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6 "Atsuo Maemoto"
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Original Articles
Colitis-associated colorectal neoplasia in ulcerative colitis with primary sclerosing cholangitis: a nationwide study
Koichi Komatsu, Takahide Shinagawa, Motoi Uchino, Hiroki Ikeuchi, Koji Okabayashi, Shiro Oka, Kitaro Futami, Michio Itabashi, Kazuhiro Watanabe, Masatsune Shibutani, Yoshiki Okita, Toshifumi Wakai, Yusuke Mizuuchi, Kinya Okamoto, Kazutaka Yamada, Yu Sato, Takayuki Ogino, Hideaki Kimura, Kenichi Takahashi, Koya Hida, Yusuke Kinugasa, Fumio Ishida, Junji Okuda, Koji Daito, Takayuki Yamamoto, Seiichiro Yamamoto, Fumikazu Koyama, Tsunekazu Hanai, Koji Komori, Dai Shida, Junya Arakaki, Yoshito Akagi, Shigeki Yamaguchi, Hideki Ueno, Keiji Matsuda, Atsuo Maemoto, Riichiro Nezu, Shin Sasaki, Eiji Sunami, Tatsuki Noguchi, Kenichi Sugihara, Yoichi Ajioka, Soichiro Ishihara, the Study Group for Inflammatory Bowel Disease Associated Intestinal Cancers by the Japanese Society for Cancer of the Colon and Rectum
Received July 14, 2025  Accepted September 21, 2025  Published online February 12, 2026  
DOI: https://doi.org/10.5217/ir.2025.00133    [Epub ahead of print]
AbstractAbstract PDFSupplementary MaterialPubReaderePub
Background/Aims
Ulcerative colitis (UC)-associated colorectal neoplasia (UCAN) in patients with UC and primary sclerosing cholangitis (PSC) has not been studied well in Japan. This retrospective study examined the clinicopathological features and prognosis of UCAN in patients with PSC-UC.
Methods
A total of 808 patients with UCAN were enrolled from 1983 to 2020 and categorized into PSC (PSC-UCAN, n = 26) and no PSC (UCAN-alone, n = 782) groups. Clinicopathological features were compared between the 2 groups, and the 10-year overall survival (OS) and cancer-specific survival (CSS) were analyzed.
Results
The PSC-UCAN group had a shorter UC duration before UCAN diagnosis (12.8 years vs. 16.9 years, P= 0.044), were younger at UCAN diagnosis (47.8 years vs. 53.3 years, P= 0.046), and developed UCAN more frequently in the right-sided colon (34.6% vs. 15.9%, P= 0.028) than the UCAN-alone group. The PSC-UCAN group showed a trend toward a lower proportion of high-grade dysplasia (19.2% vs. 30.7%) and a higher proportion of early-stage cancers (53.9% vs. 31.2%). The 10-year OS (64.6% vs. 79.3%, P=0.080) and CSS (80.8% vs. 83.9%, P=0.60) were comparable.
Conclusions
Patients with PSC-UCAN showed earlier and younger development of UCAN than patients with only UCAN, with a high prevalence in the right-sided colon. Early-stage cancer was more frequently observed in the PSC-UCAN group, despite the shorter duration of UC. Patients with PSC-UC probably benefit from early initiation of surveillance colonoscopy.
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Week 2 remission with vedolizumab as a predictor of long-term remission in patients with ulcerative colitis: a multicenter, retrospective, observational 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, Mary Cavaliere, Kaori Ishiguro, Jovelle L Fernandez, Toshifumi Hibi
Received April 9, 2024  Accepted April 6, 2025  Published online July 14, 2025  
DOI: https://doi.org/10.5217/ir.2025.00047    [Epub ahead of print]
AbstractAbstract PDFSupplementary MaterialPubReaderePub
Background/Aims
Vedolizumab (VDZ), a gut-selective monoclonal antibody for ulcerative colitis (UC) treatment, has no established biomarkers or clinical features that predict long-term remission. Week 2 remission, a potential predictor of long-term remission, could inform maintenance treatment strategy.
Methods
This retrospective, observational chart review included patients with UC in Japan who initiated VDZ between December 2018 and February 2020. Outcome measures included 14- and 54-week remission rates in patients with week 2 and non-week 2 remission (remission by week 14), 54-week remission rates in patients with week 14 remission and primary nonresponse, and predictive factors of week 2 and week 54 remission (logistic regression).
Results
Overall, 332 patients with UC (176 biologic-naïve and 156 biologic-non-naïve) were included. Significantly more biologic-naïve than biologic-non-naïve patients achieved week 2 remission (36.9% vs. 28.2%; odds ratio [OR], 1.43; 95% confidence interval [CI], 1.05–1.94; P= 0.0224). Week 54 remission rates were significantly different between week 14 remission and primary nonresponse (both groups: P< 0.0001), and between week 2 and non-week 2 remission (all patients: OR, 2.41; 95% CI, 1.30–4.48; P= 0.0052; biologic-naïve patients: OR, 2.40; 95% CI, 1.10–5.24; P= 0.0280). Week 2 remission predictors were male sex, no anti-tumor necrosis factor alpha exposure, and normal/mild endoscopic findings. Week 54 remission was significantly associated with week 2 remission and no tacrolimus use.
Conclusions
Week 2 remission with VDZ is a predictor of week 54 remission in patients with UC. Week 2 may be used as an evaluation point for UC treatment decisions. (Japanese Registry of Clinical Trials: jRCT-1080225363)

Citations

Citations to this article as recorded by  
  • Interpreting vedolizumab persistence: lessons from real-world trajectories in ulcerative colitis
    Jung Min Moon
    Intestinal Research.2026; 24(1): 3.     CrossRef
  • 5,663 View
  • 628 Download
  • 1 Crossref
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The duration of prior anti-tumor necrosis factor agents is associated with the effectiveness of vedolizumab in patients with ulcerative colitis: a real-world multicenter retrospective study
Taku Kobayashi, Tadakazu Hisamatsu, Satoshi Motoya, Minoru Matsuura, Toshimitsu Fujii, Reiko Kunisaki, Tomoyoshi Shibuya, Ken Takeuchi, Sakiko Hiraoka, Hiroshi Yasuda, Kaoru Yokoyama, Noritaka Takatsu, Atsuo Maemoto, Toshiyuki Tahara, Keiichi Tominaga, Masaaki Shimada, Nobuaki Kuno, Mary Cavaliere, Kaori Ishiguro, Jovelle L Fernandez, Toshifumi Hibi
Received August 9, 2024  Accepted March 20, 2025  Published online June 4, 2025  
DOI: https://doi.org/10.5217/ir.2024.00126    [Epub ahead of print]
AbstractAbstract PDFSupplementary MaterialPubReaderePub
Background/Aims
Previous literature suggests that the response of patients with ulcerative colitis to vedolizumab may be affected by previous biologic therapy exposure. This real-world study evaluated vedolizumab treatment effectiveness in biologicnon-naïve patients.
Methods
This was a multicenter, retrospective, observational chart review of records from 16 hospitals in Japan (December 1, 2018, to February 29, 2020). Included patients who had ulcerative colitis, were aged ≥ 20 years, and received at least 1 dose of vedolizumab. Outcomes included clinical remission rates from weeks 2 to 54 according to prior biologic exposure status and factors associated with clinical remission up to week 54.
Results
A total of 370 eligible patients were included. Clinical remission rates were significantly higher in biologic-naïve (n=197) than in biologic-non-naïve (n=173) patients for weeks 2 to 54 of vedolizumab treatment. Higher clinical remission rates up to week 54 were significantly associated with lower disease severity (partial Mayo score ≤ 4, P= 0.001; albumin ≥ 3.0, P= 0.019) and the duration of prior anti-tumor necrosis factor α (anti-TNFα) therapy (P= 0.026). Patients with anti-TNFα therapy durations of < 3 months, 3 to < 12 months, and ≥ 12 months had clinical remission rates of 28.1%, 32.7%, and 60.0%, respectively (P= 0.001 across groups).
Conclusions
The effectiveness of vedolizumab in biologic-non-naïve patients was significantly influenced by duration of prior anti-TNFα therapy. (Japanese Registry of Clinical Trials: jRCT-1080225363)

Citations

Citations to this article as recorded by  
  • Interpreting vedolizumab persistence: lessons from real-world trajectories in ulcerative colitis
    Jung Min Moon
    Intestinal Research.2026; 24(1): 3.     CrossRef
  • Long-Term Outcomes and Prognostic Factors for Vedolizumab-Treated Japanese Patients with Ulcerative Colitis
    Shinya Fukushima, Takehiko Katsurada, Takahiro Ito, Atsuo Maemoto, Fumika Orii, Toshifumi Ashida, Masanao Nasuno, Hiroki Tanaka, Katsuyoshi Ando, Mikihiro Fujiya, Yoshihiro Yokoyama, Satoshi Motoya, Hiroshi Nakase
    Inflammatory Intestinal Diseases.2025; 11(1): 1.     CrossRef
  • 4,689 View
  • 746 Download
  • 1 Web of Science
  • 2 Crossref
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IBD
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
Intest Res 2026;24(1):64-75.   Published online January 16, 2025
DOI: https://doi.org/10.5217/ir.2024.00063
AbstractAbstract PDFSupplementary MaterialPubReaderePub
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.

Citations

Citations to this article as recorded by  
  • Interpreting vedolizumab persistence: lessons from real-world trajectories in ulcerative colitis
    Jung Min Moon
    Intestinal Research.2026; 24(1): 3.     CrossRef
  • Real‐World Effectiveness and Safety of Vedolizumab in Patients ≥ 70 Versus < 70 Years With Ulcerative Colitis: Multicenter Retrospective Study
    Tadakazu Hisamatsu, Taku Kobayashi, Satoshi Motoya, Toshimitsu Fujii, Reiko Kunisaki, Tomoyoshi Shibuya, Minoru Matsuura, Sakiko Hiraoka, Ken Takeuchi, Hiroshi Yasuda, Kaoru Yokoyama, Noritaka Takatsu, Atsuo Maemoto, Toshiyuki Tahara, Keiichi Tominaga, Ma
    Journal of Gastroenterology and Hepatology.2025; 40(6): 1435.     CrossRef
  • Increasing age at diagnosis raises malignancy risk and aminosalicylate intolerance influences therapeutic strategies in ulcerative colitis: a multicenter I‑BRITE cohort study
    Shintaro Akiyama, Yuka Ito, Mamiko Shiroyama, Satoshi Suzuki, Masanori Ochi, Toshiro Kamoshida, Hiroshi Kashimura, Junichi Iwamoto, Rie Saito, Tsuyoshi Kaneko, Kazuto Ikezawa, Yoshinori Hiroshima, Junji Hattori, Takashi Mamiya, Satoshi Fukuda, Kazuho Iked
    Journal of Gastroenterology.2025; 60(10): 1259.     CrossRef
  • Mayo Endoscopic Subscore at Week 24 Is a Predictor of Future Loss of Response to Vedolizumab in Patients with Ulcerative Colitis in Clinical Remission
    Daisuke Saito, Minoru Matsuura, Hiromu Morikubo, Noritaka Hibi, Haruka Komatsu, Noriaki Oguri, Takeshi Fujima, Haruka Wada, Ryota Ogihara, Tatsuya Mitsui, Mari Hayashida, Jun Miyoshi, Teppei Omori, Tadakazu Hisamatsu
    Inflammatory Intestinal Diseases.2025; 10(1): 387.     CrossRef
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  • 4 Crossref
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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
AbstractAbstract PDFSupplementary MaterialPubReaderePub
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 Deficiency Among Patients With Inflammatory Bowel Disease: A Systematic Review and Meta-Analysis
    Rahman Hameed Mohammed Abdul , Nafisa Reyaz, Abebe Yigzaw, Bilal Asad Mohammed, Helai Hussaini, Adil Amin, Mohammed Qasim Rauf, Neelum Ali
    Cureus.2026;[Epub]     CrossRef
  • 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
  • Nano Zinc Oxide Restores Gut Barrier Integrity and Modulates Microbiota to Mitigate TNBS-Induced Colitis in Mice
    Zhengqiang Yu, Yi Qiu, Yingxiang Yang, Changlin Wen, Shiyuan Huang, Tao Liu, Rao Zhong, Xi Peng
    Biological Trace Element Research.2025; 203(12): 6213.     CrossRef
  • Clinical Significance of Marginal Zinc Deficiency as a Predictor of Covert Hepatic Encephalopathy in Patients with Liver Cirrhosis
    Takuya Matsuda, Tadashi Namisaki, Akihiko Shibamoto, Shohei Asada, Fumimasa Tomooka, Takahiro Kubo, Aritoshi Koizumi, Misako Tanaka, Satoshi Iwai, Takashi Inoue, Yuki Tsuji, Yukihisa Fujinaga, Norihisa Nishimura, Shinya Sato, Koh Kitagawa, Kosuke Kaji, Ak
    International Journal of Molecular Sciences.2025; 26(9): 4184.     CrossRef
  • Micronutrient Deficiencies in Pediatric IBD: How Often, Why, and What to Do?
    Tiziana Galeazzi, Sara Quattrini, Elena Lionetti, Simona Gatti
    Nutrients.2025; 17(9): 1425.     CrossRef
  • Investigation of competitive binding of the essential trace elements zinc, iron, copper, and manganese by gastrointestinal mucins and the effect on their absorption in vitro
    Maria Maares, Vincent Einhorn, Jacqueline Behrendt, Matthias Marczynski, Christoph Schüßler, Oliver Lieleg, Hajo Haase
    The Journal of Nutritional Biochemistry.2025; 144: 109983.     CrossRef
  • Roles of zinc and zinc transporters in development, progression, and treatment of inflammatory bowel disease (IBD)
    S. B. Mitchell, T. B. Aydemir
    Frontiers in Nutrition.2025;[Epub]     CrossRef
  • Prevalence and Impact of Zinc Deficiency on Clinical Outcomes in Inflammatory Bowel Disease
    Hend Almuhaya, Raghad Alsalamah, Asma Sallam, Amgad Alonazy, Atheer AlAwwad, Gamal Mohamed, Abdulelah Almutairdi, Mashary Attamimi, Badr Al-Bawardy
    Nutrients.2025; 17(21): 3378.     CrossRef
  • The role of dietary factors in the prevention and management of inflammatory bowel disease: a comprehensive review
    Elyas Nattagh-Eshtivani, Hanieh Barghchi, Amir Hossein Mansouri, Pegah Rahbarinejd, Amin Mokari-Yamchi, Mehdi Barati, Mohammad Rashidmyvan, Ali Jafazadeh Esfehani, Alireza Mohammadzadeh, Zachry Clyton, Parisa Marabi, Saeedeh Talebi, Naseh Pahlavani
    Nutrition & Metabolism.2025;[Epub]     CrossRef
  • The Aging Gut–Brain Axis: Effects of Dietary Polyphenols and Metal Exposure
    Luqi Cao, Saurabh Kumar Jha, Neha Gupta, Xiang Chen, Renuka Soni, Luoxi Yuan, Rashi Srivastava, Zhe‐Sheng Chen
    Chronic Diseases and Translational Medicine.2025; 11(4): 251.     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
  • 12,277 View
  • 513 Download
  • 17 Web of Science
  • 19 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
AbstractAbstract PDFPubReaderePub
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  
  • Development of New Molecularly Targeted Agents in Inflammatory Bowel Disease
    Hiroshi Nakase
    Internal Medicine.2026; 65(2): 214.     CrossRef
  • Advancing therapeutic frontiers: a pipeline of novel drugs for UC management
    Luisa Bertin, Alessandro Massano, Carlo Redavid, Marco Scarpa, Cesare Ruffolo, Imerio Angriman, Andrea Buda, Fabiana Zingone, Brigida Barberio, Edoardo Vincenzo Savarino
    Frontiers in Gastroenterology.2026;[Epub]     CrossRef
  • 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
  • Vedolizumab: Beyond Inflammatory Bowel Disease
    Yafang Li, Minli Hu, Yuan Chen, Xiao-Yun Yang, Qunying Wang, Jin Ding, Yibing Hu
    Medical Principles and Practice.2025; 34(5): 405.     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
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