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9 "Masakazu Nagahori"
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Original Articles
Lifestyle restrictions are associated with impaired quality of life but not reduction in relapse in ulcerative colitis
Hajime Yamazaki, Masakazu Nagahori, Tadakazu Hisamatsu, Taku Kobayashi, Teppei Omori, Jimmy K. Limdi, John T. McLaughlin, Shu-Chen Wei, Jovelle Fernandez, Shunichi Fukuhara, Katsuyoshi Matsuoka
Received November 29, 2024  Accepted March 18, 2025  Published online May 14, 2025  
DOI: https://doi.org/10.5217/ir.2024.00199    [Epub ahead of print]
AbstractAbstract PDFSupplementary MaterialPubReaderePub
Background/Aims
Patients with ulcerative colitis (UC) in remission commonly restrict thir lifestyle to prevent relapse; however, the effectiveness and impact on quality of life (QOL) is unclear. This study investigated whether lifestyle restrictions are associated with relapse reduction and assessed their impact on QOL.
Methods
This multicenter, prospective cohort study was conducted in Japan (2018–2021) via the YOURS registry, enrolling patients with UC in clinical remission. Patients were followed for 2 years. A baseline questionnaire evaluated lifestyle restrictions in diet, work/study/housework, and physical exercise. QOL was assessed by Disease Impact Scale every 3 months during the first year of follow-up. Associations of lifestyle restrictions with relapse and QOL were assessed by Cox regression analysis and linear mixed-effects models, respectively.
Results
Among 911 patients in clinical remission for > 90 days, 63% had adopted dietary avoidance; 47%, work/study/housework avoidance; and 8%, physical exercise avoidance. Overall, 216 patients relapsed. Lifestyle restrictions were not associated with reduced risk of relapse (multivariableadjusted hazard ratios [95% confidence interval]: dietary avoidance, 1.08 [0.81–1.44]; and work/study/housework avoidance, 1.14 [0.87–1.50]); physical exercise avoidance was associated with increased relapse (multivariable-adjusted hazard ratio, 1.58; 95% confidence interval, 1.02–2.44). All lifestyle restrictions were associated with impaired QOL (P <0.01).
Conclusions
Lifestyle restrictions were not associated with relapse reduction in patients with UC; however, they were associated with impaired QOL. Clinicians should engage in evidence-based discussions with patients with UC in remission regarding lifestyle restrictions (UMIN Clinical Trials Registry; UMIN000031995).
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Comparative short-term efficacy of upadacitinib versus tofacitinib for ulcerative colitis: a 24-week real-world study in Japan
Akiko Tamura, Hiromichi Shimizu, Toshimitsu Fujii, Ami Kawamoto, Ryo Morikawa, Shuji Hibiya, Kento Takenaka, Masakazu Nagahori, Kazuo Ohtsuka, Ryuichi Okamoto
Received November 14, 2024  Accepted February 10, 2025  Published online March 20, 2025  
DOI: https://doi.org/10.5217/ir.2024.00187    [Epub ahead of print]
AbstractAbstract PDFSupplementary MaterialPubReaderePub
Background/Aims
Tofacitinib and upadacitinib are small-molecule compounds that inhibit the Janus kinase pathway for the treatment of refractory ulcerative colitis. Only a few reports have compared the efficacy and safety of these 2 drugs in real-world practice. We aimed to show our real-world evidence of these drugs and compare the efficacy and safety profiles in the treatment of ulcerative colitis.
Methods
This study is a single-center retrospective analysis. Patients treated with tofacitinib or upadacitinib at our hospital between June 2018 and January 2024 who were monitored for 24 weeks were included. The primary outcome was steroid-free clinical remission at 24 weeks. Secondary outcomes were response and remission rates at each time point, time series changes in partial Mayo scores and laboratory results, treatment survival at 24 weeks, and the incidence of adverse events.
Results
A total of 68 patients treated with tofacitinib and 34 patients treated with upadacitinib were included. Steroid-free clinical remission rate at 24 weeks was significantly higher in upadacitinib-treated patients than in tofacitinibtreated patients (64.7% vs. 38.2%). The response rates in upadacitinib-treated patients exceeded 60% after 8 weeks of treatment through to 24 weeks, and the rates were higher than those in tofacitinib-treated patients. The incidences of adverse events were 79.4% in upadacitinib-treated patients and 38.2% in tofacitinib-treated patients. The most common adverse event was acne for upadacitinib.
Conclusions
Upadacitinib was more effective than tofacitinib in inducing remission in ulcerative colitis patients. The incidence of adverse events was significantly higher with upadacitinib than tofacitinib.
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IBD
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
Intest Res 2024;22(3):369-377.   Published online July 16, 2024
DOI: https://doi.org/10.5217/ir.2023.00194
AbstractAbstract PDFSupplementary MaterialPubReaderePub
Background/Aims
The efficacy and safety of tofacitinib for the treatment of refractory ulcerative colitis (UC) has been demonstrated in clinical trials. Although, a series of reports with real-world evidence of its short-term efficacy and safety profiles have already been published, reports of long-term real-world data have been limited. We aimed to show our 3-year evidence on the clinical use of tofacitinib for the treatment of UC, focusing on its efficacy and safety profiles.
Methods
A retrospective observational study was conducted on patients who started tofacitinib for active refractory UC at our hospital. The primary outcome was the retention rate until 156 weeks after initiating tofacitinib. The secondary outcomes were short-term efficacy at 4, 8, and 12 weeks; long-term efficacy at 52, 104, and 156 weeks; prognostic factors related to the cumulative retention rate; loss of response; and safety profile, including adverse events.
Results
Forty-six patients who were able to be monitored for up to 156 weeks after tofacitinib initiation, were enrolled in this study. Continuation of tofacitinib was possible until 156 weeks in 54.3%, with > 50% response rates and > 40% remission rates. Among patients in whom response or remission was achieved and tofacitinib was deescalated after 8 weeks of induction treatment, 54.3% experienced relapse but were successfully rescued by and retained on reinduction treatment, except for 1 patient. No serious AEs were observed in the study.
Conclusions
Tofacitinib is effective and safe as long-term treatment in a refractory cohort of UC patients in real-world clinical practice.

Citations

Citations to this article as recorded by  
  • In which patients with ulcerative colitis would filgotinib be effective?
    Jihye Park
    Intestinal Research.2025; 23(1): 1.     CrossRef
  • Tofacitinib for ulcerative colitis in Brazil: a multicenter observational study on effectiveness and safety
    Rogério Serafim Parra, Renata de Sá Brito Fróes, Daniela Oliveira Magro, Sandro da Costa Ferreira, Munique Kurtz de Mello, Matheus Freitas Cardoso de Azevedo, Aderson Omar Mourão Cintra Damião, Alexandre de Sousa Carlos, Luísa Leite Barros, Maria Luiza Qu
    BMC Gastroenterology.2025;[Epub]     CrossRef
  • State-of-the-Art Evidence for Clinical Outcomes and Therapeutic Implications of Janus Kinase Inhibitors in Moderate-to-Severe Ulcerative Colitis: A Narrative Review
    Yunseok Choi, Suhyun Lee, Hyeon Ji Kim, Taemin Park, Won Gun Kwack, Seungwon Yang, Eun Kyoung Chung
    Pharmaceuticals.2025; 18(5): 740.     CrossRef
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  • 4 Web of Science
  • 3 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
AbstractAbstract PDFSupplementary MaterialPubReaderePub
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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  • Evaluation of the transition from intravenous to subcutaneous vedolizumab in patients with inflammatory bowel disease
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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
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  • 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
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  • Microbial changes in stool, saliva, serum, and urine before and after anti-TNF-α therapy in patients with inflammatory bowel diseases
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  • Inflammatory Bowel Disease Patients’ Acceptance for Switching from Intravenous Infliximab or Vedolizumab to Subcutaneous Formulation: The Nancy Experience
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    Journal of Clinical Medicine.2022; 11(24): 7296.     CrossRef
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Brief Communications
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
PDFSupplementary MaterialPubReaderePub

Citations

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  • 255 Download
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  • 16 Crossref
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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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    Shinji Okabayashi, Taku Kobayashi, Toshifumi Hibi
    Journal of the Anus, Rectum and Colon.2020; 4(1): 1.     CrossRef
  • Exclusive enteral nutrition for induction of remission in anti-tumor necrosis factor refractory adult Crohn’s disease: the Indian experience
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    Tadakazu Hisamatsu
    Intestinal Research.2020; 18(2): 139.     CrossRef
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    Jun Miyoshi, Daisuke Saito, Mio Nakamura, Miki Miura, Tatsuya Mitsui, Toru Kudo, Shinnosuke Murakami, Minoru Matsuura, Tadakazu Hisamatsu
    Gastroenterology Research and Practice.2020; 2020: 1.     CrossRef
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    Nutrients.2019; 11(5): 1062.     CrossRef
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Statement
IBD
Predicting outcomes to optimize disease management in inflammatory bowel disease in Japan: their differences and similarities to Western countries
Taku Kobayashi, Tadakazu Hisamatsu, Yasuo Suzuki, Haruhiko Ogata, Akira Andoh, Toshimitsu Araki, Ryota Hokari, Hideki Iijima, Hiroki Ikeuchi, Yoh Ishiguro, Shingo Kato, Reiko Kunisaki, Takayuki Matsumoto, Satoshi Motoya, Masakazu Nagahori, Shiro Nakamura, Hiroshi Nakase, Tomoyuki Tsujikawa, Makoto Sasaki, Kaoru Yokoyama, Naoki Yoshimura, Kenji Watanabe, Miiko Katafuchi, Mamoru Watanabe, Toshifumi Hibi
Intest Res 2018;16(2):168-177.   Published online April 30, 2018
DOI: https://doi.org/10.5217/ir.2018.16.2.168
AbstractAbstract PDFPubReaderePub

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

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Reviews
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
AbstractAbstract PDFPubReader

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
AbstractAbstract 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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