogata, Motohiko Kato, Yasushi
    Annals of Medicine.2025;[Epub]     CrossRef
  • Which biomarkers best reflect the degree of inflammation in Crohn’s disease?
    Jihye Park
    Intestinal Research.2024; 22(1): 1.     CrossRef
  • Efficacy of serum leucine-rich alpha-2 glycoprotein in predicting findings of Crohn’s disease small bowel lesion in capsule endoscopy
    Teppei Omori, Miki Koroku, Shun Murasugi, Ayumi Ito, Maria Yonezawa, Shinichi Nakamura, Katsutoshi Tokushige
    Intestinal Research.2024; 22(4): 464.     CrossRef
  • Selection of anti-cytokine biologics by pretreatment levels of serum leucine-rich alpha-2 glycoprotein in patients with inflammatory bowel disease
    Takahiro Amano, Takeo Yoshihara, Shinichiro Shinzaki, Yuko Sakakibara, Takuya Yamada, Naoto Osugi, Satoshi Hiyama, Yoko Murayama, Koji Nagaike, Hideharu Ogiyama, Toshio Yamaguchi, Yuki Arimoto, Ichizo Kobayashi, Shoichiro Kawai, Satoshi Egawa, Takashi Kiz
    Scientific Reports.2024;[Epub]     CrossRef
  • 3,762 View
  • 305 Download
  • 4 Web of Science
  • 4 Crossref
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IBD
Rapid prediction of 1-year efficacy of tofacitinib for treating refractory ulcerative colitis
Hiromichi Shimizu, Toshimitsu Fujii, Shuji Hibiya, Maiko Motobayashi, Kohei Suzuki, Kento Takenaka, Eiko Saito, Masakazu Nagahori, Kazuo Ohtsuka, Mamoru Watanabe
Intest Res 2021;19(1):115-118.   Published online June 11, 2020
DOI: https://doi.org/10.5217/ir.2020.00030
PDFSupplementary MaterialPubReaderePub

Citations

Citations to this article as recorded by  
  • Histological healing induced by tofacitinib in ulcerative colitis: A multicentre study
    Sophie Vieujean, David Laharie, Anthony Buisson, Xavier Roblin, Mathurin Fumery, Stephane Nancey, Pauline Wils, Romain Altwegg, Laurence Seidel, Bénédicte Caron, Laurent Peyrin-Biroulet
    Digestive and Liver Disease.2024; 56(4): 613.     CrossRef
  • Continued JAK inhibitor treatment on the risk of recurrent herpes zoster reactivation in patients with immune-mediated inflammatory diseases: A nationwide population-based study in South Korea
    Young-Eun Kim, Ye-Jee Kim, Dae Hyun Jeong, Seonok Kim, Min Jee Kim, Hyeon Hwa Kim, Kyung-Wook Jo, Sang Hyoung Park, Seokchan Hong
    Seminars in Arthritis and Rheumatism.2024; 65: 152362.     CrossRef
  • Preventing and managing cardiovascular events in patients with inflammatory bowel diseases treated with small-molecule drugs, an international Delphi consensus
    Pablo A. Olivera, Axel Dignass, Marla C. Dubinsky, Giovanni Peretto, Paulo G. Kotze, Iris Dotan, Taku Kobayashi, Subrata Ghosh, Fernando Magro, Jose Rocha Faria-Neto, Britta Siegmund, Silvio Danese, Laurent Peyrin-Biroulet
    Digestive and Liver Disease.2024; 56(8): 1270.     CrossRef
  • Long-term efficacy and safety of tofacitinib in patients with ulcerative colitis: 3-year results from a real-world study
    Hiromichi Shimizu, Yuko Aonuma, Shuji Hibiya, Ami Kawamoto, Kento Takenaka, Toshimitsu Fujii, Eiko Saito, Masakazu Nagahori, Kazuo Ohtsuka, Ryuichi Okamoto
    Intestinal Research.2024; 22(3): 369.     CrossRef
  • Safety and effectiveness of tofacitinib in Korean adult patients with ulcerative colitis: post-marketing surveillance study
    Hyuk Yoon, Byong Duk Ye, Sang-Bum Kang, Kang-Moon Lee, Chang Hwan Choi, Joo-young Jo, Juwon Woo, Jae Hee Cheon
    BMC Gastroenterology.2024;[Epub]     CrossRef
  • Effectiveness of tofacitinib in patients with ulcerative colitis: an updated systematic review and meta-analysis of real-world studies
    Chien-Hung Lin, Wen-Sheng Liu, Chuan Wan, Hsin-Hui Wang
    BMJ Open Gastroenterology.2024; 11(1): e001347.     CrossRef
  • Real-World Evidence of Tofacinitib in Ulcerative Colitis: Short-Term and Long-Term Effectiveness and Safety
    María Chaparro, Diana Acosta, Cristina Rodríguez, Francisco Mesonero, Miren Vicuña, Manuel Barreiro-de Acosta, Agnès Fernández-Clotet, Álvaro Hernández Martínez, Maite Arroyo, Isabel Vera, Alexandra Ruiz-Cerulla, Beatriz Sicilia, M. José Cabello Tapia, Ca
    American Journal of Gastroenterology.2023; 118(7): 1237.     CrossRef
  • Real-life effectiveness and safety of tofacitinib treatment in patients with ulcerative colitis: a KASID multicenter cohort study
    Seung Hwan Shin, Kyunghwan Oh, Sung Noh Hong, Jungbok Lee, Shin Ju Oh, Eun Soo Kim, Soo-Young Na, Sang-Bum Kang, Seong-Joon Koh, Ki Bae Bang, Sung-Ae Jung, Sung Hoon Jung, Kyeong Ok Kim, Sang Hyoung Park, Suk-Kyun Yang, Chang Hwan Choi, Byong Duk Ye
    Therapeutic Advances in Gastroenterology.2023;[Epub]     CrossRef
  • Review article: Risk of cardiovascular events in patients with inflammatory bowel disease receiving small molecule drugs
    Pablo A. Olivera, Juan S. Lasa, Giovanni Peretto, Stephane Zuily, Silvio Danese, Laurent Peyrin‐Biroulet
    Alimentary Pharmacology & Therapeutics.2023; 57(11): 1231.     CrossRef
  • Positioning of tofacitinib in treatment of ulcerative colitis: a global perspective
    Shubhra Mishra, Anuraag Jena, Rinkalben Kakadiya, Vishal Sharma, Vineet Ahuja
    Expert Review of Gastroenterology & Hepatology.2022; 16(8): 737.     CrossRef
  • Oral beclomethasone dipropionate as an add-on therapy and response prediction in Korean patients with ulcerative colitis
    Kyuwon Kim, Hee Seung Hong, Kyunghwan Oh, Jae Yong Lee, Seung Wook Hong, Jin Hwa Park, Sung Wook Hwang, Dong-Hoon Yang, Jeong-Sik Byeon, Seung-Jae Myung, Suk-Kyun Yang, Byong Duk Ye, Sang Hyoung Park
    The Korean Journal of Internal Medicine.2022; 37(6): 1140.     CrossRef
  • Review article: guide to tofacitinib dosing in patients with ulcerative colitis
    Peter M. Irving, Yvette Leung, Marla C. Dubinsky
    Alimentary Pharmacology & Therapeutics.2022; 56(7): 1131.     CrossRef
  • Management of inflammatory bowel disease beyond tumor necrosis factor inhibitors: novel biologics and small-molecule drugs
    Soo-Young Na, You Sun Kim
    The Korean Journal of Internal Medicine.2022; 37(5): 906.     CrossRef
  • Effectiveness and Safety of Tofacitinib for Ulcerative Colitis
    Vikas Taneja, Mohammed El-Dallal, Zadid Haq, Kartikeya Tripathi, Hannah K. Systrom, Linda F. Wang, Hyder Said, Paul A. Bain, Youlian Zhou, Joseph D. Feuerstein
    Journal of Clinical Gastroenterology.2022; 56(10): e323.     CrossRef
  • Real-world experience with tofacitinib in ulcerative colitis: a systematic review and meta-analysis
    Laura A. Lucaciu, Nathan Constantine-Cooke, Nikolas Plevris, Spyros Siakavellas, Lauranne A.A.P. Derikx, Gareth-Rhys Jones, Charles W. Lees
    Therapeutic Advances in Gastroenterology.2021;[Epub]     CrossRef
  • 6,694 View
  • 252 Download
  • 17 Web of Science
  • 15 Crossref
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IBD
Seven days triple therapy for eradication of Helicobacter pylori does not alter the disease activity of patients with inflammatory bowel disease
Shinichiro Shinzaki, Toshimitsu Fujii, Shigeki Bamba, Maiko Ogawa, Taku Kobayashi, Masahide Oshita, Hiroki Tanaka, Keiji Ozeki, Sakuma Takahashi, Hiroki Kitamoto, Kazuhito Kani, Sohachi Nanjo, Takeshi Sugaya, Yuko Sakakibara, Toshihiro Inokuchi, Kazuki Kakimoto, Akihiro Yamada, Hisae Yasuhara, Yoko Yokoyama, Takuya Yoshino, Akira Matsui, Misaki Nakamura, Taku Tomizawa, Ryosuke Sakemi, Noriko Kamata, Toshifumi Hibi
Intest Res 2018;16(4):609-618.   Published online October 10, 2018
DOI: https://doi.org/10.5217/ir.2018.00044
AbstractAbstract PDFSupplementary MaterialPubReaderePub
Background/Aims
The influences of Helicobacter pylori eradication therapy on the disease course of inflammatory bowel disease (IBD) are still unclear. We therefore conducted a multicenter, retrospective cohort study to evaluate the safety of H. pylori eradication therapy for IBD patients.
Methods
IBD patients with H. pylori eradication from 2005 to 2015 (eradication group) and control patients (non-eradication group; 2 paired IBD patients without H. pylori eradication matched with each eradicated patient) were included. IBD exacerbation (increased/additional IBD drug or IBD-associated hospitalization/surgery) and disease improvement based on the physicians’ global assessment were investigated at baseline, and at 2 and 6 months after eradication or observation.
Results
A total of 429 IBD (378 ulcerative colitis, 51 Crohn’s disease) patients, comprising 144 patients in the eradication group and 285 patients in the non-eradication group, were enrolled at 25 institutions. IBD exacerbation was comparable between groups (eradication group: 8.3% at 2 months [odds ratio, 1.76; 95% confidence interval, 0.78–3.92; P=0.170], 11.8% at 6 months [odds ratio, 1.60; 95% confidence interval, 0.81–3.11; P=0.172]). Based on the physicians’ global assessment at 2 months, none of the patients in the eradication group improved, whereas 3.2% of the patients in the non-eradication group improved (P=0.019). Multivariate analysis revealed that active disease at baseline, but not H. pylori eradication, was an independent factor for IBD exacerbation during 2 months’ observation period. The overall eradication rate was 84.0%–comparable to previous reports in non-IBD patients.
Conclusions
H. pylori eradication therapy does not alter the short-term disease activity of IBD.

Citations

Citations to this article as recorded by  
  • Factors Associated With Decision to Treat or Not to Treat Helicobacter pylori Infection in Children: Data From the EuroPedHp Registry
    Thu Giang Le Thi, Katharina Werkstetter, Kallirroi Kotilea, Patrick Bontems, José Cabral, Maria Luz Cilleruelo, Michal Kori, Josefa Barrio, Matjaž Homan, Nicolas Kalach, Rosa Lima, Marta Tavares, Pedro Urruzuno, Zrinjka Misak, Vaidotas Urbonas, Sibylle Ko
    Helicobacter.2024;[Epub]     CrossRef
  • Impact of Helicobacter pylori Eradication on Inflammatory Bowel Disease Onset and Disease Activity: To Eradicate or Not to Eradicate?
    Antonietta Gerarda Gravina, Raffaele Pellegrino, Veronica Iascone, Giovanna Palladino, Alessandro Federico, Rocco Maurizio Zagari
    Diseases.2024; 12(8): 179.     CrossRef
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    Yantong Li, Limin Li, Wenmeng Yin, Juyi Wan, Xiaolin Zhong
    JGH Open.2024;[Epub]     CrossRef
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    Hang Yang, Yi Mou, Bing Hu
    Helicobacter.2023;[Epub]     CrossRef
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    Juris Pokrotnieks, Stanislav Sitkin
    Inflammatory Bowel Diseases.2023; 29(3): e5.     CrossRef
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    Li Wang, Zheng-Min Cao, Li-Li Zhang, Xin-can Dai, Zhen-ju Liu, Yi-xian Zeng, Xin-Ye Li, Qing-Juan Wu, Wen-liang Lv
    Frontiers in Immunology.2022;[Epub]     CrossRef
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    Ekram W. Abd El-Wahab, Ebtessam I. Youssef, Ehab Hassouna
    BMJ Open.2022; 12(5): e057214.     CrossRef
  • Is the Presence of Helicobacter Pylori in the Colonic Mucosa, Provocative of Activity in Ulcerative Colitis?
    Javad Ranjbar, Bita Geramizadeh, Kamran Bagheri Lankarani, Zahra Jowkar, Mitra Mirzai, Elham Moazamian
    Clinical Pathology.2022;[Epub]     CrossRef
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    Yu. P. Uspenskiy, N. V. Baryshnikova, A. N. Suvorov, A. V. Svarval
    Russian Journal of Infection and Immunity.2021; 11(1): 68.     CrossRef
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    Yuji Fujita, Keiichi Tominaga, Takanao Tanaka, Takeshi Sugaya, Shigemi Yoshihara
    BMC Gastroenterology.2021;[Epub]     CrossRef
  • Effect of sequential eradication therapy on serum osteoprotegerin levels in patients with Helicobacter pylori infection and co-existing inflammatory bowel disease
    Hussam Murad, Misbahuddin Rafeeq, Mahmoud Mosli, Mamdouh Gari, Mohammed Basheikh
    Journal of International Medical Research.2021;[Epub]     CrossRef
  • Extra-Gastric Manifestations of Helicobacter pylori Infection
    Antonietta G. Gravina, Kateryna Priadko, Paola Ciamarra, Lucia Granata, Angela Facchiano, Agnese Miranda, Marcello Dallio, Alessandro Federico, Marco Romano
    Journal of Clinical Medicine.2020; 9(12): 3887.     CrossRef
  • Comparison of new and classical point mutations associated with clarithromycin resistance in Helicobacter pylori strains isolated from dyspeptic patients and their effects on phenotypic clarithromycin resistance
    Bekir Kocazeybek, Merve Kutlu Sakli, Pelin Yuksel, Mehmet Demirci, Reyhan Caliskan, Tevhide Ziver Sarp, Suat Saribas, Suleyman Demiryas, Fatma Kalayci, Huseyin Cakan, Hayriye Kirkoyun Uysal, Nesrin Gareayaghi, Sevgi Ergin, Yusuf Ziya Erzin, Kadir Bal, İhs
    Journal of Medical Microbiology .2019; 68(4): 566.     CrossRef
  • Review:Helicobacter pyloriand extragastric diseases
    Francesco Franceschi, Marcello Covino, Claire Roubaud Baudron
    Helicobacter.2019;[Epub]     CrossRef
  • 8,236 View
  • 148 Download
  • 15 Web of Science
  • 14 Crossref
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Magnetic resonance enterography for the evaluation of the deep small intestine in Crohn's disease
Kazuo Ohtsuka, Kento Takenaka, Yoshio Kitazume, Toshimitsu Fujii, Katsuyoshi Matsuoka, Maiko Kimura, Takashi Nagaishi, Mamoru Watanabe
Intest Res 2016;14(2):120-126.   Published online April 27, 2016
DOI: https://doi.org/10.5217/ir.2016.14.2.120
AbstractAbstract PDFPubReaderePub

For the control of Crohn's disease (CD) a thorough assessment of the small intestine is essential; several modalities may be utilized, with cross-sectional imaging being important. Magnetic resonance (MR) enterography, i.e., MRE is recommended as a modality with the highest accuracy for CD lesions. MRE and MR enteroclysis are the two methods performed following distension of the small intestine. MRE has sensitivity and specificity comparable to computed tomography enterography (CTE); although images obtained using MRE are less clear compared with CTE, MRE does not expose the patient to radiation and is superior for soft-tissue contrast. Furthermore, it can assess not only static but also dynamic and functional imaging and reveals signs of CD, such as abscess, comb sign, fat edema, fistula, lymph node enhancement, less motility, mucosal lesions, stricture, and wall enhancement. Several indices of inflammatory changes and intestinal damage have been proposed for objective evaluation. Recently, diffusion-weighted imaging has been proposed, which does not need bowel preparation and contrast enhancement. Comprehension of the characteristics of MRE and other modalities is important for better management of CD.

Citations

Citations to this article as recorded by  
  • Motility Mapping Quantification Using the Classical Optical Flow Algorithm for Small Bowel Crohn’s Disease: Comparison with Balloon-assisted Enteroscopy Findings
    Yoshio Kitazume, Kento Takenaka, Kazuo Ohtsuka, Yasuo Ozawa, Koichiro Kimura, Ryosuke Watanabe, Junichi Tsuchiya, Toshimitsu Fujii, Masakazu Nagahori, Mamoru Watanabe, Ukihide Tateishi
    Magnetic Resonance in Medical Sciences.2023; 22(3): 325.     CrossRef
  • Crohn’s disease at radiological imaging: focus on techniques and intestinal tract
    Giuseppe Cicero, Silvio Mazziotti
    Intestinal Research.2021; 19(4): 365.     CrossRef
  • Magnetic Resonance Enterography and Capsule Endoscopy in Patients Undergoing Patency Capsule for the Evaluation of Small Bowel Crohn’s Disease: A Korean Clinical Experience
    Hyun Seok Lee, Yun Jeong Lim, Jin-Hee Jung, Ji Hyung Nam, Junseok Park, Sun Hyung Kang, Ki Bae Kim, Hoon Jai Chun
    Gastroenterology Research and Practice.2020; 2020: 1.     CrossRef
  • Efficacy of Novel Ultrathin Single-Balloon Enteroscopy for Crohn’s Disease: A Propensity Score-Matched Study
    Kaoru Takabayashi, Naoki Hosoe, Motohiko Kato, Yukie Hayashi, Ryoichi Miyanaga, Kosaku Nanki, Kayoko Fukuhara, Yohei Mikami, Shinta Mizuno, Tomohisa Sujino, Makoto Mutaguchi, Makoto Naganuma, Naohisa Yahagi, Haruhiko Ogata, Takanori Kanai
    Gut and Liver.2020; 14(5): 619.     CrossRef
  • High b-value computed diffusion-weighted imaging for differentiating bowel inflammation in Crohn's disease
    Yoshio Kitazume, Junichi Tsuchiya, Kento Takenaka, Kazuo Ohtsuka, Koichiro Kimura, Ryosuke Watanabe, Tomoyuki Fujioka, Toshimitsu Fujii, Mamoru Watanabe, Ukihide Tateisi
    European Journal of Radiology.2020; 133: 109362.     CrossRef
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    Stefania Chetcuti Zammit, Pierre Ellul, Reena Sidhu
    Current Opinion in Gastroenterology.2019; 35(3): 223.     CrossRef
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    Ji Hoon Lee, Yong Eun Park, Nieun Seo, Hyun Jung Lee, Soo Jung Park, Tae Il Kim, Won Ho Kim, Joon Seok Lim, Jae Hee Cheon
    Intestinal Research.2018; 16(3): 445.     CrossRef
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    Ki-Nam Shim, Seong Ran Jeon, Hyun Joo Jang, Jinsu Kim, Yun Jeong Lim, Kyeong Ok Kim, Hyun Joo Song, Hyun Seok Lee, Jae Jun Park, Ji Hyun Kim, Jaeyoung Chun, Soo Jung Park, Dong-Hoon Yang, Yang Won Min, Bora Keum, Bo-In Lee
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  • 7,002 View
  • 73 Download
  • 14 Web of Science
  • 8 Crossref
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Tacrolimus for the Treatment of Ulcerative Colitis
Katsuyoshi Matsuoka, Eiko Saito, Toshimitsu Fujii, Kento Takenaka, Maiko Kimura, Masakazu Nagahori, Kazuo Ohtsuka, Mamoru Watanabe
Intest Res 2015;13(3):219-226.   Published online June 9, 2015
DOI: https://doi.org/10.5217/ir.2015.13.3.219
AbstractAbstract PDFPubReader

Tacrolimus is a calcineurin inhibitor used for the treatment of corticosteroid-refractory ulcerative colitis (UC). Two randomized controlled trials and a number of retrospective studies have assessed the therapeutic effect of tacrolimus in UC patients. These studies showed that tacrolimus has excellent short-term efficacy in corticosteroid-refractory patients, with the rates of clinical response ranging from 61% to 96%. However, the long-term prognosis of patients treated with tacrolimus is disappointing, and almost 50% of patients eventually underwent colectomy in long-term follow-up. Tacrolimus can achieve mucosal healing in 40-50% of patients, and this is associated with a favorable long-term prognosis. Anti-tumor necrosis factor (TNF)-α antibodies are another therapeutic option in corticosteroid-refractory patients. A prospective head-to-head comparative study of tacrolimus and infliximab is currently being performed to determine which treatment is more effective in corticosteroid-refractory patients. Several retrospective studies have demonstrated that switching between tacrolimus and anti-TNF-α antibody therapy was effective in patients who were refractory to one of the treatments. Most adverse events of tacrolimus are mild; however, opportunistic infections, especially pneumocystis pneumonia, are the most important adverse events, and these should be carefully considered during treatment. Several issues on tacrolimus treatment in UC patients remain unsolved (e.g., use of tacrolimus as remission maintenance therapy). Further controlled studies are needed to optimize the use of tacrolimus for the treatment of UC.

Citations

Citations to this article as recorded by  
  • Predictive Factors for Efficacy of Oral Tacrolimus Induction Therapy in Moderate to Severe Ulcerative Colitis Patients: Large Multicenter Retrospective Cohort Study
    Naoki Oshima, Sakiko Hiraoka, Ryohei Hayashi, Sakuma Takahashi, Manabu Ishii, Shinichi Hashimoto, Kazuo Yashima, Shoko Igawa, Toshihiro Inokuchi, Yoshitaka Ueno, Tomoki Inaba, Hiroshi Matsumoto, Kousaku Kawashima, Taro Takami, Hajime Isomoto, Akiko Shiota
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    Journal of Crohn's and Colitis.2023; 17(6): 972.     CrossRef
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    Gowthami Sai Kogilathota Jagirdhar, Yashwitha Sai Pulakurthi, Himaja Dutt Chigurupati, Salim Surani
    World Journal of Virology.2023; 12(3): 136.     CrossRef
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    Ting Xue, Xiaomei Kong, Liang Ma
    Journal of Fungi.2023; 9(8): 812.     CrossRef
  • Cross-tissue transcriptome-wide association studies identify susceptibility genes shared between schizophrenia and inflammatory bowel disease
    Florian Uellendahl-Werth, Carlo Maj, Oleg Borisov, Simonas Juzenas, Eike Matthias Wacker, Isabella Friis Jørgensen, Tim Alexander Steiert, Saptarshi Bej, Peter Krawitz, Per Hoffmann, Christoph Schramm, Olaf Wolkenhauer, Karina Banasik, Søren Brunak, Stefa
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    Journal of Medicinal Chemistry.2022; 65(6): 4926.     CrossRef
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    Rachit Gupta, Julien D. Schulberg, Ola Niewiadomski, Emily K. Wright
    Autoimmunity Reviews.2022; 21(7): 103115.     CrossRef
  • Inpatient Therapy With Calcineurin Inhibitors in Severe Ulcerative Colitis
    Sujaata Dwadasi, Maryam Zafer, Donald Goens, Raghavendra Paknikar, Sushila Dalal, Russell D Cohen, Joel Pekow, David T Rubin, Atsushi Sakuraba, Dejan Micic
    Inflammatory Bowel Diseases.2021; 27(10): 1620.     CrossRef
  • Treatment of acute severe ulcerative colitis
    Jun-Rong Li, Fang-Mei Ling, Yi-Dong Chen, Ming-Yang Xu, Liang-Ru Zhu
    World Chinese Journal of Digestology.2021; 29(2): 87.     CrossRef
  • Role of Topical Tacrolimus in the Management of Proctitis, Perianal Manifestations in Crohn's Disease, and Chronic Pouchitis: A Systematic Review
    George Salem, Kai Ding, Atsushi Sakuraba, Russell Cohen
    Journal of Investigative Medicine.2021; 69(4): 796.     CrossRef
  • The Optimal Dose of Tacrolimus in Combination Therapy with an Anti-TNFα Antibody in a Mouse Colitis Model
    Yuki Murakami, Mikihiro Fujiya, Hiroaki Konishi, Shotaro Isozaki, Yuya Sugiyama, Yu Kobayashi, Takahiro Sasaki, Takehito Kunogi, Keitaro Takahashi, Katsuyoshi Ando, Nobuhiro Ueno, Shin Kashima, Kentaro Moriichi, Hiroki Tanabe, Toshikatsu Okumura
    Biological and Pharmaceutical Bulletin.2021; 44(4): 564.     CrossRef
  • Combination of Vedolizumab With Tacrolimus Is More Efficient Than Vedolizumab Alone in the Treatment of Experimental Colitis
    Roberto Manzini, Marlene Schwarzfischer, Kirstin Atrott, Andrea Laimbacher, Silvia Lang, Marcin Wawrzyniak, Andreas Rickenbacher, Matthias Turina, Petr Hruz, Donata Lissner, Britta Siegmund, Gerhard Rogler, Michael Scharl, Marianne R Spalinger
    Inflammatory Bowel Diseases.2021; 27(12): 1986.     CrossRef
  • 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
  • De Novo Inflammatory Bowel Disease Rarely Occurs During Posttransplant Immunosuppression
    Jiayun M Fang, Laura Lamps, Amoah Yeboah-Korang, Jerome Cheng, Maria Westerhoff
    American Journal of Clinical Pathology.2021; 156(6): 1113.     CrossRef
  • Immune checkpoint inhibitor treatment induces colitis with heavy infiltration of CD8 + T cells and an infiltration pattern that resembles ulcerative colitis
    Sara Hone Lopez, Gursah Kats-Ugurlu, Remco J. Renken, Henk J. Buikema, Marco R. de Groot, Marijn C. Visschedijk, Gerard Dijkstra, Mathilde Jalving, Jacco J. de Haan
    Virchows Archiv.2021; 479(6): 1119.     CrossRef
  • Protective effects of selenium in tacrolimus-induced lung toxicity: potential role of heme oxygenase 1
    Salwa Abdel-Tawab Ibrahim, Nashwa Fathy Eltahawy, Ahlam Mohamed Abdalla, Hanaa Mohamed Khalaf
    Canadian Journal of Physiology and Pharmacology.2021; 99(10): 1069.     CrossRef
  • Tacrolimus Therapy in Steroid-Refractory Ulcerative Colitis: A Review
    Biyu Wu, Jinglu Tong, Zhihua Ran
    Inflammatory Bowel Diseases.2020; 26(1): 24.     CrossRef
  • Simple water‐based tacrolimus enemas for refractory proctitis
    Sasha R. Fehily, Felicity C. Martin, Michael A. Kamm
    JGH Open.2020; 4(4): 561.     CrossRef
  • Tacrolimus is effective for neuromyelitis optica spectrum disorders with or without anti-AQP4 antibody
    Miki Kojima, Satoru Oji, Satoru Tanaka, Shoko Izaki, Baku Hashimoto, Hikoaki Fukaura, Kyoichi Nomura
    Multiple Sclerosis and Related Disorders.2020; 39: 101907.     CrossRef
  • Effectiveness and Nephrotoxicity of Long-Term Tacrolimus Administration in Patients with Ulcerative Colitis
    Keiichi Haga, Tomoyoshi Shibuya, Kei Nomura, Koki Okahara, Osamu Nomura, Dai Ishikawa, Naoto Sakamoto, Taro Osada, Akihito Nagahara
    Journal of Clinical Medicine.2020; 9(6): 1771.     CrossRef
  • Inflammatory Bowel Disease – Non-biological treatment
    Fernando Magro, Gonçalo Cordeiro, Andreia Martins Dias, Maria Manuela Estevinho
    Pharmacological Research.2020; 160: 105075.     CrossRef
  • Lactobacillus plantarum L15 Alleviates Colitis by Inhibiting LPS-Mediated NF-κB Activation and Ameliorates DSS-Induced Gut Microbiota Dysbiosis
    Peng Yu, Chuxin Ke, Jiaxin Guo, Xiuling Zhang, Bailiang Li
    Frontiers in Immunology.2020;[Epub]     CrossRef
  • 3D Printed Tacrolimus Rectal Formulations Ameliorate Colitis in an Experimental Animal Model of Inflammatory Bowel Disease
    Iria Seoane-Viaño, Noemí Gómez-Lado, Héctor Lázare-Iglesias, Xurxo García-Otero, José Ramón Antúnez-López, Álvaro Ruibal, Juan Jesús Varela-Correa, Pablo Aguiar, Abdul W. Basit, Francisco J. Otero-Espinar, Miguel González-Barcia, Alvaro Goyanes, Asteria L
    Biomedicines.2020; 8(12): 563.     CrossRef
  • A Phase 1, Multiple‐Dose Study of Vedolizumab in Japanese Patients With Ulcerative Colitis
    Kiyonori Kobayashi, Yasuo Suzuki, Kenji Watanabe, Kazunori Oda, Miyuki Mukae, Akihiro Yamada, Hirokazu Yamagami, Akira Nishimura, Hiroyuki Okamoto
    The Journal of Clinical Pharmacology.2019; 59(2): 271.     CrossRef
  • Safety and Efficacy of Combination Treatment With Calcineurin Inhibitors and Vedolizumab in Patients With Refractory Inflammatory Bowel Disease
    Britt Christensen, Peter R. Gibson, Dejan Micic, Ruben J. Colman, Sarah R. Goeppinger, Olufemi Kassim, Andres Yarur, Christopher R. Weber, Russell D. Cohen, David T. Rubin
    Clinical Gastroenterology and Hepatology.2019; 17(3): 486.     CrossRef
  • The protective role of phloretin against dextran sulfate sodium-induced ulcerative colitis in mice
    Zecai Zhang, Shan Li, Hongyang Cao, Peng Shen, Jiuxi Liu, Yunhe Fu, Yongguo Cao, Naisheng Zhang
    Food & Function.2019; 10(1): 422.     CrossRef
  • Pretreatment neutrophil-to-lymphocyte ratio predicts clinical relapse of ulcerative colitis after tacrolimus induction
    Yu Nishida, Shuhei Hosomi, Hirokazu Yamagami, Naoko Sugita, Shigehiro Itani, Tomomi Yukawa, Koji Otani, Yasuaki Nagami, Fumio Tanaka, Koichi Taira, Noriko Kamata, Tetsuya Tanigawa, Toshio Watanabe, Yasuhiro Fujiwara, Emiko Mizoguchi
    PLOS ONE.2019; 14(3): e0213505.     CrossRef
  • Performance of tacrolimus in hospitalized patients with steroid-refractory acute severe ulcerative colitis
    Peter Hoffmann, Cyrill Wehling, Johannes Krisam, Jan Pfeiffenberger, Nina Belling, Annika Gauss
    World Journal of Gastroenterology.2019; 25(13): 1603.     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
  • Toosendanin alleviates dextran sulfate sodium-induced colitis by inhibiting M1 macrophage polarization and regulating NLRP3 inflammasome and Nrf2/HO-1 signaling
    Huining Fan, Wei Chen, Jinshui Zhu, Jing Zhang, Shiqiao Peng
    International Immunopharmacology.2019; 76: 105909.     CrossRef
  • Pharmacotherapy of ulcerative colitis – current status and emerging trends
    Hilal Ahmad, Vijay L. Kumar
    Journal of Basic and Clinical Physiology and Pharmacology.2018; 29(6): 581.     CrossRef
  • Updated treatment strategies for intestinal Behçet’s disease
    Yong Eun Park, Jae Hee Cheon
    The Korean Journal of Internal Medicine.2018; 33(1): 1.     CrossRef
  • Tacrolimus: An updated review on delivering strategies for multifarious diseases
    Divya Dheer, Jyoti, Prem N. Gupta, Ravi Shankar
    European Journal of Pharmaceutical Sciences.2018; 114: 217.     CrossRef
  • Pooled analysis of the comparative efficacy between tacrolimus and infliximab for ulcerative colitis
    Yi-Juan Liu, Hua Fan, Wei-Wei Zhen, Xing Yu, Jin-Tong Chen, Cheng-Dang Wang
    Medicine.2018; 97(32): e11440.     CrossRef
  • Long-lasting Immunosuppressive Effects of tacrolimus-loaded Micelle NK61060 in Preclinical Arthritis and Colitis Models
    Takamichi Sato, Junpei Konno, Akihiro Sekiguchi, Nao Yoneki, Kana Kawano, Tomohiro Hayashi, Yukina Ogawa, Aya Kikitsu, Takashi Aijima, Kazuhisa Hara, Shintaro Hara, Hitomi Hayashi, Kimiko Fuchigami, Naoko Igo, Yuki Takashima, Yuki Kobayashi, Masayuki Mori
    Therapeutic Delivery.2018; 9(10): 711.     CrossRef
  • In Vivo Study of the Efficacy of the Essential Oil of Zanthoxylum bungeanum Pericarp in Dextran Sulfate Sodium-Induced Murine Experimental Colitis
    Zecai Zhang, Peng Shen, Jiuxi Liu, Cong Gu, Xiaojie Lu, Yanxin Li, Yongguo Cao, Bo Liu, Yunhe Fu, Naisheng Zhang
    Journal of Agricultural and Food Chemistry.2017; 65(16): 3311.     CrossRef
  • Significant contribution of TRPC6 channel-mediated Ca2+ influx to the pathogenesis of Crohn’s disease fibrotic stenosis
    Lin Hai Kurahara, Keizo Hiraishi, Miho Sumiyoshi, Mayumi Doi, Yaopeng Hu, Kunihiko Aoyagi, Yuwen Jian, Ryuji Inoue
    Journal of Smooth Muscle Research.2016; 52: 78.     CrossRef
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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
Received January 11, 2024  Accepted April 29, 2024  Published online July 15, 2024  
DOI: https://doi.org/10.5217/ir.2024.00005    [Epub ahead of print]
AbstractAbstract PDFSupplementary MaterialPubReaderePub
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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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]
AbstractAbstract PDFSupplementary MaterialPubReaderePub
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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