Intestinal Research

Original Articles

Inflammatory Bowel Diseases

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; Intest Res 2021;19(4):386-397. Published online December 1, 2020; DOI: https://doi.org/10.5217/ir.2020.00080

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Background/Aims
We aimed to evaluate the efficacy and safety of ustekinumab (UST) in the East-Asian population with moderate to severely active ulcerative colitis (UC).
Methods
This sub-analysis was conducted on data from East-Asian patients included in the UNIFI program (NCT02407236). UNIFI consisted of two double-blind, placebo-controlled trials: an 8-week induction study and a 44-week randomized withdrawal maintenance study.
Results
Of 133 East-Asian patients (Japanese: 107, Korean: 26) who underwent randomization, 131 completed induction study and 111 entered maintenance study. In the maintenance study, 78 patients were randomized. Patients who received UST 130 mg and UST 6 mg/kg showed numerically higher clinical remission at week 8 in the induction study (5/44 [11.4%] and 5/45 [11.1%], respectively) compared with those who received placebo (0/44, 0%). The proportion of patients achieved clinical remission at week 44 was numerically higher in the UST 90 mg q12w group (10/21, 47.6%), but similar in the UST 90 mg q8w group (5/26, 19.2%) compared to placebo (7/31, 22.6%). Serious adverse events were reported in 1 patient in UST 130 mg group, but no patient in UST 6 mg/kg group through week 8 in the induction study, and 1 patient in UST 90 mg q12w group and 5 patients in the UST 90 mg q8w group in the maintenance study. No deaths were reported in East-Asian patients throughout the study.
Conclusions
UST induction and maintenance treatments were effective in East-Asian patients with moderate to severe UC; the efficacy and safety profiles were consistent with the overall population.

Citations

Citations to this article as recorded by

One-year Safety and Effectiveness of Ustekinumab in Patients With Crohn’s Disease: The K-STAR Study
Chang Kyun Lee, Won Moon, Jaeyoung Chun, Eun Soo Kim, Hyung Wook Kim, Hyuk Yoon, Hyun Soo Kim, Yoo Jin Lee, Chang Hwan Choi, Yunho Jung, Sung Chul Park, Geun Am Song, Jong Hun Lee, Eun Suk Jung, Youngdoe Kim, Su Young Jung, Jong Min Choi, Byong Duk Ye
Inflammatory Bowel Diseases.2025; 31(5): 1306. CrossRef
Risk of malignancies and chemopreventive effect of statin, metformin, and aspirin in Korean patients with ulcerative colitis: a nationwide population-based study
Eun Hye Oh, Ye-Jee Kim, Minju Kim, Seung Ha Park, Tae Oh Kim, Sang Hyoung Park
Intestinal Research.2025; 23(2): 129. CrossRef
Systematic Review and Meta-analysis: The Association Between Serum Ustekinumab Trough Concentrations and Treatment Response in Inflammatory Bowel Disease
Abhinav Vasudevan, Vivek Tharayil, Laura H Raffals, David H Bruining, Michelle Becker, Mohammad Hassan Murad, Edward V Loftus
Inflammatory Bowel Diseases.2024; 30(4): 660. CrossRef
Machine learning using clinical data at baseline predicts the medium-term efficacy of ustekinumab in patients with ulcerative colitis
Hiromu Morikubo, Ryuta Tojima, Tsubasa Maeda, Katsuyoshi Matsuoka, Minoru Matsuura, Jun Miyoshi, Satoshi Tamura, Tadakazu Hisamatsu
Scientific Reports.2024;[Epub] CrossRef
Hepatic Steatosis but Not Fibrosis Is Independently Associated with Poor Outcomes in Patients with Inflammatory Bowel Disease
Hye Kyung Hyun, Hye Won Lee, Jihye Park, Soo Jung Park, Jae Jun Park, Tae Il Kim, Jae Seung Lee, Beom Kyung Kim, Jun Yong Park, Do Young Kim, Sang Hoon Ahn, Seung Up Kim, Jae Hee Cheon
Gut and Liver.2024; 18(2): 294. CrossRef
Machine Learning for Predicting Biologic Agent Efficacy in Ulcerative Colitis: An Analysis for Generalizability and Combination with Computational Models
Philippe Pinton
Diagnostics.2024; 14(13): 1324. CrossRef
Risks of colorectal cancer and biliary cancer according to accompanied primary sclerosing cholangitis in Korean patients with ulcerative colitis: a nationwide population-based study
Eun Hye Oh, Ye-Jee Kim, Minju Kim, Seung Ha Park, Tae Oh Kim, Sang Hyoung Park
Intestinal Research.2023; 21(2): 252. 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
Reviewing not Homer’s Iliad, but “Kai Bao Ben Cao”: indigo dye—the past, present, and future
Yusuke Yoshimatsu, Tomohisa Sujino, Takanori Kanai
Intestinal Research.2023; 21(2): 174. CrossRef
Concomitant ankylosing spondylitis can increase the risk of biologics or small molecule therapies to control inflammatory bowel disease
Yu Kyung Jun, Hyuk Yoon, Seong-Joon Koh, A Hyeon Kim, Kwang Woo Kim, Jun Won Park, Hyun Jung Lee, Hyoun Woo Kang, Jong Pil Im, Young Soo Park, Joo Sung Kim
Intestinal Research.2023; 21(2): 244. CrossRef
The Risk of Tuberculosis in Patients With Inflammatory Bowel Disease Treated With Vedolizumab or Ustekinumab in Korea
Myeong Geun Choi, Byong Duk Ye, Suk-Kyun Yang, Tae Sun Shim, Kyung-Wook Jo, Sang Hyoung Park
Journal of Korean Medical Science.2022;[Epub] CrossRef
Japanese pediatric patient with moderately active ulcerative colitis successfully treated with ustekinumab
Toshihiko Kakiuchi, Masato Yoshiura
Medicine.2022; 101(7): e28873. CrossRef
Personalized medicine in inflammatory bowel disease: Perspectives on Asia
Su Hyun Park, Sang Hyoung Park
Journal of Gastroenterology and Hepatology.2022; 37(8): 1434. CrossRef
Antitumor necrosis factor treatment in patients with inflammatory bowel disease does not promote psoriasis development: A meta-analysis
Yu Kyung Jun, Joo Young Park, Seong-Joon Koh, Hyunsun Park, Hyoun Woo Kang, Jong Pil Im, Joo Sung Kim
Medicine.2022; 101(27): e29872. CrossRef
Viral Hepatitis in Patients with Inflammatory Bowel Disease
Seung Hwan Shin, Sang Hyoung Park
The Korean Journal of Gastroenterology.2022; 80(2): 51. CrossRef
Effectiveness and Safety of Golimumab in Patients with Ulcerative Colitis: A Multicenter, Prospective, Postmarketing Surveillance Study
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
Gut and Liver.2022; 16(5): 764. 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
Natural history of inflammatory bowel disease: a comparison between the East and the West
Eun Mi Song, Suk-Kyun Yang
Intestinal Research.2022; 20(4): 418. CrossRef
Current status of inflammatory bowel diseases in Korea
Suk-Kyun Yang
Journal of the Korean Medical Association.2021; 64(9): 572. CrossRef

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Inflammatory Bowel Diseases

Population pharmacokinetics of vedolizumab in Asian and non-Asian patients with ulcerative colitis and Crohn’s disease: Hiroyuki Okamoto, Nathanael L. Dirks, Maria Rosario, Tetsuharu Hori, Toshifumi Hibi; Intest Res 2021;19(1):95-105. Published online July 10, 2020; DOI: https://doi.org/10.5217/ir.2019.09167

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Background/Aims
Vedolizumab is indicated for moderately-to-severely active ulcerative colitis (UC) and Crohn’s disease (CD). Because multiple factors may result in different pharmacokinetics and clinical efficacies, understanding determinants of vedolizumab clearance may enhance dose and treatment strategies. The aim was to characterize vedolizumab pharmacokinetics in Asian and non-Asian UC and CD patients.
Methods
Population pharmacokinetic analysis for repeated measures, using data from 5 studies, was conducted using nonlinear mixed-effects modeling. A Bayesian estimation approach in NONMEM 7.3 was utilized to leverage the predominantly sparse data available for this analysis with results from a prior population pharmacokinetic analysis of vedolizumab.
Results
Vedolizumab pharmacokinetics were described by a 2-compartment model with parallel linear and nonlinear elimination. Using reference covariate values, linear elimination half life of vedolizumab was 24.7 days for anti-vedolizumab antibody (AVA)-negative patients and 18.1 days for AVA-positive patients; linear clearance (CL_L) was 0.165 L/day for AVA-negative patients and 0.246 L/day for AVA-positive patients; central (V_c) and peripheral compartment volumes of distribution were 3.16 L and 1.84 L, respectively. Interindividual variabilities (percent coefficient of variation) were 30.8% for CL_L and 19% for V_c; interoccasion variability on CL_L was 20.3%; residual variance was 17.8%. For albumin, body weight and AVA, only extreme values were identified as potentially clinically important predictors of CL_L. The effect of race (Asian/non-Asian) and diagnosis (UC/CD) on CL_L was negligible and likely not of clinical importance.
Conclusions
Pharmacokinetic parameters were similar in Asian and non-Asian patients with moderately-to-severely active UC and CD. This analysis supports use of vedolizumab flat-fixed dosing in these patients. (Clinicaltrials.gov Identifiers: NCT00783718 (GEMINI 1); NCT00783692 (GEMINI 2). CCT 101; NCT02039505 and CCT-001; NCT02038920)

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Review

Inflammatory bowel diseases

Pediatric to adult inflammatory bowel disease transition: the Asian experience: Bernice Tan, David Ong; Intest Res 2020;18(1):11-17. Published online January 30, 2020; DOI: https://doi.org/10.5217/ir.2019.09144

Abstract PDF PubReader ePub

Many tertiary inflammatory bowel disease (IBD) centers recognize that a structured transition program is fundamental for an IBD unit. However, the path to ensuring a seamless transition for all stakeholders is often fraught with challenges. In this review, we go through current evidence, identify the requirementsof a successful transition program, and the barriers to seamless transfer. We also aim to shed light on differences in needs between the Western and Asian adolescent IBD populations. Majority of healthcare providers viewed having a structured transition program to be very important. The lack of a standard protocol led us to come up with a list of requirements ofa successful program. These include: multidisciplinary team meetings, alternating visits between the adultand pediatric clinics, proper documentation of records, and determining the ideal timing for transfer. The difficulties forthe Asian adolescent IBD population may be attributed to the reliance on parental support to make decisions regarding medicaltreatment. Lastly, there are various physician, patient and disease factors which are barriers to seamless transition. These includethe lack of proper documentation, and lack of patient self-efficacy. We also propose a standardized template for documentation of medical records for IBD patients.

Citations

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Efficacy, Safety, and Pharmacokinetics of Golimumab in Children with Moderately-To-Severely Active Ulcerative Colitis: Results from the PURSUIT 2 Study
Dan Turner, Kathleen G Lomax, Gigi Veereman, Anne M Griffiths, Jaroslaw Kierkuś, Ben Kang, Katherine Berezny, Lakshmi Padgett, Gary Mao, Yevgeny Zitser, Richard S Strauss, Jeroen Verhoeven, Omoniyi J Adedokun, Jeffrey S Hyams
Inflammatory Bowel Diseases.2026;[Epub] CrossRef
Experience of an Asian paediatric rheumatology transition programme: high success rate with the use of transition readiness assessment tool
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Systematic Review: Practices and Programs in Inflammatory Bowel Disease Transition Care
Patrick Chan, Jack McNamara, Angharad Vernon-Roberts, Edward M Giles, Rachael Havrlant, Britt Christensen, Amanda Thomas, Astrid-Jane Williams
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The association between perceived social support and self-management behaviors in adolescents and young adults with inflammatory bowel disease: the chain mediating role of basic psychological needs and anxiety/depression
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Frontiers in Psychology.2025;[Epub] CrossRef
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Current perspectives on pediatric inflammatory bowel disease focusing on transitional care management. What should we consider?
Constanza Bay M, Paulina Núñez F, Rodrigo Quera, Andrés J. Yarur
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Original Article

Differences in the public medical insurance systems for inflammatory bowel disease treatment in Asian countries: Shu Chen Wei; Intest Res 2016;14(3):218-223. Published online June 27, 2016; DOI: https://doi.org/10.5217/ir.2016.14.3.218

Abstract PDF PubReader ePub

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

The cost of caring for patients with inflammatory bowel disease (IBD) is high. Without government support, the cost burden will unavoidably rest on the patients and their family. However, the government providing full support will place a large financial burden on the health-care systems of a country. The aim of this study is to understand the current status of public medical insurance systems in caring for IBD patients among Asian countries.

Methods

Questionnaires inquiring about the availability of public health systems; medical, diagnostic, and endoscopy costs; and coverage rate of biologics use were designed and sent to IBD experts in each of the Asian countries studied. The results were summarized according to the feedback from the responders.

Results

The public health insurance coverage rate is high in Taiwan, Japan, South Korea, China, Hong Kong, and Singapore; but low in Malaysia and India. This probably affected the use of expensive medications mostly, such as biologics, as we found that the percentage of Crohn's disease (CD) treated with biologics were as high as 30%–40% in Japan, where the government covers all expenses for IBD patients. In India, the percentage maybe as low as 1% for CD patients, most of whom need to pay for the biologics themselves.

Conclusions

There were differences in the public health insurance systems among the Asian countries studied. This reportprovidesthe background information to understand the differences in the treatment of IBD patients among Asian countries.

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