Intestinal Research

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

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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.

Citations

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Mirikizumab – a new option in treatment of inflammatory bowel diseases
Jakub Olszewski, Katarzyna Kozon, Magdalena Sitnik, Katarzyna Herjan, Karolina Mikołap, Bartłomiej Gastoł, Maciej Bara, Piotr Armański, Marcin Sawczuk
Prospects in Pharmaceutical Sciences.2024; 22(3): 178. CrossRef
Key Interleukins in Inflammatory Bowel Disease—A Review of Recent Studies
David Aebisher, Dorota Bartusik-Aebisher, Agnieszka Przygórzewska, Piotr Oleś, Paweł Woźnicki, Aleksandra Kawczyk-Krupka
International Journal of Molecular Sciences.2024; 26(1): 121. CrossRef

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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

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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

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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
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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Review

IBD

Artificial intelligence for endoscopy in inflammatory bowel disease: Kento Takenaka, Ami Kawamoto, Ryuichi Okamoto, Mamoru Watanabe, Kazuo Ohtsuka; Intest Res 2022;20(2):165-170. Published online January 7, 2022; DOI: https://doi.org/10.5217/ir.2021.00079

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Inflammatory bowel disease (IBD), with its 2 subtypes, Crohn’s disease and ulcerative colitis, is a complex chronic condition. A precise definition of disease activity and appropriate drug management greatly improve the clinical course while minimizing the risk or cost. Artificial intelligence (AI) has been used in several medical diseases or situations. Herein, we provide an overview of AI for endoscopy in IBD. We discuss how AI can improve clinical practice and how some components have already begun to shape our knowledge. There may be a time when we can use AI in clinical practice. As AI systems contribute to the exact diagnosis and treatment of human disease, we should continue to learn best practices in health care in the field of IBD.

Citations

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Deep Learning Model Using Stool Pictures for Predicting Endoscopic Mucosal Inflammation in Patients With Ulcerative Colitis
Jung Won Lee, Dongwon Woo, Kyeong Ok Kim, Eun Soo Kim, Sung Kook Kim, Hyun Seok Lee, Ben Kang, Yoo Jin Lee, Jeongseok Kim, Byung Ik Jang, Eun Young Kim, Hyeong Ho Jo, Yun Jin Chung, Hanjun Ryu, Soo-Kyung Park, Dong-Il Park, Hosang Yu, Sungmoon Jeong
American Journal of Gastroenterology.2025; 120(1): 213. CrossRef
Could histologic healing be a new treatment target in patients with ulcerative colitis?
Soyoung Kim, Sang Hyoung Park
The Korean Journal of Internal Medicine.2024; 39(1): 2. CrossRef
From Data to Insights: How Is AI Revolutionizing Small-Bowel Endoscopy?
Joana Mota, Maria João Almeida, Francisco Mendes, Miguel Martins, Tiago Ribeiro, João Afonso, Pedro Cardoso, Helder Cardoso, Patrícia Andrade, João Ferreira, Miguel Mascarenhas, Guilherme Macedo
Diagnostics.2024; 14(3): 291. CrossRef
The Role of Artificial Intelligence in the Diagnosis and Treatment of Ulcerative Colitis
Petar Uchikov, Usman Khalid, Nikola Vankov, Maria Kraeva, Krasimir Kraev, Bozhidar Hristov, Milena Sandeva, Snezhanka Dragusheva, Dzhevdet Chakarov, Petko Petrov, Bistra Dobreva-Yatseva, Ivan Novakov
Diagnostics.2024; 14(10): 1004. CrossRef
Deep learning and minimally invasive inflammatory activity assessment: a proof-of-concept study for development and score correlation of a panendoscopy convolutional network
Pedro Cardoso, Miguel Mascarenhas, João Afonso, Tiago Ribeiro, Francisco Mendes, Miguel Martins, Patrícia Andrade, Hélder Cardoso, Miguel Mascarenhas Saraiva, João P.S. Ferreira, Guilherme Macedo
Therapeutic Advances in Gastroenterology.2024;[Epub] CrossRef
Knowledge, attitudes, and practices of endoscopy among gastroenterologists in diagnosis and management of inflammatory bowel disease in China: a multicenter cross-sectional study
Yinghao Sun, Gechong Ruan, Xiaoyin Bai, Wei Han, Minglan Yang, Lixin Jin, Yanni Huang, Xiaoxia Hou, Ke Shu, Yingying Liu, Yafeng Lu, Yan Zhao, Jie Zhong, Hong Yang
BMC Gastroenterology.2024;[Epub] CrossRef
Endoscopic findings of immune checkpoint inhibitor-related gastrointestinal adverse events
Min Kyu Kim, Sung Wook Hwang
Clinical Endoscopy.2024; 57(6): 725. CrossRef
The pathobiology of follicular lymphoma
Joaquim Carreras
Journal of Clinical and Experimental Hematopathology.2023; 63(3): 152. CrossRef
Artificial Intelligence in Digestive Endoscopy—Where Are We and Where Are We Going?
Radu-Alexandru Vulpoi, Mihaela Luca, Adrian Ciobanu, Andrei Olteanu, Oana-Bogdana Barboi, Vasile Liviu Drug
Diagnostics.2022; 12(4): 927. CrossRef
Artificial intelligence within the small bowel: are we lagging behind?
Stefania Chetcuti Zammit, Reena Sidhu
Current Opinion in Gastroenterology.2022; 38(3): 307. CrossRef

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Original Articles

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

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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

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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
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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

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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

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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)

Citations

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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
Evaluation of the transition from intravenous to subcutaneous vedolizumab in patients with inflammatory bowel disease
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Gastroenterología y Hepatología (English Edition).2025; 48(3): 502201. CrossRef
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Qiong Hu, Xing-zhou Tang, Fang Liu, De-wu Liu, Bo Cao
Therapeutic Advances in Gastroenterology.2023;[Epub] CrossRef
Network meta-analysis on efficacy and safety of different biologics for ulcerative colitis
Xinqiao Chu, Yaning Biao, Chengjiang Liu, Yixin Zhang, Chenxu Liu, Ji-zheng Ma, Yufeng Guo, Yaru Gu
BMC Gastroenterology.2023;[Epub] CrossRef
Vedolizumab as the first line of biologic therapy for ulcerative colitis and Crohn's disease – a systematic review with meta-analysis
Mohamed Attauabi, Gorm Roager Madsen, Flemming Bendtsen, Jakob Benedict Seidelin, Johan Burisch
Digestive and Liver Disease.2022; 54(9): 1168. CrossRef
AJM300 (carotegrast methyl), an oral antagonist of α4-integrin, as induction therapy for patients with moderately active ulcerative colitis: a multicentre, randomised, double-blind, placebo-controlled, phase 3 study
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Gut and Liver.2022; 16(5): 764. CrossRef
Inflammatory Bowel Disease Patients’ Acceptance for Switching from Intravenous Infliximab or Vedolizumab to Subcutaneous Formulation: The Nancy Experience
Clotilde Remy, Bénédicte Caron, Celia Gouynou, Vincent Haghnejad, Elodie Jeanbert, Patrick Netter, Silvio Danese, Laurent Peyrin-Biroulet
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Subcutaneous vedolizumab in moderately to severely active ulcerative colitis or Crohn’s disease: a profile of its use
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AJM300 (Carotegrast Methyl), an Oral Antagonist of α4-Integrin, as Induction Therapy for Patients with Moderately Active Ulcerative Colitis: A Multicentre, Randomised, Double-Blind, Placebo-Controlled Phase 3 Study
Katsuyoshi Matsuoka, Mamoru Watanabe, Toshihide Ohmori, Kouichi Nakajima, Tetsuya Ishida, Yoh Ishiguro, Kazunari Kanke, Kiyonori Kobayashi, Fumihito Hirai, Kenji Watanabe, Hidehiro Mizusawa, Shuji Kishida, Yoshiharu Miura, Akira Ohta, Toshifumi Kajioka, T
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Brief Communication

IBD

Rapid prediction of 1-year efficacy of tofacitinib for treating refractory ulcerative colitis: Hiromichi Shimizu, Toshimitsu Fujii, Shuji Hibiya, Maiko Motobayashi, Kohei Suzuki, Kento Takenaka, Eiko Saito, Masakazu Nagahori, Kazuo Ohtsuka, Mamoru Watanabe; Intest Res 2021;19(1):115-118. Published online June 11, 2020; DOI: https://doi.org/10.5217/ir.2020.00030

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Citations

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Digestive and Liver Disease.2024; 56(4): 613. CrossRef
Continued JAK inhibitor treatment on the risk of recurrent herpes zoster reactivation in patients with immune-mediated inflammatory diseases: A nationwide population-based study in South Korea
Young-Eun Kim, Ye-Jee Kim, Dae Hyun Jeong, Seonok Kim, Min Jee Kim, Hyeon Hwa Kim, Kyung-Wook Jo, Sang Hyoung Park, Seokchan Hong
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Long-term efficacy and safety of tofacitinib in patients with ulcerative colitis: 3-year results from a real-world study
Hiromichi Shimizu, Yuko Aonuma, Shuji Hibiya, Ami Kawamoto, Kento Takenaka, Toshimitsu Fujii, Eiko Saito, Masakazu Nagahori, Kazuo Ohtsuka, Ryuichi Okamoto
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María Chaparro, Diana Acosta, Cristina Rodríguez, Francisco Mesonero, Miren Vicuña, Manuel Barreiro-de Acosta, Agnès Fernández-Clotet, Álvaro Hernández Martínez, Maite Arroyo, Isabel Vera, Alexandra Ruiz-Cerulla, Beatriz Sicilia, M. José Cabello Tapia, Ca
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Review article: Risk of cardiovascular events in patients with inflammatory bowel disease receiving small molecule drugs
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Shubhra Mishra, Anuraag Jena, Rinkalben Kakadiya, Vishal Sharma, Vineet Ahuja
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Oral beclomethasone dipropionate as an add-on therapy and response prediction in Korean patients with ulcerative colitis
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Review article: guide to tofacitinib dosing in patients with ulcerative colitis
Peter M. Irving, Yvette Leung, Marla C. Dubinsky
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Therapeutic Advances in Gastroenterology.2021;[Epub] CrossRef

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Original Articles

Inflammatory bowel diseases

Anti-MAdCAM-1 antibody (PF-00547659) for active refractory Crohn’s disease in Japanese and Korean patients: the OPERA study: Masayuki Saruta, Dong Il Park, Young-Ho Kim, Suk-Kyun Yang, Byung-Ik Jang, Jae Hee Cheon, Jong Pil Im, Takanori Kanai, Tatsuro Katsuno, Yoh Ishiguro, Makoto Nagaoka, Naoki Isogawa, Yinhua Li, Anindita Banerjee, Alaa Ahmad, Mina Hassan-Zahraee, Robert Clare, Kenneth J. Gorelick, Fabio Cataldi, Mamoru Watanabe, Toshifumi Hibi; Intest Res 2020;18(1):45-55. Published online January 30, 2020; DOI: https://doi.org/10.5217/ir.2019.00039

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Background/Aims
PF-00547659 is a monoclonal antibody against human mucosal addressin cell adhesion molecule-1 (MAdCAM-1) that prevents the binding of α4β7+ lymphocytes to MAdCAM-expressing sites in the gastrointestinal tract with high affinity and selectivity, and is being developed for the treatment of Crohn’s disease (CD).
Methods
OPERA is a randomized, multicenter, double-blind, placebo-controlled study to investigate the efficacy, safety, and pharmacokinetics of PF-00547659 following subcutaneous administration in subjects with active CD, a history of failure or intolerance to anti-tumor necrosis factor and/or immunosuppressants, high-sensitivity C-reactive protein > 3.0 mg/L, and ulcers on colonoscopy. The primary endpoint was Crohn’s Disease Activity Index-70 response at week 8 or 12. Subpopulation analyses for Asian subjects were performed as some differences are observed in genetics and clinical phenotypes in Asian CD patients compared with Western patients.
Results
In this study, 265 CD subjects were randomized, with a subpopulation of 21 subjects (8 Japanese and 13 Korean) defined as the Asian population. In the overall and Asian populations; PF-00547659 was pharmacologically active as evidenced by soluble MAdCAM and circulating β7+ central memory CD4+ T-lymphocytes, although no clear evidence of efficacy was observed in any clinical endpoints; pharmacokinetics of PF-00547659 in the Asian subpopulation was generally comparable to the overall population; and the safety profile of PF-00547659 appeared acceptable up to 12 weeks of treatment.
Conclusions
In the overall and Asian populations, efficacy of PF-00547659 could not be demonstrated using any clinical endpoints compared with placebo. Pharmacokinetics and safety of PF-00547659 were generally comparable. Further studies with larger numbers of patients are required to confirm our results. (Trial Registration Number: NCT01276509)

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Novel Histone Deacetylase 6 Inhibitor Confers Anti-inflammatory Effects and Enhances Gut Barrier Function
Jae-Young Lee, Hyun Woo Ma, Ji Hyung Kim, I Seul Park, Mijeong Son, Keun Ho Ryu, Jieun Shin, Seung Won Kim, Jae Hee Cheon
Gut and Liver.2023; 17(5): 766. CrossRef
Downregulation of Heat Shock Protein 72 Contributes to Fibrostenosis in Crohn’s Disease
Seung Won Kim, Jae-Young Lee, Han Cheol Lee, Jae Bum Ahn, Ji Hyung Kim, I Seul Park, Jae Hee Cheon, Duk Hwan Kim
Gut and Liver.2023; 17(6): 905. CrossRef
Targeting Immune Cell Trafficking – Insights From Research Models and Implications for Future IBD Therapy
Maximilian Wiendl, Emily Becker, Tanja M. Müller, Caroline J. Voskens, Markus F. Neurath, Sebastian Zundler
Frontiers in Immunology.2021;[Epub] CrossRef
Renin–angiotensin system in intestinal inflammation—Angiotensin inhibitors to treat inflammatory bowel diseases?
Hanne Salmenkari, Riitta Korpela, Heikki Vapaatalo
Basic & Clinical Pharmacology & Toxicology.2021; 129(3): 161. CrossRef
Anti-integrin drugs in clinical trials for inflammatory bowel disease (IBD): insights into promising agents
Virginia Solitano, Tommaso Lorenzo Parigi, Elisa Ragaini, Silvio Danese
Expert Opinion on Investigational Drugs.2021; 30(10): 1037. CrossRef
Emerging therapeutic options in inflammatory bowel disease
Jesus K Yamamoto-Furusho, Norma N Parra-Holguín
World Journal of Gastroenterology.2021; 27(48): 8242. CrossRef

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Inflammatory bowel diseases

Predictive factors for achievement of mucosal healing by budesonide 2-mg foam in ulcerative colitis: a pooled analysis of data from two clinical trials: Toshifumi Hibi, Makoto Naganuma, Eisei Oda, Yoji Yamada, Yoshitomo Chujoh, Ryoichi Yoshihara, Mamoru Watanabe; Intest Res 2020;18(1):56-68. Published online December 11, 2019; DOI: https://doi.org/10.5217/ir.2019.00064

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Background/Aims
Mucosal healing (MH) of distal lesions in ulcerative colitis (UC) has recently been confirmed with budesonide 2-mg foam (BF) treatment in 2 clinical trials; however, few studies have investigated the predictive factors for complete MH.
Methods
We conducted a post hoc analysis using pooled data from phase II and III clinical trials evaluating the efficacy and safety of BF for UC. Additionally, we analyzed the relationships between complete MH and baseline factors and clinical symptoms from baseline to week 6.
Results
Among the 291 Japanese patients from the 2 pooled clinical studies, 119 patients in the BF twice a day group and 117 in the placebo group were included in the full analysis set. The proportion of patients with a rectal bleeding (RB) subscore of 0 was significantly higher in the BF group than in the placebo group after a 5-day treatment (P<0.05). After a 2-day treatment, significantly more patients in the BF group had a stool frequency (SF) subscore of 0 than patients in the placebo group (P<0.05). Multivariate analysis showed that complete MH at week 6 was influenced by baseline SF subscore and 5-aminosalicylic acid (5-ASA) enema or suppository use (P=0.0086 and P=0.0015, respectively). The relationship between complete MH at week 6 and RB subscore after week 2 was also confirmed.
Conclusions
Normal SF at baseline, history of 5-ASA topical product use, and elimination of RB after week 2 are suggested predictors of complete MH at week 6 with twice-daily BF treatment.

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Impact of twice‐daily budesonide foam administration on early clinical response and endoscopic remission in patients with ulcerative colitis: a post hoc analysis
Kenji Watanabe, Fumihito Hirai, Kiyonori Kobayashi, Ken Takeuchi, Shinsuke Kurosu, Katsutoshi Inagaki, Ken‐ichi Iwayama, Makoto Naganuma
Journal of Gastroenterology and Hepatology.2024; 39(11): 2367. CrossRef
Precision medicine and drug optimization in adult inflammatory bowel disease patients
Sophie Vieujean, Edouard Louis
Therapeutic Advances in Gastroenterology.2023;[Epub] CrossRef
The Prognostic Value of Residual Nonrectal Inflammation in Ulcerative Colitis
Eun Ae Kang
Gut and Liver.2022; 16(3): 487. CrossRef
Bowel frequency (night) and urgent defecation are improved by budesonide foam in patients with ulcerative colitis: a retrospective observational study
Ryosuke Miyazaki, Toshiyuki Sakurai, Mariko Shimada, Yuko Iwashita, Naoki Shibuya, Yoshihiro Akita, Haruna Miyashita, Yuki Maruyama, Masayuki Saruta
BMC Gastroenterology.2022;[Epub] 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
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
Budesonide MMX in the Treatment of Ulcerative Colitis: Current Perspectives on Efficacy and Safety
Giovanni Maconi, Deborah Camatta, Rosanna Cannatelli, Francesca Ferretti, Anna Carvalhas Gabrielli, Sandro Ardizzone
Therapeutics and Clinical Risk Management.2021; Volume 17: 285. CrossRef

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Inflammatory bowel diseases

Infliximab biosimilar CT-P13 is interchangeable with its originator for patients with inflammatory bowel disease in real world practice: Tomoo Nakagawa, Taku Kobayashi, Kiyohiro Nishikawa, Fumika Yamada, Satoshi Asai, Yukinori Sameshima, Yasuo Suzuki, Mamoru Watanabe, Toshifumi Hibi; Intest Res 2019;17(4):504-515. Published online August 23, 2019; DOI: https://doi.org/10.5217/ir.2019.00030

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Background/Aims
An interim analysis of post-marketing surveillance of CT-P13, an infliximab biosimilar, was performed to evaluate its safety and efficacy in Japanese patients with inflammatory bowel disease.
Methods
Patients were prospectively enrolled between November 2014 and March 2017, after the launch of CT-P13 in Japan, and case report forms of patients followed for at least 4 months were analyzed as of July 2018.
Results
Of 523 patients in the analysis set, 372 remained on CT-P13 therapy, while 54 (20.2%) of 267 patients with Crohn’s disease, and 97 (37.9%) of 256 patients with ulcerative colitis were withdrawn during follow-up. A total of 144 adverse drug reactions (ADRs) were reported in 106 patients (20.3%). Infusion reaction was the most frequent ADR observed in 49 patients (9.4%). Efficacy parameters decreased immediately after the start of treatment in naïve patients to anti-tumor necrosis factor-α antibody. In the patients switched from originator infliximab for nonmedical reasons, the decreased parameters due to proceeded treatment with the originator were maintained in low ranges, and the treatment continuation rate was high with low ADR incidence. In contrast, in patients switched for medical reasons such as adverse event or loss of response, the incidence of ADRs was high. However, the efficacy parameters were improved, and the treatment continuation rate was not significantly different from that of the naïve patient group.
Conclusions
In this interim analysis, CT-P13 was comparable to the originator infliximab with respect to ADRs and efficacy, and is therefore considered to be a cost-efficient interchangeable biosimilar for Japanese patients with inflammatory bowel disease.

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Current Medical Research and Opinion.2021; 37(9): 1529. CrossRef
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Hyo Yeop Song, Geom Seog Seo
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Review

IBD

Stem cell-based therapy for inflammatory bowel disease: Hiromichi Shimizu, Kohei Suzuki, Mamoru Watanabe, Ryuichi Okamoto; Intest Res 2019;17(3):311-316. Published online July 25, 2019; DOI: https://doi.org/10.5217/ir.2019.00043

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Inflammatory bowel disease (IBD) is an idiopathic, multi-etiological disease characterized by inflammation and mucosal destruction of the gastrointestinal tract. Despite the remarkable advance in immunomodulating therapies, there still remains a certain population of patients who are refractory to conventional as well as biologic therapies and fail to achieve mucosal healing. To improve the prognosis of those patients, at least 2 types of stem cells have been tested for their potential therapeutic use. Transplantation of hematopoietic stem cells or mesenchymal stem cells have been tested in several clinical studies, but their beneficial effect still remains controversial. In this review, we would like to overview the recent clinical challenges of stem cell-based therapies in IBD and also introduce our new therapeutic plan of intestinal stem cell transplantation for IBD, based on our ex vivo intestinal organoid culture technique.

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Corrigenda and Errata

Corrigendum: Tofacitinib induction and maintenance therapy in East Asian patients with active ulcerative colitis: subgroup analyses from three phase 3 multinational studies: Satoshi Motoya, Mamoru Watanabe, Hyo Jong Kim, Young Ho Kim, Dong Soo Han, Hirotoshi Yuasa, Junichi Tabira, Naoki Isogawa, Shoko Arai, Isao Kawaguchi, Toshifumi Hibi; Intest Res 2018;16(3):499-501. Published online July 27, 2018; DOI: https://doi.org/10.5217/ir.2018.16.3.499

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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

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Original Article

IBD

Tofacitinib induction and maintenance therapy in East Asian patients with active ulcerative colitis: subgroup analyses from three phase 3 multinational studies: Satoshi Motoya, Mamoru Watanabe, Hyo Jong Kim, Young Ho Kim, Dong Soo Han, Hirotoshi Yuasa, Junichi Tabira, Naoki Isogawa, Shoko Arai, Isao Kawaguchi, Toshifumi Hibi; Intest Res 2018;16(2):233-245. Published online April 30, 2018; DOI: https://doi.org/10.5217/ir.2018.16.2.233

Abstract PDF Supplementary Material PubReader ePub

Background/Aims

Tofacitinib is an oral, small-molecule Janus kinase inhibitor being investigated for ulcerative colitis (UC). In OCTAVE Induction 1 and 2, patients with moderately to severely active UC received placebo or tofacitinib 10 mg twice daily (BID) for 8 weeks. Clinical responders in OCTAVE Induction were re-randomized to 52 weeks' therapy with placebo, tofacitinib 5 mg BID, or tofacitinib 10 mg BID.

Methods

We conducted post-hoc efficacy and safety analyses of East Asian patients in OCTAVE Induction 1 and 2 and OCTAVE Sustain.

Results

A total of 121 East Asian (Japan, Korea, and Taiwan) patients were randomized in OCTAVE Induction 1 and 2 (placebo, n=26; tofacitinib 10 mg BID, n=95), and 63 in OCTAVE Sustain (placebo, n=20; tofacitinib 5 mg BID, n=22; tofacitinib 10 mg BID, n=21). At week 8 of OCTAVE Induction 1 and 2, 18.9% of patients (18/95) achieved remission with tofacitinib 10 mg BID versus 3.8% (1/26) with placebo. In OCTAVE Sustain, the week 52 remission rates were 45.5% (10/22), 47.6% (10/21), and 15.0% (3/20) with 5 mg BID, 10 mg BID, and placebo, respectively. Adverse event rates were similar between groups in OCTAVE Induction and numerically higher with tofacitinib in OCTAVE Sustain. Serious adverse event rates were similar across groups in all studies. Infections were numerically more frequent with tofacitinib than placebo. Increases in serum lipid levels were observed with tofacitinib.

Conclusions

In East Asian patients with UC, tofacitinib demonstrated numerically greater efficacy versus placebo as induction and maintenance therapy, with a safety profile consistent with the global study population. ClinicalTrials.gov: NCT01465763; NCT01458951; NCT01458574.

Citations

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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

Abstract PDF PubReader ePub

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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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

Abstract PDF PubReader ePub

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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Intestinal Research.2018; 16(4): 588. CrossRef
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Mario Fernández-Ruiz, José María Aguado
Expert Review of Anti-infective Therapy.2018; 16(12): 939. CrossRef

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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

Abstract PDF PubReader ePub

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.

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The Korean Journal of Gastroenterology.2020; 75(1): 1. CrossRef
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Jihye Kim, Jong Pil Im, Jae-Joon Yim, Chang Kyun Lee, Dong Il Park, Chang Soo Eun, Sung-Ae Jung, Jeong Eun Shin, Kang-Moon Lee, Jae Hee Cheon
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Rupa Banerjee, Raja Affendi Raja Ali, Shu Chen Wei, Shashi Adsul
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High risk of tuberculosis during infliximab therapy despite tuberculosis screening in inflammatory bowel disease patients in India
Ashish Agarwal, Saurabh Kedia, Saransh Jain, Vipin Gupta, Sawan Bopanna, Dawesh P Yadav, Sandeep Goyal, Venigalla Pratap Mouli, Rajan Dhingra, Govind Makharia, Vineet Ahuja
Intestinal Research.2018; 16(4): 588. CrossRef

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Original Article

Pregnancy outcome in women with inflammatory bowel disease treated with anti-tumor necrosis factor and/or thiopurine therapy: a multicenter study from Japan: Shunsuke Komoto, Satoshi Motoya, Yuji Nishiwaki, Toshiyuki Matsui, Reiko Kunisaki, Katsuyoshi Matsuoka, Naoki Yoshimura, Takashi Kagaya, Makoto Naganuma, Nobuyuki Hida, Mamoru Watanabe, Toshifumi Hibi, Yasuo Suzuki, Soichiro Miura, Ryota Hokari; Intest Res 2016;14(2):139-145. Published online April 27, 2016; DOI: https://doi.org/10.5217/ir.2016.14.2.139

Abstract PDF PubReader ePub

Background/Aims

Anti-tumor necrosis factor drugs (anti-TNF) and thiopurines are important treatment options in patients with inflammatory bowel disease (IBD), including during pregnancy. However, there are limited data on the benefit/risk profile of anti-TNF and thiopurines during pregnancy in Asia. The aim of this study was to analyze pregnancy outcomes of female Japanese IBD patients treated with anti-TNF and/or thiopurines.

Methods

This cross-sectional study assessed pregnancy outcomes in 72 women with IBD. Pregnancy outcomes were compared among 31 pregnancies without exposure to infliximab (IFX), adalimumab (ADA), or thiopurines; 24 pregnancies with exposure to anti-TNF treatment (23 IFX, 1 ADA); 7 pregnancies with exposure to thiopurines alone; and 10 pregnancies with exposure to both IFX and thiopurines.

Results

Thirty-five of the 41 pregnancies (85.3%) that were exposed to anti-TNF treatment and/or thiopurines resulted in live births after a median gestational period of 38 weeks. Of the 35 live births, 3 involved premature deliveries; 7, low birth weight; and 1, a congenital abnormality. There were 6 spontaneous abortions in pregnancies that were exposed to anti-TNF treatment (17.7%). Pregnancy outcomes among the 4 groups were similar, except for the rate of spontaneous abortions (P =0.037).

Conclusions

Exposure to anti-TNF treatment or thiopurines during pregnancy was not related to a higher incidence of adverse pregnancy outcomes in Japanese IBD patients except for spontaneous abortion.

Citations

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Reviews

Magnetic resonance enterography for the evaluation of the deep small intestine in Crohn's disease: Kazuo Ohtsuka, Kento Takenaka, Yoshio Kitazume, Toshimitsu Fujii, Katsuyoshi Matsuoka, Maiko Kimura, Takashi Nagaishi, Mamoru Watanabe; Intest Res 2016;14(2):120-126. Published online April 27, 2016; DOI: https://doi.org/10.5217/ir.2016.14.2.120

Abstract PDF PubReader ePub

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

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Tacrolimus for the Treatment of Ulcerative Colitis: Katsuyoshi Matsuoka, Eiko Saito, Toshimitsu Fujii, Kento Takenaka, Maiko Kimura, Masakazu Nagahori, Kazuo Ohtsuka, Mamoru Watanabe; Intest Res 2015;13(3):219-226. Published online June 9, 2015; DOI: https://doi.org/10.5217/ir.2015.13.3.219

Abstract PDF PubReader

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

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Pathogenesis of Inflammatory Bowel Diseases: Masakazu Nagahori, Yasuhiro Nemoto, Mamoru Watanabe; Intest Res 2010;8(1):9-17. Published online June 30, 2010; DOI: https://doi.org/10.5217/ir.2010.8.1.9

Abstract PDF

Our understanding of IBD pathogenesis has been increasing rapidly. The genetically determined interplay between the commensal microbiota, intestinal epithelial cells, and the immune system has been appreciated deeply. The interplay is also considered to be modified by specific environmental factors. This review examines the recent findings from the animal and human studies on IBD pathogenesis and the implications for future effective therapies. (Intest Res 2010;8:9-17)

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