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Original Article
IBD
Efficacy and safety of filgotinib as induction and maintenance therapy for Japanese patients with moderately to severely active ulcerative colitis: a post-hoc analysis of the phase 2b/3 SELECTION trial
Toshifumi Hibi, Satoshi Motoya, Tadakazu Hisamatsu, Fumihito Hirai, Kenji Watanabe, Katsuyoshi Matsuoka, Masayuki Saruta, Taku Kobayashi, Brian G Feagan, Chantal Tasset, Robin Besuyen, Chohee Yun, Gerald Crans, Jie Zhang, Akira Kondo, Mamoru Watanabe
Intest Res 2023;21(1):110-125.   Published online March 11, 2022
DOI: https://doi.org/10.5217/ir.2021.00143
AbstractAbstract PDFSupplementary MaterialPubReaderePub
Background/Aims
The safety and efficacy of filgotinib, a once-daily oral Janus kinase 1 preferential inhibitor, were evaluated in Japanese patients with ulcerative colitis (UC) in the phase 2b/3 SELECTION trial.
Methods
SELECTION (NCT02914522) was a randomized, placebo-controlled trial comprising 2 induction studies and a maintenance study. Adults with moderately to severely active UC were randomized in induction study A (biologic-naïve) or B (biologic-experienced) to receive filgotinib 200 mg, 100 mg, or placebo once daily for 11 weeks. Patients in clinical remission or Mayo Clinic score response at week 10 entered the 47-week maintenance study. Efficacy and safety outcomes were assessed in Japanese patients enrolled in Japan.
Results
Overall, 37 and 72 Japanese patients were enrolled in Japan in induction studies A and B, respectively, and 54 entered the maintenance study. Numerically higher proportions of filgotinib 200 mg-treated than placebo-treated patients achieved clinical remission in induction study A (4/15 [26.7%] vs. 0/6 [0%]) and the maintenance study (5/20 [25.0%] vs. 0/9 [0%]), but not induction study B (1/29 [3.4%] vs. 1/14 [7.1%]). Both doses were well tolerated, and no new safety signals were noted. Herpes zoster was reported in 1 filgotinib 200 mg-treated patient in each of induction study A (2.3%, 1/44) and the maintenance study (5.0%, 1/20).
Conclusions
These data, alongside those of the overall SELECTION population, suggest the potential of filgotinib 200 mg as a viable treatment option for Japanese patients with UC. Owing to small patient numbers, data should be interpreted cautiously.

Citations

Citations to this article as recorded by  
  • 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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    Katsuyoshi Matsuoka, Satoshi Motoya, Takayuki Yamamoto, Minoru Matsuura, Toshimitsu Fujii, Shinichiro Shinzaki, Yohei Mikami, Shoko Arai, Junichi Oshima, Yutaka Endo, Hirotoshi Yuasa, Masato Hoshi, Keiko Sato, Tadakazu Hisamatsu
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    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
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    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
  • 8,463 View
  • 810 Download
  • 14 Web of Science
  • 14 Crossref
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Review
Inflammatory bowel diseases
Clinical management for small bowel of Crohn’s disease in the treat-to-target era: now is the time to optimize treatment based on the dominant lesion
Kenji Watanabe
Intest Res 2020;18(4):347-354.   Published online October 26, 2020
DOI: https://doi.org/10.5217/ir.2020.00032
AbstractAbstract PDFPubReaderePub
A treat-to-target strategy, in which treatment is continuously adjusted according to the results of scheduled objective monitoring, is optimal for patients with Crohn’s disease (CD) in the era of biologics. The small bowel is a common site of intractable CD, which may result from multiple strictures or expanding lesions. To improve the prognosis of patients with small bowel CD, lesions should be proactively monitored within the subclinical phase. Objective assessment of small bowel lesions is technically difficult, however, due to the relatively poor correlation between endoscopic activity and clinical symptoms or biomarker titers. The presence of proximal small bowel lesions and asymptomatic “Real Silent CD” must be considered. Endoscopy remains the gold standard to assess these lesions. In clinical practice, the advantages and disadvantages of each imaging modality and biomarker must be carefully weighed for appropriate application and reliable monitoring. The prevalence of small bowel lesions depends on the precision of the imaging modality used for detection. Clinical management should be based on the dominant location of the intestinal lesions rather than classical classification. Optimal strategies for detecting and treating small bowel lesions in patients with CD must be developed utilizing reliable, precise, and objective monitoring.

Citations

Citations to this article as recorded by  
  • Outcomes of Patients With Prior Biologic Intolerance Are Better Than Those With Biologic Failure in Clinical Trials of Inflammatory Bowel Disease
    Sunil Samnani, Emily C L Wong, Hasan Hamam, Parambir S Dulai, John K Marshall, Vipul Jairath, Walter Reinisch, Neeraj Narula
    Journal of Crohn's and Colitis.2025;[Epub]     CrossRef
  • Intestinal ultrasound accurately predicts future therapy failure in Crohn’s disease patients in a biologics-induced remission
    Ahmad Albshesh, Alon Abend, Reuma Margalit Yehuda, Hussein Mahajna, Bella Ungar, Shomron Ben-Horin, Uri Kopylov, Dan Carter
    European Journal of Gastroenterology & Hepatology.2025; 37(2): 184.     CrossRef
  • Small bowel vasculitis? what a gastroenterologist should know - from diagnosis to management
    João Carlos Gonçalves, Bruno Rosa, José Cotter
    Current Opinion in Gastroenterology.2025; 41(3): 132.     CrossRef
  • Leucine-rich alpha-2 glycoprotein as a superior biomarker to C-reactive protein for detecting small bowel lesions in Crohn’s disease
    Masashi Ohno, Atsushi Nishida, Akinori Otsuki, Yoshihiro Yokota, Takayuki Imai, Shigeki Bamba, Osamu Inatomi
    World Journal of Gastrointestinal Endoscopy.2025;[Epub]     CrossRef
  • Guidelines for endoscopic diagnosis and treatment of inflammatory bowel diseases
    Takayuki Matsumoto, Tadakazu Hisamatsu, Motohiro Esaki, Teppei Omori, Hirotake Sakuraba, Shinichiro Shinzaki, Ken Sugimoto, Kento Takenaka, Makoto Naganuma, Shigeki Bamba, Takashi Hisabe, Sakiko Hiraoka, Mikihiro Fujiya, Minoru Matsuura, Shunichi Yanai, K
    Digestive Endoscopy.2025; 37(4): 319.     CrossRef
  • Role of noncontrast enhanced abdominal ultrasound in the diagnostic assessment of pediatric inflammatory bowel disease
    Katie Ritchie, Angharad Vernon‐Roberts, Andrew S. Day
    Journal of Pediatric Gastroenterology and Nutrition.2025; 80(6): 979.     CrossRef
  • Comparison of an Endoscopic Scoring System and the Simplified Magnetic Resonance Index of Activity in Patients with Small Bowel Crohn’s Disease
    Ji Eun Na, Hon Soul Kim, Sung Noh Hong, Kyoung Doo Song, Ji Eun Kim, Eun Ran Kim, Young-Ho Kim, Dong Kyung Chang
    Gut and Liver.2024; 18(1): 97.     CrossRef
  • Use of double-balloon endoscopy and an endoscopic scoring system to assess endoscopic remission in isolated small bowel Crohn’s disease after treatment with infliximab
    Wei Han, Jing Hu, Juan Wu, Peipei Zhang, Qiuyuan Liu, Naizhong Hu, Qiao Mei
    Therapeutic Advances in Gastroenterology.2024;[Epub]     CrossRef
  • Compositional changes in fecal microbiota associated with clinical phenotypes and prognosis in Korean patients with inflammatory bowel disease
    Seung Yong Shin, Young Kim, Won-Seok Kim, Jung Min Moon, Kang-Moon Lee, Sung-Ae Jung, Hyesook Park, Eun Young Huh, Byung Chang Kim, Soo Chan Lee, Chang Hwan Choi
    Intestinal Research.2023; 21(1): 148.     CrossRef
  • Impact of Crohn’s Disease on the Survival of Patients with Small-Bowel Adenocarcinoma in Korea: A Bicenter Cohort Study
    Kyuwon Kim, Kookhwan Choi, Sung Wook Hwang, Jong Pil Im, Byong Duk Ye, Joo Sung Kim, Kyu Joo Park, Suk-Kyun Yang, Seong-Joon Koh, Sang Hyoung Park
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  • Diagnosis of Crohn’s disease and ulcerative colitis using the microbiome
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  • Combined Endoscopic and Radiologic Healing Is Associated With a Better Prognosis Than Endoscopic Healing Only in Patients With Crohn's Disease Receiving Anti-TNF Therapy
    Kyunghwan Oh, Eun Hye Oh, Soo Min Noh, Seong Ho Park, Nayoung Kim, Sung Wook Hwang, Sang Hyoung Park, Dong-Hoon Yang, Jeong-Sik Byeon, Seung-Jae Myung, Suk-Kyun Yang, Byong Duk Ye
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    Yoo Jin Lee
    Gut and Liver.2021; 15(3): 325.     CrossRef
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    Shana Rakowsky, Adam S. Cheifetz, Konstantinos Papamichael
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  • 232 Download
  • 27 Web of Science
  • 27 Crossref
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Original Article
IBD
Usefulness of fecal calprotectin by monoclonal antibody testing in adult Japanese with inflammatory bowel diseases: a prospective multicenter study
Shiro Nakamura, Hirotsugu Imaeda, Hiroki Nishikawa, Masaki Iimuro, Minoru Matsuura, Hideo Oka, Junsuke Oku, Takako Miyazaki, Hirohito Honda, Kenji Watanabe, Hiroshi Nakase, Akira Andoh
Intest Res 2018;16(4):554-562.   Published online October 10, 2018
DOI: https://doi.org/10.5217/ir.2018.00027
AbstractAbstract PDFPubReaderePub
Background/Aims
Noninvasive objective monitoring is advantageous for optimizing treatment strategies in patients inflammatory bowel disease (IBD). Fecal calprotectin (FCP) is superior to traditional biomarkers in terms of assessing the activity in patients with IBD. However, there are the differences among several FCP assays in the dynamics of FCP. In this prospective multicenter trial, we investigated the usefulness of fecal FCP measurements in adult Japanese patients with IBD by reliable enzyme immunoassay using a monoclonal antibody.
Methods
We assessed the relationship between FCP levels and disease or endoscopic activity in patients with ulcerative colitis (UC, n=64) or Crohn’s disease (CD, n=46) compared with healthy controls (HCs, n=64).
Results
FCP levels in UC patients strongly correlated with the Disease Activity Index (rs=0.676, P<0.0001) and Mayo endoscopic subscore (MES; rs=0.677, P<0.0001). FCP levels were significantly higher even in patients with inactive UC or CD compared with HCs (P=0.0068, P<0.0001). The optimal cutoff value between MES 1 and 2 exhibited higher sensitivity (94.1%). FCP levels were significantly higher in active UC patients than in inactive patients (P<0.001), except those with proctitis. The Crohn’s Disease Activity Index tended to correlate with the FCP level (rs=0.283, P=0.0565).
Conclusions
Our testing method using a monoclonal antibody for FCP was well-validated and differentiated IBD patients from HCs. FCP may be a useful biomarker for objective assessment of disease activity in adult Japanese IBD patients, especially those with UC.

Citations

Citations to this article as recorded by  
  • Combining mechanistic modeling with machine learning as a strategy to predict inflammatory bowel disease clinical scores
    Jaehee V. Shim, Markus Rehberg, Britta Wagenhuber, Piet H. van der Graaf, Douglas W. Chung
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  • Clinical management for small bowel of Crohn’s disease in the treat-to-target era: now is the time to optimize treatment based on the dominant lesion
    Kenji Watanabe
    Intestinal Research.2020; 18(4): 347.     CrossRef
  • 7,903 View
  • 180 Download
  • 5 Web of Science
  • 4 Crossref
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Brief Communication
IBD
Effect of elemental diet combined with infliximab dose escalation in patients with Crohn's disease with loss of response to infliximab: CERISIER trial
Tadakazu Hisamatsu, Reiko Kunisaki, Shiro Nakamura, Tomoyuki Tsujikawa, Fumihito Hirai, Hiroshi Nakase, Kenji Watanabe, Kaoru Yokoyama, Masakazu Nagahori, Takanori Kanai, Makoto Naganuma, Hirofumi Michimae, Akira Andoh, Akihiro Yamada, Tadashi Yokoyama, Noriko Kamata, Shinji Tanaka, Yasuo Suzuki, Toshifumi Hibi, Mamoru Watanabe
Intest Res 2018;16(3):494-498.   Published online July 27, 2018
DOI: https://doi.org/10.5217/ir.2018.16.3.494
PDFSupplementary MaterialPubReaderePub

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
AbstractAbstract PDFPubReaderePub

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

Citations

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