Intestinal Research

Yoh Ishiguro

2 Articles

Inflammatory bowel diseases

Anti-MAdCAM-1 antibody (PF-00547659) for active refractory Crohn’s disease in Japanese and Korean patients: the OPERA study: Masayuki Saruta, Dong Il Park, Young-Ho Kim, Suk-Kyun Yang, Byung-Ik Jang, Jae Hee Cheon, Jong Pil Im, Takanori Kanai, Tatsuro Katsuno, Yoh Ishiguro, Makoto Nagaoka, Naoki Isogawa, Yinhua Li, Anindita Banerjee, Alaa Ahmad, Mina Hassan-Zahraee, Robert Clare, Kenneth J. Gorelick, Fabio Cataldi, Mamoru Watanabe, Toshifumi Hibi; Intest Res 2020;18(1):45-55. Published online January 30, 2020; DOI: https://doi.org/10.5217/ir.2019.00039

Background/Aims
PF-00547659 is a monoclonal antibody against human mucosal addressin cell adhesion molecule-1 (MAdCAM-1) that prevents the binding of α4β7+ lymphocytes to MAdCAM-expressing sites in the gastrointestinal tract with high affinity and selectivity, and is being developed for the treatment of Crohn’s disease (CD).
Methods
OPERA is a randomized, multicenter, double-blind, placebo-controlled study to investigate the efficacy, safety, and pharmacokinetics of PF-00547659 following subcutaneous administration in subjects with active CD, a history of failure or intolerance to anti-tumor necrosis factor and/or immunosuppressants, high-sensitivity C-reactive protein > 3.0 mg/L, and ulcers on colonoscopy. The primary endpoint was Crohn’s Disease Activity Index-70 response at week 8 or 12. Subpopulation analyses for Asian subjects were performed as some differences are observed in genetics and clinical phenotypes in Asian CD patients compared with Western patients.
Results
In this study, 265 CD subjects were randomized, with a subpopulation of 21 subjects (8 Japanese and 13 Korean) defined as the Asian population. In the overall and Asian populations; PF-00547659 was pharmacologically active as evidenced by soluble MAdCAM and circulating β7+ central memory CD4+ T-lymphocytes, although no clear evidence of efficacy was observed in any clinical endpoints; pharmacokinetics of PF-00547659 in the Asian subpopulation was generally comparable to the overall population; and the safety profile of PF-00547659 appeared acceptable up to 12 weeks of treatment.
Conclusions
In the overall and Asian populations, efficacy of PF-00547659 could not be demonstrated using any clinical endpoints compared with placebo. Pharmacokinetics and safety of PF-00547659 were generally comparable. Further studies with larger numbers of patients are required to confirm our results. (Trial Registration Number: NCT01276509)

Citations

Citations to this article as recorded by

Novel Histone Deacetylase 6 Inhibitor Confers Anti-inflammatory Effects and Enhances Gut Barrier Function
Jae-Young Lee, Hyun Woo Ma, Ji Hyung Kim, I Seul Park, Mijeong Son, Keun Ho Ryu, Jieun Shin, Seung Won Kim, Jae Hee Cheon
Gut and Liver.2023; 17(5): 766. CrossRef
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Gut and Liver.2023; 17(6): 905. 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
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World Journal of Gastroenterology.2021; 27(48): 8242. CrossRef

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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

Abstract PDF PubReader ePub

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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7,643 View
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