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Original Articles
Real-world use of biologics during the first year of treatment for newly diagnosed Crohn’s disease in Japan: a claims analysis from 2010 to 2021
Jun Miyoshi, Annabelle Yoon, Minoru Matsuura, Tadakazu Hisamatsu
Received June 5, 2024  Accepted October 5, 2024  Published online January 23, 2025  
DOI: https://doi.org/10.5217/ir.2024.00082    [Epub ahead of print]
AbstractAbstract PDFSupplementary MaterialPubReaderePub
Background/Aims
Crohn’s disease (CD) leads to bowel damage and disability if suboptimally treated. We investigated firstyear treatment decisions and real-world use of biologics in patients with CD in Japan.
Methods
In this retrospective observational study (2010–2021) from the JMDC claims database, patients with a new diagnosis of CD (no CD claims record within 12 months before index) who received ≥ 1 pre-defined treatment were grouped by use of biologics and systemic corticosteroids (SCS) within the first year of diagnosis.
Results
Of 823 patients included, 470 (57.1%) were prescribed biologics and 353 (42.9%) were not; 77.6% were male, 75.7% had adult-onset CD, and median age was 24 years. Patients prescribed biologics were younger (median: 23 years vs. 28 years) and more had perianal lesions (43.0% vs. 22.9%) than those not prescribed biologics; 64.9% (95% confidence interval, 60.4%–69.2%) received a top-down treatment approach (no SCS before biologics). Factors significantly associated with a top-down treatment approach were male sex, perianal lesions, no use of immunomodulators, and use of anti-tumor necrosis factor therapies. The proportion of patients receiving SCS before biologics (step-up approach) increased after 2018, with a shift from prednisolone to budesonide from 2016. Persistence with first biologics decreased over time, with no differences between biologic types.
Conclusions
Use of biologics for treatment of CD within the first year of diagnosis in Japan has remained stable over the past decade. However, there was a shift to a step-up treatment approach, with an increase in use of SCS before biologics over time.
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IBD
Changes in the clinical course and prognosis of ulcerative colitis in Chinese populations: a retrospective cohort study
Xinyu Liu, Qingfan Yang, Na Diao, Jian Tang, Zicheng Huang, Xiang Gao, Kang Chao
Intest Res 2024;22(3):357-368.   Published online May 7, 2024
DOI: https://doi.org/10.5217/ir.2023.00106
AbstractAbstract PDFSupplementary MaterialPubReaderePub
Background/Aims
Data on the natural course of Chinese patients with ulcerative colitis (UC) was lacking. This study aimed to evaluate the natural history and prognosis of patients with UC in the past 15 years in China.
Methods
This cohort study included patients with UC in a tertiary hospital in southern China from 2007 to 2021 (cohort I: 2007–2011, cohort II: 2012–2016, cohort III: 2017–2021). Patients’ clinical characteristics and natural history were analyzed retrospectively.
Results
Of 1,139 included patients, 683 patients presented with proctitis or left-sided colitis at diagnosis and 38.5% of them (263/683) developed proximal disease extension. Fifty-eight percent of patients experienced relapse, chronic continuous and intermittent active course. Five patients (0.4%) developed colorectal tumors/dysplasia. The overall surgery rate was 8.6%, and the rates were 14.2%, 7.8%, and 8.0% in the 3 cohorts, respectively (P= 0.059). Average time from diagnosis to surgery decreased from cohorts I to III (144 months vs. 36 months, P< 0.001), so did the use of glucocorticoids (58.2% vs. 43.5%, P< 0.001) and immunosuppressants (14.1% vs. 13.4%, P= 0.016), and days of hospitalization (13 days vs. 9 days, P< 0.001). Biologics were used more frequently during the first year (0.8%, 2.1%, and 13.7% for cohorts I to III, respectively; P< 0.001). The rate of mucosal healing increased over time.
Conclusions
In Chinese UC patients, one-third of patients experienced proximal disease extension. The rates of malignancy and mortality were low. More biologics were used, while use of immunosuppressants and glucocorticoids were reduced over time. Early biologics use seemed to promote mucosal healing, but the rate of colectomy has not dramatically decreased.
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IBD
Live-attenuated vaccination in patients with inflammatory bowel disease while continuing or after elective switch to vedolizumab
Hisashi Shiga, Hiroshi Nagai, Yusuke Shimoyama, Takeo Naito, Rintaro Moroi, Yoichi Kakuta, Yoshitaka Kinouchi, Atsushi Masamune
Intest Res 2024;22(3):378-386.   Published online March 26, 2024
DOI: https://doi.org/10.5217/ir.2023.00203
AbstractAbstract PDFPubReaderePub
Background/Aims
Vedolizumab (VDZ) is a gut-selective agent with a favorable safety profile. We aimed to assess the feasibility of elective switch from other advanced therapies to VDZ and subsequent live-attenuated vaccination while continuing VDZ in patients with inflammatory bowel diseases (IBD).
Methods
We measured antibody titers specific for measles, rubella, mumps, and varicella viruses in IBD patients under immunosuppressive therapy. Those with negative titers and without vaccination history were judged unimmunized. Patients were administered vaccines while continuing VDZ or switched to VDZ if receiving other advanced therapies and then administered vaccines. Co-primary outcomes were the rate of maintaining disease severity after vaccination and the rate without vaccine-induced infection.
Results
Among 107 unimmunized patients, 37 agreed to receive live-attenuated vaccines while continuing VDZ (17 patients) or after switching to VDZ (20 patients). In the 20 patients who electively switched to VDZ, disease severity was maintained except for 1 patient who developed intestinal infection. After 54 weeks, 18 patients (90%) continued to receive VDZ, excluding 2 patients who reverted to their originally administered biologics. In all 37 patients administered live-attenuated vaccines under VDZ treatment, disease severity was maintained after vaccination. Antibody titers became positive or equivocal in 34 patients (91.9%). There were no cases of vaccine-induced infection during a median observation period of 121 weeks.
Conclusions
While live-attenuated vaccines are contraindicated under immunosuppressive therapy, they may be safely administered while receiving VDZ immunotherapy. Switching from other advanced therapies to VDZ and subsequently receiving live-attenuated vaccines may be a safe alternative in unimmunized patients.

Citations

Citations to this article as recorded by  
  • Live Typhoid and Yellow Fever Vaccines Administered to a Patient With Ulcerative Colitis on Vedolizumab
    Yash Hegde, Mary S. Hayney, Freddy Caldera
    ACG Case Reports Journal.2024; 11(10): e01507.     CrossRef
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  • 300 Download
  • 1 Web of Science
  • 1 Crossref
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Review
IBD
The practice of fecal microbiota transplantation in inflammatory bowel disease
Umang Arora, Saurabh Kedia, Vineet Ahuja
Intest Res 2024;22(1):44-64.   Published online November 21, 2023
DOI: https://doi.org/10.5217/ir.2023.00085
AbstractAbstract PDFPubReaderePub
Current evidence posits a central role for gut microbiota and the metabolome in the pathogenesis and progression of inflammatory bowel disease (IBD). Fecal microbiota transplantation (FMT) has been established as a means to manipulate this microbiome safely and sustainably. Several aspects of the technical improvement including pretreatment with antibiotics, use of frozen stool samples as well as short donor-to-recipient time are proposed to improve its response rates. Its efficacy in ulcerative colitis has been proven in clinical trials while data is emerging for Crohn’s disease. This review describes briefly the biology behind FMT, the available evidence for its use in IBD, and the host, recipient and procedural factors which determine the clinical outcomes.

Citations

Citations to this article as recorded by  
  • Advances in Fecal Microbiota Transplantation for Gut Dysbiosis‐Related Diseases
    Shuna Hou, Jiachen Yu, Yongshuang Li, Duoyi Zhao, Zhiyu Zhang
    Advanced Science.2025;[Epub]     CrossRef
  • Gut Microbial Targets in Inflammatory Bowel Disease: Current Position and Future Developments
    Naveen Sivakumar, Ashwin Krishnamoorthy, Harshita Ryali, Ramesh P. Arasaradnam
    Biomedicines.2025; 13(3): 716.     CrossRef
  • Medical management of acute severe ulcerative colitis in the hospitalized patient
    Loren G Rabinowitz, Ajay Gade, Joseph D. Feuerstein
    Expert Review of Gastroenterology & Hepatology.2025; : 1.     CrossRef
  • Perception of fecal microbiota transplantation in patients with ulcerative colitis in Korea: a KASID multicenter study
    Jebyung Park, Sung Noh Hong, Hong Sub Lee, Jongbeom Shin, Eun Hye Oh, Kwangwoo Nam, Gyeol Seong, Hyun Gun Kim, Jin-Oh Kim, Seong Ran Jeon
    The Korean Journal of Internal Medicine.2024; 39(5): 783.     CrossRef
  • Microbiome-based therapeutics for Parkinson's disease
    Adam M. Hamilton, Ian N. Krout, Alexandria C. White, Timothy R. Sampson
    Neurotherapeutics.2024; 21(6): e00462.     CrossRef
  • 5,742 View
  • 342 Download
  • 5 Crossref
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Original Article
IBD
Performing colonoscopy before steroid induction is associated with shorter steroid use in patients with ulcerative colitis
Taku Kobayashi, Eri Udagawa, Lisa Hirose, Toshifumi Hibi
Intest Res 2023;21(2):205-215.   Published online December 15, 2022
DOI: https://doi.org/10.5217/ir.2021.00164
AbstractAbstract PDFPubReaderePub
Background/Aims
Risks of long-term steroid use in patients with ulcerative colitis (UC) outweigh the benefits, thus dosing should be tapered once a response is achieved. Colonoscopy is a key technique for assessing disease severity and optimizing treatment involving steroids. This retrospective longitudinal cohort study of patients with UC explored factors associated with the duration of systemic steroid use.
Methods
The Japan Medical Data Center database, an employer-based insurance claims database, was used to select individuals initiating prednisolone, with a prescription issued between January 1, 2010, and January 31, 2018. The study included adults with a confirmed diagnosis of UC, who had received ≥1 year of continuous treatment with 5-aminosalicylic acid, biologics, or thiopurine. Factors associated with prednisolone duration were assessed using a multivariate regression model.
Results
Median duration of prednisolone treatment was 98 days, and colonoscopy was performed ≤1 month before or at the first prescription of prednisolone (index date) in 32.8% of patients (607/1,853). Shorter durations of prednisolone treatment were associated with colonoscopy ≤1 month before or at the index date and higher prednisolone dose at index date, with incidence rate ratios (IRRs) of 0.776 (95% confidence interval [CI], 0.682–0.884; P<0.001) and 0.998 (95% CI, 0.996–1.000; P=0.018), respectively. Charlson Comorbidity Index scores of 1 and ≥2 predicted longer prednisolone treatment (IRR, 1.332; 95% CI, 1.174–1.511; P<0.001 and IRR, 1.599; 95% CI, 1.357–1.885; P<0.001, respectively).
Conclusions
Performing colonoscopy before or at the time of initiating steroid was associated with a shorter duration of steroid use in patients with UC.

Citations

Citations to this article as recorded by  
  • Quercus infectoria galls mitigates colitis in mice through alleviating mucosal barrier impairment and suppressing inflammatory factors
    Yan Ding, Jiao-Jiao Bai, Sabahat Ablimit, Muyassar Yasen, Arfidin Anwar, Kudelaidi Kuerban, Mubarak Iminjan, Guo-Qiang Zhang
    Journal of Ethnopharmacology.2025; 343: 119487.     CrossRef
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  • 2 Web of Science
  • 1 Crossref
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Review
Functional bowel disorder
An Asian perspective on irritable bowel syndrome
Kee Wook Jung, Seung-Jae Myung
Intest Res 2023;21(2):189-195.   Published online May 31, 2022
DOI: https://doi.org/10.5217/ir.2021.00136
AbstractAbstract PDFPubReaderePub
Irritable bowel syndrome (IBS) is a prevalent chronic disorder, and its epidemiology depends on the diagnostic criteria used. Recently, the Rome IV criteria for IBS were published by changing the frequency of abdominal pain and excluding abdominal discomfort from the previously used Rome III criteria. However, the recent Asian consensus on IBS recommends the inclusion of abdominal discomfort and abdominal pain as diagnostic criteria. The low fermentable oligo-, di-, mono-saccharides, and polyols (FODMAP) diet has been proven to be effective in Western patients. Moreover, recent well-designed studies reported its effectiveness and the microbial changes after implementing it in Asian patients with IBS. However, traditional Korean foods including kimchi, one of representative FODMAP-rich food, exhibited a poor correlation with the food-related symptoms of IBS. Therefore, the low FODMAP diet protocol should be cautiously applied to IBS patients, especially to Korean patients with IBS. In Asian countries, there are lots of traditional herbal medicines and treatments for IBS; however, these studies have limitations including the heterogeneity of herbal mixtures and relatively small sample size. Therefore, well-designed studies based on large samples are required to validate complementary and alternative medicine in the treatment of Asian patients with IBS.

Citations

Citations to this article as recorded by  
  • The Role of Diet in the Management of Irritable Bowel Syndrome: A Comprehensive Review
    Maleesha Jayasinghe , Vinuri Karunanayake, Ali Mohtashim, Dilushini Caldera , Piyalka Mendis , Omesh Prathiraja, Fatemeh Rashidi, John A Damianos
    Cureus.2024;[Epub]     CrossRef
  • Downregulated APOD and FCGR2A correlates with immune infiltration and lipid-induced symptoms of irritable bowel syndrome
    Yamei Ran, Kangqi Wu, Chenglin Hu, Renzheng Liang, Li Zhang, Juan Xiao, Yongmei Peng, Wenjing Sun
    Scientific Reports.2023;[Epub]     CrossRef
  • Technical Feasibility of Quantitative Measurement of Various Degrees of Small Bowel Motility Using Cine Magnetic Resonance Imaging
    Ji Young Choi, Jihye Yun, Subin Heo, Dong Wook Kim, Sang Hyun Choi, Jiyoung Yoon, Kyuwon Kim, Kee Wook Jung, Seung-Jae Myung
    Korean Journal of Radiology.2023; 24(11): 1093.     CrossRef
  • Letter to the Editor: Survey-Based Analysis of Clinical Treatment Status of Irritable Bowel Syndrome in Korea: Suggestions for Future Research
    Ji Young Chang
    Journal of Korean Medical Science.2023;[Epub]     CrossRef
  • Effectiveness of Medilac-S as an Adjuvant to Conventional Irritable Bowel Syndrome Treatments: A Systematic Review with Meta-Analysis
    Annie Tremblay, Xiaoyu Xu, James Colee, Thomas A. Tompkins, Sylvie Binda
    Gastroenterology Insights.2023; 14(4): 491.     CrossRef
  • Comments on Efficacy of a Synbiotic Containing Lactobacillus paracasei DKGF1 and Opuntia humifusa in Elderly Patients with Irritable Bowel Syndrome: A Randomized, Double-Blind, Placebo-Controlled Trial
    Kwang Woo Kim
    Gut and Liver.2023; 17(6): 954.     CrossRef
  • 5,967 View
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  • 6 Web of Science
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Original Articles
IBD
One-year clinical efficacy and safety of indigo naturalis for active ulcerative colitis: a real-world prospective study
Yuichi Matsuno, Takehiro Torisu, Junji Umeno, Hiroki Shibata, Atsushi Hirano, Yuta Fuyuno, Yasuharu Okamoto, Shin Fujioka, Keisuke Kawasaki, Tomohiko Moriyama, Tomohiro Nagasue, Keizo Zeze, Yoichiro Hirakawa, Shinichiro Kawatoko, Yutaka Koga, Yoshinao Oda, Motohiro Esaki, Takanari Kitazono
Intest Res 2022;20(2):260-268.   Published online April 29, 2022
DOI: https://doi.org/10.5217/ir.2021.00124
AbstractAbstract PDFSupplementary MaterialPubReaderePub
Background/Aims
Recent studies suggested a favorable effect of indigo naturalis (IN) in inducing remission for refractory ulcerative colitis (UC), however, the maintenance effect of IN for patients with UC remains unknown. Therefore, we conducted a prospective uncontrolled open-label study to analyze the efficacy and safety of IN for patients with UC.
Methods
Patients with moderate to severe active UC (clinical activity index [CAI] ≥ 8) took 2 g/day of IN for 52 weeks. CAI at weeks 0, 4, 8, and 52 and Mayo endoscopic subscore (MES) and Geboes score (GS) at weeks 0, 4, and 52 were assessed. Clinical remission (CAI ≤ 4), mucosal healing (MES ≤ 1), and histological healing (GS ≤ 1) rates at each assessment were evaluated. Overall adverse events (AEs) during study period were also evaluated. The impact of IN on mucosal microbial composition was assessed using 16S ribosomal RNA gene sequences.
Results
Thirty-three patients were enrolled. The rates of clinical remission at weeks 4, 8, and 52 were 67%, 76%, and 73%, respectively. The rates of mucosal healing at weeks 4 and 52 were 48% and 70%, respectively. AEs occurred in 17 patients (51.5%) during follow-up. Four patients (12.1%) showed severe AEs, among whom 3 manifested acute colitis. No significant alteration in the mucosal microbial composition was observed with IN treatment.
Conclusions
One-year treatment of moderate to severe UC with IN was effective. IN might be a promising therapeutic option for maintaining remission in UC, although the relatively high rate of AEs should be considered.

Citations

Citations to this article as recorded by  
  • Risk of Infection in Patients With Inflammatory Bowel Disease Treated With Interleukin-Targeting Agents: A Systematic Review and Meta-Analysis
    Konstantinos Ouranos, Hira Saleem, Stephanos Vassilopoulos, Athanasios Vassilopoulos, Evangelia K Mylona, Fadi Shehadeh, Markos Kalligeros, Bincy P Abraham, Eleftherios Mylonakis
    Inflammatory Bowel Diseases.2025; 31(1): 37.     CrossRef
  • Selected Use of Complementary and Alternative Medicine (CAM) Agents in IBD
    Monica Dzwonkowski, Janak Bahirwani, Samantha Rollins, Alicia Muratore, Vikram Christian, Yecheskel Schneider
    Current Gastroenterology Reports.2025;[Epub]     CrossRef
  • Indigo naturalis‑associated ischemic injury of colorectal mucosa: A case series study
    Yiheng Ke, Liang Xu, Qi Tang, Zheyu Ruan, Junjie Liu, Shuiliang Ruan
    Experimental and Therapeutic Medicine.2025;[Epub]     CrossRef
  • Indigo naturalis (Qing dai) for inflammatory bowel disease: A systematic review and meta-analysis
    Rinkalben Kakdiya, Daya Krishna Jha, Arup Choudhury, Anuraag Jena, Vishal Sharma
    Clinics and Research in Hepatology and Gastroenterology.2024; 48(1): 102250.     CrossRef
  • Reply to “Ferroptosis in the colon epithelial cells as a therapeutic target for ulcerative colitis”
    Akihito Yokote, Noriyuki Imazu, Junji Umeno, Keisuke Kawasaki, Shin Fujioka, Yuta Fuyuno, Yuichi Matsuno, Tomohiko Moriyama, Kohta Miyawaki, Koichi Akashi, Takanari Kitazono, Takehiro Torisu
    Journal of Gastroenterology.2024; 59(1): 77.     CrossRef
  • Herbal Medicines for the Treatment of Active Ulcerative Colitis: A Systematic Review and Meta-Analysis
    Preetha Iyengar, Gala Godoy-Brewer, Isha Maniyar, Jacob White, Laura Maas, Alyssa M. Parian, Berkeley Limketkai
    Nutrients.2024; 16(7): 934.     CrossRef
  • Clinical Efficacy and Future Application of Indigo Naturalis in the Treatment of Ulcerative colitis
    Dianzhen Wu, Qi Huang, Yingbi Xu, Ruiyi Cao, Ming Yang, Jin Xie, Dingkun Zhang
    Journal of Ethnopharmacology.2024; : 118782.     CrossRef
  • Ferroptosis in the colon epithelial cells as a therapeutic target for ulcerative colitis
    Akihito Yokote, Noriyuki Imazu, Junji Umeno, Keisuke Kawasaki, Shin Fujioka, Yuta Fuyuno, Yuichi Matsuno, Tomohiko Moriyama, Kohta Miyawaki, Koichi Akashi, Takanari Kitazono, Takehiro Torisu
    Journal of Gastroenterology.2023; 58(9): 868.     CrossRef
  • Hyaluronic acid/inulin-based nanocrystals with an optimized ratio of indigo and indirubin for combined ulcerative colitis therapy via immune and intestinal flora regulation
    Jin Xie, Qi Huang, Huijuan Xie, Jun Liu, Shimin Tian, Ruiyi Cao, Ming Yang, Junzhi Lin, Li Han, Dingkun Zhang
    International Journal of Biological Macromolecules.2023; 252: 126502.     CrossRef
  • High-Quality Indigo Naturalis Obtained with Automatic Foam Separation
    Xin Yang, Jun Tang, Juan Su, Xin Yang, Ming Yang, Xiangbo Yang, Qisen Ji, Yanan He, Li Han, Dingkun Zhang
    ACS Applied Materials & Interfaces.2023; 15(37): 43272.     CrossRef
  • 6,854 View
  • 249 Download
  • 7 Web of Science
  • 10 Crossref
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IBD
Drug therapy and monitoring for inflammatory bowel disease: a multinational questionnaire investigation in Asia
Chenwen Cai, Juntao Lu, Lijie Lai, Dongjuan Song, Jun Shen, Jinlu Tong, Qing Zheng, Kaichun Wu, Jiaming Qian, Zhihua Ran
Intest Res 2022;20(2):213-223.   Published online April 29, 2022
DOI: https://doi.org/10.5217/ir.2021.00031
AbstractAbstract PDFSupplementary MaterialPubReaderePub
Background/Aims
The incidence and prevalence of inflammatory bowel disease (IBD) is rising in Asia recently. The study aimed to obtain a comprehensive understanding of the current status of drug therapy and monitoring for IBD in Asia.
Methods
A questionnaire investigation on drug therapy and monitoring for IBD was conducted right before the 6th Annual Meeting of Asian Organization for Crohn’s & Colitis. Questionnaires were provided to Asian physicians to fill out via emails between March and May 2018.
Results
In total, responses of 166 physicians from 129 medical centers were included for analysis. Among the surveyed regions, the most average number of IBD specialist gastroenterologists and nurses was 4.8 per center in Taiwan and 2.5 per center in Mainland China, respectively. 5-Aminosalicylic acid/sulfasalazine (99.4%) was the most preferred first-line choice for mild-moderate ulcerative colitis (UC), meanwhile corticosteroid (83.7%) was widely applied for severe UC. The first-line medication for Crohn’s disease (CD) markedly varied as corticosteroid (68.1%) was the most favored in Mainland China, Japan, and South Korea, followed by infliximab (52.4%) and azathioprine (47.0%). Step-up strategy was preferred in mild-moderate UC (96.4%), while 51.8% of the physicians selected top-down treatment for CD. Only 25.9% and 17.5% of the physicians could test blood concentration of infliximab and antibody to infliximab in their hospitals, respectively.
Conclusions
The current status of drug therapy and monitoring for IBD in Asia possesses commonalities as well as differences. Asian recommendations, IBD specialist teams and practice of therapeutic drug monitoring are required to improve IBD management in Asia.

Citations

Citations to this article as recorded by  
  • Expression and role of CTHRC1 in inflammatory bowel disease in children
    Heng Tang, Xiang Gao, Zhaofang Wu, Jia Chen, Li Chen, Xiang Du
    Cytotechnology.2025;[Epub]     CrossRef
  • Importance of STAT3 signaling in preeclampsia (Review)
    Daniela Marzioni, Federica Piani, Nicoletta Di Simone, Stefano Giannubilo, Andrea Ciavattini, Giovanni Tossetta
    International Journal of Molecular Medicine.2025;[Epub]     CrossRef
  • New genetic biomarkers predicting 5-aminosalicylate-induced adverse events in patients with inflammatory bowel diseases
    Jihye Park, I. Seul Park, Ji Hyung Kim, Jung Hyun Ji, Soo Jung Park, Jae Jun Park, Tae Il Kim, Seung Won Kim, Jae Hee Cheon
    Therapeutic Advances in Gastroenterology.2024;[Epub]     CrossRef
  • Primary surgery versus pharmacotherapy for newly diagnosed ileocecal Crohn’s disease: a hospital-based cohort study
    Yehyun Park, Soo Jung Park, Tae Il Kim, Won Ho Kim, Jae Hee Cheon
    The Korean Journal of Internal Medicine.2024; 39(5): 759.     CrossRef
  • Signal detection and analysis of sulfasalazine adverse reaction events based on the US FDA adverse event reporting database
    Yikuan Du, Lingzhi Zhang, Liang Shi, Zhuoming Guo, Ziyi Luo, Ye Zheng, Yu Zeng, Yin Huang, Jiawen Luo, Xiaochun Guo, Mianda Hu, Yuhong Chen, Jinfeng Zhu, Yi Liu, Chun Yang
    Expert Opinion on Drug Safety.2024; : 1.     CrossRef
  • Impact of Concomitant 5-Aminosalicylic Acid Therapy on Vedolizumab Efficacy and Safety in Inflammatory Bowel Disease: Post Hoc Analyses of Clinical Trial Data
    Ryan C Ungaro, Harisha Kadali, Wenwen Zhang, Shashi Adsul, Walter Reinisch
    Journal of Crohn's and Colitis.2023; 17(12): 1949.     CrossRef
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IBD
Efficacy and tolerability of hyperbaric oxygen therapy in small bowel stricturing Crohn’s disease: a pilot study
Bhaskar Kante, Pabitra Sahu, Saurabh Kedia, Sudheer K. Vuyyuru, Kapil Soni, Maneesh Singhal, Raju Sharma, Govind Makharia, Vineet Ahuja
Intest Res 2022;20(2):231-239.   Published online February 8, 2022
DOI: https://doi.org/10.5217/ir.2021.00056
AbstractAbstract PDFSupplementary MaterialPubReaderePub
Background/Aims
Existing therapeutic options for complicated Crohn’s disease (CD) like biologics and surgery are limited by inadequate long-term efficacy, cost, and adverse effects. Tissue hypoxia is important in CD pathogenesis and may be ameliorated with hyperbaric oxygen therapy (HBOT). We assessed the efficacy and tolerability of HBOT in small bowel stricturing CD.
Methods
This pilot study included patients of small bowel stricturing CD (from April 2019 to January 2020) who underwent HBOT. These patients were refractory to conventional medical treatment or had multiple strictures not amenable to resection. Each session of HBOT was given for 60 minutes with a pressure of 1.5–2.5 atm. Clinical, biochemical responses and Short Inflammatory Bowel Disease (SIBD) questionnaire were evaluated at 2 and 6 months, and radiological response was evaluated at 6 months.
Results
Fourteen patients (mean age, 42.9±15.7 years; male, 50%) were subjected to 168 HBOT sessions. Thirteen patients (92.7%) had strictures and 1 patient had enterocutaneous fistula in addition. Median number of HBOT sessions was 11 (range, 3–20) which were administered over a median of 4 weeks. Most patients tolerated it well except 1 who had hemotympanum. At 2 and 6 months of follow-up, 64.2% of patients had a clinical response, 50% and 64.2% of patients had clinical remission respectively. Steroid-free clinical remission was seen in 8 (57%) of patients with radiological improvement in 50%. There was a significant improvement in SIBD scores at 2-month follow-up (59.4 vs. 44.5, P=0.03).
Conclusions
HBOT can be a safe and effective therapeutic option in patients with stricturing small bowel CD refractory to conventional medical treatment.

Citations

Citations to this article as recorded by  
  • Risk of avascular necrosis in patients with inflammatory bowel disease: Insights from a nationwide cohort study and the impact of corticosteroid use
    Jung Min Moon, Kyoung-Eun Kwon, Ju Won Lee, Kyung Rok Minn, Kyuwon Kim, Jeongkuk Seo, Seung Yong Shin, Sun-Young Jung, Chang Hwan Choi
    Digestive and Liver Disease.2025; 57(1): 176.     CrossRef
  • Hyperbaric oxygen therapy as a possible therapeutic candidate for sepsis-associated encephalopathy: A novel hypothesis
    Sung Eun Lee, Eunjung Park, Ji-yun Kim, HyukHoon Kim
    Medical Hypotheses.2024; 182: 111212.     CrossRef
  • Treating paediatric Crohn’s disease is challenging but new treatments hold promise
    Tina Nie
    Drugs & Therapy Perspectives.2024; 40(3): 121.     CrossRef
  • The Future of Advanced Therapies for Pediatric Crohn’s Disease
    Julie Gallagher, Joel R. Rosh, Benjamin Sahn
    Pediatric Drugs.2023; 25(6): 621.     CrossRef
  • Role of hyperbaric oxygen therapy in patients with inflammatory bowel disease
    Harpreet Kaur, Gursimran Singh Kochhar, Parambir S. Dulai
    Current Opinion in Gastroenterology.2023; 39(4): 263.     CrossRef
  • 6,189 View
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  • 5 Web of Science
  • 5 Crossref
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IBD
Incidence comparison of adverse events in patients with inflammatory bowel disease receiving different biologic agents: retrospective long-term evaluation
Brigida Barberio, Edoardo Vincenzo Savarino, Timothy Card, Cristina Canova, Francesco Baldisser, Alessandro Gubbiotti, Davide Massimi, Matteo Ghisa, Fabiana Zingone
Intest Res 2022;20(1):114-123.   Published online August 4, 2021
DOI: https://doi.org/10.5217/ir.2021.00037
AbstractAbstract PDFSupplementary MaterialPubReaderePub
Background/Aims
Current literature is lacking in studies comparing the incidence of adverse events (AEs) in patients with inflammatory bowel diseases (IBD) treated with adalimumab (ADA) or vedolizumab (VDZ) in a real-life scenario. Therefore, our primary aim was to compare the AEs occurring in patients taking ADA to those of patients taking VDZ.
Methods
In this single center study, data on AEs from IBD patients who underwent treatment with ADA and VDZ were retrospectively collected. AE rates per 100 person-years were calculated. A Cox regression model was used to estimate the hazard ratios of the AEs between the 2 drugs.
Results
A total of 16 ADA patients (17.2%) and 11 VDZ patients (7.6%) had AEs causing drug interruption during the study period (P=0.02). Most of the AEs were noninfectious extraintestinal events (50% in ADA and 54.5% in VDZ) while infections accounted for 31.2% of the AEs in patients treated with ADA and 27.3% in those treated with VDZ. The incidence rate of AEs causing withdrawal of therapy was 13.2 per 100 person-years for ADA and 5.3 per 100 person-years for VDZ, corresponding to a 76% lower risk in patients in VDZ. Considering the first year of treatment, we observed 34 subjects treated with ADA (36.5%) having at least 1 AEs and 57 (39.3%) among those taking VDZ (P=0.67).
Conclusions
VDZ has a lower incidence rate of AEs causing withdrawal of treatment compared to ADA but a similar risk of AEs not causing drug interruption. Real-life head-to-head studies are still necessary to further explore the safety profile of these drugs.

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IBD
Factors associated with anti-tumor necrosis factor effectiveness to prevent postoperative recurrence in Crohn’s disease
Anthony Buisson, Lisa Cannon, Konstantin Umanskiy, Roger D. Hurst, Neil H. Hyman, Atsushi Sakuraba, Joel Pekow, Sushila Dalal, Russell D. Cohen, Bruno Pereira, David T. Rubin
Intest Res 2022;20(3):303-312.   Published online August 4, 2021
DOI: https://doi.org/10.5217/ir.2021.00018
AbstractAbstract PDFSupplementary MaterialPubReaderePub
Background/Aims
We assessed the effectiveness of anti-TNF agents and its associated factors to prevent endoscopic and clinical postoperative recurrence (POR) in Crohn’s disease (CD).
Methods
From a prospectively-maintained database, we retrieved 316 CD patients who underwent intestinal resection (2011–2017). Endoscopic (Rutgeerts index ≥ i2 at 6 months) and clinical (recurrence of symptoms leading to hospitalization or therapeutic escalation) POR were assessed.
Results
In 117 anti-TNF-naïve patients, anti-TNF therapy was more effective than immunosuppressive agents (odds ratio [OR], 8.8; 95% confidence interval [CI], 1.8–43.9; P= 0.008) and no medication/5-aminosalicylates (OR, 5.2; 95% CI, 1.0–27.9; P= 0.05) to prevent endoscopic POR. In 199 patients exposed to anti-TNF prior to the surgery, combination with anti-TNF and immunosuppressive agents was more effective than anti-TNF monotherapy (OR, 2.32; 95% CI, 1.02–5.31; P= 0.046) to prevent endoscopic POR. Primary failure to anti-TNF agent prior to surgery was predictive of anti-TNF failure to prevent endoscopic POR (OR, 2.41; 95% CI, 1.10–5.32; P= 0.03). When endoscopic POR despite anti-TNF prophylactic medication (n = 55), optimizing anti-TNF and adding an immunosuppressive drug was the most effective option to prevent clinical POR (hazard ratio, 7.38; 95% CI, 1.54–35.30; P= 0.012). Anti-TNF therapy was the best option to prevent clinical POR (hazard ratio, 3.10; 95% CI, 1.09–8.83; P= 0.034) in patients with endoscopic POR who did not receive any biologic to prevent endoscopic POR (n = 55).
Conclusions
Anti-TNF was the most effective medication to prevent endoscopic and clinical POR. Combination with anti-TNF and immunosuppressive agents should be considered in patients previously exposed to anti-TNF.

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Review
Inflammatory bowel diseases
Update of endoscopic management of Crohn’s disease strictures
Akshay Pokala, Bo Shen
Intest Res 2020;18(1):1-10.   Published online January 30, 2020
DOI: https://doi.org/10.5217/ir.2019.09158
AbstractAbstract PDFPubReaderePub
One of the most common complications of Crohn’s disease (CD) is the formation of strictures. Endoscopy plays a vital role not only in the diagnosis, differential diagnosis, and disease monitoring of CD, but also the delivery of effective treatment. The purpose of this review is to update the endoscopic management of strictures in CD. Endoscopic therapy has provided minimally invasive treatment for CD. Commonly used endoscopic treatment modalities include balloon dilation, endoscopic stricturotomy, endoscopic strictureplasty, and endoscopic stenting. The pros and cons of these endoscopic treatment modalities are discussed.

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Focused Reviews
Colorectal neoplasia
Nutritional issues in patients with cancer
Duk Hwan Kim
Intest Res 2019;17(4):455-462.   Published online October 14, 2019
DOI: https://doi.org/10.5217/ir.2019.00076
AbstractAbstract PDFPubReaderePub
Cancer is a catabolic inflammatory disease that causes patients to often experience weight loss, or even cachexia in severe cases. Undernourishment in patients with cancer impairs the quality of life and therapeutic response, further leading to poor prognosis. Active and frequent nutritional screening and assessment using valid tools are important for fast and appropriate nutritional intervention. Additionally, a suitable individualized nutritional intervention strategy should be established based on the nutritional assessment result. In general, nutritional intervention begins with nutritional counseling of patients diagnosed with cancer, and a well-planned nutritional counseling improves the treatment adherence and nutritional status. When planning nutritional supplementation for cancer patients, specific nutrients, including amino acids and fatty acids, should be considered. However, there has been no consistent result showing that any particular nutrient significantly improves the prognosis of cancer patients. Hence, continuous attention from clinical physicians is needed to plan nutritional improvement in patients with cancer.

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Microbiota
Importance of nutritional therapy in the management of intestinal diseases: beyond energy and nutrient supply
Seong-Eun Kim
Intest Res 2019;17(4):443-454.   Published online September 4, 2019
DOI: https://doi.org/10.5217/ir.2019.00075
AbstractAbstract PDFPubReaderePub
The gut is an immune-microbiome-epithelial complex. Gut microbiome-host interactions have widespread biological implications, and the role of this complex system extends beyond the digestion of food and nutrient absorption. Dietary nutrients can affect this complex and play a key role in determining gut homeostasis to maintain host health. In this article, we review various dietary nutrients and their contribution to the pathogenesis and treatment of various intestinal diseases including inflammatory bowel disease, irritable bowel syndrome, colorectal cancer, and diverticulitis, among other such disorders. A better understanding of diet-host-gut microbiome interactions is essential to provide beneficial nutrients for gut health and to limit nutritional hazards to ensure successful nutritional management of gastrointestinal conditions in clinical practice.

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Original Articles
Inflammatory bowel diseases
Ustekinumab is effective in biological refractory Crohn’s disease patients–regardless of approval study selection criteria
Sadik Saman, Martin Goetz, Judith Wendler, Nisar P. Malek, Jan Wehkamp, Thomas Klag
Intest Res 2019;17(3):340-348.   Published online May 31, 2019
DOI: https://doi.org/10.5217/ir.2019.00012
AbstractAbstract PDFPubReaderePub
Background/Aims
Ustekinumab is effective in active Crohn’s disease. In a retrospective study we assessed the clinical outcome in nonresponders to anti-tumor necrosis factor therapy, and/or conventional therapy and/or the α4β7-integrin inhibitor vedolizumab. As approval study populations do not always reflect the average “real world” patient cohort, we assessed weather patients who would not have qualified for approval studies show similar outcomes.
Methods
Forty-one patients with mild to severe active Crohn’s disease were treated with ustekinumab (intravenous 6 mg per kg/body weight) followed by subcutaneous ustekinumab (90 mg) at week 8. Depending on the clinical response maintenance therapy was chosen every 8 or 12 weeks. Clinical response was defined by Crohn’s Disease Activity Index (CDAI) decline, decline of stool frequency or clinical improvement. Inclusion criteria for approval studies were assessed.
Results
The 58.5% (24/41) showed clinical response to ustekinumab. The 58.3% of this group (14/24) achieved clinical remission. Clinical response correlated significantly with drop of stool frequency and improvement of CDAI score. The 39 out of 41 patients had no side effects and we observed no serious infections. About a third of our patients would not have met ustekinumab approval study criteria. However, patients who did not meet study criteria showed clinical improvement numerically in the same range compared to patients who would have qualified for approval studies.
Conclusions
Ustekinumab is effective, safe and well tolerated in a highly therapy refractory patient cohort. Even though a reasonable number of patients did not meet ustekinumab approval study criteria, approval study results seem to be representative to the overall patient cohort.

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    Hongsheng Yang, Bingyang Li, Qin Guo, Jian Tang, Bo Peng, Ni Ding, Miao Li, Qingfang Yang, Zicheng Huang, Na Diao, Xia Zhu, Jun Deng, Huili Guo, Pinjin Hu, Kang Chao, Xiang Gao
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Inflammatory bowel diseases
Risk of surgery in patients with stricturing type of Crohn’s disease at the initial diagnosis: a single center experience
Yuji Maehata, Yutaka Nagata, Tomohiko Moriyama, Yuichi Matsuno, Atsushi Hirano, Junji Umeno, Takehiro Torisu, Tatsuya Manabe, Takanari Kitazono, Motohiro Esaki
Intest Res 2019;17(3):357-364.   Published online February 21, 2019
DOI: https://doi.org/10.5217/ir.2018.00107
AbstractAbstract PDFPubReaderePub
Background/Aims
It remains uncertain which patients with stricturing-type Crohn’s disease (CD) require early small bowel surgery after the initial diagnosis. We aimed to clarify clinical characteristics associated with the intervention in such condition of CD.
Methods
We retrospectively evaluated the clinical course of 53 patients with CD and small bowel strictures who were initially treated with medications after the initial diagnosis. We investigated possible associations between small bowel surgery and the following: clinical factors and radiologic findings at initial diagnosis and the types of medications administered during follow-up.
Results
Twenty-eight patients (53%) required small bowel resection during a median follow-up period of 5.0 years (range, 0.5–14.3 years). The cumulative incidence rates of small bowel surgery at 2, 5, and 10 years were 26.4%, 41.0%, and 63.2%, respectively. Univariate analysis indicated that obstructive symptoms (P=0.036), long-segment stricture (P<0.0001), and prestenotic dilation (P<0.0001) on radiography were associated with small bowel surgery, and immunomodulatory (P=0.037) and biological therapy (P=0.008) were significant factors during follow-up. Multivariate analysis revealed that long-segment stricture (hazard ratio [HR], 4.25; 95% confidence interval [CI], 1.78–10.53; P=0.001) and prestenotic dilation (HR, 3.41; 95% CI, 1.24–9.62; P=0.018) on radiography showed a positive correlation with small bowel surgery, and biological therapy (HR, 0.40; 95% CI, 0.15–0.99; P=0.048) showed a negative correlation.
Conclusions
CD patients with long-segment stricture and prestenotic dilation on radiography seem to be at a higher risk of needing small bowel surgery. For such patients, early surgical intervention might be appropriate, even at initial diagnosis.

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Case Reports
Fecal microbiota transplantation for refractory Crohn's disease
Seon Ho Bak, Hyun Ho Choi, Jinhee Lee, Mi Hee Kim, Youn Hee Lee, Jin Su Kim, Young-Seok Cho
Intest Res 2017;15(2):244-248.   Published online April 27, 2017
DOI: https://doi.org/10.5217/ir.2017.15.2.244
AbstractAbstract PDFPubReaderePub

Approximately one-third of patients with Crohn's disease do not respond to conventional treatments, and some experience significant adverse effects, such as serious infections and lymphoma, and many patients require surgery due to complications. Increasing evidence suggests that specific changes in the composition of gut microbiota, termed as dysbiosis, are a common feature in patients with inflammatory bowel disease (IBD). Dysbiosis can lead to activation of the mucosal immune system, resulting in chronic inflammation and the development of mucosal lesions. Recently, fecal microbiota transplantation, aimed at modifying the composition of gut microbiota to overcome dysbiosis, has become a potential alternative therapeutic option for IBD. Herein, we present a patient with Crohn's colitis in whom biologic therapy failed previously, but clinical remission and endoscopic improvement was achieved after a single fecal microbiota transplantation infusion.

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Refractory Clostridium difficile Infection Cured With Fecal Microbiota Transplantation in Vancomycin-Resistant Enterococcus Colonized Patient
Mi-Ok Jang, Jun Hwan An, Sook-In Jung, Kyung-Hwa Park
Intest Res 2015;13(1):80-84.   Published online January 29, 2015
DOI: https://doi.org/10.5217/ir.2015.13.1.80
AbstractAbstract PDFPubReader

The rates and severity of Clostridium difficile infections, including pseudomembranous colitis, have increased markedly. However, there are few effective treatments for refractory or recurrent C. difficile infections and the outcomes are poor. Fecal microbiota transplantation is becoming increasingly accepted as an effective and safe intervention in patients with recurrent disease, likely due to the restoration of a disrupted microbiome. Cure rates of >90% are being consistently reported from multiple centers. We cured a case of severe refractory C. difficile infection with fecal microbiota transplantation in a patient colonized by vancomycin-resistant enterococcus.

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