Intestinal Research

ORIGINAL ARTICLE

Efficacy and safety of etrasimod in Japanese patients with ulcerative colitis: results from a phase 2 dose-ranging study: Ken Takeuchi, Hiroshi Nakase, Tadakazu Hisamatsu, Katsuyoshi Matsuoka, Shoko Arai, Hirotoshi Yuasa, Motoki Oe, Ryosuke Ono, Michael Keating, Guibao Gu, Krisztina Lazin, Aoibhinn McDonnell, Koki Fukuta, Toshifumi Hibi; Received December 17, 2024 Accepted March 4, 2025 Published online April 25, 2025; DOI: https://doi.org/10.5217/ir.2024.00213 [Epub ahead of print]

Abstract PDF: Background/Aims
Etrasimod is an oral, once-daily, selective sphingosine 1-phosphate1,4,5 receptor modulator for the treatment of moderately to severely active ulcerative colitis (UC). However, its efficacy, safety, and the appropriate dosage have not been extensively investigated in the Japanese population.
Methods
This phase 2, multicenter, randomized, double-blind, placebo-controlled dose-ranging, 12-week trial was carried out among Japanese patients with moderately to severely active UC. Patients were randomized 1:1:1 to receive etrasimod 1 mg once daily (QD), etrasimod 2 mg QD, or placebo. The primary efficacy endpoint was the proportion of patients achieving clinical remission at week 12. Secondary efficacy endpoints and treatmentemergent adverse events (TEAEs) were also investigated. Efficacy endpoints were presented as proportions of patients achieving each outcome.
Results
Overall, 17, 19, and 18 patients received etrasimod 1 mg QD, etrasimod 2 mg QD, and placebo, respectively. One patient receiving etrasimod 1 mg (6.7%), 5 patients receiving etrasimod 2 mg (26.3%), and no patients receiving placebo (0%) achieved clinical remission. More patients receiving etrasimod versus placebo achieved secondary endpoints, except endoscopic normalization, at week 12. TEAEs were experienced by 9 patients receiving etrasimod 1 mg (52.9%), 13 patients receiving etrasimod 2 mg (68.4%), and 10 patients receiving placebo (55.6%). None of the TEAEs were serious and none experienced by patients receiving etrasimod led to treatment discontinuation.
Conclusions
Overall, etrasimod 2 mg QD for up to 12 weeks appeared efficacious and safe in these Japanese patients with moderately to severely active UC. All TEAEs were mild to moderate in severity. (ClinicalTrials.gov: NCT05061446)

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Original Articles

Clinical characteristics of patients with difficult-to-treat ulcerative colitis: a nested case-control study using a Japanese claims database: Katsuyoshi Matsuoka, Ataru Igarashi, Noriko Sato, Naomi Mizuno, Manabu Ishii, Masato Iizuka, Katsuhiko Iwasaki, Ayako Shoji, Tadakazu Hisamatsu; Received July 22, 2024 Accepted February 11, 2025 Published online April 25, 2025; DOI: https://doi.org/10.5217/ir.2024.00119 [Epub ahead of print]

Abstract PDF: Background/Aims
Despite the advent of advanced therapies, cases of so-called “difficult-to-treat” (D2T) ulcerative colitis (UC) persist. This study aims to clarify the epidemiological and clinical characteristics of patients with D2T UC.
Methods
We conducted a nested case-control study using the Medical Data Vision Claims Database in patients with UC who began an advanced therapy (biologics, advanced small molecules, calcineurin inhibitors) from January 2018 through April 2023. D2T UC patients were defined as having 2 or more switches of advanced therapies, or as undergoing surgery for UC, within 2 years after the first advanced therapy.
Results
Four hundred and one (16.7%) and 1,996 patients (83.3%) met the definitions of patients with D2T UC and non-D2T UC, respectively. After 1:1 matching by index year, 355 patients per group were included in the analysis. Multivariate logistic regression analyses, including sensitivity analyses based on follow-up period after the first advanced therapy, showed that a prescribed corticosteroid dose of ≥ 30 mg/day during the 6-month baseline period was associated with D2T UC. In D2T UC patients, median duration of the first advanced therapy was 99 days, and median number of advanced therapies per year was 1.7. The first advanced therapy was continued for 2 years in 78% of patients with non-D2T UC.
Conclusions
The proportion of D2T UC patients among UC patients starting advanced therapy was 16.7%. The factor most associated with D2T UC was the need for a corticosteroid dose ≥ 30 mg/day during the 6 months before initiation of advanced therapy.

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Persistence of advanced therapies in patients with inflammatory bowel disease: retrospective cohort study using a large healthcare claims database in Japan: Katsuyoshi Matsuoka, Ko Nakajo, Shiho Kawamura, Yongjing Zhang, Hsingwen Chung, Bryan Wahking, Jin Yu Tan, Hong Qiu; Received July 22, 2024 Accepted October 8, 2024 Published online January 2, 2025; DOI: https://doi.org/10.5217/ir.2024.00118 [Epub ahead of print]

Abstract PDF Supplementary Material PubReader ePub: Background/Aims
There are few studies that comprehensively report real-world persistence for first-line advanced therapies used to treat inflammatory bowel disease. We aimed to describe persistence of first-line advanced therapies among incident biologic or Janus kinase inhibitor users with inflammatory bowel disease.
Methods
Retrospective cohort study using the Japan Medical Data Center database from January 1, 2010, until September 30, 2022. Patients aged ≥15 years with relevant diagnostic and treatment codes were included. All eligible patients were observed until study end (September 30, 2022), death, or disenrollment, whichever occurred first.
Results
Among 1,115 patients with Crohn’s disease included in the analysis, 41.4% initiated adalimumab, 37.4% infliximab, 18.1% ustekinumab, and 3.0% vedolizumab. Median age was 31.2–34.8 years, 72.8% to 85.9% were male. Persistence at 12 months was 84.7% for adalimumab, 87.7% for infliximab, 91.3% for ustekinumab, and 53.1% for vedolizumab. Persistence at 24 months was 76.3%, 76.8%, 80.4%, and 28.6%, respectively. Among 1,942 patients with ulcerative colitis, 24.8% initiated adalimumab, 33.6% infliximab, 11.2% golimumab, 17.5% vedolizumab, 5.6% ustekinumab, and 7.3% tofacitinib. Mean age was 38.2–40.4 years, 57.4% to 65.8% were male. Persistence at 12 months was 57.6% for adalimumab, 87.7% for infliximab, 54.9% for golimumab, 69.7% for vedolizumab, and 84.0% for ustekinumab. At month 24, persistence for ustekinumab was 75.0%, versus 42.9%–59.4% for other treatments.
Conclusions
Index treatment with ustekinumab resulted in high persistence through 24 months after initiation in patients with Crohn’s disease or ulcerative colitis. Our study provides insights into the real-world usage of advanced treatments for patients with IBD in Japan.

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IBD

Efficacy and safety of mirikizumab as induction and maintenance therapy for Japanese patients with moderately to severely active ulcerative colitis: a subgroup analysis of the global phase 3 LUCENT-1 and LUCENT-2 studies: Taku Kobayashi, Katsuyoshi Matsuoka, Mamoru Watanabe, Tadakazu Hisamatsu, Fumihito Hirai, Joe Milata, Xingyuan Li, Nathan Morris, Vipin Arora, Tomoko Ishizuka, Koji Matsuo, Yoichi Satoi, Catherine Milch, Toshifumi Hibi; Intest Res 2024;22(2):172-185. Published online April 25, 2024; DOI: https://doi.org/10.5217/ir.2023.00043

Abstract PDF Supplementary Material PubReader ePub

Background/Aims
Mirikizumab is a p19-directed anti-interleukin-23 antibody with potential efficacy against ulcerative colitis (UC). We evaluated the efficacy and safety of mirikizumab in a Japanese subpopulation with moderately to severely active UC from the LUCENT-1 and LUCENT-2 studies.
Methods
LUCENT-1 and LUCENT-2 were phase 3, randomized, double-blind, placebo-controlled trials of mirikizumab therapy in adults with moderately to severely active UC. LUCENT-1 was a 12-week induction trial where patients were randomized 3:1 to receive intravenous mirikizumab 300 mg or placebo every 4 weeks (Q4W). Patients achieving a clinical response with mirikizumab following the induction study were re-randomized 2:1 to double-blind treatment with either mirikizumab 200 mg or placebo subcutaneously Q4W during the 40-week maintenance study. The primary outcomes were clinical remission at week 12 of LUCENT-1 and week 40 of LUCENT-2.
Results
A total of 137 patients enrolled in Japan were randomized to mirikizumab (n = 102) or placebo (n = 35). Compared with placebo, patients who received mirikizumab showed numerically higher clinical remission at week 12 of induction (32.4% [n = 33] vs. 2.9% [n = 1]) and at week 40 of maintenance (48.9% [n = 23] vs. 28.0% [n = 7]). A greater number of patients achieved key secondary endpoints in the mirikizumab group compared with placebo. The frequency of treatment-emergent adverse events was similar across mirikizumab and placebo groups. Efficacy and safety results observed in the Japanese subpopulation were generally consistent with those in the overall population.
Conclusions
Mirikizumab induction and maintenance treatments were effective in Japanese patients with moderately to severely active UC. No new safety concerns were identified.

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Mirikizumab – a new option in treatment of inflammatory bowel diseases
Jakub Olszewski, Katarzyna Kozon, Magdalena Sitnik, Katarzyna Herjan, Karolina Mikołap, Bartłomiej Gastoł, Maciej Bara, Piotr Armański, Marcin Sawczuk
Prospects in Pharmaceutical Sciences.2024; 22(3): 178. CrossRef
Key Interleukins in Inflammatory Bowel Disease—A Review of Recent Studies
David Aebisher, Dorota Bartusik-Aebisher, Agnieszka Przygórzewska, Piotr Oleś, Paweł Woźnicki, Aleksandra Kawczyk-Krupka
International Journal of Molecular Sciences.2024; 26(1): 121. CrossRef

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IBD

Association between oral corticosteroid starting dose and the incidence of pneumonia in Japanese patients with ulcerative colitis: a nation-wide claims database study: Katsuyoshi Matsuoka, Tomoyuki Inoue, Hiroaki Tsuchiya, Katsumasa Nagano, Toshiyuki Iwahori; Intest Res 2024;22(3):319-335. Published online February 6, 2024; DOI: https://doi.org/10.5217/ir.2023.00071

Abstract PDF Supplementary Material PubReader ePub: Background/Aims
A previous study demonstrated that half of patients started oral corticosteroids (OCS) for ulcerative colitis (UC) exacerbations at lower doses than recommended by Japanese treatment guidelines (initial OCS prednisolone equivalent dose, 30–40 mg). This may relate to physician’s concern about infection, especially pneumonia including Pneumocystis jirovecii pneumonia (PJP), from high OCS doses. We assessed whether pneumonia incidence is increased with guideline-recommended OCS initial doses.
Methods
This retrospective cohort study used the Japan Medical Data Center claims database (2012–2021). The whole cohort consisted of all UC patients who started OCS during the study period meeting the inclusion and exclusion criteria. The matched cohort was created by propensity score matching; the lower (initial OCS dose < 30 mg), guideline-recommended (30–40 mg), and higher groups ( > 40 mg) in a 2:2:1 ratio. Pneumonia incidence in the primary analysis was evaluated in the matched cohort. A Poisson regression model determined pneumonia-related risk factors in the whole cohort.
Results
After screening, 3,349 patients comprised the whole cohort; 1,775 patients comprised the matched cohort (lower dose, n = 710; guideline-recommended dose, n = 710; higher dose, n = 355). The incidence of any pneumonia was low; no differences were observed in incidence rates across these dose subgroups. In total, 3 PJP cases were found in the whole cohort, but not detected in the matched cohort. Several risk factors for any pneumonia were identified, including age, higher comorbidities index, treatment in large facility and hospitalization.
Conclusions
The incidence of pneumonia, including PJP, in UC patients was low across initial OCS dose treatment subgroups.

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IBD

Vaccination in patients with inflammatory bowel disease–Asian perspectives: the results of a multinational web-based survey in the 8th Asian Organization for Crohn’s and Colitis meeting: Su Bum Park, Kyeong Ok Kim, Hong Sub Lee, Chang Hwan Choi, Shu Chen Wei, Min Hu Chen, Katsuyoshi Matsuoka; Intest Res 2023;21(3):363-374. Published online June 16, 2023; DOI: https://doi.org/10.5217/ir.2023.00015

Abstract PDF Supplementary Material PubReader ePub

Background/Aims
Long-term immunosuppressive therapies used to treat inflammatory bowel disease (IBD) are associated with an increased risk of infections, many of which can be prevented by vaccination. We assessed physicians’ current approaches and clinical practices regarding vaccinations for IBD patients in different Asian countries/regions.
Methods
An internet-based survey was conducted among members of the Asian Organization for Crohn’s and Colitis from September 2020 to November 2020. The questionnaire consisted of 2 parts covering general opinion on the relevance of vaccinations and clinical practice of vaccination.
Results
Overall, 384 Asian medical doctors responded to the survey. The majority of respondents considered it very (57.6%) or sufficiently (39.6%) important to perform vaccinations as recommended by the guidelines. About half of the Asian physicians (52.6%) were usually or always performing vaccinations. The influenza vaccine was the most frequently recommended vaccine for IBD patients. Half of the respondents (51.3%) did not recommend hepatitis A vaccine, especially in China (61.6%) and Japan (93.6%). The diphtheria, tetanus, and pertussis vaccine were never (35.2%) or rarely (29.4%) recommended.
Conclusions
The findings of this survey indicated similarities among countries/regions in terms of the current approaches and practices regarding vaccination of IBD patients; however, there are some differences that might reflect each country’s domestic vaccination guidelines and health insurance particularly with certain vaccines in some countries/regions. Although Asian physicians largely recommend vaccination, more awareness among doctors and Asian consensus regarding differences in IBD vaccination among countries/regions may be required.

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Suboptimal Vaccination Coverage and Serological Screening in Western Australian Children With Inflammatory Bowel Disease Receiving Immunosuppressive Therapy: An Opportunity for Improvement
Muhammad Shahzad Shabir, Sibgha Arif, Dan Yeoh, Zubin Grover
Cureus.2024;[Epub] CrossRef
Beyond the survey, to the ideal therapy for Asian
Ki Jae Jo, Jong Pil Im
Intestinal Research.2023; 21(3): 280. CrossRef
Crohn's disease and clinical management today: How it does?
Ronaldo Teixeira da Silva Júnior, Jonathan Santos Apolonio, Jessica Oliveira de Souza Nascimento, Bruna Teixeira da Costa, Luciano Hasimoto Malheiro, Marcel Silva Luz, Lorena Sousa de Carvalho, Cleiton da Silva Santos, Fabrício Freire de Melo
World Journal of Methodology.2023; 13(5): 399. CrossRef

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IBD

Incidence rates for hospitalized infections, herpes zoster, and malignancies in patients with ulcerative colitis in Japan: an administrative health claims database analysis: Katsuyoshi Matsuoka, Kanae Togo, Noritoshi Yoshii, Masato Hoshi, Shoko Arai; Intest Res 2023;21(1):88-99. Published online March 11, 2022; DOI: https://doi.org/10.5217/ir.2021.00154

Abstract PDF Supplementary Material PubReader ePub

Background/Aims
Patients with ulcerative colitis (UC) are at an increased risk of certain infections and malignancies compared with the general population. Incidence rates (IRs) of hospitalized infections, herpes zoster (HZ), and malignancies in patients with UC, stratified by treatment, in Japan were estimated.
Methods
This retrospective study identified patients with UC treated with corticosteroids, immunosuppressants, or tumor necrosis factor inhibitors (TNFi) from 2 administrative databases (Japan Medical Data Center [JMDC] and Medical Data Vision [MDV]). IRs (unique patients with events per 100 patient‐years) were estimated for hospitalized infections, HZ, and malignancies, between June 2010 and May 2018.
Results
Among 6,033 MDV patients with UC receiving corticosteroids, immunosuppressants, or TNFi, IRs (95% confidence intervals) were: hospitalized infections, 1.73 (1.52–1.93); HZ, 1.00 (0.85–1.16), and malignancies, 1.48 (1.29–1.66). Among 958 JMDC patients with UC receiving corticosteroids, immunosuppressants, or TNFi, IRs (95% confidence intervals) were: HZ, 1.82 (1.27–2.37) and malignancies, 1.35 (0.87–1.82). In both cohorts, IRs of malignancies were generally similar among patients receiving immunosuppressants, TNFi, or combination therapy (immunosuppressants and TNFi); this was also true for IRs of hospitalized infections and HZ in the MDV cohort. IRs of hospitalized infections, HZ, and malignancies were higher in patients receiving calcineurin inhibitors compared with immunosuppressants or TNFi, in both cohorts.
Conclusions
IRs of hospitalized infections, HZ, and malignancies among patients with UC were generally similar regardless of UC treatment, except for calcineurin inhibitors.

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Post-marketing surveillance of tofacitinib in patients with ulcerative colitis in Japan: a final report of safety and effectiveness data
Katsuyoshi Matsuoka, Satoshi Motoya, Takayuki Yamamoto, Minoru Matsuura, Toshimitsu Fujii, Shinichiro Shinzaki, Yohei Mikami, Shoko Arai, Junichi Oshima, Yutaka Endo, Hirotoshi Yuasa, Masato Hoshi, Keiko Sato, Tadakazu Hisamatsu
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Mycoses.2024;[Epub] CrossRef
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Hyuk Yoon, Byong Duk Ye, Sang-Bum Kang, Kang-Moon Lee, Chang Hwan Choi, Joo-young Jo, Juwon Woo, Jae Hee Cheon
BMC Gastroenterology.2024;[Epub] CrossRef
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Ryota Hase, Daisuke Suzuki, Cynthia de Luise, Haoqian Chen, Edward Nonnenmacher, Takakazu Higuchi, Kayoko Katayama, Mitsuyo Kinjo, Sadao Jinno, Toshitaka Morishima, Naonobu Sugiyama, Yoshiya Tanaka, Soko Setoguchi
BMC Infectious Diseases.2023;[Epub] CrossRef
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Yoo Jin Lee, Eun Soo Kim
The Korean Journal of Internal Medicine.2022; 37(5): 920. CrossRef

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IBD

Efficacy and safety of filgotinib as induction and maintenance therapy for Japanese patients with moderately to severely active ulcerative colitis: a post-hoc analysis of the phase 2b/3 SELECTION trial: Toshifumi Hibi, Satoshi Motoya, Tadakazu Hisamatsu, Fumihito Hirai, Kenji Watanabe, Katsuyoshi Matsuoka, Masayuki Saruta, Taku Kobayashi, Brian G Feagan, Chantal Tasset, Robin Besuyen, Chohee Yun, Gerald Crans, Jie Zhang, Akira Kondo, Mamoru Watanabe; Intest Res 2023;21(1):110-125. Published online March 11, 2022; DOI: https://doi.org/10.5217/ir.2021.00143

Abstract PDF Supplementary Material PubReader ePub

Background/Aims
The safety and efficacy of filgotinib, a once-daily oral Janus kinase 1 preferential inhibitor, were evaluated in Japanese patients with ulcerative colitis (UC) in the phase 2b/3 SELECTION trial.
Methods
SELECTION (NCT02914522) was a randomized, placebo-controlled trial comprising 2 induction studies and a maintenance study. Adults with moderately to severely active UC were randomized in induction study A (biologic-naïve) or B (biologic-experienced) to receive filgotinib 200 mg, 100 mg, or placebo once daily for 11 weeks. Patients in clinical remission or Mayo Clinic score response at week 10 entered the 47-week maintenance study. Efficacy and safety outcomes were assessed in Japanese patients enrolled in Japan.
Results
Overall, 37 and 72 Japanese patients were enrolled in Japan in induction studies A and B, respectively, and 54 entered the maintenance study. Numerically higher proportions of filgotinib 200 mg-treated than placebo-treated patients achieved clinical remission in induction study A (4/15 [26.7%] vs. 0/6 [0%]) and the maintenance study (5/20 [25.0%] vs. 0/9 [0%]), but not induction study B (1/29 [3.4%] vs. 1/14 [7.1%]). Both doses were well tolerated, and no new safety signals were noted. Herpes zoster was reported in 1 filgotinib 200 mg-treated patient in each of induction study A (2.3%, 1/44) and the maintenance study (5.0%, 1/20).
Conclusions
These data, alongside those of the overall SELECTION population, suggest the potential of filgotinib 200 mg as a viable treatment option for Japanese patients with UC. Owing to small patient numbers, data should be interpreted cautiously.

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Inflammatory bowel diseases

NUDT15 gene variants and thiopurine-induced leukopenia in patients with inflammatory bowel disease: Katsuyoshi Matsuoka; Intest Res 2020;18(3):275-281. Published online June 3, 2020; DOI: https://doi.org/10.5217/ir.2020.00002

Abstract PDF PubReader ePub

Thiopurine has been used to maintain remission and to reduce antidrug antibody formation in monoclonal antibody therapy in patients with inflammatory bowel disease (IBD). The use of thiopurine is limited by side effects such as leukopenia. Thiopurine S-methyltransferase (TPMT) variants are associated with thiopurine-induced leukopenia in Westerners, but the frequency of the risk alleles is low in Asians. Recently, a variant in the nudix hydrolase 15 (NUDT15) gene (R139C, c.415C > T) was reported to be associated with early severe leukopenia in Asians. NUDT15 is an enzyme that converts 6-thio-(deoxy)guanosine triphosphate (6-T(d)GTP) to 6-thio-(deoxy)guanosine monophosphate (6-T(d)GMTP). The R139C variant impairs the stability of the protein and increases incorporation of 6-TGTP and 6-TdGTP into RNA and DNA, respectively, resulting in leukopenia. The frequency of C/C, C/T, and T/T are approximately 80%, 20%, and 1%, respectively in East Asians. Early leukopenia occurred in less than 3% of patients with C/C and in around 20% of those with C/T, whereas it occurred in almost all patients with T/T. Patients homozygous for this variant also develop severe hair loss. The measurement of NUDT15 R139C can increase the safety of thiopurine dramatically and is a successful example of personalized medicine in the field of IBD.

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Case Report

IBD

5-Aminosalicylic acid aggravates colitis mimicking exacerbation of ulcerative colitis: Jun Miyoshi, Katsuyoshi Matsuoka, Atsushi Yoshida, Makoto Naganuma, Tadakazu Hisamatsu, Tomoharu Yajima, Nagamu Inoue, Susumu Okamoto, Yasushi Iwao, Haruhiko Ogata, Fumiaki Ueno, Toshifumi Hibi, Takanori Kanai; Intest Res 2018;16(4):635-640. Published online October 10, 2018; DOI: https://doi.org/10.5217/ir.2018.00015

Abstract PDF PubReader ePub

Ulcerative colitis (UC) is one of the major clinical phenotypes of inflammatory bowel diseases. Although 5-aminosalicylic acid (5-ASA) is widely used for UC and its efficacy and safety have been demonstrated, a few patients paradoxically develop a severe exacerbation of colitis by 5-ASA administration. It is crucial to know clinical features including endoscopic findings in this condition for making a correct diagnosis and a prompt decision to withdraw the medication. Here, we report case series with UC exacerbated by 5-ASA. Medical records of 8 UC patients experiencing an exacerbation of colitis after induction of 5-ASA that was improved by the withdrawal of 5-ASA but also re-aggravated by dose increase or re-administration of 5-ASA were reviewed. The patients were newly diagnosed with UC, started 5-ASA and developed an exacerbation in approximately 2 to 3 weeks. They did not appear to have systemic allergic reactions. Seven of the 8 patients had a high fever. Three of 5 patients who undertook total colonoscopy showed right-side-dominant colitis. These findings suggest clinical characteristics in this condition. Further assessment of clinical and endoscopic features in more cases is necessary for establishing diagnostic criteria and understanding underlying mechanisms in those cases where 5-ASA aggravates the colitis.

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Yuka Minoura, Koji Yokoyama, Yuko Okada, Shinya Fukuda, Hideki Kumagai
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Yingying Liu, Ainsley M. Robinson, Xiao Qun Su, Kulmira Nurgali
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Ye Yang, Min Kim, Ho Lee, Won-Yung Lee, Ju-Hye Yang, Hun Kim, Min Shim, Ji Heo, Jae Son, Woo Kim, Gon Kim, Hu-Jang Lee, Young-Woo Kim, Kwang Kim, Kwang Park
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Hiroshi Matsumoto, Momoyo Sasahira, Tei Tei Go, Shogen Yo, Takehiro Ninomiya, Motoyasu Osawa, Osamu Handa, Eiji Umegami, Ryo Inoue, Akiko Shiotani
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Naoki Abe, Naomi Iwata, Ryuhei Yasuoka, Daisuke Nishida, Asami Oohara, Haruna Nakaseko, Shiro Sugiura, Shinji Kawabe
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Yohei Mikami, Junya Tsunoda, Shohei Suzuki, Ichiro Mizushima, Hiroki Kiyohara, Takanori Kanai
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Original Article

IBD

β-(1,3)-Glucan derived from Candida albicans induces inflammatory cytokines from macrophages and lamina propria mononuclear cells derived from patients with Crohn's disease: Kiyoto Mori, Makoto Naganuma, Shinta Mizuno, Hiroaki Suzuki, Mina T. Kitazume, Katsuyoshi Shimamura, Sayako Chiba, Akira Sugita, Katsuyoshi Matsuoka, Tadakazu Hisamatsu, Takanori Kanai; Intest Res 2018;16(3):384-392. Published online July 27, 2018; DOI: https://doi.org/10.5217/ir.2018.16.3.384

Abstract PDF Supplementary Material PubReader ePub

Background/Aims

Recent research has highlighted the importance of interactions between commensal fungi and intestinal inflammation. However, there are few studies investigating whether commensal fungi contribute to inflammation in patients with Crohn's disease (CD). The aim of this study is to investigate reveal interactions between commensal fungi and host immune cells in CD.

Methods

CD14-positive monocytes were isolated from peripheral blood mononuclear cells from healthy human volunteers and then differentiated in the presence of macrophage colony-stimulating factor (M-CSF) (referred to as M-macrophages, M-Mϕs) or M-CSF and interferon-γ (IFN-γ) (referred to as M-gamma macrophages, Mγ-Mϕs). Cytokine production by these in vitro differentiated macrophages in response to β-(1,3)-glucan was analyzed by flow cytometry. Expression of Dectin-1 was examined using flow cytometry, western blotting, and quantitative reverse transcription-polymerase chain reaction. Cytokine production by in vitro differentiated macrophages in response to β-(1,3)-glucan was measured in the presence of an anti-Dectin-1 receptor antagonist, anti-Syr, or an anti-Fas-1 antibody. Cytokine production by lamina propria mononuclear cells (LPMCs) derived from CD patients in response to β-(1,3)-glucan was also analyzed.

Results

Mγ-Mϕs produced a large amount of tumor necrosis factor-α (TNF-α) and interleukin-6 in response to β-(1,3)-glucan. Dectin-1 expression was significantly higher in Mγ-Mϕs than in M-Mϕs. The increase in TNF-α production by Mγ-Mϕs stimulated with glucan was reversed by blocking Dectin-1, Syr or Fas-1. LPMCs derived from CD patients stimulated with β-(1,3)-glucan produced significantly higher amount of TNF-α than LPMCs derived from UC patients.

Conclusions

These results suggest that commensal fungal microbiota may contribute to the pathogenesis of CD by inducing macrophages-derived pro-inflammatory cytokines.

Citations

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Serum 1,3-beta-D-glucan as a noninvasive test to predict histologic activity in patients with inflammatory bowel disease
Katia Farias e Silva, Hayandra F Nanini, Cynthia Machado Cascabulho, Siane L B Rosas, Patricia T Santana, Antonio José de V Carneiro, Elias Anaissie, Marcio Nucci, Heitor Siffert Pereira de Souza
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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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Case Report

IBD

Fecal microbiota transplantation for recurrent Clostridium difficile infection in a patient with ulcerative colitis: Kosaku Nanki, Shinta Mizuno, Katsuyoshi Matsuoka, Keiko Ono, Shinya Sugimoto, Hiroki Kiyohara, Mari Arai, Moeko Nakashima, Kozue Takeshita, Keiichiro Saigusa, Mitsutoshi Senoh, Tadashi Fukuda, Makoto Naganuma, Haru Kato, Wataru Suda, Masahira Hattori, Takanori Kanai; Intest Res 2018;16(1):142-146. Published online January 18, 2018; DOI: https://doi.org/10.5217/ir.2018.16.1.142

Abstract PDF PubReader ePub

Fecal microbiota transplantation (FMT) has been reported as a safe and effective therapy in patients with refractory and recurrent Clostridium difficile infection (CDI). FMT has also been reported as a promising therapy in patients with ulcerative colitis (UC). Both, CDI and UC, are believed to be caused by dysbiosis, such as altered compositions or decreased diversity of the intestinal microbiota. This report describes a patient with UC in remission with a second recurrent episode of CDI, who was treated with FMT. A single FMT performed via colonoscopy completely resolved the patient's diarrhea and eradicated C. difficile bacteriologically without any severe complications. Molecular biological analysis of the patient's fecal microbiota showed that FMT could dramatically change the altered composition of intestinal microbiota and restore its diversity. Despite the restoration of the intestinal microbiota, FMT could not prevent a relapse of UC in this patient. However, it improved the intestinal symptoms of CDI and could prevent further recurrences of CDI.

Citations

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Impact of Clostridioides difficile Infection on Clinical Outcomes in Hospitalized IBD Patients and the Role of Fecal Microbiota Transplantation: A Retrospective Cohort Study
Puo‐Hsien Le, Chyi‐Liang Chen, Chia‐Jung Kuo, Pai‐Jui Yeh, Chien‐Chang Chen, Yi‐Ching Chen, Cheng‐Tang Chiu, Hao‐Tsai Cheng, Yung‐Kuan Tsou, Yu‐Bin Pan, Cheng‐Hsun Chiu
The Kaohsiung Journal of Medical Sciences.2025;[Epub] CrossRef
Comparative Efficacy of Fecal Microbiota Transplantation in Treating Refractory or Recurrent Clostridioides difficile Infection among Patients with and without Inflammatory Bowel Disease: A Retrospective Cohort Study
Jing-Han Chen, Cheng-Hsun Chiu, Chien-Chang Chen, Yi-Ching Chen, Pai-Jui Yeh, Chia-Jung Kuo, Cheng-Tang Chiu, Hao-Tsai Cheng, Yu-Bin Pan, Puo-Hsien Le
Biomedicines.2024; 12(7): 1396. CrossRef
Case report: Fecal microbiota transplant for Clostridium difficile infection in a pregnant patient with acute severe ulcerative colitis
Hanyu Wang, Feihong Deng, Min Luo, Xuehong Wang
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The first international Rome consensus conference on gut microbiota and faecal microbiota transplantation in inflammatory bowel disease
Loris Riccardo Lopetuso, Sara Deleu, Lihi Godny, Valentina Petito, Pierluigi Puca, Federica Facciotti, Harry Sokol, Gianluca Ianiro, Luca Masucci, Maria Abreu, Iris Dotan, Samuel Paul Costello, Ailsa Hart, Tariq H Iqbal, Sudarshan Paramsothy, Maurizio San
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Fecal microbiota transplantation as therapy for recurrent Clostridioides difficile infection is associated with amelioration of delirium and accompanied by changes in fecal microbiota and the metabolome
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Original Articles

Single fecal microbiota transplantation failed to change intestinal microbiota and had limited effectiveness against ulcerative colitis in Japanese patients: Shinta Mizuno, Kosaku Nanki, Katsuyoshi Matsuoka, Keiichiro Saigusa, Keiko Ono, Mari Arai, Shinya Sugimoto, Hiroki Kiyohara, Moeko Nakashima, Kozue Takeshita, Makoto Naganuma, Wataru Suda, Masahira Hattori, Takanori Kanai; Intest Res 2017;15(1):68-74. Published online January 31, 2017; DOI: https://doi.org/10.5217/ir.2017.15.1.68

Abstract PDF Supplementary Material PubReader ePub

Background/Aims

Recent developments in analytical techniques including next-generation sequencing have clarified the correlation between intestinal microbiota and inflammatory bowel disease. Fecal microbiota transplantation (FMT) for patients with ulcerative colitis (UC) is proposed as a potential approach to resolving their dysbiosis; however, its safety and efficacy have not been confirmed. This single-arm, open-label, non-randomized study aimed to evaluate the safety and efficacy of FMT for Japanese patients with UC as the first registered clinical trial in Japan.

Methods

We enrolled 10 patients with active UC despite medical therapy. The donors were the patients' relatives and were carefully screened for infectious diseases. Fecal material was administered via colonoscopy, and the primary endpoint was the presence or absence of serious adverse events related to FMT. The secondary endpoint was a change in partial Mayo score at 12 weeks post-FMT. Scores ≤2 were considered a clinical response. Fecal samples were collected to follow changes in gut microbiota, while extracted complementary DNA were analyzed by a next-generation sequencer. We obtained written informed consent from all patients and donors. This study was approved by our Institutional Review Board and is registered in the University hospital Medical Information Network (UMIN) Clinical Trials Registry (UMIN 000012814).

Results

Five patients with moderate disease and five with severe disease were enrolled. No severe adverse effects were observed. One patient achieved clinical response; however, none of the patients' microbiota diversity recovered to the donor levels.

Conclusions

The use of single FMT for UC was safe; however, we failed to show its clinical efficacy and potential to change the intestinal microbiota.

Citations

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Single-Donor and Pooling Strategies for Fecal Microbiota Transfer Product Preparation in Ulcerative Colitis: A Systematic Review and Meta-analysis
Benoît Levast, Mathieu Fontaine, Stéphane Nancey, Pierre Dechelotte, Joël Doré, Philippe Lehert
Clinical and Translational Gastroenterology.2023; 14(5): e00568. CrossRef
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Oshrit Shtossel, Sondra Turjeman, Alona Riumin, Michael R. Goldberg, Arnon Elizur, Yarin Bekor, Hadar Mor, Omry Koren, Yoram Louzoun
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Medicine.2022; 101(30): e29790. CrossRef
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Infection and Drug Resistance.2022; Volume 15: 7495. CrossRef
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Valentin Mocanu, Sabitha Rajaruban, Jerry Dang, Janice Y. Kung, Edward C. Deehan, Karen L. Madsen
Journal of Clinical Medicine.2021; 10(5): 959. CrossRef
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Ohara Tadashi
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Ivana Cibulková, Veronika Řehořová, Jan Hajer, František Duška
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Abnormal Intestinal Microbiome in Medical Disorders and Potential Reversibility by Fecal Microbiota Transplantation
Herbert L. DuPont, Zhi-Dong Jiang, Andrew W. DuPont, Netanya S. Utay
Digestive Diseases and Sciences.2020; 65(3): 741. CrossRef
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Xiao Yan Guo, Xin Juan Liu, Jian Yu Hao
Journal of Digestive Diseases.2020; 21(3): 147. CrossRef
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Luciane de Fátima Caldeira, Helena H. Borba, Fernanda S. Tonin, Astrid Wiens, Fernando Fernandez-Llimos, Roberto Pontarolo, Udai P. Singh
PLOS ONE.2020; 15(9): e0238910. CrossRef
Fecal Microbiota Transplantation for Ulcerative Colitis: An Evolving Therapy
Ajit Sood, Arshdeep Singh, Vandana Midha, Ramit Mahajan, Dina Kao, David T Rubin, Charles N Bernstein
Crohn's & Colitis 360.2020;[Epub] CrossRef
Efficacy and safety of fecal microbiota transplantation for treating patients with ulcerative colitis: A systematic review and meta‐analysis
Hai Lan Zhao, Shu Zhen Chen, Hao Ming Xu, You Lian Zhou, Jie He, Hong Li Huang, Jing Xu, Yu Qiang Nie
Journal of Digestive Diseases.2020; 21(10): 534. CrossRef
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Ajit Sood, Vandana Midha, Harmeet Kaur, Arshdeep Singh
Journal of Gastrointestinal Infections.2020; 10(1): 16. CrossRef
Multi-session fecal microbiota transplantation using colonoscopy has favorable outcomes for the treatment of steroid-dependent ulcerative colitis
Young-Seok Cho
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Jung Hoon Song, You Sun Kim
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Seong Ran Jeon, Jocelyn Chai, Christiana Kim, Christine H. Lee
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Chang Soo Eun
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Shinta Mizuno, Tatsuhiro Masaoka, Makoto Naganuma, Taishiro Kishimoto, Momoko Kitazawa, Shunya Kurokawa, Moeko Nakashima, Kozue Takeshita, Wataru Suda, Masaru Mimura, Masahira Hattori, Takanori Kanai
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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.

Citations

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Reviews

Magnetic resonance enterography for the evaluation of the deep small intestine in Crohn's disease: Kazuo Ohtsuka, Kento Takenaka, Yoshio Kitazume, Toshimitsu Fujii, Katsuyoshi Matsuoka, Maiko Kimura, Takashi Nagaishi, Mamoru Watanabe; Intest Res 2016;14(2):120-126. Published online April 27, 2016; DOI: https://doi.org/10.5217/ir.2016.14.2.120

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For the control of Crohn's disease (CD) a thorough assessment of the small intestine is essential; several modalities may be utilized, with cross-sectional imaging being important. Magnetic resonance (MR) enterography, i.e., MRE is recommended as a modality with the highest accuracy for CD lesions. MRE and MR enteroclysis are the two methods performed following distension of the small intestine. MRE has sensitivity and specificity comparable to computed tomography enterography (CTE); although images obtained using MRE are less clear compared with CTE, MRE does not expose the patient to radiation and is superior for soft-tissue contrast. Furthermore, it can assess not only static but also dynamic and functional imaging and reveals signs of CD, such as abscess, comb sign, fat edema, fistula, lymph node enhancement, less motility, mucosal lesions, stricture, and wall enhancement. Several indices of inflammatory changes and intestinal damage have been proposed for objective evaluation. Recently, diffusion-weighted imaging has been proposed, which does not need bowel preparation and contrast enhancement. Comprehension of the characteristics of MRE and other modalities is important for better management of CD.

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Motility Mapping Quantification Using the Classical Optical Flow Algorithm for Small Bowel Crohn’s Disease: Comparison with Balloon-assisted Enteroscopy Findings
Yoshio Kitazume, Kento Takenaka, Kazuo Ohtsuka, Yasuo Ozawa, Koichiro Kimura, Ryosuke Watanabe, Junichi Tsuchiya, Toshimitsu Fujii, Masakazu Nagahori, Mamoru Watanabe, Ukihide Tateishi
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High b-value computed diffusion-weighted imaging for differentiating bowel inflammation in Crohn's disease
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Tacrolimus for the Treatment of Ulcerative Colitis: Katsuyoshi Matsuoka, Eiko Saito, Toshimitsu Fujii, Kento Takenaka, Maiko Kimura, Masakazu Nagahori, Kazuo Ohtsuka, Mamoru Watanabe; Intest Res 2015;13(3):219-226. Published online June 9, 2015; DOI: https://doi.org/10.5217/ir.2015.13.3.219

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Tacrolimus is a calcineurin inhibitor used for the treatment of corticosteroid-refractory ulcerative colitis (UC). Two randomized controlled trials and a number of retrospective studies have assessed the therapeutic effect of tacrolimus in UC patients. These studies showed that tacrolimus has excellent short-term efficacy in corticosteroid-refractory patients, with the rates of clinical response ranging from 61% to 96%. However, the long-term prognosis of patients treated with tacrolimus is disappointing, and almost 50% of patients eventually underwent colectomy in long-term follow-up. Tacrolimus can achieve mucosal healing in 40-50% of patients, and this is associated with a favorable long-term prognosis. Anti-tumor necrosis factor (TNF)-α antibodies are another therapeutic option in corticosteroid-refractory patients. A prospective head-to-head comparative study of tacrolimus and infliximab is currently being performed to determine which treatment is more effective in corticosteroid-refractory patients. Several retrospective studies have demonstrated that switching between tacrolimus and anti-TNF-α antibody therapy was effective in patients who were refractory to one of the treatments. Most adverse events of tacrolimus are mild; however, opportunistic infections, especially pneumocystis pneumonia, are the most important adverse events, and these should be carefully considered during treatment. Several issues on tacrolimus treatment in UC patients remain unsolved (e.g., use of tacrolimus as remission maintenance therapy). Further controlled studies are needed to optimize the use of tacrolimus for the treatment of UC.

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Immunological Abnormalities in the Pathogenesis of Inflammatory Bowel Disease: Tadakazu Hisamatsu, Yohei Mikami, Katsuyoshi Matsuoka, Takanori Kanai, Toshifumi Hibi; Intest Res 2012;10(4):317-323. Published online October 31, 2012; DOI: https://doi.org/10.5217/ir.2012.10.4.317

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Crohn's disease and ulcerative colitis represent two distinct forms of inflammatory bowel diseases (IBD). In this paper, we discuss how immunological mechanisms contribute to the pathogenesis of IBD. Intestinal homeostasis is sustained by various kinds of cells, such as epithelial cells, lymphocytes, antigen presenting cells, and other innate immune cells. We pay special attention to intestinal CD14+ macrophages. Intestinal macrophages play a central role in the regulation of immune responses against commensal bacteria. In the physiological condition, intestinal macrophages lack the expression of innate-immune receptor CD14 and do not produce proinfl ammatory cytokines. We identified a unique macrophage subset of IBD in the human intestine, which expressed both macrophage (CD14, CD33, CD68) and dendritic cell (DC) markers (CD205, CD209) and produced larger amounts of proinflammatory cytokines, such as interleukin (IL)-23 and tumor necrosis factor (TNF)-Ձ. In addition, the CD14+ macrophages contributed to interferon (IFN)-Ճ production rather than IL-17 production by lamina propria mononuclear cells dependent on IL-23. We discuss herein this IL-23/IFN-Ճ-positive feedback loop in IBD patients. We also discuss IFN-Ճ and IL-17 production from mucosal T cells and natural killer (NK) cells. Here, we show our recent findings about the plasticity of T helper cells in colitis. Th 17 cells express T-bet, and finally lose the expression of retinoic acid-related orphan receptor (ROR)Ճt, the master regulator of Th 17 cells, and are differentiated 'alternative Th 1 cells.' In addition to Th 1 cells, mucosal NK cells are also important sources of IFN-Ճ. Some of our ideas may be provocative, but we hope this review paper will provide new and firm understanding of the pathogenesis of IBD. (Intest Res 2012;10:317-323)

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