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20 "Tadakazu Hisamatsu"
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Original Articles
IBD
Efficacy and safety of mirikizumab as induction and maintenance therapy for Japanese patients with moderately to severely active ulcerative colitis: a subgroup analysis of the global phase 3 LUCENT-1 and LUCENT-2 studies
Taku Kobayashi, Katsuyoshi Matsuoka, Mamoru Watanabe, Tadakazu Hisamatsu, Fumihito Hirai, Joe Milata, Xingyuan Li, Nathan Morris, Vipin Arora, Tomoko Ishizuka, Koji Matsuo, Yoichi Satoi, Catherine Milch, Toshifumi Hibi
Intest Res 2024;22(2):172-185.   Published online April 25, 2024
DOI: https://doi.org/10.5217/ir.2023.00043
AbstractAbstract PDFSupplementary MaterialPubReaderePub
Background/Aims
Mirikizumab is a p19-directed anti-interleukin-23 antibody with potential efficacy against ulcerative colitis (UC). We evaluated the efficacy and safety of mirikizumab in a Japanese subpopulation with moderately to severely active UC from the LUCENT-1 and LUCENT-2 studies.
Methods
LUCENT-1 and LUCENT-2 were phase 3, randomized, double-blind, placebo-controlled trials of mirikizumab therapy in adults with moderately to severely active UC. LUCENT-1 was a 12-week induction trial where patients were randomized 3:1 to receive intravenous mirikizumab 300 mg or placebo every 4 weeks (Q4W). Patients achieving a clinical response with mirikizumab following the induction study were re-randomized 2:1 to double-blind treatment with either mirikizumab 200 mg or placebo subcutaneously Q4W during the 40-week maintenance study. The primary outcomes were clinical remission at week 12 of LUCENT-1 and week 40 of LUCENT-2.
Results
A total of 137 patients enrolled in Japan were randomized to mirikizumab (n = 102) or placebo (n = 35). Compared with placebo, patients who received mirikizumab showed numerically higher clinical remission at week 12 of induction (32.4% [n = 33] vs. 2.9% [n = 1]) and at week 40 of maintenance (48.9% [n = 23] vs. 28.0% [n = 7]). A greater number of patients achieved key secondary endpoints in the mirikizumab group compared with placebo. The frequency of treatment-emergent adverse events was similar across mirikizumab and placebo groups. Efficacy and safety results observed in the Japanese subpopulation were generally consistent with those in the overall population.
Conclusions
Mirikizumab induction and maintenance treatments were effective in Japanese patients with moderately to severely active UC. No new safety concerns were identified.
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IBD
Treatment of inflammatory bowel disease–Asian perspectives: the results of a multinational web-based survey in the 8th Asian Organization for Crohn’s and Colitis meeting
Eun Mi Song, Soo-Young Na, Sung Noh Hong, Siew Chien Ng, Tadakazu Hisamatsu, Byong Duk Ye
Intest Res 2023;21(3):339-352.   Published online July 27, 2023
DOI: https://doi.org/10.5217/ir.2022.00135
AbstractAbstract PDFSupplementary MaterialPubReaderePub
Background/Aims
As the characteristics of inflammatory bowel disease (IBD) differ between Asians and Westerners, it is necessary to determine adequate therapeutic strategy for Asian IBD patients. We evaluated the current treatment of IBD in Asian countries/regions using a web-based survey.
Methods
The Korean Association for the Study of Intestinal Diseases conducted a multinational web-based survey for current IBD care in Asia between September 16, 2020, and November 13, 2020.
Results
A total of 384 doctors treating IBD patients from 24 Asian countries/regions responded to the survey. Anti-tumor necrosis factor (TNF) agents, anti-integrins, and anti-interleukin-12/23 agents were available for use by 93.8%, 72.1%, and 70.1% of respondents in Asian countries/regions. Compared with a previous survey performed in 2014, an increased tendency for treatment with biologics, including anti-TNF agents, was observed. In the treatment of corticosteroid-refractory acute severe ulcerative colitis, 72.1% of respondents chose anti-TNF agents, followed by tacrolimus (11.7%). In the treatment of corticosteroid-refractory Crohn’s disease, 90.4% chose anti-TNF agents, followed by thiopurines (53.1%), anti-interleukin-12/23 agents (39.3%), and anti-integrin agents (35.7%). In the treatment of Crohn’s disease patients refractory to anti-TNF agents, the most preferred strategy was to measure serum levels of anti-TNF and anti-drug antibodies (40.9%), followed by empiric dose escalation or shortening of dosing intervals (25.3%).
Conclusions
Although there were some differences, treatment strategies for patients with IBD were mostly similar among Asian doctors. Based on the therapeutic outcomes, it is necessary to identify the most appropriate therapeutic strategy for Asian IBD patients.

Citations

Citations to this article as recorded by  
  • Impact of age at diagnosis on long‐term prognosis in patients with intestinal Behçet's disease
    Ji Young Chang, Soo Jung Park, Jae Jun Park, Tae Il Kim, Jae Hee Cheon, Jihye Park
    Journal of Gastroenterology and Hepatology.2024; 39(3): 519.     CrossRef
  • Continuing or stopping 5‐aminosalicylates in patients with inflammatory bowel disease on anti‐TNF therapy: A nationwide population‐based study
    Jeongkuk Seo, Seonok Kim, Seung Wook Hong, Sung Wook Hwang, Sang Hyoung Park, Dong‐Hoon Yang, Jeong‐Sik Byeon, Seung‐Jae Myung, Suk‐Kyun Yang, Ye‐Jee Kim, Byong Duk Ye
    Alimentary Pharmacology & Therapeutics.2024; 60(3): 389.     CrossRef
  • The Potential of Molecular Remission: Tissue Neutrophil Elastase Is Better Than Histological Activity for Predicting Long-Term Relapse in Patients With Ulcerative Colitis in Endoscopic Remission
    Yu Kyung Jun, Hyeon Jeong Oh, Ji Ae Lee, Yonghoon Choi, Cheol Min Shin, Young Soo Park, Nayoung Kim, Dong Ho Lee, Hyuk Yoon
    Inflammatory Bowel Diseases.2024;[Epub]     CrossRef
  • How have treatment patterns for patients with inflammatory bowel disease changed in Asian countries?
    Jihye Park
    Intestinal Research.2023; 21(3): 275.     CrossRef
  • Enrichment of Activated Fibroblasts as a Potential Biomarker for a Non-Durable Response to Anti-Tumor Necrosis Factor Therapy in Patients with Crohn’s Disease
    Soo-Kyung Park, Gi-Young Lee, Sangsoo Kim, Chil-Woo Lee, Chang-Hwan Choi, Sang-Bum Kang, Tae-Oh Kim, Jaeyoung Chun, Jae-Myung Cha, Jong-Pil Im, Kwang-Sung Ahn, Seon-Young Kim, Min-Suk Kim, Chang-Kyun Lee, Dong-Il Park
    International Journal of Molecular Sciences.2023; 24(19): 14799.     CrossRef
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  • 118 Download
  • 6 Web of Science
  • 5 Crossref
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Review
IBD
First aid with color atlas for the use of intestinal ultrasound for inflammatory bowel disease in daily clinical practice
Jun Miyoshi, Hiromu Morikubo, Hiromi Yonezawa, Hideaki Mori, Tadakazu Hisamatsu
Intest Res 2023;21(2):177-188.   Published online April 28, 2023
DOI: https://doi.org/10.5217/ir.2023.00003
AbstractAbstract PDFPubReaderePub
Intestinal ultrasound (IUS) is a promising modality for the management of inflammatory bowel disease (IBD) and has the potential to particularly contribute in monitoring disease activity, an advantage crucial for optimizing the therapeutic strategy. While many IBD physicians appreciate and are interested in the use of IUS for IBD, currently only a limited number of facilities can employ this examination in daily clinical practice. A lack of guidance is one of the major barriers to introducing this procedure. Standardized protocols and assessment criteria are needed such that IUS for IBD can be considered a feasible, reliable examination in clinical practice, and multicenter clinical studies can be conducted for further clinical evidence of the application of IUS in IBD for best patient care. In this article, we provide an overview of how to start IUS for IBD and introduce basic procedures. Furthermore, IUS images from our practice are provided as a color atlas for understanding sonographic findings and scoring systems. We anticipate this “first aid” article will be helpful to promote IUS for IBD in daily practice.

Citations

Citations to this article as recorded by  
  • A combination of bowel wall thickness and submucosa index is useful for estimating endoscopic improvement in ulcerative colitis: external validation of the Kyorin Ultrasound Criterion
    Haruka Komatsu, Hiromu Morikubo, Yoko Kimura, Chihiro Moue, Hiromi Yonezawa, Minoru Matsuura, Jun Miyoshi, Tadakazu Hisamatsu
    Journal of Gastroenterology.2024; 59(3): 209.     CrossRef
  • Early Sonographic Improvement Predicts Clinical Remission and Mucosal Healing With Molecular-Targeted Drugs in Ulcerative Colitis
    Yoko Kimura, Jun Miyoshi, Hiromu Morikubo, Haruka Komatsu, Chihiro Moue, Hiromi Yonezawa, Minoru Matsuura, Tadakazu Hisamatsu
    Gastro Hep Advances.2024; 3(6): 703.     CrossRef
  • IBD barriers across the continents – East Asia
    Joyce Wing Yan Mak, Agnes Hiu Yan Ho, Siew Chien Ng
    Therapeutic Advances in Gastroenterology.2023;[Epub]     CrossRef
  • 3,460 View
  • 302 Download
  • 2 Web of Science
  • 3 Crossref
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Original Articles
IBD
Efficacy and safety of filgotinib as induction and maintenance therapy for Japanese patients with moderately to severely active ulcerative colitis: a post-hoc analysis of the phase 2b/3 SELECTION trial
Toshifumi Hibi, Satoshi Motoya, Tadakazu Hisamatsu, Fumihito Hirai, Kenji Watanabe, Katsuyoshi Matsuoka, Masayuki Saruta, Taku Kobayashi, Brian G Feagan, Chantal Tasset, Robin Besuyen, Chohee Yun, Gerald Crans, Jie Zhang, Akira Kondo, Mamoru Watanabe
Intest Res 2023;21(1):110-125.   Published online March 11, 2022
DOI: https://doi.org/10.5217/ir.2021.00143
AbstractAbstract PDFSupplementary MaterialPubReaderePub
Background/Aims
The safety and efficacy of filgotinib, a once-daily oral Janus kinase 1 preferential inhibitor, were evaluated in Japanese patients with ulcerative colitis (UC) in the phase 2b/3 SELECTION trial.
Methods
SELECTION (NCT02914522) was a randomized, placebo-controlled trial comprising 2 induction studies and a maintenance study. Adults with moderately to severely active UC were randomized in induction study A (biologic-naïve) or B (biologic-experienced) to receive filgotinib 200 mg, 100 mg, or placebo once daily for 11 weeks. Patients in clinical remission or Mayo Clinic score response at week 10 entered the 47-week maintenance study. Efficacy and safety outcomes were assessed in Japanese patients enrolled in Japan.
Results
Overall, 37 and 72 Japanese patients were enrolled in Japan in induction studies A and B, respectively, and 54 entered the maintenance study. Numerically higher proportions of filgotinib 200 mg-treated than placebo-treated patients achieved clinical remission in induction study A (4/15 [26.7%] vs. 0/6 [0%]) and the maintenance study (5/20 [25.0%] vs. 0/9 [0%]), but not induction study B (1/29 [3.4%] vs. 1/14 [7.1%]). Both doses were well tolerated, and no new safety signals were noted. Herpes zoster was reported in 1 filgotinib 200 mg-treated patient in each of induction study A (2.3%, 1/44) and the maintenance study (5.0%, 1/20).
Conclusions
These data, alongside those of the overall SELECTION population, suggest the potential of filgotinib 200 mg as a viable treatment option for Japanese patients with UC. Owing to small patient numbers, data should be interpreted cautiously.

Citations

Citations to this article as recorded by  
  • Efficacy and safety of filgotinib for ulcerative colitis: A real‐world multicenter retrospective study in Japan
    Shintaro Akiyama, Kaoru Yokoyama, Soichi Yagi, Shinichiro Shinzaki, Kozo Tsuruta, Shinichiro Yoshioka, Minako Sako, Hiromichi Shimizu, Mariko Kobayashi, Toshiyuki Sakurai, Kei Nomura, Tomoyoshi Shibuya, Masahiro Takahara, Sakiko Hiraoka, Kyohei Sugai, Shu
    Alimentary Pharmacology & Therapeutics.2024; 59(11): 1413.     CrossRef
  • Real-World Data on the Effectiveness and Safety of Filgotinib for Ulcerative Colitis in Japanese Patients: A Single-Center Experience
    Takahito Toba, Ryo Karashima, Kodai Fujii, Keiichi Inoue, Nanako Inoue, Yurie Ogawa, Aya Hojo, Ai Fujimoto, Takahisa Matsuda
    Cureus.2024;[Epub]     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
  • Patients’ Preference on Advanced Therapy and Follow-Up Procedure for Inflammatory Bowel Disease in Japan: A Web-Based 3A Survey
    Toshifumi Morishita, Shunichi Yanai, Yosuke Toya, Takayuki Matsumoto
    Inflammatory Intestinal Diseases.2024; 9(1): 174.     CrossRef
  • The role and prospect of tofacitinib in patients with ulcerative colitis
    Jun Lee
    Intestinal Research.2023; 21(1): 168.     CrossRef
  • Advances in pharmacotherapy for ulcerative colitis: a focus on JAK1 inhibitors
    Alexander Goetsch, Ferdinando D’Amico, Mariangela Allocca, Gionata Fiorino, Federica Furfaro, Alessandra Zilli, Tommaso Lorenzo Parigi, Simona Radice, Laurent Peyrin-Biroulet, Silvio Danese
    Expert Opinion on Pharmacotherapy.2023; 24(7): 849.     CrossRef
  • Understanding the efficacy of individual Janus kinase inhibitors in the treatment of ulcerative colitis for future positioning in inflammatory bowel disease treatment
    Hiroshi Nakase
    Immunological Medicine.2023; 46(3): 121.     CrossRef
  • Inflammation-Driven Colorectal Cancer Associated with Colitis: From Pathogenesis to Changing Therapy
    Olga Maria Nardone, Irene Zammarchi, Giovanni Santacroce, Subrata Ghosh, Marietta Iacucci
    Cancers.2023; 15(8): 2389.     CrossRef
  • Extraintestinal Cancers in Inflammatory Bowel Disease: A Literature Review
    Alessandro Massano, Luisa Bertin, Fabiana Zingone, Andrea Buda, Pierfrancesco Visaggi, Lorenzo Bertani, Nicola de Bortoli, Matteo Fassan, Marco Scarpa, Cesare Ruffolo, Imerio Angriman, Cristina Bezzio, Valentina Casini, Davide Giuseppe Ribaldone, Edoardo
    Cancers.2023; 15(15): 3824.     CrossRef
  • Integrated safety analysis of filgotinib for ulcerative colitis: Results from SELECTION and SELECTIONLTE
    Stefan Schreiber, Gerhard Rogler, Mamoru Watanabe, Séverine Vermeire, Christian Maaser, Silvio Danese, Margaux Faes, Paul Van Hoek, Jeremy Hsieh, Ulrik Moerch, Yan Zhou, Angela de Haas, Christine Rudolph, Alessandra Oortwijn, Edward V. Loftus
    Alimentary Pharmacology & Therapeutics.2023; 58(9): 874.     CrossRef
  • Recent advances in anti-inflammatory active components and action mechanisms of natural medicines
    Zhimin Wu, Tao Zhang, Xiaofei Ma, Shuai Guo, Qingqing Zhou, Arshad Zahoor, Ganzhen Deng
    Inflammopharmacology.2023; 31(6): 2901.     CrossRef
  • Filgotinib for moderately to severely active ulcerative colitis
    Alessandro Mannucci, Ferdinando D’Amico, Ahmad El Saadi, Laurent Peyrin-Biroulet, Silvio Danese
    Expert Review of Gastroenterology & Hepatology.2022; 16(10): 927.     CrossRef
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  • 12 Crossref
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Inflammatory Bowel Diseases
Efficacy and safety of ustekinumab in East Asian patients with moderately to severely active ulcerative colitis: a subpopulation analysis of global phase 3 induction and maintenance studies (UNIFI)
Tadakazu Hisamatsu, Hyo Jong Kim, Satoshi Motoya, Yasuo Suzuki, Yoshifumi Ohnishi, Noriyuki Fujii, Nobuko Matsushima, Richuan Zheng, Colleen W. Marano
Intest Res 2021;19(4):386-397.   Published online December 1, 2020
DOI: https://doi.org/10.5217/ir.2020.00080
AbstractAbstract PDFSupplementary MaterialPubReaderePub
Background/Aims
We aimed to evaluate the efficacy and safety of ustekinumab (UST) in the East-Asian population with moderate to severely active ulcerative colitis (UC).
Methods
This sub-analysis was conducted on data from East-Asian patients included in the UNIFI program (NCT02407236). UNIFI consisted of two double-blind, placebo-controlled trials: an 8-week induction study and a 44-week randomized withdrawal maintenance study.
Results
Of 133 East-Asian patients (Japanese: 107, Korean: 26) who underwent randomization, 131 completed induction study and 111 entered maintenance study. In the maintenance study, 78 patients were randomized. Patients who received UST 130 mg and UST 6 mg/kg showed numerically higher clinical remission at week 8 in the induction study (5/44 [11.4%] and 5/45 [11.1%], respectively) compared with those who received placebo (0/44, 0%). The proportion of patients achieved clinical remission at week 44 was numerically higher in the UST 90 mg q12w group (10/21, 47.6%), but similar in the UST 90 mg q8w group (5/26, 19.2%) compared to placebo (7/31, 22.6%). Serious adverse events were reported in 1 patient in UST 130 mg group, but no patient in UST 6 mg/kg group through week 8 in the induction study, and 1 patient in UST 90 mg q12w group and 5 patients in the UST 90 mg q8w group in the maintenance study. No deaths were reported in East-Asian patients throughout the study.
Conclusions
UST induction and maintenance treatments were effective in East-Asian patients with moderate to severe UC; the efficacy and safety profiles were consistent with the overall population.

Citations

Citations to this article as recorded by  
  • Systematic Review and Meta-analysis: The Association Between Serum Ustekinumab Trough Concentrations and Treatment Response in Inflammatory Bowel Disease
    Abhinav Vasudevan, Vivek Tharayil, Laura H Raffals, David H Bruining, Michelle Becker, Mohammad Hassan Murad, Edward V Loftus
    Inflammatory Bowel Diseases.2024; 30(4): 660.     CrossRef
  • Machine learning using clinical data at baseline predicts the medium-term efficacy of ustekinumab in patients with ulcerative colitis
    Hiromu Morikubo, Ryuta Tojima, Tsubasa Maeda, Katsuyoshi Matsuoka, Minoru Matsuura, Jun Miyoshi, Satoshi Tamura, Tadakazu Hisamatsu
    Scientific Reports.2024;[Epub]     CrossRef
  • Hepatic Steatosis but Not Fibrosis Is Independently Associated with Poor Outcomes in Patients with Inflammatory Bowel Disease
    Hye Kyung Hyun, Hye Won Lee, Jihye Park, Soo Jung Park, Jae Jun Park, Tae Il Kim, Jae Seung Lee, Beom Kyung Kim, Jun Yong Park, Do Young Kim, Sang Hoon Ahn, Seung Up Kim, Jae Hee Cheon
    Gut and Liver.2024; 18(2): 294.     CrossRef
  • Machine Learning for Predicting Biologic Agent Efficacy in Ulcerative Colitis: An Analysis for Generalizability and Combination with Computational Models
    Philippe Pinton
    Diagnostics.2024; 14(13): 1324.     CrossRef
  • One-year Safety and Effectiveness of Ustekinumab in Patients With Crohn’s Disease: The K-STAR Study
    Chang Kyun Lee, Won Moon, Jaeyoung Chun, Eun Soo Kim, Hyung Wook Kim, Hyuk Yoon, Hyun Soo Kim, Yoo Jin Lee, Chang Hwan Choi, Yunho Jung, Sung Chul Park, Geun Am Song, Jong Hun Lee, Eun Suk Jung, Youngdoe Kim, Su Young Jung, Jong Min Choi, Byong Duk Ye
    Inflammatory Bowel Diseases.2024;[Epub]     CrossRef
  • Risks of colorectal cancer and biliary cancer according to accompanied primary sclerosing cholangitis in Korean patients with ulcerative colitis: a nationwide population-based study
    Eun Hye Oh, Ye-Jee Kim, Minju Kim, Seung Ha Park, Tae Oh Kim, Sang Hyoung Park
    Intestinal Research.2023; 21(2): 252.     CrossRef
  • A critical review of ustekinumab for the treatment of active ulcerative colitis in adults
    Sophie Vieujean, Edouard Louis, Silvio Danese, Laurent Peyrin-Biroulet
    Expert Review of Gastroenterology & Hepatology.2023; 17(5): 413.     CrossRef
  • Reviewing not Homer’s Iliad, but “Kai Bao Ben Cao”: indigo dye—the past, present, and future
    Yusuke Yoshimatsu, Tomohisa Sujino, Takanori Kanai
    Intestinal Research.2023; 21(2): 174.     CrossRef
  • Concomitant ankylosing spondylitis can increase the risk of biologics or small molecule therapies to control inflammatory bowel disease
    Yu Kyung Jun, Hyuk Yoon, Seong-Joon Koh, A Hyeon Kim, Kwang Woo Kim, Jun Won Park, Hyun Jung Lee, Hyoun Woo Kang, Jong Pil Im, Young Soo Park, Joo Sung Kim
    Intestinal Research.2023; 21(2): 244.     CrossRef
  • The Risk of Tuberculosis in Patients With Inflammatory Bowel Disease Treated With Vedolizumab or Ustekinumab in Korea
    Myeong Geun Choi, Byong Duk Ye, Suk-Kyun Yang, Tae Sun Shim, Kyung-Wook Jo, Sang Hyoung Park
    Journal of Korean Medical Science.2022;[Epub]     CrossRef
  • Japanese pediatric patient with moderately active ulcerative colitis successfully treated with ustekinumab
    Toshihiko Kakiuchi, Masato Yoshiura
    Medicine.2022; 101(7): e28873.     CrossRef
  • Personalized medicine in inflammatory bowel disease: Perspectives on Asia
    Su Hyun Park, Sang Hyoung Park
    Journal of Gastroenterology and Hepatology.2022; 37(8): 1434.     CrossRef
  • Antitumor necrosis factor treatment in patients with inflammatory bowel disease does not promote psoriasis development: A meta-analysis
    Yu Kyung Jun, Joo Young Park, Seong-Joon Koh, Hyunsun Park, Hyoun Woo Kang, Jong Pil Im, Joo Sung Kim
    Medicine.2022; 101(27): e29872.     CrossRef
  • Viral Hepatitis in Patients with Inflammatory Bowel Disease
    Seung Hwan Shin, Sang Hyoung Park
    The Korean Journal of Gastroenterology.2022; 80(2): 51.     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
  • 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
  • Natural history of inflammatory bowel disease: a comparison between the East and the West
    Eun Mi Song, Suk-Kyun Yang
    Intestinal Research.2022; 20(4): 418.     CrossRef
  • Current status of inflammatory bowel diseases in Korea
    Suk-Kyun Yang
    Journal of the Korean Medical Association.2021; 64(9): 572.     CrossRef
  • 6,598 View
  • 423 Download
  • 19 Web of Science
  • 18 Crossref
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Inflammatory Bowel Diseases
Long-term safety and effectiveness of adalimumab in Japanese patients with Crohn’s disease: 3-year results from a real-world study
Tadakazu Hisamatsu, Yasuo Suzuki, Mariko Kobayashi, Takashi Hagiwara, Takeshi Kawaberi, Haruhiko Ogata, Toshiyuki Matsui, Mamoru Watanabe, Toshifumi Hibi
Intest Res 2021;19(4):408-418.   Published online November 20, 2020
DOI: https://doi.org/10.5217/ir.2020.00025
AbstractAbstract PDFPubReaderePub
Background/Aims
Crohn’s disease is a chronic disorder; therefore, it is essential to investigate long-term safety and efficacy of treatments. This study assessed the safety and effectiveness of adalimumab for up to 3 years in Japanese patients with Crohn’s disease in real-world settings.
Methods
This was a multicenter, single-cohort, observational study of patients with Crohn’s disease. Safety assessments included incidence of adverse drug reactions. Effectiveness assessments included clinical remission, mucosal healing, and Work Productivity and Activity Impairment (WPAI).
Results
The safety and effectiveness analysis populations comprised 389 and 310 patients, respectively. Mean (standard deviation) exposure to adalimumab in the safety analysis population was 793.4 (402.8) days, with a 58.1% retention rate. A total of 105 patients (27.0%) and 43 patients (11.1%) experienced adverse drug reactions and serious adverse drug reactions, respectively, with no patient reporting tuberculosis or hepatitis B. Infections and serious infections were reported in 37 patients (9.5%) and 17 patients (4.4%), respectively. Malignancy was reported as an adverse drug reaction in 2 patients (0.5%). Remission rate increased from 37.8% (98/259) at baseline to 73.9% (167/226) at week 4 and remained > 70% over 3 years. Proportion of patients without mucosal ulcerations increased from 2.7% (2/73) at baseline to 42.3% (11/26) between years > 2 to ≤ 3. WPAI improvement started at 4 weeks, with the overall work impairment score improving from 42.7 (n = 102) at baseline to 26.9 (n = 84) at 4 weeks.
Conclusions
Results from this study confirm the long-term safety and effectiveness of adalimumab treatment in Japanese patients with Crohn’s disease in the real-world setting.

Citations

Citations to this article as recorded by  
  • Effect of Perianal Fistula on the Quality of Life and Work Productivity of Patients with Crohn's Disease: Report of a Questionnaire Survey
    Naoto Saigusa, Takeshi Inaba
    Nippon Daicho Komonbyo Gakkai Zasshi.2024; 77(2): 89.     CrossRef
  • Real-world effectiveness and safety of adalimumab in Korean patients with intestinal Behcet’s disease: a Korean Association for the Study of Intestinal Diseases (KASID) multicenter study
    Seung Bum Lee, Hee Seung Hong, Chang Kyun Lee, Bo-In Lee, Sol Kim, Seong-Joon Koh, Hosun Yu, Jung-Bin Park, Sung Wook Hwang, Byong Duk Ye, Suk-Kyun Yang, Sang Hyoung Park
    The Korean Journal of Internal Medicine.2023; 38(5): 661.     CrossRef
  • Clinical features of enteric and colo-duodenal fistula in patients with Crohn’s disease
    Jun Su Lee, Sang-Bum Kang, Kwangbeom Park, Yong Sik Yoon, Chang Sik Yu, Sung Wook Hwang, Byong Duk Ye, Suk-Kyun Yang, Jong Lyul Lee, Sang Hyoung Park
    Intestinal Research.2023; 21(3): 406.     CrossRef
  • TNF-Alpha Inhibitors and Ustekinumab for the Treatment of Psoriasis: Therapeutic Utility in the Era of IL-17 and IL-23 Inhibitors
    Julie J. Hong, Edward K. Hadeler, Megan L. Mosca, Nicholas D. Brownstone, Tina Bhutani, Wilson J. Liao
    Journal of Psoriasis and Psoriatic Arthritis.2022; 7(2): 79.     CrossRef
  • Infliximab versus Adalimumab: Can We Choose the Right One for the Right Patients with Ulcerative Colitis?
    Sang Hyoung Park, Byong Duk Ye, Suk-Kyun Yang
    Gut and Liver.2022; 16(1): 138.     CrossRef
  • Biological Therapies for the Management of Enteric Disease: Considerations for the Clinician
    Adam Saleh, Usman Ansari, Shaadi Abughazaleh, Kerri Glassner, Bincy P Abraham
    Biologics: Targets and Therapy.2022; Volume 16: 67.     CrossRef
  • Prevention of postoperative recurrence in Crohn’s disease: the never-ending story
    Jung-Bin Park, Sang Hyoung Park
    Intestinal Research.2022; 20(3): 279.     CrossRef
  • Updates on conventional therapies for inflammatory bowel diseases: 5-aminosalicylates, corticosteroids, immunomodulators, and anti-TNF-α
    Jihye Park, Jae Hee Cheon
    The Korean Journal of Internal Medicine.2022; 37(5): 895.     CrossRef
  • Viral Hepatitis in Patients with Inflammatory Bowel Disease
    Seung Hwan Shin, Sang Hyoung Park
    The Korean Journal of Gastroenterology.2022; 80(2): 51.     CrossRef
  • Adalimumab for induction of remission in patients with Crohn's disease: a systematic review and meta-analysis
    Juntao Yin, Yang Li, Yangyang Chen, Chaoyang Wang, Xiaoyong Song
    European Journal of Medical Research.2022;[Epub]     CrossRef
  • Natural history of inflammatory bowel disease: a comparison between the East and the West
    Eun Mi Song, Suk-Kyun Yang
    Intestinal Research.2022; 20(4): 418.     CrossRef
  • Can Anti-Tumor Necrosis Factor Agents Be Discontinued in Patients with Inflammatory Bowel Disease?
    Jihye Park, Jae Hee Cheon
    Gut and Liver.2021; 15(5): 641.     CrossRef
  • Pharmacogenetics-based personalized treatment in patients with inflammatory bowel disease: A review
    Ji Young Chang, Jae Hee Cheon
    Precision and Future Medicine.2021; 5(4): 151.     CrossRef
  • 5,969 View
  • 325 Download
  • 17 Web of Science
  • 13 Crossref
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Corrigendum
Corrigendum: Randomized, crossover questionnaire survey of acceptabilities of controlled-release mesalazine tablets and granules in ulcerative colitis patients
Keiji Yagisawa, Taku Kobayashi, Ryo Ozaki, Shinji Okabayashi, Takahiko Toyonaga, Miki Miura, Mari Hayashida, Eiko Saito, Masaru Nakano, Hajime Matsubara, Tadakazu Hisamatsu, Toshifumi Hibi
Intest Res 2020;18(3):343-344.   Published online July 20, 2020
DOI: https://doi.org/10.5217/ir.2018.00078-c1
Corrects: Intest Res 2019;17(1):87
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Editorial
Inflammatory bowel diseases
Enteral nutrition in the biologic era: learn from yesterday, live for today, hope for tomorrow
Tadakazu Hisamatsu
Intest Res 2020;18(2):139-140.   Published online April 20, 2020
DOI: https://doi.org/10.5217/ir.2019.09192
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Citations

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    Duo Xu, Ziheng Peng, Yong Li, Qian Hou, Yu Peng, Xiaowei Liu
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Review
IBD
Best practices on immunomodulators and biologic agents for ulcerative colitis and Crohn’s disease in Asia
Choon Jin Ooi, Ida Hilmi, Rupa Banerjee, Sai Wei Chuah, Siew Chien Ng, Shu Chen Wei, Govind K Makharia, Pises Pisespongsa, Min Hu Chen, Zhi Hua Ran, Byong Duk Ye, Dong Il Park, Khoon Lin Ling, David Ong, Vineet Ahuja, Khean Lee Goh, Jose Sollano, Wee Chian Lim, Wai Keung Leung, Raja Affendi Raja Ali, Deng Chyang Wu, Evan Ong, Nazri Mustaffa, Julajak Limsrivilai, Tadakazu Hisamatsu, Suk Kyun Yang, Qin Ouyang, Richard Geary, Janaka H De Silva, Rungsun Rerknimitr, Marcellus Simadibrata, Murdani Abdullah, Rupert WL Leong, the Asia Pacific Association of Gastroenterology (APAGE) Working Group on Inflammatory Bowel Disease and Asian Organization for Crohn’s and Colitis
Intest Res 2019;17(3):285-310.   Published online May 31, 2019
DOI: https://doi.org/10.5217/ir.2019.00026
AbstractAbstract PDFPubReaderePub
The Asia-Pacific Working Group on inflammatory bowel disease (IBD) was established in Cebu, Philippines, under the auspices of the Asian Pacific Association of Gastroenterology with the goal of improving IBD care in Asia. This consensus is carried out in collaboration with Asian Organization for Crohn’s and Colitis. With biologic agents and biosimilars becoming more established, it is necessary to conduct a review on existing literature and establish a consensus on when and how to introduce biologic agents and biosimilars in the conjunction with conventional treatments for ulcerative colitis (UC) and Crohn’s disease (CD) in Asia. These statements also address how pharmacogenetics influence the treatments of UC and CD and provide guidance on response monitoring and strategies to restore loss of response. Finally, the review includes statements on how to manage treatment alongside possible hepatitis B and tuberculosis infections, both common in Asia. These statements have been prepared and voted upon by members of IBD workgroup employing the modified Delphi process. These statements do not intend to be all-encompassing and future revisions are likely as new data continue to emerge.

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    Soo-Kyung Park, Chang Hwan Choi, Jaeyoung Chun, Heeyoung Lee, Eun Sun Kim, Jae Jun Park, Chan Hyuk Park, Bo-In Lee, Yunho Jung, Dong-Il Park, Do Young Kim, Hana Park, Yoon Tae Jeen
    Intestinal Research.2020; 18(1): 18.     CrossRef
  • Association of Faecal Calprotectin Level and Combined Endoscopic and Radiological Healing in Patients With Crohn’s Disease Receiving Anti-tumour Necrosis Factor Therapy
    Soo Min Noh, Eun Hye Oh, Seong Ho Park, Jung Bok Lee, Jin Yong Kim, Jae Cheol Park, Jeongseok Kim, Nam Seok Ham, Sung Wook Hwang, Sang Hyoung Park, Dong-Hoon Yang, Jeong-Sik Byeon, Seung-Jae Myung, Suk-Kyun Yang, Beyong Duk Ye
    Journal of Crohn's and Colitis.2020; 14(9): 1231.     CrossRef
  • Changes in prevalence and perception of complementary and alternative medicine use in Korean inflammatory bowel disease patients: results of an 8-year follow-up survey
    Sun-Ho Lee, Kiju Chang, Ki Seok Seo, Yun Kyung Cho, Eun Mi Song, Sung Wook Hwang, Dong-Hoon Yang, Byong Duk Ye, Jeong-Sik Byeon, Seung-Jae Myung, Suk-Kyun Yang, Sang Hyoung Park
    Intestinal Research.2020; 18(2): 192.     CrossRef
  • Indigo Naturalis Alleviates Dextran Sulfate Sodium-Induced Colitis in Rats via Altering Gut Microbiota
    Zhongmei Sun, Junxiang Li, Yi Dai, Wenting Wang, Rui Shi, Zhibin Wang, Panghua Ding, Qiongqiong Lu, Hui Jiang, Wenjing Pei, Xingjie Zhao, Yi Guo, Jiali Liu, Xiang Tan, Tangyou Mao
    Frontiers in Microbiology.2020;[Epub]     CrossRef
  • Similar Clinical Outcomes of Early and Late Anti-TNF Initiation for Ulcerative Colitis: A Nationwide Population-Based Study
    Minkyung Han, Yoon Suk Jung, Jae Hee Cheon, Sohee Park
    Yonsei Medical Journal.2020; 61(5): 382.     CrossRef
  • Long-term prognosis of ulcerative colitis and its temporal changes between 1986 and 2015 in a population-based cohort in the Songpa-Kangdong district of Seoul, Korea
    Jae Myung Cha, Sang Hyoung Park, Kyoung Hoon Rhee, Sung Noh Hong, Young-Ho Kim, Seung In Seo, Kyung Ho Kim, Seung Kyu Jeong, Ji Hyun Lee, Sun Yong Park, Hyunju Park, Joo Sung Kim, Jong Pil Im, Hyuk Yoon, Sung Hoon Kim, Jisun Jang, Jeong Hwan Kim, Seong O
    Gut.2020; 69(8): 1432.     CrossRef
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    Fernando Magro, Gonçalo Cordeiro, Andreia Martins Dias, Maria Manuela Estevinho
    Pharmacological Research.2020; 160: 105075.     CrossRef
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    Seong Ran Jeon
    The Korean Journal of Internal Medicine.2020; 35(4): 854.     CrossRef
  • Impact of early anti-TNF use on clinical outcomes in Crohn’s disease: a nationwide population-based study
    Yoon Suk Jung, Minkyung Han, Sohee Park, Jae Hee Cheon
    The Korean Journal of Internal Medicine.2020; 35(5): 1104.     CrossRef
  • Nanocomposites-based targeted oral drug delivery systems with infliximab in a murine colitis model
    Jung Min Kim, Da Hye Kim, Hyo Jeong Park, Hyun Woo Ma, I Seul Park, Mijeong Son, So Youn Ro, Seokmann Hong, Hyo Kyung Han, Soo Jeong Lim, Seung Won Kim, Jae Hee Cheon
    Journal of Nanobiotechnology.2020;[Epub]     CrossRef
  • Challenges in the diagnosis and management of inflammatory bowel disease in resource-limited settings in Asia
    Rupa Banerjee, Partha Pal, Joyce Wing Yan Mak, Siew C Ng
    The Lancet Gastroenterology & Hepatology.2020; 5(12): 1076.     CrossRef
  • Optimising management strategies of inflammatory bowel disease in resource-limited settings in Asia
    Siew C Ng, Joyce Wing Yan Mak, Partha Pal, Rupa Banerjee
    The Lancet Gastroenterology & Hepatology.2020; 5(12): 1089.     CrossRef
  • NUDT15 C415T variant compared with TPMT genotyping in predicting azathioprine‐induced leucopenia: prospective analysis of 1014 inflammatory bowel disease patients in India
    Rupa Banerjee, Vishnubhotla Venkata Ravikanth, Partha Pal, Govardhan Bale, Urmila Steffie Avanthi, Idan Goren, B. Ganesh Girish, Sasikala Mitnala, D. Nageshwar Reddy
    Alimentary Pharmacology & Therapeutics.2020; 52(11-12): 1683.     CrossRef
  • 28,324 View
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Original Articles
IBD
Randomized, crossover questionnaire survey of acceptabilities of controlled-release mesalazine tablets and granules in ulcerative colitis patients
Keiji Yagisawa, Taku Kobayashi, Ryo Ozaki, Shinji Okabayashi, Takahiko Toyonaga, Miki Miura, Mari Hayashida, Eiko Saito, Masaru Nakano, Hajime Matsubara, Tadakazu Hisamatsu, Toshifumi Hibi
Intest Res 2019;17(1):87-93.   Published online December 14, 2018
DOI: https://doi.org/10.5217/ir.2018.00078
Correction in: Intest Res 2020;18(3):343
AbstractAbstract PDFPubReaderePub
Background/Aims
Oral mesalazine is an important treatment for ulcerative colitis (UC), and non-adherence to mesalazine increases the risk of relapse. Controlled-release (CR) mesalazine has 2 formulations: tablets and granules. The relative acceptabilities of these formulations may influence patient adherence; however, they have not been compared to date. This study aimed to evaluate the acceptabilities of the 2 formulations of CR mesalazine in relation to patient adherence using a crossover questionnaire survey.
Methods
UC patients were randomly assigned to 2 groups in a 1:1 ratio. Patients in each group took either 4 g of CR mesalazine tablets or granules for 6 to 9 weeks, and then switched to 4 g of the other formulation for a further 6 to 9 weeks. The acceptability and efficacy were evaluated by questionnaires, and adherence was assessed using a visual analog scale. The difference in acceptabilities between the 2 formulations and its impact on adherence were assessed.
Results
A total of 49 patients were prospectively enrolled and 33 patients were included in the analysis. Significantly more patients found the tablets to be less acceptable than the granules (76% vs. 33%, P=0.0005). The granules were preferable to the tablets when the 2 formulations were compared directly (73% vs. 21%, P=0.004), for their portability, size, and numbers of pills. The adherence rate was slightly better among patients taking the granules (94% vs. 91%) during the observation period, but the difference was not significant (P=0.139).
Conclusions
CR mesalazine granules are more acceptable than tablets, and may therefore be a better option for long-term medication.

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  • Continuing or stopping 5‐aminosalicylates in patients with inflammatory bowel disease on anti‐TNF therapy: A nationwide population‐based study
    Jeongkuk Seo, Seonok Kim, Seung Wook Hong, Sung Wook Hwang, Sang Hyoung Park, Dong‐Hoon Yang, Jeong‐Sik Byeon, Seung‐Jae Myung, Suk‐Kyun Yang, Ye‐Jee Kim, Byong Duk Ye
    Alimentary Pharmacology & Therapeutics.2024; 60(3): 389.     CrossRef
  • A review on taste masked multiparticulate dosage forms for paediatric
    Khater AL-Japairai, Samah Hamed Almurisi, Abd Almonem Doolaanea, Syed Mahmood, Fawaz Alheibshy, Ahmed Alobaida, Nadiya Abdul-Halim, Bappaditya Chatterjee
    International Journal of Pharmaceutics.2023; 632: 122571.     CrossRef
  • Medication Formulation Preference of Mild and Moderate Ulcerative Colitis Patients: a European Survey
    Xavier Hébuterne, Stephan R Vavricka, Helen C Thorne, Lara MacKenzie-Smith, Raphaël Laoun, Johan Burisch
    Inflammatory Intestinal Diseases.2023; 8(1): 41.     CrossRef
  • Efficacy and Safety of Vitamin D Adjuvant Therapy for Ulcerative Colitis: A Meta-Analysis
    Xinyi Guo, Changxing Liu, Yahui Huang, Naeem Jan
    Computational and Mathematical Methods in Medicine.2022; 2022: 1.     CrossRef
  • Factors Associated with Self-reported Medication Adherence in Japanese Community-dwelling Elderly Individuals: The Nakajima Study
    Natsuko Ishida, Yurina Tokumoto, Yukio Suga, Moeko Noguchi-Shinohara, Chiemi Abe, Sohshi Yuki-Nozaki, Ayaka Mori, Mai Horimoto, Koji Hayashi, Kazuo Iwasa, Masami Yokogawa, Mai Ishimiya, Hiroyuki Nakamura, Kiyonobu Komai, Ryo Matsushita, Junko Ishizaki, Ma
    YAKUGAKU ZASSHI.2021; 141(5): 751.     CrossRef
  • Treatment of inflammatory bowel diseases: focusing on 5-aminosalicylates and immunomodulators
    You Sun Kim
    Journal of the Korean Medical Association.2021; 64(9): 596.     CrossRef
  • Pharmacogenetics-based personalized treatment in patients with inflammatory bowel disease: A review
    Ji Young Chang, Jae Hee Cheon
    Precision and Future Medicine.2021; 5(4): 151.     CrossRef
  • Association of Self-Reported Medication Adherence with Potentially Inappropriate Medications in Elderly Patients: A Cross-Sectional Pilot Study
    Motoyasu Miyazaki, Masanobu Uchiyama, Yoshihiko Nakamura, Koichi Matsuo, Chika Ono, Miwa Goto, Ayako Unoki, Akio Nakashima, Osamu Imakyure
    International Journal of Environmental Research and Public Health.2020; 17(16): 5940.     CrossRef
  • Mesalazine granule formulation improves clinical data in Crohn's disease compared with tablet formulation
    Satoshi Tamura, Natsuki Ishida, Takahiro Miyazu, Shunya Onoue, Shinya Tani, Mihoko Yamade, Yasushi Hamaya, Moriya Iwaizumi, Satoshi Osawa, Takahisa Furuta, Ken Sugimoto
    Scientific Reports.2020;[Epub]     CrossRef
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WITHDRAWN:Knowledge and viewpoints on biosimilar monoclonal antibodies from members of the Asian Organization of Crohn’s and Colitis: comparison with European Crohn’s and Colitis members
Soo-Kyung Park, Tadakazu Hisamatsu, Zhihua Ran, Shu-Chen Wei, Dong Il Park
Received June 12, 2018  Accepted October 6, 2018  Published online November 12, 2018  
DOI: https://doi.org/10.5217/ir.2018.00084

Citations

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  • Awareness and Knowledge of Pharmacists toward Biosimilar Medicines: A Survey in Jordan
    Muna Oqal, Bushra Hijazi, Abdelrahim Alqudah, Ahmad Al-Smadi, Basima A Almomani, Roaa Alnajjar, Majd Abu Ghunaim, Mohammad Irshaid, Aroob Husam, Gergely Feher
    International Journal of Clinical Practice.2022; 2022: 1.     CrossRef
  • 65,535 View
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Case Report
IBD
5-Aminosalicylic acid aggravates colitis mimicking exacerbation of ulcerative colitis
Jun Miyoshi, Katsuyoshi Matsuoka, Atsushi Yoshida, Makoto Naganuma, Tadakazu Hisamatsu, Tomoharu Yajima, Nagamu Inoue, Susumu Okamoto, Yasushi Iwao, Haruhiko Ogata, Fumiaki Ueno, Toshifumi Hibi, Takanori Kanai
Intest Res 2018;16(4):635-640.   Published online October 10, 2018
DOI: https://doi.org/10.5217/ir.2018.00015
AbstractAbstract PDFPubReaderePub
Ulcerative colitis (UC) is one of the major clinical phenotypes of inflammatory bowel diseases. Although 5-aminosalicylic acid (5-ASA) is widely used for UC and its efficacy and safety have been demonstrated, a few patients paradoxically develop a severe exacerbation of colitis by 5-ASA administration. It is crucial to know clinical features including endoscopic findings in this condition for making a correct diagnosis and a prompt decision to withdraw the medication. Here, we report case series with UC exacerbated by 5-ASA. Medical records of 8 UC patients experiencing an exacerbation of colitis after induction of 5-ASA that was improved by the withdrawal of 5-ASA but also re-aggravated by dose increase or re-administration of 5-ASA were reviewed. The patients were newly diagnosed with UC, started 5-ASA and developed an exacerbation in approximately 2 to 3 weeks. They did not appear to have systemic allergic reactions. Seven of the 8 patients had a high fever. Three of 5 patients who undertook total colonoscopy showed right-side-dominant colitis. These findings suggest clinical characteristics in this condition. Further assessment of clinical and endoscopic features in more cases is necessary for establishing diagnostic criteria and understanding underlying mechanisms in those cases where 5-ASA aggravates the colitis.

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  • Krill Oil and Its Bioactive Components as a Potential Therapy for Inflammatory Bowel Disease: Insights from In Vivo and In Vitro Studies
    Yingying Liu, Ainsley M. Robinson, Xiao Qun Su, Kulmira Nurgali
    Biomolecules.2024; 14(4): 447.     CrossRef
  • Ziziphus jujuba Miller Ethanol Extract Restores Disrupted Intestinal Barrier Function via Tight Junction Recovery and Reduces Inflammation
    Ye Jin Yang, Min Jung Kim, Ho Jeong Lee, Won-Yung Lee, Ju-Hye Yang, Hun Hwan Kim, Min Sup Shim, Ji Woong Heo, Jae Dong Son, Woo H. Kim, Gon Sup Kim, Hu-Jang Lee, Young-Woo Kim, Kwang Youn Kim, Kwang Il Park
    Antioxidants.2024; 13(5): 575.     CrossRef
  • Characteristics of Mucosa-Associated Microbiota in Ulcerative Colitis Patients with 5-Aminosalicylic Acid Intolerance
    Hiroshi Matsumoto, Momoyo Sasahira, Tei Tei Go, Shogen Yo, Takehiro Ninomiya, Motoyasu Osawa, Osamu Handa, Eiji Umegami, Ryo Inoue, Akiko Shiotani
    Biomedicines.2024; 12(9): 2125.     CrossRef
  • Risk factors for intolerance of oral 5‐aminosalicylic acid preparations in pediatric ulcerative colitis
    Naoki Abe, Naomi Iwata, Ryuhei Yasuoka, Daisuke Nishida, Asami Oohara, Haruna Nakaseko, Shiro Sugiura, Shinji Kawabe
    Pediatrics International.2023;[Epub]     CrossRef
  • Significance of 5-Aminosalicylic Acid Intolerance in the Clinical Management of Ulcerative Colitis
    Yohei Mikami, Junya Tsunoda, Shohei Suzuki, Ichiro Mizushima, Hiroki Kiyohara, Takanori Kanai
    Digestion.2023; 104(1): 58.     CrossRef
  • APE1/Ref-1 as a Therapeutic Target for Inflammatory Bowel Disease
    Lauren Sahakian, Ainsley M. Robinson, Linda Sahakian, Rhian Stavely, Mark R. Kelley, Kulmira Nurgali
    Biomolecules.2023; 13(11): 1569.     CrossRef
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Brief Communication
IBD
Effect of elemental diet combined with infliximab dose escalation in patients with Crohn's disease with loss of response to infliximab: CERISIER trial
Tadakazu Hisamatsu, Reiko Kunisaki, Shiro Nakamura, Tomoyuki Tsujikawa, Fumihito Hirai, Hiroshi Nakase, Kenji Watanabe, Kaoru Yokoyama, Masakazu Nagahori, Takanori Kanai, Makoto Naganuma, Hirofumi Michimae, Akira Andoh, Akihiro Yamada, Tadashi Yokoyama, Noriko Kamata, Shinji Tanaka, Yasuo Suzuki, Toshifumi Hibi, Mamoru Watanabe
Intest Res 2018;16(3):494-498.   Published online July 27, 2018
DOI: https://doi.org/10.5217/ir.2018.16.3.494
PDFSupplementary MaterialPubReaderePub

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  • Prospective study of an adalimumab combined with partial enteral nutrition in the induction period of Crohn’s disease
    Sisi Zhou, Zeyu Huang, Wenjing Hou, Yiting Lin, Jing Yu
    Inflammation Research.2024; 73(2): 199.     CrossRef
  • Role of diet in prevention versus treatment of Crohn’s disease and ulcerative colitis
    Emma P Halmos, Lihi Godny, Julie Vanderstappen, Chen Sarbagili-Shabat, Vaios Svolos
    Frontline Gastroenterology.2024; : flgastro-2023-102417.     CrossRef
  • Immunoregulatory Effects of Elemental Diet and Its Ingredient, Tryptophan, via Activation of the Aryl Hydrocarbon Receptor in Mice
    Atsuhito Kubota, Shungo Imai, Ryoichi Aoyagi, Wataru Murase, Masaru Terasaki, Mitsuru Sugawara, Yoh Takekuma, Hiroyuki Kojima
    International Journal of Molecular Sciences.2024; 25(6): 3448.     CrossRef
  • Real-world evidence of combined treatment of biologics and exclusive enteral nutrition in patients with ileum-dominant Crohn's disease: A multicenter study
    Wei Wang, Anning Yin, Jing Wang, Jiao Li, Jingyun Cheng, Jian Kang, Yaqing Xu, Yueyue Lu, Yuanping Yang, Juan Su, Qian Zhou, Ya Liu, Zhishun Tang, Haixia Ren, Weiwei Li, Weiguo Dong, Baoping Yu, Ping An
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    Marcel A. Behr, Ildiko Mehes, Charles N. Bernstein
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    Ignacio Catalán-Serra, Pret Ricanek, Tore Grimstad
    Revista Española de Enfermedades Digestivas.2022;[Epub]     CrossRef
  • Nutritional Therapy Strategies in Pediatric Crohn’s Disease
    Charlotte M. Verburgt, Mohammed Ghiboub, Marc A. Benninga, Wouter J. de Jonge, Johan E. Van Limbergen
    Nutrients.2021; 13(1): 212.     CrossRef
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    Hiroshi Nakase, Motoi Uchino, Shinichiro Shinzaki, Minoru Matsuura, Katsuyoshi Matsuoka, Taku Kobayashi, Masayuki Saruta, Fumihito Hirai, Keisuke Hata, Sakiko Hiraoka, Motohiro Esaki, Ken Sugimoto, Toshimitsu Fuji, Kenji Watanabe, Shiro Nakamura, Nagamu I
    Journal of Gastroenterology.2021; 56(6): 489.     CrossRef
  • Diet and nutrition in the management of inflammatory bowel disease
    Pabitra Sahu, Saurabh Kedia, Vineet Ahuja, Rakesh K. Tandon
    Indian Journal of Gastroenterology.2021; 40(3): 253.     CrossRef
  • Nutritional Aspects of Pediatric Gastrointestinal Diseases
    Teresa Di Chio, Christiane Sokollik, Diego G. Peroni, Lara Hart, Giacomo Simonetti, Franziska Righini-Grunder, Osvaldo Borrelli
    Nutrients.2021; 13(6): 2109.     CrossRef
  • Efficacy and tolerability of exclusive enteral nutrition in adult patients with complicated Crohn’s disease
    Sanchit Sharma, Arti Gupta, Saurabh Kedia, Samagra Agarwal, Namrata Singh, Sandeep Goyal, Saransh Jain, Vipin Gupta, Pabitra Sahu, Sudheer Kumar Vuyyuru, Bhaskar Kante, Raju Sharma, Rajesh Panwar, Peush Sahni, Govind Makharia, Vineet Ahuja
    Intestinal Research.2021; 19(3): 291.     CrossRef
  • Nutritional Therapies and Their Influence on the Intestinal Microbiome in Pediatric Inflammatory Bowel Disease
    Lara Hart, Charlotte M. Verburgt, Eytan Wine, Mary Zachos, Alisha Poppen, Mallory Chavannes, Johan Van Limbergen, Nikhil Pai
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  • Efficacy of enteral nutrition in patients with Crohn’s disease on maintenance anti-TNF-alpha antibody therapy: a meta-analysis
    Fumihito Hirai, Teruyuki Takeda, Yasumichi Takada, Masahiro Kishi, Tsuyoshi Beppu, Noritaka Takatsu, Masaki Miyaoka, Takashi Hisabe, Kenshi Yao, Tosiharu Ueki
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    Shinji Okabayashi, Taku Kobayashi, Toshifumi Hibi
    Journal of the Anus, Rectum and Colon.2020; 4(1): 1.     CrossRef
  • Exclusive enteral nutrition for induction of remission in anti-tumor necrosis factor refractory adult Crohn’s disease: the Indian experience
    Ajit Sood, Arshdeep Singh, Ritu Sudhakar, Vandana Midha, Ramit Mahajan, Varun Mehta, Yogesh Kumar Gupta, Kirandeep Kaur
    Intestinal Research.2020; 18(2): 184.     CrossRef
  • Enteral nutrition in the biologic era: learn from yesterday, live for today, hope for tomorrow
    Tadakazu Hisamatsu
    Intestinal Research.2020; 18(2): 139.     CrossRef
  • Half-Elemental Diet Shifts the Human Intestinal Bacterial Compositions and Metabolites: A Pilot Study with Healthy Individuals
    Jun Miyoshi, Daisuke Saito, Mio Nakamura, Miki Miura, Tatsuya Mitsui, Toru Kudo, Shinnosuke Murakami, Minoru Matsuura, Tadakazu Hisamatsu
    Gastroenterology Research and Practice.2020; 2020: 1.     CrossRef
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    Johan E. Van Limbergen, Bart G. P. Koot, J. Peter de Winter
    European Journal of Pediatrics.2020; 179(12): 1921.     CrossRef
  • Bases for the Adequate Development of Nutritional Recommendations for Patients with Inflammatory Bowel Disease
    Esteban Sáez-González, Beatriz Mateos, Pedro López-Muñoz, Marisa Iborra, Inés Moret, Pilar Nos, Belén Beltrán
    Nutrients.2019; 11(5): 1062.     CrossRef
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Original Articles
IBD
β-(1,3)-Glucan derived from Candida albicans induces inflammatory cytokines from macrophages and lamina propria mononuclear cells derived from patients with Crohn's disease
Kiyoto Mori, Makoto Naganuma, Shinta Mizuno, Hiroaki Suzuki, Mina T. Kitazume, Katsuyoshi Shimamura, Sayako Chiba, Akira Sugita, Katsuyoshi Matsuoka, Tadakazu Hisamatsu, Takanori Kanai
Intest Res 2018;16(3):384-392.   Published online July 27, 2018
DOI: https://doi.org/10.5217/ir.2018.16.3.384
AbstractAbstract PDFSupplementary MaterialPubReaderePub
<b>Background/Aims</b><br/>

Recent research has highlighted the importance of interactions between commensal fungi and intestinal inflammation. However, there are few studies investigating whether commensal fungi contribute to inflammation in patients with Crohn's disease (CD). The aim of this study is to investigate reveal interactions between commensal fungi and host immune cells in CD.

Methods

CD14-positive monocytes were isolated from peripheral blood mononuclear cells from healthy human volunteers and then differentiated in the presence of macrophage colony-stimulating factor (M-CSF) (referred to as M-macrophages, M-Mϕs) or M-CSF and interferon-γ (IFN-γ) (referred to as M-gamma macrophages, Mγ-Mϕs). Cytokine production by these in vitro differentiated macrophages in response to β-(1,3)-glucan was analyzed by flow cytometry. Expression of Dectin-1 was examined using flow cytometry, western blotting, and quantitative reverse transcription-polymerase chain reaction. Cytokine production by in vitro differentiated macrophages in response to β-(1,3)-glucan was measured in the presence of an anti-Dectin-1 receptor antagonist, anti-Syr, or an anti-Fas-1 antibody. Cytokine production by lamina propria mononuclear cells (LPMCs) derived from CD patients in response to β-(1,3)-glucan was also analyzed.

Results

Mγ-Mϕs produced a large amount of tumor necrosis factor-α (TNF-α) and interleukin-6 in response to β-(1,3)-glucan. Dectin-1 expression was significantly higher in Mγ-Mϕs than in M-Mϕs. The increase in TNF-α production by Mγ-Mϕs stimulated with glucan was reversed by blocking Dectin-1, Syr or Fas-1. LPMCs derived from CD patients stimulated with β-(1,3)-glucan produced significantly higher amount of TNF-α than LPMCs derived from UC patients.

Conclusions

These results suggest that commensal fungal microbiota may contribute to the pathogenesis of CD by inducing macrophages-derived pro-inflammatory cytokines.

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  • Heat Shock Protein SSA1 Enriched in Hypoxic Secretome of Candida albicans Exerts an Immunomodulatory Effect via Regulating Macrophage Function
    Wei Teng, Phawinee Subsomwong, Kouji Narita, Akio Nakane, Krisana Asano
    Cells.2024; 13(2): 127.     CrossRef
  • Antifungal immunity mediated by C-type lectin receptors may be a novel target in immunotherapy for urothelial bladder cancer
    Tianhang Li, Tianyao Liu, Zihan Zhao, Yuchen Pan, Xinyan Xu, Yulin Zhang, Shoubin Zhan, Shengkai Zhou, Wenjie Zhu, Hongqian Guo, Rong Yang
    Frontiers in Immunology.2022;[Epub]     CrossRef
  • Serum 1,3-beta-D-glucan as a noninvasive test to predict histologic activity in patients with inflammatory bowel disease
    Katia Farias e Silva, Hayandra F Nanini, Cynthia Machado Cascabulho, Siane L B Rosas, Patricia T Santana, Antonio José de V Carneiro, Elias Anaissie, Marcio Nucci, Heitor Siffert Pereira de Souza
    World Journal of Gastroenterology.2021; 27(9): 866.     CrossRef
  • Effects of Medicinal Fungi-Derived β-Glucan on Tumor Progression
    Vaclav Vetvicka, Tamara V. Teplyakova, Alexandra B. Shintyapina, Tatiana A. Korolenko
    Journal of Fungi.2021; 7(4): 250.     CrossRef
  • The Role of IL-17-Producing Cells in Cutaneous Fungal Infections
    Yu Sawada, Ayako Setoyama, Yumiko Sakuragi, Natsuko Saito-Sasaki, Haruna Yoshioka, Motonobu Nakamura
    International Journal of Molecular Sciences.2021; 22(11): 5794.     CrossRef
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IBD
Evaluation of the drug-induced lymphocyte stimulation test for diagnosing mesalazine allergy
Daisuke Saito, Mari Hayashida, Taro Sato, Shintaro Minowa, Osamu Ikezaki, Tatsuya Mitsui, Miki Miura, Akihito Sakuraba, Tadakazu Hisamatsu
Intest Res 2018;16(2):273-281.   Published online April 30, 2018
DOI: https://doi.org/10.5217/ir.2018.16.2.273
AbstractAbstract PDFPubReaderePub
<b>Background/Aims</b><br/>

Mesalazine is an effective drug for treating ulcerative colitis (UC), but causes allergic symptoms in a few cases. Therefore, the objective of this study was to evaluate the usefulness of the drug-induced lymphocyte stimulation test (DLST) for the diagnosis of mesalazine allergy.

Methods

Patients with UC treated with mesalazine with or without a history of associated adverse events (AEs) were enrolled at Kyorin University Hospital from July 2016 to April 2017.

Results

The DLST was performed in 104 patients with UC, of which 24 had a history of AEs due to mesalazine treatment. The control value of DLST was 337.4±296.3 counts per minute (cpm) in the AE+ group and 408.0±371.9 cpm in the AE group. The measured value of DLST was 578.8±424.7 cpm in the AE+ group and 476.5±471.8 cpm in the AE group. The stimulation index (SI) was 243.9%±291.1% in the AE+ group and 119.8%±53.0% in the AE group. The SI value and DLST positivity were significantly higher in the AE+ group than in the AE group (P=0.030 and P=0.029, respectively). The test sensitivity and specificity were 0.240 and 0.805, respectively, and the false-positive and false-negative rate was 0.195 and 0.760, respectively.

Conclusions

The DLST for mesalazine showed low sensitivity and high specificity, suggesting that it may be useful for the definitive diagnosis of allergy to mesalazine.

Citations

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  • Drug-induced Interstitial Nephritis in a Patient with Ulcerative Colitis Treated with 5-Aminosalicylic Acid
    Daichi Hayashi, Tsutomu Nishida, Naoto Osugi, Yasuo Kusunoki, Satoru Okabe, Yoshifumi Fujii, Dai Nakamatsu, Kengo Matsumoto, Masashi Yamamoto, Koji Fukui
    Internal Medicine.2024; 63(8): 1081.     CrossRef
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Statement
IBD
Predicting outcomes to optimize disease management in inflammatory bowel disease in Japan: their differences and similarities to Western countries
Taku Kobayashi, Tadakazu Hisamatsu, Yasuo Suzuki, Haruhiko Ogata, Akira Andoh, Toshimitsu Araki, Ryota Hokari, Hideki Iijima, Hiroki Ikeuchi, Yoh Ishiguro, Shingo Kato, Reiko Kunisaki, Takayuki Matsumoto, Satoshi Motoya, Masakazu Nagahori, Shiro Nakamura, Hiroshi Nakase, Tomoyuki Tsujikawa, Makoto Sasaki, Kaoru Yokoyama, Naoki Yoshimura, Kenji Watanabe, Miiko Katafuchi, Mamoru Watanabe, Toshifumi Hibi
Intest Res 2018;16(2):168-177.   Published online April 30, 2018
DOI: https://doi.org/10.5217/ir.2018.16.2.168
AbstractAbstract PDFPubReaderePub

Inflammatory bowel disease (IBD), including Crohn's disease (CD) and ulcerative colitis (UC), is a chronic inflammatory disease of the gastrointestinal tract, with increasing prevalence worldwide. IBD Ahead is an international educational program that aims to explore questions commonly raised by clinicians about various areas of IBD care and to consolidate available published evidence and expert opinion into a consensus for the optimization of IBD management. Given differences in the epidemiology, clinical and genetic characteristics, management, and prognosis of IBD between patients in Japan and the rest of the world, this statement was formulated as the result of literature reviews and discussions among Japanese experts as part of the IBD Ahead program to consolidate statements of factors for disease prognosis in IBD. Evidence levels were assigned to summary statements in the following categories: disease progression in CD and UC; surgery, hospitalization, intestinal failure, and permanent stoma in CD; acute severe UC; colectomy in UC; and colorectal carcinoma and dysplasia in IBD. The goal is that this statement can aid in the optimization of the treatment strategy for Japanese patients with IBD and help identify high-risk patients that require early intervention, to provide a better long-term prognosis in these patients.

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    Ashwin N. Ananthakrishnan
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  • 6,793 View
  • 131 Download
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Special Review
IBD
Asian Organization for Crohn's and Colitis and Asia Pacific Association of Gastroenterology consensus on tuberculosis infection in patients with inflammatory bowel disease receiving anti-tumor necrosis factor treatment. Part 1: risk assessment
Dong Il Park, Tadakazu Hisamatsu, Minhu Chen, Siew Chien Ng, Choon Jin Ooi, Shu Chen Wei, Rupa Banerjee, Ida Normiha Hilmi, Yoon Tae Jeen, Dong Soo Han, Hyo Jong Kim, Zhihua Ran, Kaichun Wu, Jiaming Qian, Pin-Jin Hu, Katsuyoshi Matsuoka, Akira Andoh, Yasuo Suzuki, Kentaro Sugano, Mamoru Watanabe, Toshifumi Hibi, Amarender S. Puri, Suk-Kyun Yang
Intest Res 2018;16(1):4-16.   Published online January 18, 2018
DOI: https://doi.org/10.5217/ir.2018.16.1.4
AbstractAbstract PDFPubReaderePub

Because anti-tumor necrosis factor (anti-TNF) therapy has become increasingly popular in many Asian countries, the risk of developing active tuberculosis (TB) among anti-TNF users may raise serious health problems in this region. Thus, the Asian Organization for Crohn's and Colitis and the Asia Pacific Association of Gastroenterology have developed a set of consensus statements about risk assessment, detection and prevention of latent TB infection, and management of active TB infection in patients with inflammatory bowel disease (IBD) receiving anti-TNF treatment. Twenty-three consensus statements were initially drafted and then discussed by the committee members. The quality of evidence and the strength of recommendations were assessed by using the Grading of Recommendations Assessment, Development, and Evaluation methodology. Web-based consensus voting was performed by 211 IBD specialists from 9 Asian countries concerning each statement. A consensus statement was accepted if at least 75% of the participants agreed. Part 1 of the statements comprised 2 parts: risk of TB infection Recommendaduring anti-TNF therapy, and screening for TB infection prior to commencing anti-TNF therapy. These consensus statements will help clinicians optimize patient outcomes by reducing the morbidity and mortality related to TB infections in patients with IBD receiving anti-TNF treatment.

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  • 9,563 View
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  • 28 Web of Science
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Close layer
Special Review: Consensus on TB in IBD
IBD
Asian Organization for Crohn's and Colitis and Asia Pacific Association of Gastroenterology consensus on tuberculosis infection in patients with inflammatory bowel disease receiving anti-tumor necrosis factor treatment. Part 2: management
Dong Il Park, Tadakazu Hisamatsu, Minhu Chen, Siew Chien Ng, Choon Jin Ooi, Shu Chen Wei, Rupa Banerjee, Ida Normiha Hilmi, Yoon Tae Jeen, Dong Soo Han, Hyo Jong Kim, Zhihua Ran, Kaichun Wu, Jiaming Qian, Pin-Jin Hu, Katsuyoshi Matsuoka, Akira Andoh, Yasuo Suzuki, Kentaro Sugano, Mamoru Watanabe, Toshifumi Hibi, Amarender S. Puri, Suk-Kyun Yang
Intest Res 2018;16(1):17-25.   Published online January 18, 2018
DOI: https://doi.org/10.5217/ir.2018.16.1.17
AbstractAbstract PDFPubReaderePub

Because anti-tumor necrosis factor (anti-TNF) therapy has become increasingly popular in many Asian countries, the risk of developing active tuberculosis (TB) among anti-TNF users may raise serious health problems in this region. Thus, the Asian Organization for Crohn's and Colitis and the Asia Pacific Association of Gastroenterology have developed a set of consensus statements about risk assessment, detection and prevention of latent TB infection, and management of active TB infection in patients with inflammatory bowel disease (IBD) receiving anti-TNF treatment. Twenty-three consensus statements were initially drafted and then discussed by the committee members. The quality of evidence and the strength of recommendations were assessed by using the Grading of Recommendations Assessment, Development, and Evaluation methodology. Web-based consensus voting was performed by 211 IBD specialists from 9 Asian countries concerning each statement. A consensus statement was accepted if at least 75% of the participants agreed. Part 2 of the statements comprised 3 parts: management of latent TB in preparation for anti-TNF therapy, monitoring during anti-TNF therapy, and management of an active TB infection after anti-TNF therapy. These consensus statements will help clinicians optimize patient outcomes by reducing the morbidity and mortality related to TB infections in patients with IBD receiving anti-TNF treatment.

Citations

Citations to this article as recorded by  
  • Risk of Tuberculosis and Hepatitis B Reactivation in Patients With Crohn’s Disease on Ustekinumab: A Nationwide Real-World Study
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    Way Seah Lee, Katsuhiro Arai, George Alex, Suporn Treepongkaruna, Kyung Mo Kim, Chee Liang Choong, Karen S. C. Mercado, Andy Darma, Anshu Srivastava, Marion M. Aw
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  • Korean clinical practice guidelines on biologics and small molecules for moderate-to-severe ulcerative colitis
    Soo-Young Na, Chang Hwan Choi, Eun Mi Song, Ki Bae Bang, Sang Hyoung Park, Eun Soo Kim, Jae Jun Park, Bora Keum, Chang Kyun Lee, Bo-In Lee, Seung-Bum Ryoo, Seong-Joon Koh, Miyoung Choi, Joo Sung Kim
    Intestinal Research.2023; 21(1): 61.     CrossRef
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    Shruti Verma, Arshdeep Singh, Chandan Kakkar, Ashish Tripathi, Vandana Midha, Ajit Sood
    ACG Case Reports Journal.2023; 10(6): e01066.     CrossRef
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    Bhavesh Bhut, Akshay Kulkarni, Varnika Rai, Vinita Agrawal, Abhai Verma, Manoj Jain, Rungmei S K Marak, Ajai Kumar Dixit, Uday C Ghoshal
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Focused Review: Intestinal Behçet's Disease
Treatment and outcomes: medical and surgical treatment for intestinal Behçet's disease
Tadakazu Hisamatsu, Mari Hayashida
Intest Res 2017;15(3):318-327.   Published online June 12, 2017
DOI: https://doi.org/10.5217/ir.2017.15.3.318
AbstractAbstract PDFPubReaderePub

Behçet's disease (BD) is a chronic relapsing disease involving multiple organ systems. BD is characterized clinically by oral and genital aphthae, cutaneous lesions, and ophthalmological, neurological, and/or gastrointestinal manifestations. It is widely recognized that the presence of intestinal lesions may be a poor prognostic factor in intestinal BD, increasing the risk of surgery and decreasing the quality of life. Despite this, the management of intestinal BD has not been standardized. Empirical therapies including 5-aminosalicylic acid and corticosteroids have been used anecdotally to treat intestinal BD, but recent studies have provided evidence for the efficacy of anti-tumor necrosis factor α monoclonal antibodies. The development of agents targeting tumor necrosis factor α continues, it seems likely that they will change the therapeutic strategy and clinical outcomes of intestinal BD and inflammatory bowel disease. Monitoring disease activity such as endoscopic evaluation will become more important to obtain better outcomes. Here, we review current and future perspectives in the treatment and outcomes of intestinal BD.

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Review
Immunological Abnormalities in the Pathogenesis of Inflammatory Bowel Disease
Tadakazu Hisamatsu, Yohei Mikami, Katsuyoshi Matsuoka, Takanori Kanai, Toshifumi Hibi
Intest Res 2012;10(4):317-323.   Published online October 31, 2012
DOI: https://doi.org/10.5217/ir.2012.10.4.317
AbstractAbstract PDF
Crohn's disease and ulcerative colitis represent two distinct forms of inflammatory bowel diseases (IBD). In this paper, we discuss how immunological mechanisms contribute to the pathogenesis of IBD. Intestinal homeostasis is sustained by various kinds of cells, such as epithelial cells, lymphocytes, antigen presenting cells, and other innate immune cells. We pay special attention to intestinal CD14+ macrophages. Intestinal macrophages play a central role in the regulation of immune responses against commensal bacteria. In the physiological condition, intestinal macrophages lack the expression of innate-immune receptor CD14 and do not produce proinfl ammatory cytokines. We identified a unique macrophage subset of IBD in the human intestine, which expressed both macrophage (CD14, CD33, CD68) and dendritic cell (DC) markers (CD205, CD209) and produced larger amounts of proinflammatory cytokines, such as interleukin (IL)-23 and tumor necrosis factor (TNF)-Ձ. In addition, the CD14+ macrophages contributed to interferon (IFN)-Ճ production rather than IL-17 production by lamina propria mononuclear cells dependent on IL-23. We discuss herein this IL-23/IFN-Ճ-positive feedback loop in IBD patients. We also discuss IFN-Ճ and IL-17 production from mucosal T cells and natural killer (NK) cells. Here, we show our recent findings about the plasticity of T helper cells in colitis. Th 17 cells express T-bet, and finally lose the expression of retinoic acid-related orphan receptor (ROR)Ճt, the master regulator of Th 17 cells, and are differentiated 'alternative Th 1 cells.' In addition to Th 1 cells, mucosal NK cells are also important sources of IFN-Ճ. Some of our ideas may be provocative, but we hope this review paper will provide new and firm understanding of the pathogenesis of IBD. (Intest Res 2012;10:317-323)

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