Intestinal Research

Tadashi Yokoyama

3 Articles

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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Gastroenterología y Hepatología.2024; : 502201. CrossRef
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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
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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
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The Lancet Gastroenterology & Hepatology.2022; 7(7): 648. CrossRef
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Jongwook Yu, Soo Jung Park, Hyung Wook Kim, Yun Jeong Lim, Jihye Park, Jae Myung Cha, Byong Duk Ye, Tae Oh Kim, Hyun-Soo Kim, Hyun Seok Lee, Su Young Jung, Youngdoe Kim, Chang Hwan Choi
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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
Sheridan M. Hoy
Drugs & Therapy Perspectives.2021; 37(12): 563. 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
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
SSRN Electronic Journal .2021;[Epub] 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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Citations

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Prospective study of an adalimumab combined with partial enteral nutrition in the induction period of Crohn’s disease
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Role of diet in prevention versus treatment of Crohn’s disease and ulcerative colitis
Emma P Halmos, Lihi Godny, Julie Vanderstappen, Chen Sarbagili-Shabat, Vaios Svolos
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Immunoregulatory Effects of Elemental Diet and Its Ingredient, Tryptophan, via Activation of the Aryl Hydrocarbon Receptor in Mice
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Nutrients.2021; 13(1): 212. CrossRef
Evidence-based clinical practice guidelines for inflammatory bowel disease 2020
Hiroshi Nakase, Motoi Uchino, Shinichiro Shinzaki, Minoru Matsuura, Katsuyoshi Matsuoka, Taku Kobayashi, Masayuki Saruta, Fumihito Hirai, Keisuke Hata, Sakiko Hiraoka, Motohiro Esaki, Ken Sugimoto, Toshimitsu Fuji, Kenji Watanabe, Shiro Nakamura, Nagamu I
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Diet and nutrition in the management of inflammatory bowel disease
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Indian Journal of Gastroenterology.2021; 40(3): 253. CrossRef
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Teresa Di Chio, Christiane Sokollik, Diego G. Peroni, Lara Hart, Giacomo Simonetti, Franziska Righini-Grunder, Osvaldo Borrelli
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Gastroenterology Research and Practice.2020; 2020: 1. CrossRef
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Bases for the Adequate Development of Nutritional Recommendations for Patients with Inflammatory Bowel Disease
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Nutrients.2019; 11(5): 1062. CrossRef

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IBD

Comparison of efficacy of once daily multimatrix mesalazine 2.4 g/day and 4.8 g/day with other 5-aminosalicylic acid preparation in active ulcerative colitis: a randomized, double-blind study: Haruhiko Ogata, Tadashi Yokoyama, Seiichi Mizushima, Atsushi Hagino, Toshifumi Hibi; Intest Res 2018;16(2):255-266. Published online April 30, 2018; DOI: https://doi.org/10.5217/ir.2018.16.2.255

Abstract PDF Supplementary Material PubReader ePub

<b>Background/Aims</b><br/>

This study compared the efficacy of multimatrix mesalazine 2.4 g/day and 4.8 g/day with controlled-release mesalazine 2.25 g/day.

Methods

In this multicenter, randomized, double-blind study, 251 patients with mildly to moderately active ulcerative colitis received multimatrix mesalazine 2.4 g/day once daily (Multimatrix-2.4), 4.8 g/day once daily (Multimatrix-4.8), or controlled-release (time-dependent) mesalazine 2.25 g/day 3 times daily (Time-2.25) for 8 weeks. The primary efficacy endpoint was the change in the ulcerative colitis-disease activity index (UC-DAI) score.

Results

The mean change in the UC-DAI score and standard deviation in the per protocol set was −1.9±2.5 for Multimatrix-2.4 and −2.4±2.8 for Time-2.25. The difference between Multimatrix-2.4 and Time-2.25 was 0.3 (two-sided 95% confidence interval [CI], −0.5 to 1.1), thus non-inferiority was not demonstrated based on the pre-defined non-inferiority margin (1.0). In the full analysis set, the difference between Multimatrix-4.8 and Time-2.25 was −1.2 (two-sided 95% CI, −2.0 to −0.5), and the mean change in UC-DAI score in the FAS was −3.3 (two-sided 95% CI, −3.9 to −2.8) for Multimatrix-4.8 and −1.9 (two-sided 95% CI, −2.5 to −1.3) for Multimatrix-2.4, indicating that Multimatrix-4.8 was more effective than Time-2.25 and Multimatrix-2.4. There was no difference among the treatment groups in terms of safety.

Conclusions

This study showed that the efficacy of multimatrix mesalazine 2.4 g/day was comparable to controlled release mesalazine 2.25 g/day, although non-inferiority was not demonstrated. Importantly, this was the first study to indicate that multimatrix mesalazine 4.8 g/day was more effective than 2.4g/day with no associated safety concerns.

Citations

Citations to this article as recorded by

The gut wall’s potential as a partner for precision oncology in immune checkpoint treatment
Sara Hone Lopez, Mathilde Jalving, Rudolf S.N. Fehrmann, Wouter B. Nagengast, Elisabeth G.E. de Vries, Jacco J. de Haan
Cancer Treatment Reviews.2022; 107: 102406. CrossRef
Differential effects of mesalazine formulations on thiopurine metabolism through thiopurine S‐methyltransferase inhibition
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Journal of Gastroenterology and Hepatology.2021; 36(8): 2116. CrossRef
Efficacy of Oral, Topical, or Combined Oral and Topical 5-Aminosalicylates, in Ulcerative Colitis: Systematic Review and Network Meta-analysis
Brigida Barberio, Jonathan P Segal, M Nabil Quraishi, Christopher J Black, Edoardo V Savarino, Alexander C Ford
Journal of Crohn's and Colitis.2021; 15(7): 1184. CrossRef
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Journal of Gastroenterology.2021; 56(6): 489. CrossRef
Outcomes of a drug shortage requiring switching in patients with ulcerative colitis
Daniel R van Langenberg, Richard Kai-Yuan Cheng, Mayur Garg
World Journal of Gastrointestinal Pathophysiology.2020; 11(2): 32. CrossRef
Comparative assessment of budesonide‐MMX and mesalamine in active, mild‐to‐moderate ulcerative colitis: A systematic review and network meta‐analysis
Stefanos Bonovas, Georgios K. Nikolopoulos, Daniele Piovani, Marien González‐Lorenzo, Katerina Pantavou, Theodore Lytras, Laurent Peyrin‐Biroulet, Silvio Danese
British Journal of Clinical Pharmacology.2019; 85(10): 2244. CrossRef
Switching between Three Types of Mesalazine Formulation and Sulfasalazine in Patients with Active Ulcerative Colitis Who Have Already Received High-Dose Treatment with These Agents
Eriko Yasutomi, Sakiko Hiraoka, Shumpei Yamamoto, Shohei Oka, Mami Hirai, Yasushi Yamasaki, Toshihiro Inokuchi, Hideaki Kinugasa, Masahiro Takahara, Keita Harada, Jun Kato, Hiroyuki Okada
Journal of Clinical Medicine.2019; 8(12): 2109. CrossRef
Is once daily multimatrix mesalazine therapy effective regardless of the dose in patients with mild to moderate ulcerative colitis?
Seong Ran Jeon
Intestinal Research.2018; 16(2): 163. CrossRef

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