Intestinal Research

Original Articles

IBD

Insomnia is common in inflammatory bowel disease (IBD) and is associated with mental health conditions as well as IBD activity: Alex Barnes, Jane M Andrews, Sutapa Mukherjee, Robert V Bryant, Peter Bampton, Robert J. Fraser, Réme Mountifield; Intest Res 2024;22(1):104-114. Published online November 1, 2023; DOI: https://doi.org/10.5217/ir.2023.00028

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Background/Aims
Insomnia is common in people with chronic medical conditions, such as inflammatory bowel disease (IBD), and is readily treatable through cognitive behavioral therapy for insomnia. This study aimed to describe the associations with insomnia in people with IBD and its relationship to IBD-related disability.
Methods
An online questionnaire was administered through 3 tertiary IBD centers, social media, and Crohn’s Colitis Australia. The questionnaire included the Insomnia Severity Index (ISI), a validated assessment of insomnia. Measures of anxiety, depression, physical activity, and disability were also included. IBD activity was assessed using validated patient reported scores. A multivariate model was constructed for clinically significant insomnia and ISI scores. Subpopulations of Crohn’s disease and ulcerative colitis were considered.
Results
In a cohort of 670 respondents the median age was 41 years (range, 32–70 years), with the majority female (78.4%), the majority had Crohn’s disease (57.3%). Increasingly severe disability was associated with worse insomnia score. Clinically significant insomnia was associated with clinically active IBD, abdominal pain, anxiety, and depression, in a multivariate model. In an ulcerative colitis population, Simple Clinical Colitis Activity Index components of general well-being and urgency were associated with worse ISI score in a model including depression and anxiety. In those with Crohn’s disease, the multivariate model included Harvey Bradshaw Index score in addition to depression and anxiety.
Conclusions
Insomnia is common in people with IBD and is associated with increased disability. Abdominal pain and mental health conditions should prompt consideration for screening for insomnia and referral for cognitive behavioral therapy for insomnia.

Citations

Citations to this article as recorded by

Dietary succinoglycan riclin ameliorates spontaneous gut inflammation by restoring immune homeostasis in Period2-deficient mice
Junhao Liu, Xiaodong Xu, Sijia Sun, Tiantian Zhou, Yimeng Cai, Zi Wang, Zhao Ding
Journal of Functional Foods.2026; 138: 107198. CrossRef
The IBD Clinic of Tomorrow: Holistic, Patient-Centric, and Value-based Care
Benjamin Click, Raymond K. Cross, Miguel Regueiro, Laurie Keefer
Clinical Gastroenterology and Hepatology.2025; 23(3): 419. CrossRef
Chronic Poor Sleep is Associated with Increased Disease Activity in Patients with Ulcerative Colitis: Prospective Observational Study in Japan
Hideaki Oyama, Rintaro Moroi, Atsushi Sakuma, Yusuke Shimoyama, Hiroshi Nagai, Takeo Naito, Hisashi Shiga, Yoichi Kakuta, Yoshitaka Kinouchi, Atsushi Masamune
Journal of Crohn's and Colitis.2025;[Epub] CrossRef
Association between depression and anxiety with the risk and flare of inflammatory bowel disease: a systematic review and meta-analysis
Guowei Gong, Cong Xu, Zhenxia Zhang, Yuzhong Zheng
Internal and Emergency Medicine.2025; 20(1): 35. CrossRef
The Spectrum of Psychiatric Comorbidity in Individuals With Inflammatory Bowel Disease
Kianna Cadogan, Ruth Ann Marrie, Lesley A Graff, Renee El Gabalawy, Murray W Enns, James M Bolton, Jitender Sareen, Charles N Bernstein
Crohn's & Colitis 360.2025;[Epub] CrossRef
Type D personality, insomnia severity, perceived stress, and health-related quality of life in inflammatory bowel disease: A case–control study
Hassan Mohammed Sonbol, Mona Metwally El-Sayed, Mahmoud Abdelwahab Khedr, Mohamad Abulhassan Ibrahim, Manar Osama, Asmaa Adel Abdel-Sattar, Hiam Fathy Elsaied, Eman Abdeen Ali, Shorouk Mohsen, Alaa Salah Abdel Mawgoud
Journal of Psychosomatic Research.2025; 195: 112199. CrossRef
Development of a technology-enhanced patient-reported outcome evaluation system for inflammatory bowel disease: A multidimensional approach to assessing survival quality
Qian Jiang, Ling Du
Technology and Health Care.2025;[Epub] CrossRef
Fatigue in inflammatory bowel disease: a practical guide for gastroenterology clinicians
Yaa Danso, Ailsa L Hart, James L Alexander, Calum D Moulton
Frontline Gastroenterology.2025; : flgastro-2024-103035. CrossRef
Fatigue in inflammatory bowel disease: Prevalence, risk factors, assessment, outcomes, and management
Suprabhat Giri, Sidharth Harindranath, Akshay Kulkarni, Jiten Kumar Sahoo, Harshad Joshi, Preetam Nath, Manoj Kumar Sahu
World Journal of Gastrointestinal Pathophysiology.2025;[Epub] CrossRef
Mind-Body Interventions for Comorbid Sleep and Gastrointestinal Concerns
Elyse R. Thakur, Tran Tran, Brooke A. Duarte, Jamie M. Horrigan, Elizabeth W. Lampe, Hyder Said, Jessica K. Salwen-Deremer
Current Sleep Medicine Reports.2025;[Epub] CrossRef
The impact of sleep quality on the prognosis of inflammatory bowel disease commonly overlooked by gastroenterologists
Ji Young Chang
Intestinal Research.2024; 22(1): 5. CrossRef
Sleep quality is associated with reduced quality of life in inflammatory bowel disease through its interaction with pain
Alex Barnes, Robert V Bryant, Sutapa Mukherjee, Paul Spizzo, Réme Mountifield
JGH Open.2024;[Epub] CrossRef
Abdominal Pain in Inflammatory Bowel Disease-Epidemiology, Pathophysiology, and Management: A Narrative Review
Wei-wei Tan, Zi-xuan Liu, Xiao-Yan Liu, Wei-bing Zhang, Lie Zheng, Ya-Li Zhang, Yan-Cheng Dai
Pain and Therapy.2024; 13(6): 1447. CrossRef
Impact of Inflammatory Bowel Disease on Patient’s Quality of Life – A Review
Kamila Duszyńska, Karol Dolepski, Alicja Góral, Krystian Żuk, Michał Czachajda
Journal of Health Study and Medicine.2024; 2024(1): 185. CrossRef

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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

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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

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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
Safety and Effectiveness of QingDai (Indigo naturalis) in Children With Mild-to-Moderate Ulcerative Colitis: A Short-Term 6-Week Open-Label Trial
Dotan Yogev, Yael Weintraub, Oren Ledder, Manar Matar, Alex Krauthammer, Zivia Shavit-Brunschwig, Amichay Rotstein, Max E Godfrey, Amit Assa, Raanan Shamir, Dan Turner, Nir Salomon, Esther Orlanski-Meyer, Dror S Shouval
Inflammatory Bowel Diseases.2025; 31(10): 2917. CrossRef
Macrophage‐Mediated Transport of Insoluble Indirubin Induces Hepatic Injury During Intestinal Inflammation
Yiqi Xu, Jingchun Shi, Heung‐Lam Mok, Cheng Lyu, Junbang Chen, Chunhua Huang, Hongyan Qin, Chengyuan Lin, Hor‐Yue Tan, Zhaoxiang Bian
Advanced Science.2025;[Epub] CrossRef
Indigo naturalis for inflammatory bowel disease: evidence from animal studies and molecular mechanisms
Jie Hu, Mengen Zhou, Li Huang, Xiutian Guo, Pingping Mei, Peng Li, Yiting Wang, Yan Chen
Frontiers in Pharmacology.2025;[Epub] CrossRef
Reaching for Remission: Integrating Complementary and Alternative Strategies into Inflammatory Bowel Disease Management
Kelsey Ryan, Asha Cunningham, Joseph Runde
Pediatric Annals.2025;[Epub] CrossRef
Understanding Vascular Toxicity of Indigo Naturalis in Anti-Inflammatory Applications: Mendelian Randomization and Co-localization Study
Jie Liu, Chengjian Liu, Haitao Xiao, Zhiping Xu
BIO Integration.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

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IBD

Maintaining infliximab induced clinical remission with azathioprine and 5-aminosalicylates in acute severe steroid-refractory ulcerative colitis has lower cost and high efficacy (MIRACLE): a multicenter study: Ramit Mahajan, Arshdeep Singh, Saurabh Kedia, Kirandeep Kaur, Vandana Midha, Pabitra Sahu, Varun Mehta, Dharmatma Singh, Namita Bansal, Khushdeep Dharni, Sandeep Kaushal, Vineet Ahuja, Ajit Sood; Intest Res 2022;20(1):64-71. Published online February 3, 2021; DOI: https://doi.org/10.5217/ir.2020.00100

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Background/Aims
Infliximab (IFX) has been used to induce and maintain remission in patients with severe steroid-refractory ulcerative colitis (UC). Long-term use of biologics in developing countries is limited by high cost and frequent side effects. An optimal maintenance strategy in these patients needs to be established.
Methods
A retrospective analysis of maintenance of clinical remission with combination of azathioprine (AZA) and 5-aminosalicylates (5-ASA) in patients with severe steroidrefractory UC where IFX (5 mg/kg intravenously at weeks 0, 2, 6) had been used only as an induction therapy was done at 2 centers in India. Primary outcome was the proportion of patients maintaining corticosteroid-free sustained clinical remission (SCR) at the end of study period. Rates of relapse and cost of therapy were also analyzed.
Results
Of the 137 patients who received rescue IFX induction therapy, 77 (56.2%) achieved clinical remission (mean age 34.81 ± 13.32 years, 68.83% males, median follow-up 4 years, range 3 months to 6 years) and were included. Cumulative corticosteroid-free SCR was maintained in 68%, 59%, 42%, and 35% patients at 1, 2, 4, and 6 years respectively. Sixty-seven relapses were observed in 33 patients. Majority of the relapses (45/67, 67.16%) occurred within first 2 years of follow-up. Two relapses were managed with re-induction with IFX, one required colectomy, whereas all other responded to repeat course(s) of corticosteroids. Annual per capita maintenance therapy with 5-ASA and AZA was cheaper by US$ 4,526 compared to maintaining remission with IFX.
Conclusions
Clinical remission achieved with IFX induction therapy in severe steroid-refractory UC can be sustained over long time with a combination of AZA and 5-ASA.

Citations

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ECCO consensus on management of inflammatory bowel disease in low- and middle-income countries
Alaa El-Hussuna, Almuthe Christina Hauer, Tarkan Karakan, Valerie Pittet, Henit Yanai, Jalpa Devi, Jesus K Yamamoto-Furusho, Ali Reza Sima, Hailemichael Desalegn, Mutaz Idrees Sultan, Vishal Sharma, Hany Shehab, Lamya Mrabti, Natalia Queiroz, Anuraag Jena
Journal of Crohn’s and Colitis.2026;[Epub] CrossRef
Revisiting thiopurines and therapeutic drug monitoring in IBD: Insights and implications in the Indian context
Arshdeep Singh, Ajit Sood
Indian Journal of Gastroenterology.2025;[Epub] CrossRef
Biomarkers of mitochondrial permeability transition-driven necrosis in the regulation of ulcerative colitis
Manqin Sun, Fengjun Ni, Yong Yao, Huayuan Yang
PeerJ.2025; 13: e20345. CrossRef
Effect of Ornithine α-Ketoglutarate on Intestinal Microbiota and Serum Inflammatory Cytokines in Dextran Sulfate Sodium Induced Colitis
Tao Wang, Junquan Tian, Wenxuan Su, Fan Yang, Jie Yin, Qian Jiang, Yuying Li, Kang Yao, Tiejun Li, Yulong Yin
Nutrients.2023; 15(11): 2476. CrossRef
Management of Ulcerative Colitis: A Review of Indian Literature
Santhosh Rajendran, Ratnakar Kini, K. Muthukumaran, I. Shubha, A. Chezhian, R. Murali
Gastroenterology, Hepatology and Endoscopy Practice.2023; 3(4): 127. CrossRef
Advancements in the Management of Moderate-to-Severe Ulcerative Colitis: A Revised 2023 Korean Treatment Guidelines
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The Korean Journal of Medicine.2023; 98(5): 223. CrossRef
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Physician education can minimize inappropriate steroid use in patients with inflammatory bowel disease: the ACTION study
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Identifying Care Challenges as Opportunities for Research and Education in Inflammatory Bowel Disease in South Asia
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Clinical Gastroenterology and Hepatology.2022; 20(11): 2421. 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

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Inflammatory Bowel Diseases

Efficacy and safety of vedolizumab in Crohn’s disease in patients from Asian countries in the GEMINI 2 study: Rupa Banerjee, Sai Wei Chuah, Ida Normiha Hilmi, Deng-Chyang Wu, Suk-Kyun Yang, Dirk Demuth, Dirk Lindner, Shashi Adsul; Intest Res 2021;19(1):83-94. Published online December 31, 2020; DOI: https://doi.org/10.5217/ir.2019.09160

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Background/Aims
The efficacy and safety of vedolizumab in moderate-to-severely active Crohn’s disease (CD) were demonstrated in the GEMINI 2 study (NCT00783692). This post-hoc exploratory analysis aimed to assess the efficacy and safety of vedolizumab in the subgroup of patients from Asian countries.
Methods
During the induction phase (doses at day 1, 15), clinical remission, enhanced clinical response, and change in C-reactive protein at 6 weeks; during the maintenance phase, clinical remission, enhanced clinical response, glucocorticoid-free remission and durable clinical remission at 52 weeks, were the efficacy outcomes of interest. Efficacy and safety of vedolizumab compared to placebo were assessed in Asian countries (Hong Kong, India, Malaysia, Singapore, South Korea, and Taiwan) using descriptive analyses.
Results
During the induction phase, in Asian countries (n = 51), 14.7% of the vedolizumab-treated patients achieved clinical remission at week 6 compared to none with placebo (difference, 14.7%; 95% confidence interval, 15.8%–43.5%). In non-Asian countries (n = 317), the remission rate at week 6 with vedolizumab was 14.5%. During maintenance, in Asian countries, clinical remission rates at 52 weeks with vedolizumab administered every 4 weeks, vedolizumab administered every 8 weeks and placebo were 41.7%, 36.4%, and 0%, respectively; while enhanced clinical response rates were 41.7%, 63.6%, and 42.9%, respectively. During induction, 39.7% of patients with vedolizumab experienced an adverse event compared to 58.8% of patients with placebo, and vedolizumab was generally well-tolerated.
Conclusions
This post-hoc analysis demonstrates the treatment effect and safety of vedolizumab in moderateto-severely active CD in patients from Asian countries.

Citations

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A Comprehensive Review of the Role of Biologics and Small-Molecule Therapies in the Long-Term Management of Crohn’s Disease
Syeda F Zaidi, Keval B Patel, Maria Gabriela Cerdas, Ekanta Timalsina, Abirami Rajendiran, Duaa Behbehani, Sara Mahmood Aljallawi, Gnaneswar Pendurthi, Saad Ullah, Mounia N Bellaha, Tsion Gebregiorgis, Zahra Nazir
Cureus.2025;[Epub] CrossRef
Comparative efficacy and safety of subcutaneous infliximab and vedolizumab in patients with Crohn’s disease and ulcerative colitis included in randomised controlled trials
Laurent Peyrin‐Biroulet, Perttu Arkkila, Alessandro Armuzzi, Silvio Danese, Marc Ferrante, Jordi Guardiola, Jørgen Jahnsen, Edouard Louis, Milan Lukáš, Walter Reinisch, Xavier Roblin, Philip J Smith, Taek Kwon, Jeeyoung Kim, Sangwook Yoon, Dong-Hyeon Kim
BMC Gastroenterology.2024;[Epub] CrossRef
A Review on Nanosystem-Based Delivery of Tofacitinib for Enhanced Treatment of Autoimmune Diseases and Inflammation
Thi-Thao-Linh Nguyen, Van-An Duong
BioNanoScience.2024; 14(2): 2048. CrossRef
Application of clinical decision support tools for predicting outcomes with vedolizumab therapy in patients with inflammatory bowel disease: A KASID multicentre study
Kyuwon Kim, Jae Jun Park, Hyuk Yoon, Jun Lee, Kyeong Ok Kim, Eun Sun Kim, Su Young Kim, Sun‐Jin Boo, Yunho Jung, Jun Hwan Yoo, Sung Wook Hwang, Sang Hyoung Park, Suk‐Kyun Yang, Byong Duk Ye
Alimentary Pharmacology & Therapeutics.2024; 59(12): 1539. CrossRef
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Yu Chen, Guolin Zhang, Yuewen Yang, Shuangshuang Zhang, Haozheng Jiang, Kang Tian, Arenbaoligao, Dapeng Chen
Biomedicine & Pharmacotherapy.2023; 157: 114081. CrossRef
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Wei-Chen Lin, Wei-Chen Tai, Chung-Hsin Chang, Chia-Hung Tu, I-Che Feng, Ming-Jium Shieh, Chen-Shuan Chung, Hsu-Heng Yen, Jen-Wei Chou, Jau-Min Wong, Yu-Hwa Liu, Tien-Yu Huang, Chiao-Hsiung Chuang, Tzung-Jiun Tsai, Feng-Fan Chiang, Chien-Yu Lu, Wen-Hung Hs
Inflammatory Bowel Diseases.2023; 29(11): 1730. CrossRef
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Joo Kyung Kim, Jae Hee Cheon
Journal of Yeungnam Medical Science.2023; 40(1): 37. 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
Comparative efficacy and safety of infliximab and vedolizumab therapy in patients with inflammatory bowel disease: a systematic review and meta-analysis
Laurent Peyrin-Biroulet, Perttu Arkkila, Alessandro Armuzzi, Silvio Danese, Jordi Guardiola, Jørgen Jahnsen, Charles Lees, Edouard Louis, Milan Lukáš, Walter Reinisch, Xavier Roblin, Minyoung Jang, Han Geul Byun, Dong-Hyeon Kim, Sung Jeong Lee, Raja Atrey
BMC Gastroenterology.2022;[Epub] CrossRef
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Su Hyun Park, Sang Hyoung Park
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Seung Hwan Shin, Sang Hyoung Park
The Korean Journal of Gastroenterology.2022; 80(2): 51. CrossRef
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Soo-Young Na, You Sun Kim
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Eun Mi Song, Suk-Kyun Yang
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Hyo Yeop Song, Geom Seog Seo
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Suk-Kyun Yang
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Inflammatory Bowel Diseases

Efficacy and safety of a new vedolizumab subcutaneous formulation in Japanese patients with moderately to severely active ulcerative colitis: Taku Kobayashi, Hiroaki Ito, Toshifumi Ashida, Tadashi Yokoyama, Masakazu Nagahori, Tomoki Inaba, Mitsuhiro Shikamura, Takayoshi Yamaguchi, Tetsuharu Hori, Philippe Pinton, Mamoru Watanabe, Toshifumi Hibi; Intest Res 2021;19(4):448-460. Published online August 18, 2020; DOI: https://doi.org/10.5217/ir.2020.00026

Abstract PDF Supplementary Material PubReader ePub

Background/Aims
A subgroup analysis was conducted in Japanese patients with moderate to severe ulcerative colitis (UC) enrolled in the phase 3 VISIBLE 1 study, which evaluated the safety and efficacy of a new vedolizumab subcutaneous (SC) formulation.
Methods
Eligible patients received open-label infusions of vedolizumab 300 mg intravenous (IV) at weeks 0 and 2 in the induction phase. Patients with clinical response by complete Mayo score at week 6 entered the double-blind maintenance phase and were randomized to vedolizumab 108 mg SC every 2 weeks, placebo, or vedolizumab 300 mg IV every 8 weeks. The primary endpoint was clinical remission (complete Mayo score ≤ 2 points; no individual subscore > 1 point) at week 52.
Results
Of 49 patients who entered the induction phase, 22 out of 49 patients (45%) had clinical response at week 6 and were randomized to vedolizumab 108 mg SC (n = 10), placebo (n = 10), or vedolizumab 300 mg IV (n = 2). At week 52, 4 out of 10 patients (40%) who received vedolizumab SC had clinical remission versus 2 out of 10 patients (20%) who received placebo (difference: 20% [95% confidence interval, –27.9 to 61.8]). Two patients (2/10, 20%) who received vedolizumab SC experienced an injection-site reaction versus none who received placebo.
Conclusions
Our results indicate that the efficacy of vedolizumab SC in a subgroup of Japanese patients with UC are similar with those in the overall VISIBLE 1 study population, and with those established with vedolizumab IV. The safety and tolerability of vedolizumab SC were generally similar to that established for vedolizumab IV. (ClinicalTrials.gov ID NCT02611830; EudraCT 2015-000480-14)

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Valoración de la transición de vedolizumab intravenoso a subcutáneo en pacientes con enfermedad inflamatoria intestinal
Carmen Amor Costa, Cristina Suárez Ferrer, Laura García Ramírez, Eduardo Martín-Arranz, Joaquín Poza Cordón, José Luis Rueda García, María Sánchez Azofra, Irene González Diaz, Clara Amiama Roig, María Dolores Martín-Arranz
Gastroenterología y Hepatología.2025; 48(3): 502201. CrossRef
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Qiong Hu, Xing-zhou Tang, Fang Liu, De-wu Liu, Bo Cao
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Mohamed Attauabi, Gorm Roager Madsen, Flemming Bendtsen, Jakob Benedict Seidelin, Johan Burisch
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Yong Eun Park, Hye Su Moon, Dongeun Yong, Hochan Seo, Jinho Yang, Tae-Seop Shin, Yoon-Keun Kim, Jin Ran Kim, Yoo Na Lee, Young-Ho Kim, Joo Sung Kim, Jae Hee Cheon
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Comparison of efficacies of once-daily dose multimatrix mesalazine and multiple-dose mesalazine for the maintenance of remission in ulcerative colitis: a randomized, double-blind study: Haruhiko Ogata, Akihiro Ohori, Haruo Nishino, Seiichi Mizushima, Atsushi Hagino, Toshifumi Hibi; Intest Res 2017;15(3):358-367. Published online June 12, 2017; DOI: https://doi.org/10.5217/ir.2017.15.3.358

Abstract PDF PubReader ePub

Background/Aims

This study compared the efficacy of once-daily administration of multimatrix mesalazine 2.4 g/day with multiple-dose mesalazine for the maintenance of remission.

Methods

In this multicenter, randomized, double-blind study, 203 patients with ulcerative colitis in remission received multimatrix mesalazine 2.4 g/day once-daily or time-dependent (controlled-release) mesalazine 2.25 g/day 3 times-daily for 48 weeks. The primary efficacy endpoint was the proportion of patients without rectal bleeding.

Results

The proportion of patients without rectal bleeding during the 48-week treatment period in the per protocol set was 84.8% (84/99) in the multimatrix mesalazine 2.4 g/day group and 78.0% (78/100) in the controlled-release mesalazine 2.25 g/day group. The difference between the 2 treatment groups was 6.8% (two-sided 95% confidence interval, −3.9% to 17.6%). The noninferiority margin of −10% was met in the comparison of multimatrix mesalazine 2.4 g/day once-daily with controlled-release mesalazine 2.25 g/day. Multimatrix mesalazine 2.4 g/day once-daily demonstrated consistent efficacy in all subgroups. There was no difference between the 2 treatment groups with regard to safety.

Conclusions

A once-daily dose of 2 multimatrix mesalazine tablets (2.4 g) was not inferior to controlled-release mesalazine 2.25 g/day 3 times-daily in maintaining absence of rectal bleeding in ulcerative colitis.

Citations

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Long-Term Efficacy and Safety of Multi-Matrix Mesalazine Maintenance Therapy in Pediatric Patients with Ulcerative Colitis
Toshiaki Shimizu, Daisuke Tokuhara, Shigeo Nishimata, Takashi Ishige, Takahiro Kudo, Masahiro Takatsu, Kanako Nishimura, Akiko Matsuda, Koichi Hayashi, Katsuhiro Arai
Pediatric Gastroenterology, Hepatology & Nutrition.2026; 29(1): 44. CrossRef
Culture-based characterization of gut microbiota in inflammatory bowel disease
Hyunjoon Park, Soyoung Yeo, Taekyu Lee, Yumin Han, Chang Beom Ryu, Chul Sung Huh
Frontiers in Microbiology.2025;[Epub] CrossRef
A review on the current status and definitions of activity indices in inflammatory bowel disease: how to use indices for precise evaluation
Masahiro Kishi, Fumihito Hirai, Noritaka Takatsu, Takashi Hisabe, Yasumichi Takada, Tsuyoshi Beppu, Ken Takeuchi, Makoto Naganuma, Kazuo Ohtsuka, Kenji Watanabe, Takayuki Matsumoto, Motohiro Esaki, Kazutaka Koganei, Akira Sugita, Keisuke Hata, Kitarou Fut
Journal of Gastroenterology.2022; 57(4): 246. CrossRef
Inflammatory Bowel Disease – Non-biological treatment
Fernando Magro, Gonçalo Cordeiro, Andreia Martins Dias, Maria Manuela Estevinho
Pharmacological Research.2020; 160: 105075. CrossRef
Systematic review: safety of mesalazine in ulcerative colitis
P. Sehgal, J.‐F. Colombel, A. Aboubakr, N. Narula
Alimentary Pharmacology & Therapeutics.2018; 47(12): 1597. CrossRef
How to Optimally Use Currently Available Drugs in a Therapeutic Algorithm?
You Sun Kim
The Korean Journal of Gastroenterology.2018; 71(2): 74. CrossRef

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Efficacy and Safety of Long-Term Thiopurine Maintenance Treatment in Japanese Patients With Ulcerative Colitis: Satoshi Yamada, Takuya Yoshino, Minoru Matsuura, Masamichi Kimura, Yorimitsu Koshikawa, Naoki Minami, Takahiko Toyonaga, Yusuke Honzawa, Hiroshi Nakase; Intest Res 2015;13(3):250-258. Published online June 9, 2015; DOI: https://doi.org/10.5217/ir.2015.13.3.250

Abstract PDF Supplementary Material PubReader

Background/Aims

The long-term clinical outcomes of patients with bio-naive ulcerative colitis (UC) who maintain remission with thiopurine are unclear. The aim of this study was to assess the long-term efficacy and safety of maintenance treatment with thiopurine in UC patients.

Methods

This was a retrospective observational cohort analysis conducted at a single center. Between December 1998 and August 2013, 59 of 87 patients with bio-naive UC who achieved remission after induction with treatments other than biologics were enrolled. Remission maintenance with thiopurine was defined as no concomitant treatment needed other than 5-aminosalicylate without relapse. We assessed the remission-maintenance rate, mucosal healing rate, colectomy-free rate, and treatment safety in UC patients who received thiopurine as maintenance treatment.

Results

The 84-month cumulative remission-maintenance and colectomy-free survival rates in the UC patients who were receiving maintenance treatment with thiopurine and 5-aminosalicylate were 43.9% and 88.0%, respectively. Of the 38 patients who underwent colonoscopy during thiopurine maintenance treatment, 23 (60.5%) achieved mucosal healing. Of the 59 patients who achieved clinical remission with thiopurine, 6 patients (10.2%) discontinued the thiopurine therapy because of adverse events.

Conclusions

Our study demonstrates the long-term efficacy and safety of thiopurine treatment in patients with bio-naive UC.

Citations

Citations to this article as recorded by

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Xi Chen, Xiaohua Tang, Sixuan Chen, Yang Ye, Fei Mao
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Zhaobei Cai, Shu Wang, Jiannan Li
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Hiroshi Nakase
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Natalia Sutiman, Sylvia Chen, Khoon Lin Ling, Sai Wei Chuah, Wai Fook Leong, Vinayak Nadiger, Madeline Tjai, Chris San Choon Kong, Brian John Schwender, Webber Chan, Hang Hock Shim, Wee Chian Lim, Chiea Chuen Khor, Yin Bun Cheung, Balram Chowbay
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Toshiyuki Sato, Tetsuya Takagawa, Yoichi Kakuta, Akihiro Nishio, Mikio Kawai, Koji Kamikozuru, Yoko Yokoyama, Yuko Kita, Takako Miyazaki, Masaki Iimuro, Nobuyuki Hida, Kazutoshi Hori, Hiroki Ikeuchi, Shiro Nakamura
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Yoon Jee Lee, Jae Hee Cheon, Jae Hyun Kim, SunHo Yoo, Hyun Jung Lee, Soo Jung Park, Sung Pil Hong, Tae Il Kim, Won Ho Kim
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Caroline Prieux-Klotz, Stéphane Nahon, Aurelien Amiot, Leila Sinayoko, Carole Galéano-Cassaz, Stanislas Chaussade, Romain Coriat, Pierre Lahmek, Vered Abitbol
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Jae Hyun Kim, Jae Hee Cheon, Yehyun Park, Hyun Jung Lee, Soo Jung Park, Tae Il Kim, Won Ho Kim
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Seong Ran Jeon, Won Ho Kim
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7,776 View
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