Skip Navigation
Skip to contents

Intest Res : Intestinal Research

IMPACT FACTOR

Author index

Page Path
HOME > Browse articles > Author index
Search
Christopher Gasink 1 Article
Efficacy and safety of ustekinumab in Japanese patients with moderately to severely active Crohn's disease: a subpopulation analysis of phase 3 induction and maintenance studies
Toshifumi Hibi, Yuya Imai, Yoko Murata, Nobuko Matsushima, Richuan Zheng, Christopher Gasink
Intest Res 2017;15(4):475-486.   Published online October 23, 2017
DOI: https://doi.org/10.5217/ir.2017.15.4.475
AbstractAbstract PDFSupplementary MaterialPubReaderePub
<b>Background/Aims</b><br/>

Efficacy and safety of ustekinumab were evaluated in a Japanese subpopulation with moderately to severely active Crohn's disease (CD) in UNITI-1, UNITI-2 and IM-UNITI studies and results were compared with the overall population.

Methods

Overall, patients in UNITI-1 (Japan, n=56; failed response to tumor necrosis factor antagonist) and UNITI-2 (Japan, n=26; failed response to prior conventional therapy) were randomized to placebo or ustekinumab intravenous induction (130 mg or ~6 mg/kg) at week 0. Responders to ustekinumab induction therapy (Japan, n=21) were randomized to placebo or ustekinumab (90 mg, subcutaneous) maintenance (every 12 weeks [q12w] or 8 weeks [q8w]) in IM-UNITI. The primary endpoint was clinical response at week 6 for induction studies and clinical remission at week 44 for maintenance study.

Results

Percentage of patients achieving clinical response at week 6 was greater in ustekinumab 130 mg and ~6 mg/kg groups than in the placebo group (UNITI-1: 36.8% and 31.6% vs. 27.8%, respectively, for Japanese; 34.3% and 33.7% vs. 21.5%, respectively, for overall; UNITI-2: 37.5% and 55.6% vs. 11.1%, respectively, for Japanese; 51.7% and 55.5% vs. 28.7%, respectively, for overall). Clinical remission rate at week 44 during maintenance was greater in the ustekinumab 90 mg SC q12w and q8w groups than in the placebo group (50.0% and 55.6% vs. 25.0%, respectively, for Japanese; 48.8% and 53.1% vs. 35.9%, respectively, for overall). Efficacy and safety results observed in the Japanese subpopulation were generally consistent with those in the overall population.

Conclusions

Ustekinumab could be considered as a new therapeutic option for moderately to severely active CD in Japanese patients. Both ustekinumab induction and maintenance treatments were generally well tolerated (Clinical Trial Registration: NCT01369329, NCT01369342, NCT01369355).

Citations

Citations to this article as recorded by  
  • Saudi consensus guidance for the diagnosis and management of inflammatory bowel disease in children and adolescents
    Omar I. Saadah, Turki AlAmeel, Ahmed Al Sarkhy, Mohammed Hasosah, Abdulrahman Al-Hussaini, Majid A. Almadi, Badr Al-Bawardy, Talal A. Altuwaijri, Mohammed AlEdreesi, Shakir A. Bakkari, Othman R. Alharbi, Nahla A. Azzam, Abdulelah Almutairdi, Khalidah A. A
    Saudi Journal of Gastroenterology.2024;[Epub]     CrossRef
  • The treatment of inflammatory bowel disease with monoclonal antibodies in Asia
    Yu Chen, Guolin Zhang, Yuewen Yang, Shuangshuang Zhang, Haozheng Jiang, Kang Tian, Arenbaoligao, Dapeng Chen
    Biomedicine & Pharmacotherapy.2023; 157: 114081.     CrossRef
  • A Retrospective Cohort Study of Clinical Features and Treatment Patterns With Ustekinumab in Patients With Crohn Disease Utilizing a Health Care Database in Japan
    Yanfang Liu, Choo Hua Goh, Hong Qiu, Kuan-Chih Huang, Hsingwen Chung, Carine Saadoun
    Annals of Pharmacotherapy.2023; 57(9): 1053.     CrossRef
  • Real-world effectiveness and safety of ustekinumab induction therapy for Korean patients with Crohn’s disease: a KASID prospective multicenter study
    Kyunghwan Oh, Hee Seung Hong, Nam Seok Ham, Jungbok Lee, Sang Hyoung Park, Suk-Kyun Yang, Hyuk Yoon, You Sun Kim, Chang Hwan Choi, Byong Duk Ye
    Intestinal Research.2023; 21(1): 137.     CrossRef
  • A critical review of ustekinumab for the treatment of active ulcerative colitis in adults
    Sophie Vieujean, Edouard Louis, Silvio Danese, Laurent Peyrin-Biroulet
    Expert Review of Gastroenterology & Hepatology.2023; 17(5): 413.     CrossRef
  • Feasibility of a Clinical Decision Support Tool for Ustekinumab to Predict Clinical Remission and Relapse in Patients With Crohn’s Disease: A Multicenter Observational Study
    Jihye Park, Jaeyoung Chun, Hyuk Yoon, Jae Hee Cheon
    Inflammatory Bowel Diseases.2022;[Epub]     CrossRef
  • Management of inflammatory bowel disease beyond tumor necrosis factor inhibitors: novel biologics and small-molecule drugs
    Soo-Young Na, You Sun Kim
    The Korean Journal of Internal Medicine.2022; 37(5): 906.     CrossRef
  • Association of Anti–Tumor Necrosis Factor Therapy With Mortality Among Veterans With Inflammatory Bowel Disease
    Shirley Cohen-Mekelburg, Beth I. Wallace, Tony Van, Wyndy L. Wiitala, Shail M. Govani, Jennifer Burns, Rachel Lipson, Huifeng Yun, Jason Hou, James D. Lewis, Jason A. Dominitz, Akbar K. Waljee
    JAMA Network Open.2021; 4(3): e210313.     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
    Journal of Gastroenterology.2021; 56(6): 489.     CrossRef
  • Safety and effectiveness of ustekinumab in Crohn's disease: Interim results of post‐marketing surveillance in Japan
    Seiji Yokoyama, Teita Asano, Katsumasa Nagano, Hiroaki Tsuchiya, Masayuki Takagishi, Shigeharu Tsujioka, Naomi Miura, Takayuki Matsumoto
    Journal of Gastroenterology and Hepatology.2021; 36(11): 3069.     CrossRef
  • Translating Treg Therapy for Inflammatory Bowel Disease in Humanized Mice
    Sushmita Negi, Sheetal Saini, Nikunj Tandel, Kiran Sahu, Ravi P.N. Mishra, Rajeev K. Tyagi
    Cells.2021; 10(8): 1847.     CrossRef
  • Efficacy and safety of ustekinumab in East Asian patients with moderately to severely active ulcerative colitis: a subpopulation analysis of global phase 3 induction and maintenance studies (UNIFI)
    Tadakazu Hisamatsu, Hyo Jong Kim, Satoshi Motoya, Yasuo Suzuki, Yoshifumi Ohnishi, Noriyuki Fujii, Nobuko Matsushima, Richuan Zheng, Colleen W. Marano
    Intestinal Research.2021; 19(4): 386.     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
  • Interleukin 23 and autoimmune diseases: current and possible future therapies
    Ahmad Ismail Khaled Abdo, Gee Jun Tye
    Inflammation Research.2020; 69(5): 463.     CrossRef
  • Long-Term Clinical Effectiveness of Ustekinumab in Patients With Crohn’s Disease: A Retrospective Cohort Study
    Takahiro Ito, Atsuo Maemoto, Takehiko Katsurada, Hiroki Tanaka, Satoshi Motoya, Nobuhiro Ueno, Mikihiro Fujiya, Toshifumi Ashida, Daisuke Hirayama, Hiroshi Nakase
    Crohn's & Colitis 360.2020;[Epub]     CrossRef
  • Novel drug delivery systems of Chinese medicine for the treatment of inflammatory bowel disease
    Caifang Gao, Lijuan Liu, Yangyang Zhou, Zhaoxiang Bian, Shengpeng Wang, Yitao Wang
    Chinese Medicine.2019;[Epub]     CrossRef
  • Ustekinumab is effective in biological refractory Crohn’s disease patients–regardless of approval study selection criteria
    Sadik Saman, Martin Goetz, Judith Wendler, Nisar P. Malek, Jan Wehkamp, Thomas Klag
    Intestinal Research.2019; 17(3): 340.     CrossRef
  • Perspectives on Current and Novel Treatments for Inflammatory Bowel Disease
    Soo-Young Na, Won Moon
    Gut and Liver.2019; 13(6): 604.     CrossRef
  • Anti-IL-12/23p40 antibodies for maintenance of remission in Crohn's disease
    Sarah C Davies, Tran M Nguyen, Claire E Parker, John K MacDonald, Vipul Jairath, Reena Khanna
    Cochrane Database of Systematic Reviews.2019;[Epub]     CrossRef
  • Novel treatments for inflammatory bowel disease
    Hyo Sun Lee, Soo-Kyung Park, Dong Il Park
    The Korean Journal of Internal Medicine.2018; 33(1): 20.     CrossRef
  • Emerging Therapies: What Are Promising in the Near Future?
    Geom Seog Seo, Sung Hee Lee
    The Korean Journal of Gastroenterology.2018; 71(2): 81.     CrossRef
  • 6,671 View
  • 143 Download
  • 18 Web of Science
  • 21 Crossref
Close layer

Intest Res : Intestinal Research
Close layer
TOP