Intestinal Research

Original Articles

Factors affecting 1-year persistence with vedolizumab for ulcerative colitis: a multicenter, retrospective real-world study: Taku Kobayashi, Tadakazu Hisamatsu, Satoshi Motoya, Toshimitsu Fujii, Reiko Kunisaki, Tomoyoshi Shibuya, Minoru Matsuura, Ken Takeuchi, Sakiko Hiraoka, Hiroshi Yasuda, Kaoru Yokoyama, Noritaka Takatsu, Atsuo Maemoto, Toshiyuki Tahara, Keiichi Tominaga, Masaaki Shimada, Nobuaki Kuno, Jovelle L. Fernandez, Kaori Ishiguro, Mary Cavaliere, Hisato Deguchi, Toshifumi Hibi; Received May 1, 2024 Accepted October 5, 2024 Published online January 16, 2025; DOI: https://doi.org/10.5217/ir.2024.00063 [Epub ahead of print]

Abstract PDF Supplementary Material PubReader ePub: Background/Aims
The objectives of this real-world study were to determine 1-year persistence with vedolizumab in patients with ulcerative colitis and to evaluate factors contributing to loss of response.
Methods
In this multicenter, retrospective, observational chart review, patients with moderately to severely active ulcerative colitis who received ≥ 1 dose of vedolizumab in clinical practice at 16 tertiary hospitals in Japan (from December 2018 through February 2020) were enrolled.
Results
Persistence with vedolizumab was 64.5% (n = 370); the median follow-up time was 53.2 weeks. Discontinuation due to loss of response among initial clinical remitters was reported in 12.5% (35/281) of patients. Multivariate analysis showed that concomitant use of tacrolimus (odds ratio [OR], 2.76; 95% confidence interval [CI], 1.00–7.62; P= 0.050) and shorter disease duration (OR for median duration ≥ 7.8 years vs. < 7.8 years, 0.33; 95% CI, 0.13–0.82; P= 0.017) were associated with discontinuation due to loss of response. Loss of response was not associated with prior use of anti-tumor necrosis factor alpha therapy, age at the time of treatment, disease severity, or concomitant corticosteroids or immunomodulators. Of the 25 patients with disease duration < 1 year, 32.0% discontinued due to loss of response.
Conclusions
Persistence with vedolizumab was consistent with previous reports. Use of tacrolimus and shorter disease duration were the main predictors of decreased persistence.

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IBD

Effectiveness of administering zinc acetate hydrate to patients with inflammatory bowel disease and zinc deficiency: a retrospective observational two-center study: Kensuke Sakurai, Shigeru Furukawa, Takehiko Katsurada, Shinsuke Otagiri, Kana Yamanashi, Kazunori Nagashima, Reizo Onishi, Keiji Yagisawa, Haruto Nishimura, Takahiro Ito, Atsuo Maemoto, Naoya Sakamoto; Intest Res 2022;20(1):78-89. Published online January 22, 2021; DOI: https://doi.org/10.5217/ir.2020.00124

Abstract PDF Supplementary Material PubReader ePub

Background/Aims
Inflammatory bowel disease (IBD) patients frequently have zinc deficiency. IBD patients with zinc deficiency have higher risks of IBD-related hospitalization, complications, and requiring surgery. This study aimed to examine the effectiveness of zinc acetate hydrate (ZAH; Nobelzin) in IBD patients with zinc deficiency.
Methods
IBD patients with zinc deficiency who received ZAH from March 2017 to April 2020 were registered in this 2-center, retrospective, observational study. Changes in serum zinc levels and disease activity (Crohn’s Disease Activity Index [CDAI]) before and after ZAH administration were analyzed.
Results
Fifty-one patients with Crohn’s disease (CD, n = 40) or ulcerative colitis (UC, n = 11) were registered. Median serum zinc level and median CDAI scores significantly improved (55.5–91.0 μg/dL, P< 0.001; 171.5–129, P< 0.001, respectively) in CD patients 4 weeks after starting ZAH administration. Similarly, median serum zinc levels and CDAI scores significantly improved (57.0–81.0 μg/dL, P< 0.001; 177–148, P= 0.012, respectively) 20 weeks after starting ZAH administration. Similar investigations were conducted in groups where no treatment change, other than ZAH administration, was implemented; significant improvements were observed in both serum zinc level and CDAI scores. Median serum zinc levels in UC patients 4 weeks after starting ZAH administration significantly improved from 63.0 to 94.0 μg/dL (P= 0.002), but no significant changes in disease activity were observed. One patient experienced side effects of abdominal discomfort and nausea.
Conclusions
ZAH administration is effective in improving zinc deficiency and may contribute to improving disease activity in IBD.

Citations

Citations to this article as recorded by

Zinc and Inflammatory Bowel Disease: From Clinical Study to Animal Experiment
Xi Peng, Yingxiang Yang, Rao Zhong, Yuexuan Yang, Fang Yan, Na Liang, Shibin Yuan
Biological Trace Element Research.2025; 203(2): 624. CrossRef
The association between serum zinc level and clinical features in patients with inflammatory bowel disease
Tatsushi Omatsu, Tomohisa Takagi, Takeshi Yasuda, Yuki Nakahata, Sadanari Hayashi, Rieko Mukai, Takuya Kurobe, Yuriko Yasuda, Nobuhiro Fukuta, Naoyuki Sakamoto, Kazuhiko Uchiyama, Akihiro Obora, Yoshiki Murakami, Takao Kojima, Yuji Naito, Yoshito Itoh, No
Journal of Clinical Biochemistry and Nutrition.2025; 76(1): 50. CrossRef
Metal Dyshomeostasis as a Driver of Gut Pathology in Autism Spectrum Disorders
Katelyn O'Grady, Andreas M. Grabrucker
Journal of Neurochemistry.2025;[Epub] CrossRef
Dietary Zinc Ameliorates TNBS-Induced Colitis in Mice Associated with Regulation of Th1/Th2/Th17 Balance and NF-κB/NLRP3 Signaling Pathway
Changlin Wen, Jiayu Wang, Zhenhua Sun, Rao Zhong, Mengjie Li, Xuemei Shen, Qiaobo Ye, Kaihua Qin, Xi Peng
Biological Trace Element Research.2024; 202(2): 659. CrossRef
Nutritional Biomarkers for the Prediction of Response to Anti-TNF-α Therapy in Crohn’s Disease: New Tools for New Approaches
Fernando Rizzello, Ilaria Maria Saracino, Paolo Gionchetti, Maria Chiara Valerii, Chiara Ricci, Veronica Imbesi, Eleonora Filippone, Irene Bellocchio, Nikolas Konstantine Dussias, Thierry Dervieux, Enzo Spisni
Nutrients.2024; 16(2): 280. CrossRef
Zinc supplementation for dysgeusia in patients with unresectable pancreatic cancer
Yusuke Seiki, Kenji Ikezawa, Ko Watsuji, Makiko Urabe, Yugo Kai, Ryoji Takada, Takuo Yamai, Kaori Mukai, Tasuku Nakabori, Hiroyuki Uehara, Miki Ishibashi, Kazuyoshi Ohkawa
International Journal of Clinical Oncology.2024; 29(8): 1173. CrossRef
Role of Combination Treatment of Aspirin and Zinc in DMH-DSS-induced Colon Inflammation, Oxidative Stress and Tumour Progression in Male BALB/c Mice
Singothu Siva Nagendra Babu, Shivani Singla, Gopabandhu Jena
Biological Trace Element Research.2023; 201(3): 1327. CrossRef
Retrospective study on the therapeutic efficacy of zinc acetate hydrate administration to patients with hypozincemia-induced dysgeusia
Tomoaki Shintani, Kouji Ohta, Toshinori Ando, Yasutaka Hayashido, Souichi Yanamoto, Mikihito Kajiya, Hideki Shiba
BMC Oral Health.2023;[Epub] CrossRef
Nutrition, Nutritional Status, Micronutrients Deficiency, and Disease Course of Inflammatory Bowel Disease
Marco Valvano, Annalisa Capannolo, Nicola Cesaro, Gianpiero Stefanelli, Stefano Fabiani, Sara Frassino, Sabrina Monaco, Marco Magistroni, Angelo Viscido, Giovanni Latella
Nutrients.2023; 15(17): 3824. CrossRef
Prevalence of Zinc Deficiency in Inflammatory Bowel Disease: A Systematic Review and Meta-Analysis
Roberta Zupo, Annamaria Sila, Fabio Castellana, Roberto Bringiotti, Margherita Curlo, Giovanni De Pergola, Sara De Nucci, Gianluigi Giannelli, Mauro Mastronardi, Rodolfo Sardone
Nutrients.2022; 14(19): 4052. CrossRef

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Inflammatory bowel diseases

Efficacy and safety of abrilumab, an α4β7 integrin inhibitor, in Japanese patients with moderate-to-severe ulcerative colitis: a phase II study: Toshifumi Hibi, Satoshi Motoya, Toshifumi Ashida, Souken Sai, Yukinori Sameshima, Shiro Nakamura, Atsuo Maemoto, Masahiro Nii, Barbara A Sullivan, Robert A. Gasser Jr, Yasuo Suzuki; Intest Res 2019;17(3):375-386. Published online February 12, 2019; DOI: https://doi.org/10.5217/ir.2018.00141

Abstract PDF PubReader ePub

Background/Aims
Inhibition of α4β7 integrin has been shown to be effective for induction and maintenance therapy in patients with ulcerative colitis (UC). We investigated the effects of varying doses of the α4β7 inhibitor abrilumab in Japanese patients with moderate-to-severe UC despite conventional treatments.
Methods
In this randomized, double-blind, placebocontrolled study, 45 UC patients were randomized to abrilumab 21 mg (n=11), 70 mg (n=12), 210 mg (n=9), or placebo (n=13) via subcutaneous (SC) injection for 12 weeks. The double-blind period was followed by a 36-week open-label period, in which all patients received abrilumab 210 mg SC every 12 weeks, and a 28-week safety follow-up period. The primary efficacy variable was clinical remission at week 8 (total Mayo score ≤2 points with no individual subscore >1 point).
Results
Clinical remission at week 8 was 4 out of 31 (12.9%) overall in the abrilumab groups versus 0 out of 13 in the placebo group (abrilumab 21 mg, 1/10 [10.0%]; 70 mg, 2/12 [16.7%]; 210 mg, 1/9 [11.1%]). In both the double-blind and open-label periods, fewer patients in the abrilumab groups experienced ≥1 adverse event compared with those in the placebo group. There were no cases of progressive multifocal leukoencephalopathy and no deaths.
Conclusions
Abrilumab 70 mg and 210 mg yielded numerically better results in terms of clinical remission rate at Week 8 than placebo, with the 210 mg dose showing more consistent treatment effects. Abrilumab was well tolerated in Japanese patients with UC.

Citations

Citations to this article as recorded by

Paradigm Shift in Inflammatory Bowel Disease Management: Precision Medicine, Artificial Intelligence, and Emerging Therapies
Antonio M. Caballero Mateos, Guillermo A. Cañadas de la Fuente, Beatriz Gros
Journal of Clinical Medicine.2025; 14(5): 1536. CrossRef
Biosimilars versus biological therapy in inflammatory bowel disease: challenges and targeting strategies using drug delivery systems
Ahmed Aljabri, Ghareb M. Soliman, Yasmin N. Ramadan, Mohammed A. Medhat, Helal F. Hetta
Clinical and Experimental Medicine.2025;[Epub] CrossRef
Drug-Induced Progressive Multifocal Leukoencephalopathy (PML): A Systematic Review and Meta-Analysis
Lorenzo Vittorio Rindi, Drieda Zaçe, Neva Braccialarghe, Barbara Massa, Virginia Barchi, Roberta Iannazzo, Ilenia Fato, Francesco De Maria, Dimitra Kontogiannis, Vincenzo Malagnino, Loredana Sarmati, Marco Iannetta
Drug Safety.2024; 47(4): 333. CrossRef
Targeting integrin pathways: mechanisms and advances in therapy
Xiaocong Pang, Xu He, Zhiwei Qiu, Hanxu Zhang, Ran Xie, Zhiyan Liu, Yanlun Gu, Nan Zhao, Qian Xiang, Yimin Cui
Signal Transduction and Targeted Therapy.2023;[Epub] CrossRef
Emerging drugs for the treatment of moderately to severely active ulcerative colitis: review of phase II and III clinical trials
Laura Neurath, Ferdinando D’Amico, Silvio Danese
Expert Opinion on Emerging Drugs.2023; 28(1): 27. CrossRef
Inflammatory Bowel Disease: Emerging Therapies and Future Treatment Strategies
Elisabetta Bretto, Davide Giuseppe Ribaldone, Gian Paolo Caviglia, Giorgio Maria Saracco, Elisabetta Bugianesi, Simone Frara
Biomedicines.2023; 11(8): 2249. CrossRef
Integrin signaling in cancer: bidirectional mechanisms and therapeutic opportunities
Siyi Li, Chibuzo Sampson, Changhao Liu, Hai-long Piao, Hong-Xu Liu
Cell Communication and Signaling.2023;[Epub] CrossRef
Immunology of Inflammatory Bowel Disease: Molecular Mechanisms and Therapeutics
Quan Lu, Mei-feng Yang, Yu-jie Liang, Jing Xu, Hao-ming Xu, Yu-qiang Nie, Li-sheng Wang, Jun Yao, De-feng Li
Journal of Inflammation Research.2022; Volume 15: 1825. CrossRef
Factors predicting clinical and endoscopic remission with placebo therapy in East Asian patients with ulcerative colitis: a systematic review and meta-analysis
Jian Zeng, Zhong Wang, Xiao-Jun Yang
European Journal of Clinical Pharmacology.2022; 78(7): 1069. CrossRef
Tackling Inflammatory Bowel Diseases: Targeting Proinflammatory Cytokines and Lymphocyte Homing
Yijie Song, Man Yuan, Yu Xu, Hongxi Xu
Pharmaceuticals.2022; 15(9): 1080. 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
Anti-Integrins for the Treatment of Inflammatory Bowel Disease: Current Evidence and Perspectives
John Gubatan, Kian Keyashian, Samuel JS Rubin, Jenny Wang, Cyrus Buckman, Sidhartha Sinha
Clinical and Experimental Gastroenterology.2021; Volume 14: 333. 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
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
Intestinal Research.2021; 19(4): 448. 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
Subcutaneous integrin inhibitors may provide more treatment options for patients with moderate-to-severe ulcerative colitis
Hyuk Yoon
Intestinal Research.2019; 17(3): 283. CrossRef

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