Intestinal Research

Original Articles

IBD

Real-world data for golimumab treatment in patients with ulcerative colitis in Japan: interim analysis in post-marketing surveillance: Shiro Nakamura, Teita Asano, Hiroaki Tsuchiya, Kanami Sugimoto, Yuya Imai, Seiji Yokoyama, Yasuo Suzuki; Intest Res 2022;20(3):329-341. Published online August 4, 2021; DOI: https://doi.org/10.5217/ir.2021.00032

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Background/Aims
Golimumab (GLM) is an anti-tumor necrosis factor-α drug approved for treating moderate-to-severe active ulcerative colitis (UC). A 52-week post-marketing surveillance (PMS) was initiated to evaluate its safety and effectiveness in patients with UC in Japan. We present an interim report of the ongoing PMS.
Methods
Patients received 200 mg of subcutaneous GLM at week 0, 100 mg at week 2, and 100 mg 4 weekly thereafter. The safety analysis set included 392 patients with UC, and the effectiveness analysis set 387 patients. Safety and effectiveness were assessed at week 6.
Results
Adverse drug reactions (ADRs) were reported in 8.2% (32/392) and serious ADRs in 4.6% (18/392). The most frequent ADRs were infection and infestation (3.3%), with herpes zoster being the most common. ADRs were significantly higher in patients with concomitant corticosteroid use (odds ratio [OR], 3.45; 95% confidence interval [CI], 1.40–9.68). No significant difference in ADR incidence was observed between patients aged ≥65 and <65 years (OR, 1.23; 95% CI, 0.35–3.47). Six-week effectiveness of GLM was confirmed by a decrease in the partial Mayo score (–2.3; 95% CI, –2.6 to –2.1) and C-reactive protein levels (–0.64; 95% CI, –0.92 to –0.36), including in the biologics-experienced population.
Conclusions
The safety and effectiveness of GLM at week 6 in a real-world setting were demonstrated in patients with UC in Japan. ADR patterns were consistent with previous reports with no new safety signals. Concomitant corticosteroid use may be associated with increased ADR incidence. The final results of the ongoing PMS are necessary for further evaluation.

Citations

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Real-world effectiveness and safety of advanced therapies for the treatment of moderate-to-severe ulcerative colitis: Evidence from a systematic literature review
Peter M. Irving, Peter Hur, Raju Gautam, Xiang Guo, Severine Vermeire
Journal of Managed Care & Specialty Pharmacy.2024; 30(9): 1026. 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
Golimumab for Ulcerative Colitis: One More Option to SAVE the Colon
Sang Hyoung Park
Crohn's & Colitis 360.2023;[Epub] CrossRef
Advancements in the Management of Moderate-to-Severe Ulcerative Colitis: A Revised 2023 Korean Treatment Guidelines
Soo-Young Na
The Korean Journal of Medicine.2023; 98(5): 223. CrossRef
Pharmacogenetics-based personalized treatment in patients with inflammatory bowel disease: A review
Ji Young Chang, Jae Hee Cheon
Precision and Future Medicine.2021; 5(4): 151. CrossRef

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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

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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
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.2024;[Epub] 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

Long-term safety and effectiveness of adalimumab in Japanese patients with Crohn’s disease: 3-year results from a real-world study: Tadakazu Hisamatsu, Yasuo Suzuki, Mariko Kobayashi, Takashi Hagiwara, Takeshi Kawaberi, Haruhiko Ogata, Toshiyuki Matsui, Mamoru Watanabe, Toshifumi Hibi; Intest Res 2021;19(4):408-418. Published online November 20, 2020; DOI: https://doi.org/10.5217/ir.2020.00025

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Background/Aims
Crohn’s disease is a chronic disorder; therefore, it is essential to investigate long-term safety and efficacy of treatments. This study assessed the safety and effectiveness of adalimumab for up to 3 years in Japanese patients with Crohn’s disease in real-world settings.
Methods
This was a multicenter, single-cohort, observational study of patients with Crohn’s disease. Safety assessments included incidence of adverse drug reactions. Effectiveness assessments included clinical remission, mucosal healing, and Work Productivity and Activity Impairment (WPAI).
Results
The safety and effectiveness analysis populations comprised 389 and 310 patients, respectively. Mean (standard deviation) exposure to adalimumab in the safety analysis population was 793.4 (402.8) days, with a 58.1% retention rate. A total of 105 patients (27.0%) and 43 patients (11.1%) experienced adverse drug reactions and serious adverse drug reactions, respectively, with no patient reporting tuberculosis or hepatitis B. Infections and serious infections were reported in 37 patients (9.5%) and 17 patients (4.4%), respectively. Malignancy was reported as an adverse drug reaction in 2 patients (0.5%). Remission rate increased from 37.8% (98/259) at baseline to 73.9% (167/226) at week 4 and remained > 70% over 3 years. Proportion of patients without mucosal ulcerations increased from 2.7% (2/73) at baseline to 42.3% (11/26) between years > 2 to ≤ 3. WPAI improvement started at 4 weeks, with the overall work impairment score improving from 42.7 (n = 102) at baseline to 26.9 (n = 84) at 4 weeks.
Conclusions
Results from this study confirm the long-term safety and effectiveness of adalimumab treatment in Japanese patients with Crohn’s disease in the real-world setting.

Citations

Citations to this article as recorded by

Effect of Perianal Fistula on the Quality of Life and Work Productivity of Patients with Crohn's Disease: Report of a Questionnaire Survey
Naoto Saigusa, Takeshi Inaba
Nippon Daicho Komonbyo Gakkai Zasshi.2024; 77(2): 89. CrossRef
Real-world effectiveness and safety of adalimumab in Korean patients with intestinal Behcet’s disease: a Korean Association for the Study of Intestinal Diseases (KASID) multicenter study
Seung Bum Lee, Hee Seung Hong, Chang Kyun Lee, Bo-In Lee, Sol Kim, Seong-Joon Koh, Hosun Yu, Jung-Bin Park, Sung Wook Hwang, Byong Duk Ye, Suk-Kyun Yang, Sang Hyoung Park
The Korean Journal of Internal Medicine.2023; 38(5): 661. CrossRef
Clinical features of enteric and colo-duodenal fistula in patients with Crohn’s disease
Jun Su Lee, Sang-Bum Kang, Kwangbeom Park, Yong Sik Yoon, Chang Sik Yu, Sung Wook Hwang, Byong Duk Ye, Suk-Kyun Yang, Jong Lyul Lee, Sang Hyoung Park
Intestinal Research.2023; 21(3): 406. CrossRef
TNF-Alpha Inhibitors and Ustekinumab for the Treatment of Psoriasis: Therapeutic Utility in the Era of IL-17 and IL-23 Inhibitors
Julie J. Hong, Edward K. Hadeler, Megan L. Mosca, Nicholas D. Brownstone, Tina Bhutani, Wilson J. Liao
Journal of Psoriasis and Psoriatic Arthritis.2022; 7(2): 79. CrossRef
Infliximab versus Adalimumab: Can We Choose the Right One for the Right Patients with Ulcerative Colitis?
Sang Hyoung Park, Byong Duk Ye, Suk-Kyun Yang
Gut and Liver.2022; 16(1): 138. CrossRef
Biological Therapies for the Management of Enteric Disease: Considerations for the Clinician
Adam Saleh, Usman Ansari, Shaadi Abughazaleh, Kerri Glassner, Bincy P Abraham
Biologics: Targets and Therapy.2022; Volume 16: 67. CrossRef
Prevention of postoperative recurrence in Crohn’s disease: the never-ending story
Jung-Bin Park, Sang Hyoung Park
Intestinal Research.2022; 20(3): 279. CrossRef
Updates on conventional therapies for inflammatory bowel diseases: 5-aminosalicylates, corticosteroids, immunomodulators, and anti-TNF-α
Jihye Park, Jae Hee Cheon
The Korean Journal of Internal Medicine.2022; 37(5): 895. 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
Adalimumab for induction of remission in patients with Crohn's disease: a systematic review and meta-analysis
Juntao Yin, Yang Li, Yangyang Chen, Chaoyang Wang, Xiaoyong Song
European Journal of Medical Research.2022;[Epub] 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
Can Anti-Tumor Necrosis Factor Agents Be Discontinued in Patients with Inflammatory Bowel Disease?
Jihye Park, Jae Hee Cheon
Gut and Liver.2021; 15(5): 641. CrossRef
Pharmacogenetics-based personalized treatment in patients with inflammatory bowel disease: A review
Ji Young Chang, Jae Hee Cheon
Precision and Future Medicine.2021; 5(4): 151. CrossRef

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Inflammatory Bowel Diseases

Long-term safety and effectiveness of adalimumab in 462 patients with intestinal Behçet’s disease: results from a large real-world observational study: Yasuo Suzuki, Takashi Hagiwara, Mariko Kobayashi, Kazuo Morita, Tomoyo Shimamoto, Toshifumi Hibi; Intest Res 2021;19(3):301-312. Published online August 20, 2020; DOI: https://doi.org/10.5217/ir.2020.00013

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Background/Aims
The safety and effectiveness of adalimumab was demonstrated in a phase 3 trial in Japanese patients with intestinal Behçet’s disease. The aim of this study was to evaluate the long-term safety and effectiveness of adalimumab in Japanese patients with intestinal Behçet’s disease.
Methods
This prospective, all-case, post-marketing study was conducted at 254 centers in Japanese patients with intestinal Behçet’s disease receiving adalimumab. The primary endpoint was incidence of adverse drug reactions. Effectiveness endpoints included global improvement rating and change in C-reactive protein levels.
Results
Of the 473 registered patients, 462 and 383 included in the safety and effectiveness populations were administered adalimumab for a mean of 515.3 and 579.5 days, respectively. Overall, 395 patients (85.5%) received adalimumab at the recommended dose. Adverse drug reactions and serious adverse drug reactions were reported in 120 (25.97%) and 51 (11.04%) patients, respectively. The incidence of adverse drug reactions was significantly higher in patients with comorbidities (P< 0.0001), patients taking concomitant oral corticosteroids (P< 0.0001), and those not self-administering adalimumab (P= 0.0257). At study end, global improvement rating was “effective” (n = 156, 40.7%) or “markedly effective” (n = 168, 43.9%) in 324 patients (overall effective, 84.6%). Mean C-reactive protein levels (mg/dL) decreased from 1.96 at baseline (n = 324) to 0.58 at week 24 (n = 208) and 0.25 at week 156 (n = 37).
Conclusions
This large real-world study confirmed the long-term safety and effectiveness of adalimumab in patients with intestinal Behçet’s disease. No new safety concerns were identified. (Clinical trial registration number: NCT01960790)

Citations

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Assessment of IL-6 Pathway Inhibition in Gastrointestinal Behçet’s Disease from Immunological and Clinical Perspectives
Makoto Naganuma, Mitsuhiro Takeno, Aykut Ferhat Çelik, Robert Moots, Philippe Pinton, Tadakazu Hisamatsu
Biomedicines.2025; 13(1): 247. CrossRef
Small bowel vasculitis? what a gastroenterologist should know - from diagnosis to management
João Carlos Gonçalves, Bruno Rosa, José Cotter
Current Opinion in Gastroenterology.2025;[Epub] CrossRef
Optimal Treatment Approaches to Intestinal Behçet's Disease Complicated by Myelodysplastic Syndrome: The KASID and KSBD Multicenter Study
Jung-Bin Park, So Jung Han, Seung Bum Lee, Dong Hyun Kim, Jae Hee Cheon, Sung Wook Hwang, Byong Duk Ye, Suk-Kyun Yang, Soo Jung Park, Sang Hyoung Park
Yonsei Medical Journal.2024; 65(5): 265. CrossRef
Neither hepatic steatosis nor fibrosis is associated with clinical outcomes in patients with intestinal Behçet’s disease
Hye Kyung Hyun, Jihye Park, Soo Jung Park, Jae Jun Park, Tae Il Kim, Jae Seung Lee, Hye Won Lee, Beom Kyung Kim, Jun Yong Park, Do Young Kim, Sang Hoon Ahn, Seung Up Kim, Jae Hee Cheon
European Journal of Gastroenterology & Hepatology.2024; 36(4): 445. CrossRef
Prevalence and risk factors for gallstone and renal stone formation in patients with intestinal Behçet’s disease
Jaewon Song, Soo Jung Park, Jae Jun Park, Tae Il Kim, Jihye Park, Jae Hee Cheon
The Korean Journal of Internal Medicine.2024; 39(5): 770. CrossRef
Long‐term clinical outcomes of intestinal Behçet's disease: A 30‐year cohort study at a tertiary hospital in South Korea
Jihye Park, Soo Jung Park, Jae Jun Park, Tae Il Kim, Jae Hee Cheon
Journal of Gastroenterology and Hepatology.2023; 38(3): 386. CrossRef
Risk Factors for Surgery in Patients with Intestinal Behçet’s Disease During Anti-Tumor Necrosis Factor-Alpha Therapy
So Jung Han, Eun Ae Kang, Jihye Park, Soo Jung Park, Jae Jun Park, Tae Il Kim, Won Ho Kim, Jae Hee Cheon
Yonsei Medical Journal.2023; 64(2): 111. CrossRef
Interplay between chronic inflammation and clonal haematopoiesis of indeterminate potential in Behçet’s disease
Jihye Park, Hongyul An, Jiwoo Lim, I Seul Park, Mi Hyun Kim, Ji Hyung Kim, Seung Won Kim, Young Il Koh, Eun Young Lee, Jae Hee Cheon
Arthritis Research & Therapy.2023;[Epub] CrossRef
Real-world effectiveness and safety of adalimumab in Korean patients with intestinal Behcet’s disease: a Korean Association for the Study of Intestinal Diseases (KASID) multicenter study
Seung Bum Lee, Hee Seung Hong, Chang Kyun Lee, Bo-In Lee, Sol Kim, Seong-Joon Koh, Hosun Yu, Jung-Bin Park, Sung Wook Hwang, Byong Duk Ye, Suk-Kyun Yang, Sang Hyoung Park
The Korean Journal of Internal Medicine.2023; 38(5): 661. CrossRef
Characteristics and Treatment Outcomes of Transition among Patients with Inflammatory Bowel Disease
Eun Jin Yoo, Sang-Hoon Cho, Soo Jung Park, Tae Il Kim, Won Ho Kim, Jae Hee Cheon
Yonsei Medical Journal.2023; 64(9): 541. CrossRef
Efficacy and Safety of Infliximab in Intestinal Behçet’s Disease: A Multicenter, Phase 3 Study (BEGIN)
Jae Hee Cheon, Hyun-Soo Kim, Dong Soo Han, Sung Kook Kim, Sung Jae Shin, Joo Sung Kim, Byong Duk Ye, Geun Am Song, YoungJa Lee, Youngdoe Kim, Yoosun Lee, Won Ho Kim
Gut and Liver.2023; 17(5): 777. CrossRef
Behçet's disease with intestinal involvement: a case report and review of the literature
Lin Li, Jing Wang, Huifang Li, Chiyi He, Xiaoping Niu
Journal of Medical Case Reports.2023;[Epub] CrossRef
PD-1-positive cells contribute to the diagnosis of inflammatory bowel disease and can aid in predicting response to vedolizumab
Min Kyu Kim, Su In Jo, Sang-Yeob Kim, Hyun Lim, Ho Suk Kang, Sung‑Hoon Moon, Byong Duk Ye, Jae Seung Soh, Sung Wook Hwang
Scientific Reports.2023;[Epub] CrossRef
Effectiveness and safety of adalimumab in patients with intestinal Behçet’s disease: a real-world prospective observational study in South Korea
Jongwook Yu, Sung Jae Shin, Yune-Jung Park, Hyung Wook Kim, Bo-In Lee, Byong Duk Ye, Geun-Tae Kim, Sung Kook Kim, Joo Sung Kim, Young-Ho Kim, Seonjeong Jeong, Jae Hee Cheon
BMC Gastroenterology.2023;[Epub] CrossRef
Efficacy and Safety of Anti-Tumor Necrosis Factor-Alpha Agents for Patients with Intestinal Behcet’s Disease: A Systematic Review and Meta-Analysis
Qingfeng Zhang, Chunyan Ma, Rongrong Dong, Weizhen Xiang, Meiqi Li, Zhenzhen Ma, Qingrui Yang
Yonsei Medical Journal.2022; 63(2): 148. CrossRef
Efficacy of Anti-Tumor Necrosis Factor-α Therapy Against Intestinal Behçet’s Disease Complicated by Recurrent Enterocutaneous Fistulae
Hitomi Kashima, Satohiro Matsumoto, Shu Kojima, Yudai Koito, Takaya Miura, Takehiro Ishii, Hirosato Mashima
Biologics: Targets and Therapy.2022; Volume 16: 1. CrossRef
Long-Term Safety and Effectiveness of Adalimumab in Japanese Patients with Noninfectious Intermediate, Posterior, or Panuveitis: Post-Marketing Surveillance of 251 Patients
Kenichi Namba, Toshikatsu Kaburaki, Hidekazu Tsuruga, Yohei Ogawa, Eri Iwashita, Hiroshi Goto
Ophthalmology and Therapy.2022; 11(3): 1147. CrossRef
Anti-TNF-α agents for refractory intestinal Behçet’s disease: case series and meta-analysis
Shukai Zhan, Caiguang Liu, Na Li, Tong Li, Zhenyi Tian, Min Zhao, Dongxuan Wu, Minhu Chen, Zhirong Zeng, Xiaojun Zhuang
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Clinical Course of Patients with Intestinal Behçet’s Disease According to Consensus-Based Diagnostic Categories
Yu Young Joo, Bo-In Lee, Seung-Jun Kim, Han Hee Lee, Jin Su Kim, Jae Myung Park, Young-Seok Cho, Kang Moon Lee, Sang Woo Kim, Hwang Choi, Myung-Gyu Choi
Gut and Liver.2022; 16(5): 746. CrossRef
Case report: Refractory intestinal Behçet’s syndrome successfully treated with tofacitinib: A report of four cases
Na Zhao, Yanchun Tang, Shaokun Wang, Liping Cui, Xuehui Sun, Zhihua Wang, Ying Liu
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Successful Switch to Adalimumab after Long-Term Thalidomide-Based Maintenance Therapy for Juvenile Onset Intestinal Behçet's Disease: A Case Report
Masaki Yamashita, Hiroshi Yasuda, Masaki Kato, Hirofumi Kiyokawa, Yoshinori Sato, Tadateru Maehata, Satoko Kimura, Keisuke Tateishi
Journal of St. Marianna University.2022; 13(2): 149. CrossRef
A Contemporary Review of Behcet’s Syndrome
Jingjing Chen, Xu Yao
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Behçet syndrome
Yusuf Yazici, Gulen Hatemi, Bahram Bodaghi, Jae Hee Cheon, Noburu Suzuki, Nicola Ambrose, Hasan Yazici
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C-reactive protein is associated with postoperative outcomes in patients with intestinal Behçet’s disease
Eun Ae Kang, Jung Won Park, Yehyun Park, Soo Jung Park, Tae Il Kim, Won Ho Kim, Min Soo Cho, Jae Hee Cheon
BMC Gastroenterology.2021;[Epub] CrossRef

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Inflammatory bowel diseases

Phenotypic characteristics of pediatric inflammatory bowel disease in Japan: results from a multicenter registry: Katsuhiro Arai, Reiko Kunisaki, Fumihiko Kakuta, Shin-ichiro Hagiwara, Takatsugu Murakoshi, Tadahiro Yanagi, Toshiaki Shimizu, Sawako Kato, Takashi Ishige, Tomoki Aomatsu, Mikihiro Inoue, Takeshi Saito, Itaru Iwama, Hisashi Kawashima, Hideki Kumagai, Hitoshi Tajiri, Naomi Iwata, Takahiro Mochizuki, Atsuko Noguchi, Toshihiko Kashiwabara, Hirotaka Shimizu, Yasuo Suzuki, Yuri Hirano, Takeo Fujiwara; Intest Res 2020;18(4):412-420. Published online August 18, 2020; DOI: https://doi.org/10.5217/ir.2019.00130

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Background/Aims
There are few published registry studies from Asia on pediatric inflammatory bowel disease (IBD). Registry network data enable comparisons among ethnic groups. This study examined the characteristics of IBD in Japanese children and compared them with those in European children.
Methods
This was a cross-sectional multicenter registry study of newly diagnosed Japanese pediatric IBD patients. The Paris classification was used to categorize IBD features, and results were compared with published EUROKIDS data.
Results
A total of 265 pediatric IBD patients were initially registered, with 22 later excluded for having incomplete demographic data. For the analysis, 91 Crohn’s disease (CD), 146 ulcerative colitis (UC), and 6 IBD-unclassified cases were eligible. For age at diagnosis, 20.9% of CD, 21.9% of UC, and 83.3% of IBD-unclassified cases were diagnosed before age 10 years. For CD location, 18.7%, 13.2%, 64.8%, 47.3%, and 20.9% were classified as involving L1 (ileocecum), L2 (colon), L3 (ileocolon), L4a (esophagus/stomach/duodenum), and L4b (jejunum/proximal ileum), respectively. For UC extent, 76% were classified as E4 (pancolitis). For CD behavior, B1 (non-stricturing/non-penetrating), B2 (stricturing), B3 (penetrating), and B2B3 were seen in 83.5%, 11.0%, 3.3%, and 2.2%, respectively. A comparison between Japanese and European children showed less L2 involvement (13.2% vs. 27.3%, P< 0.01) but more L4a (47.3% vs. 29.6%, P< 0.01) and L3 (64.8% vs. 52.7%, P< 0.05) involvement in Japanese CD children. Pediatric perianal CD was more prevalent in Japanese children (34.1% vs. 9.7%, P< 0.01).
Conclusions
Upper gastrointestinal and perianal CD lesions are more common in Japanese children than in European children.

Citations

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Long‐term clinical and endoscopic outcomes of ustekinumab in pediatric Crohn's disease with anti‐tumor necrosis factor failure
Yoko Yamamoto, Ichiro Takeuchi, Hirotaka Shimizu, Hiroki Fujikawa, Masanori Toda, Eri Miyata, Hiroaki To, Satoru Nagata, Katsuhiro Arai
Journal of Gastroenterology and Hepatology.2025; 40(1): 123. CrossRef
Outcome of pediatric inflammatory bowel disease in Asian children: a multinational 1-year follow-up study
Pornthep Tanpowpong, Suporn Treepongkaruna, James Guoxian Huang, Kee Seang Chew, Karen Sophia Calixto Mercado, Almida Reodica, Shaman Rajindrajith, Wathsala Hathagoda, Yoko Kin Yoke Wong, Way Seah Lee, Marion Margaret Aw
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Inflammatory bowel diseases

Infliximab biosimilar CT-P13 is interchangeable with its originator for patients with inflammatory bowel disease in real world practice: Tomoo Nakagawa, Taku Kobayashi, Kiyohiro Nishikawa, Fumika Yamada, Satoshi Asai, Yukinori Sameshima, Yasuo Suzuki, Mamoru Watanabe, Toshifumi Hibi; Intest Res 2019;17(4):504-515. Published online August 23, 2019; DOI: https://doi.org/10.5217/ir.2019.00030

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Background/Aims
An interim analysis of post-marketing surveillance of CT-P13, an infliximab biosimilar, was performed to evaluate its safety and efficacy in Japanese patients with inflammatory bowel disease.
Methods
Patients were prospectively enrolled between November 2014 and March 2017, after the launch of CT-P13 in Japan, and case report forms of patients followed for at least 4 months were analyzed as of July 2018.
Results
Of 523 patients in the analysis set, 372 remained on CT-P13 therapy, while 54 (20.2%) of 267 patients with Crohn’s disease, and 97 (37.9%) of 256 patients with ulcerative colitis were withdrawn during follow-up. A total of 144 adverse drug reactions (ADRs) were reported in 106 patients (20.3%). Infusion reaction was the most frequent ADR observed in 49 patients (9.4%). Efficacy parameters decreased immediately after the start of treatment in naïve patients to anti-tumor necrosis factor-α antibody. In the patients switched from originator infliximab for nonmedical reasons, the decreased parameters due to proceeded treatment with the originator were maintained in low ranges, and the treatment continuation rate was high with low ADR incidence. In contrast, in patients switched for medical reasons such as adverse event or loss of response, the incidence of ADRs was high. However, the efficacy parameters were improved, and the treatment continuation rate was not significantly different from that of the naïve patient group.
Conclusions
In this interim analysis, CT-P13 was comparable to the originator infliximab with respect to ADRs and efficacy, and is therefore considered to be a cost-efficient interchangeable biosimilar for Japanese patients with inflammatory bowel disease.

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Tsubasa Oike, Naoki Akizue, Yuki Ohta, Hirotaka Koseki, Masaya Saito, Yuya Yokoyama, Yushi Imai, Takashi Taida, Kenichiro Okimoto, Keiko Saito, Sadahisa Ogasawara, Tomoaki Matsumura, Tomoo Nakagawa, Makoto Arai, Tatsuro Katsuno, Yoshihiro Fukuda, Yoshio K
Arab Journal of Gastroenterology.2024; 25(3): 257. CrossRef
Systematic review: effectiveness and safety of switching between originator infliximab and biosimilar infliximab in patients with inflammatory bowel disease
Gary R. Lichtenstein, Arif Soonasra, Mark Latymer, Sheena Singh, Brian G. Feagan
Expert Opinion on Biological Therapy.2024; 24(7): 691. CrossRef
Clinical experience of using biosimilars in Crohn’s disease and their effectiveness
Léa Sequier, Bénédicte Caron, Silvio Danese, Laurent Peyrin-Biroulet
Expert Opinion on Biological Therapy.2024; 24(10): 1145. CrossRef
Comparison of the Pharmacokinetics of CT-P13 Between Crohn’s Disease and Ulcerative Colitis
Eun Soo Kim, Sung Kook Kim, Dong Il Park, Hyo Jong Kim, Yoo Jin Lee, Ja Seol Koo, Eun Sun Kim, Hyuk Yoon, Ji Hyun Lee, Ji Won Kim, Sung Jae Shin, Hyung Wook Kim, Hyun-Soo Kim, Young Sook Park, You Sun Kim, Tae Oh Kim, Jun Lee, Chang Hwan Choi, Dong Soo Ha
Journal of Clinical Gastroenterology.2023; 57(6): 601. CrossRef
Long-term effectiveness and safety of infliximab-biosimilar: A multicenter Phoenix retrospective cohort study
Tomoe Kazama, Katsuyoshi Ando, Nobuhiro Ueno, Mikihiro Fujiya, Takahiro Ito, Atsuo Maemoto, Keisuke Ishigami, Masanori Nojima, Hiroshi Nakase, Shintaro Sagami
PLOS ONE.2023; 18(9): e0288393. CrossRef
Real-World Safety and Efficacy of Biosimilar CT-P13 in Patients with Immune-Mediated Inflammatory Diseases: Integrated Analysis of Three Japanese Prospective Observational Studies
Tsutomu Takeuchi, Kiyohiro Nishikawa, Fumika Yamada, Akimichi Morita, Mamitaro Ohtsuki, Yasuo Suzuki, Mamoru Watanabe, Hisashi Yamanaka, Toshifumi Hibi
Drug Safety.2023; 46(10): 991. CrossRef
Real-world safety and efficacy of CT-P13, an infliximab biosimilar, in Japanese rheumatoid arthritis patients naïve to or switched from biologics
Tsutomu Takeuchi, Kiyohiro Nishikawa, Fumika Yamada, Shiro Ohshima, Makoto Inoue, Yutaka Yoshioka, Hisashi Yamanaka
Modern Rheumatology.2022; 32(4): 718. CrossRef
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Bincy Abraham, Bertus Eksteen, Khan Nedd, Hrishikesh Kale, Dipen Patel, Jennifer Stephens, Ahmed Shelbaya, Richard Chambers, Arif Soonasra
Advances in Therapy.2022; 39(5): 2109. CrossRef
Safety, efficacy, and drug survival of the infliximab biosimilar CT‐P13 in post‐marketing surveillance of Japanese patients with psoriasis
Akimichi Morita, Kiyohiro Nishikawa, Fumika Yamada, Keiichi Yamanaka, Hideki Nakajima, Mamitaro Ohtsuki
The Journal of Dermatology.2022; 49(10): 957. CrossRef
Post‐marketing analysis for biosimilar CT‐P13 in inflammatory bowel disease compared with external data of originator infliximab in Japan
Shintaro Sagami, Kiyohiro Nishikawa, Fumika Yamada, Yasuo Suzuki, Mamoru Watanabe, Toshifumi Hibi
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Brian Godman, Mainul Haque, Santosh Kumar, Salequl Islam, Jaykaran Charan, Farhana Akter, Amanj Kurdi, Eleonora Allocati, Muhammed Abu Bakar, Sagir Abdur Rahim, Nusrat Sultana, Farzana Deeba, M. A. Halim Khan, A. B. M Muksudul Alam, Iffat Jahan, Zubair Ma
Current Medical Research and Opinion.2021; 37(9): 1529. CrossRef
Infliximab Biosimilar CT-P13 Observational Studies for Rheumatoid Arthritis, Inflammatory Bowel Diseases, and Ankylosing Spondylitis: Pooled Analysis of Long-Term Safety and Effectiveness
Jae Hee Cheon, Seongsu Nah, Hyoun Woo Kang, Yun Jeong Lim, Sang-Hoon Lee, Sang Joon Lee, Sung Hyun Kim, Na Hyun Jung, Jeong Eun Park, Yeo Jin Lee, Da Bee Jeon, Yeon Mi Lee, Jong Min Kim, Sung-Hwan Park
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Jimmy K Limdi, Francis A Farraye
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Hyo Yeop Song, Geom Seog Seo
Journal of the Korean Medical Association.2021; 64(9): 605. CrossRef
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Stephanie L. Ho, Fang Niu, Suresh Pola, Fernando S. Velayos, Xian Ning, Rita L. Hui
BioDrugs.2020; 34(3): 395. CrossRef
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Sang Joon Lee, KyungMin Baek, Sujin Lee, Yoon Jee Lee, Jeong Eun Park, Seul Gi Lee
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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

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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.

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Maximilian Wiendl, Emily Becker, Tanja M. Müller, Caroline J. Voskens, Markus F. Neurath, Sebastian Zundler
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John Gubatan, Kian Keyashian, Samuel JS Rubin, Jenny Wang, Cyrus Buckman, Sidhartha Sinha
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Virginia Solitano, Tommaso Lorenzo Parigi, Elisa Ragaini, Silvio Danese
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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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Subcutaneous integrin inhibitors may provide more treatment options for patients with moderate-to-severe ulcerative colitis
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Brief Communication

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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Statement

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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Special Review

IBD

Asian Organization for Crohn's and Colitis and Asia Pacific Association of Gastroenterology consensus on tuberculosis infection in patients with inflammatory bowel disease receiving anti-tumor necrosis factor treatment. Part 1: risk assessment: Dong Il Park, Tadakazu Hisamatsu, Minhu Chen, Siew Chien Ng, Choon Jin Ooi, Shu Chen Wei, Rupa Banerjee, Ida Normiha Hilmi, Yoon Tae Jeen, Dong Soo Han, Hyo Jong Kim, Zhihua Ran, Kaichun Wu, Jiaming Qian, Pin-Jin Hu, Katsuyoshi Matsuoka, Akira Andoh, Yasuo Suzuki, Kentaro Sugano, Mamoru Watanabe, Toshifumi Hibi, Amarender S. Puri, Suk-Kyun Yang; Intest Res 2018;16(1):4-16. Published online January 18, 2018; DOI: https://doi.org/10.5217/ir.2018.16.1.4

Abstract PDF PubReader ePub

Because anti-tumor necrosis factor (anti-TNF) therapy has become increasingly popular in many Asian countries, the risk of developing active tuberculosis (TB) among anti-TNF users may raise serious health problems in this region. Thus, the Asian Organization for Crohn's and Colitis and the Asia Pacific Association of Gastroenterology have developed a set of consensus statements about risk assessment, detection and prevention of latent TB infection, and management of active TB infection in patients with inflammatory bowel disease (IBD) receiving anti-TNF treatment. Twenty-three consensus statements were initially drafted and then discussed by the committee members. The quality of evidence and the strength of recommendations were assessed by using the Grading of Recommendations Assessment, Development, and Evaluation methodology. Web-based consensus voting was performed by 211 IBD specialists from 9 Asian countries concerning each statement. A consensus statement was accepted if at least 75% of the participants agreed. Part 1 of the statements comprised 2 parts: risk of TB infection Recommendaduring anti-TNF therapy, and screening for TB infection prior to commencing anti-TNF therapy. These consensus statements will help clinicians optimize patient outcomes by reducing the morbidity and mortality related to TB infections in patients with IBD receiving anti-TNF treatment.

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Special Review: Consensus on TB in IBD

IBD

Asian Organization for Crohn's and Colitis and Asia Pacific Association of Gastroenterology consensus on tuberculosis infection in patients with inflammatory bowel disease receiving anti-tumor necrosis factor treatment. Part 2: management: Dong Il Park, Tadakazu Hisamatsu, Minhu Chen, Siew Chien Ng, Choon Jin Ooi, Shu Chen Wei, Rupa Banerjee, Ida Normiha Hilmi, Yoon Tae Jeen, Dong Soo Han, Hyo Jong Kim, Zhihua Ran, Kaichun Wu, Jiaming Qian, Pin-Jin Hu, Katsuyoshi Matsuoka, Akira Andoh, Yasuo Suzuki, Kentaro Sugano, Mamoru Watanabe, Toshifumi Hibi, Amarender S. Puri, Suk-Kyun Yang; Intest Res 2018;16(1):17-25. Published online January 18, 2018; DOI: https://doi.org/10.5217/ir.2018.16.1.17

Abstract PDF PubReader ePub

Because anti-tumor necrosis factor (anti-TNF) therapy has become increasingly popular in many Asian countries, the risk of developing active tuberculosis (TB) among anti-TNF users may raise serious health problems in this region. Thus, the Asian Organization for Crohn's and Colitis and the Asia Pacific Association of Gastroenterology have developed a set of consensus statements about risk assessment, detection and prevention of latent TB infection, and management of active TB infection in patients with inflammatory bowel disease (IBD) receiving anti-TNF treatment. Twenty-three consensus statements were initially drafted and then discussed by the committee members. The quality of evidence and the strength of recommendations were assessed by using the Grading of Recommendations Assessment, Development, and Evaluation methodology. Web-based consensus voting was performed by 211 IBD specialists from 9 Asian countries concerning each statement. A consensus statement was accepted if at least 75% of the participants agreed. Part 2 of the statements comprised 3 parts: management of latent TB in preparation for anti-TNF therapy, monitoring during anti-TNF therapy, and management of an active TB infection after anti-TNF therapy. These consensus statements will help clinicians optimize patient outcomes by reducing the morbidity and mortality related to TB infections in patients with IBD receiving anti-TNF treatment.

Citations

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Yibing Hu, Zhenping Wu, Xiaoyun Yang, Jin Ding, Qunying Wang, Hao Fang, Lujian Zhu, Minli Hu
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Medical management of pediatric inflammatory bowel disease in the Asia‐Pacific region: A position paper by the Asian Pan‐Pacific Society for Pediatric Gastroenterology, Hepatology, and Nutrition (APPSPGHAN) PIBD Working Group
Way Seah Lee, Katsuhiro Arai, George Alex, Suporn Treepongkaruna, Kyung Mo Kim, Chee Liang Choong, Karen S. C. Mercado, Andy Darma, Anshu Srivastava, Marion M. Aw
Journal of Gastroenterology and Hepatology.2023; 38(4): 523. CrossRef
Korean clinical practice guidelines on biologics and small molecules for moderate-to-severe ulcerative colitis
Soo-Young Na, Chang Hwan Choi, Eun Mi Song, Ki Bae Bang, Sang Hyoung Park, Eun Soo Kim, Jae Jun Park, Bora Keum, Chang Kyun Lee, Bo-In Lee, Seung-Bum Ryoo, Seong-Joon Koh, Miyoung Choi, Joo Sung Kim
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Comparison of outcomes of continuation/discontinuation of 5-aminosalicylic acid after initiation of anti-tumor necrosis factor-alpha therapy in patients with inflammatory bowel disease
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Original Articles

Pregnancy outcome in women with inflammatory bowel disease treated with anti-tumor necrosis factor and/or thiopurine therapy: a multicenter study from Japan: Shunsuke Komoto, Satoshi Motoya, Yuji Nishiwaki, Toshiyuki Matsui, Reiko Kunisaki, Katsuyoshi Matsuoka, Naoki Yoshimura, Takashi Kagaya, Makoto Naganuma, Nobuyuki Hida, Mamoru Watanabe, Toshifumi Hibi, Yasuo Suzuki, Soichiro Miura, Ryota Hokari; Intest Res 2016;14(2):139-145. Published online April 27, 2016; DOI: https://doi.org/10.5217/ir.2016.14.2.139

Abstract PDF PubReader ePub

Background/Aims

Anti-tumor necrosis factor drugs (anti-TNF) and thiopurines are important treatment options in patients with inflammatory bowel disease (IBD), including during pregnancy. However, there are limited data on the benefit/risk profile of anti-TNF and thiopurines during pregnancy in Asia. The aim of this study was to analyze pregnancy outcomes of female Japanese IBD patients treated with anti-TNF and/or thiopurines.

Methods

This cross-sectional study assessed pregnancy outcomes in 72 women with IBD. Pregnancy outcomes were compared among 31 pregnancies without exposure to infliximab (IFX), adalimumab (ADA), or thiopurines; 24 pregnancies with exposure to anti-TNF treatment (23 IFX, 1 ADA); 7 pregnancies with exposure to thiopurines alone; and 10 pregnancies with exposure to both IFX and thiopurines.

Results

Thirty-five of the 41 pregnancies (85.3%) that were exposed to anti-TNF treatment and/or thiopurines resulted in live births after a median gestational period of 38 weeks. Of the 35 live births, 3 involved premature deliveries; 7, low birth weight; and 1, a congenital abnormality. There were 6 spontaneous abortions in pregnancies that were exposed to anti-TNF treatment (17.7%). Pregnancy outcomes among the 4 groups were similar, except for the rate of spontaneous abortions (P =0.037).

Conclusions

Exposure to anti-TNF treatment or thiopurines during pregnancy was not related to a higher incidence of adverse pregnancy outcomes in Japanese IBD patients except for spontaneous abortion.

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Efficacy and safety of two pH-dependent-release mesalamine doses in moderately active ulcerative colitis: a multicenter, randomized, double-blind, parallel-group study: Yasuo Suzuki, Mitsuo Iida, Hiroaki Ito, Isamu Saida, Toshifumi Hibi; Intest Res 2016;14(1):50-59. Published online January 26, 2016; DOI: https://doi.org/10.5217/ir.2016.14.1.50

Abstract PDF PubReader ePub

Background/Aims

The therapeutic effect of mesalamine is considered to be dose-dependent; however, no consensus has been reached regarding the optimal doses for individual patients. This study aimed to provide new insight for dose optimization using two doses of pH-dependent release mesalamine for induction of remission of moderately active ulcerative colitis (UC).

Methods

In a multicenter, double-blind, randomized study, 110 patients with moderately active UC were assigned to two groups after treatment with a constant dose of mesalamine. Fifty-five patients were treated with a pH-dependent release formulation of 3.6 or 4.8 g/day for 8 weeks. The primary endpoint was a decrease in the UC disease activity index (UCDAI) adjusted by covariates.

Results

In the full analysis set (n=110), the mean decrease in UCDAI was 3.1 in the 3.6 g/day group and 3.4 in the 4.8 g/day group (P>0.05). In a subgroup analysis, the effectiveness of the 4.8 g/day dose was greater in particular populations, such as those who had been previously treated with a lower dose of mesalamine and those with more severe disease. The safety was comparable between the two groups.

Conclusions

The results suggest that treatment with pH-dependent release mesalamine at either 3.6 or 4.8 g/day was effective and safe for the induction of remission in patients with moderately active UC. However, the patients receiving mesalamine at 2.4 g/day but in whom the therapeutic effect is not sufficient and having more severe symptoms (UCDAI 9-10), benefit from higher doses of mesalamine compared to others.

Citations

Citations to this article as recorded by

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Seong Jae Yeo, Hyun Seok Lee, Byung Ik Jang, Eun Soo Kim, Seong Woo Jeon, Sung Kook Kim, Kyeong Ok Kim, Yoo Jin Lee, Hyun Jik Lee, Kyung Sik Park, Yun Jin Jung, Eun Young Kim, Chang Heon Yang
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Comparison of efficacy of multimatrix mesalazine 4.8 g/day once-daily with other high-dose mesalazine in active ulcerative colitis: a randomized, double-blind study
Haruhiko Ogata, Nobuo Aoyama, Seiichi Mizushima, Atsushi Hagino, Toshifumi Hibi
Intestinal Research.2017; 15(3): 368. CrossRef
Remission endpoints in ulcerative colitis: A systematic review
Maki Jitsumura, Rory Frederick Kokelaar, Dean Anthony Harris
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Alicia Algaba, Iván Guerra, Ana García García de Paredes, María Hernández Tejero, Carlos Ferre, Daniel Bonillo, Lara Aguilera, Antonio López-Sanromán, Fernando Bermejo
Revista Española de Enfermedades Digestivas.2016;[Epub] CrossRef

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Conventional Versus Biological Therapy for Prevention of Postoperative Endoscopic Recurrence in Patients With Crohn's Disease: an International, Multicenter, and Observational Study: Paulo Gustavo Kotze, Antonino Spinelli, Rodolff Nunes da Silva, Ivan Folchini de Barcelos, Fábio Vieira Teixeira, Rogério Saad-Hossne, Idblan Carvalho de Albuquerque, Marcia Olandoski, Lorete Maria da Silva Kotze, Yasuo Suzuki, Akihiro Yamada, Ken Takeuchi, Matteo Sacchi, Takayuki Yamamoto; Intest Res 2015;13(3):259-265. Published online June 9, 2015; DOI: https://doi.org/10.5217/ir.2015.13.3.259

Abstract PDF PubReader

Background/Aims

Postoperative endoscopic recurrence (PER) occurs in nearly 80% of patients 1 year after ileocecal resection in patients with Crohn's disease (CD). Biological agents were more effective in reducing the rates of PER in comparison with conventional therapy, in prospective trials. The aim of this study was to compare the PER rates of biological versus conventional therapy after ileocecal resections in patients with CD in real-world practice.

Methods

The MULTIPER (Multicenter International Postoperative Endoscopic Recurrence) database is a retrospective analysis of PER rates in CD patients after ileocecal resection, from 7 referral centers in 3 different countries. All consecutive patients who underwent ileocecal resections between 2008 and 2012 and in whom colonoscopies had been performed up to 12 months after surgery, were included. Recurrence was defined as Rutgeerts' score ≥i2. The patients were allocated to either biological or conventional therapy after surgery, and PER rates were compared between the groups.

Results

Initially, 231 patients were evaluated, and 63 were excluded. Of the 168 patients in the database, 96 received anti-tumor necrosis factor agents and 72 were treated with conventional therapy after resection. The groups were comparable regarding age, gender, and perianal disease. There was longer disease duration, more previous resections, and more open surgical procedures in patients on biologicals postoperatively. PER was identified in 25/96 (26%) patients on biological therapy and in 24/72 (33.3%) patients on conventional therapy (P=0.310).

Conclusions

In this retrospective observational analysis from an international database, no difference was observed between biological and conventional therapy in preventing PER after ileocecal resections in CD patients.

Citations

Citations to this article as recorded by

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Intestinal Research.2018; 16(1): 75. CrossRef
Factors affecting the incidence of early endoscopic recurrence after ileocolonic resection for Crohn's disease: a multicentre observational study
I. F. de Barcelos, P. G. Kotze, A. Spinelli, Y. Suzuki, F. V. Teixeira, I. C. de Albuquerque, R. Saad‐Hossne, L. M. da Silva Kotze, T. Yamamoto
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