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19 "Taku Kobayashi"
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Original Articles
Propensity score-matched real-world comparative treatment outcomes of Janus kinase inhibitors for ulcerative colitis in patients with and without prior exposure to anti-tumor necrosis factor α antibody
Maiko Ikenouchi, Hirokazu Fukui, Soichi Yagi, Akira Nogami, Koji Kaku, Toshiyuki Sato, Mikio Kawai, Koji Kamikozuru, Yoko Yokoyama, Tetsuya Takagawa, Toshihiko Tomita, Taku Kobayashi, Shinichiro Shinzaki
Received September 22, 2024  Accepted November 20, 2024  Published online February 3, 2025  
DOI: https://doi.org/10.5217/ir.2024.00148    [Epub ahead of print]
AbstractAbstract PDF
Background/Aims
Tofacitinib (TFB), filgotinib (FIL), and upadacitinib (UPA) are Janus kinase (JAK) inhibitors approved for moderate-to-severe ulcerative colitis (UC). The appropriate positioning of each JAK inhibitor in the treatment algorithm, however, is unclear. Furthermore, real-world efficacy of JAK inhibitors for patients with UC and prior anti-tumor necrosis factor α antibody (aTNF) treatment are not fully investigated. We compared the efficacy and safety of 3 JAK inhibitors in patients with UC, considering their prior aTNF exposure.
Methods
A retrospective study was conducted in patients with UC who started TFB, FIL, or UPA at 2 academic centers. This propensity score-matched cohort study assessed the effectiveness of the 3 JAK inhibitors for UC in patients with and without prior aTNF exposure, comparing steroid-free clinical remission and response rates after 8 weeks.
Results
Among 274 patients who met the inclusion criteria, 145 experienced aTNF exposure (TFB: 59.2%, 100/169; FIL: 34.5%, 20/58; UPA: 53.2%, 25/47). Based on propensity score-matching, UPA led to a higher steroid-free clinical remission rates than TFB (adjusted odds ratio [aOR], 5.57; 95% confidence interval [CI], 1.42–21.90) or FIL (aOR, 9.00; 95% CI, 1.42–57.10) in patients exposed to aTNF. Steroid-free clinical remission and clinical response rates did not differ significantly between each group in patients non-exposed to aTNF. The incidence of adverse events was slightly higher with UPA than TFB or FIL.
Conclusions
UPA may be more effective for UC than TFB or FIL, especially in patients with previous aTNF exposure, although consideration should be given to adverse events.
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Factors affecting 1-year persistence with vedolizumab for ulcerative colitis: a multicenter, retrospective real-world study
Taku Kobayashi, Tadakazu Hisamatsu, Satoshi Motoya, Toshimitsu Fujii, Reiko Kunisaki, Tomoyoshi Shibuya, Minoru Matsuura, Ken Takeuchi, Sakiko Hiraoka, Hiroshi Yasuda, Kaoru Yokoyama, Noritaka Takatsu, Atsuo Maemoto, Toshiyuki Tahara, Keiichi Tominaga, Masaaki Shimada, Nobuaki Kuno, Jovelle L. Fernandez, Kaori Ishiguro, Mary Cavaliere, Hisato Deguchi, Toshifumi Hibi
Received May 1, 2024  Accepted October 5, 2024  Published online January 16, 2025  
DOI: https://doi.org/10.5217/ir.2024.00063    [Epub ahead of print]
AbstractAbstract PDFSupplementary MaterialPubReaderePub
Background/Aims
The objectives of this real-world study were to determine 1-year persistence with vedolizumab in patients with ulcerative colitis and to evaluate factors contributing to loss of response.
Methods
In this multicenter, retrospective, observational chart review, patients with moderately to severely active ulcerative colitis who received ≥ 1 dose of vedolizumab in clinical practice at 16 tertiary hospitals in Japan (from December 2018 through February 2020) were enrolled.
Results
Persistence with vedolizumab was 64.5% (n = 370); the median follow-up time was 53.2 weeks. Discontinuation due to loss of response among initial clinical remitters was reported in 12.5% (35/281) of patients. Multivariate analysis showed that concomitant use of tacrolimus (odds ratio [OR], 2.76; 95% confidence interval [CI], 1.00–7.62; P= 0.050) and shorter disease duration (OR for median duration ≥ 7.8 years vs. < 7.8 years, 0.33; 95% CI, 0.13–0.82; P= 0.017) were associated with discontinuation due to loss of response. Loss of response was not associated with prior use of anti-tumor necrosis factor alpha therapy, age at the time of treatment, disease severity, or concomitant corticosteroids or immunomodulators. Of the 25 patients with disease duration < 1 year, 32.0% discontinued due to loss of response.
Conclusions
Persistence with vedolizumab was consistent with previous reports. Use of tacrolimus and shorter disease duration were the main predictors of decreased persistence.
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Review
IBD
Optimizing 5-aminosalicylate for moderate ulcerative colitis: expert recommendations from the Asia-Pacific, Middle East, and Africa Inflammatory Bowel Disease Coalition
Filiz Akyüz, Yoon Kyo An, Jakob Begun, Satimai Aniwan, Huu Hoang Bui, Webber Chan, Chang Hwan Choi, Nazeer Chopdat, Susan J Connor, Devendra Desai, Emma Flanagan, Taku Kobayashi, Allen Yu-Hung Lai, Rupert W Leong, Alex Hwong-Ruey Leow, Wai Keung Leung, Julajak Limsrivilai, Virly Nanda Muzellina, Kiran Peddi, Zhihua Ran, Shu Chen Wei, Jose Sollano, Michelle Mui Hian Teo, Kaichun Wu, Byong Duk Ye, Choon Jin Ooi
Intest Res 2025;23(1):37-55.   Published online November 4, 2024
DOI: https://doi.org/10.5217/ir.2024.00089
AbstractAbstract PDFPubReaderePub
The lack of clear definition and classification for “moderate ulcerative colitis (UC)” creates ambiguity regarding the suitability of step-up versus top-down treatment approaches. In this paper, experts address crucial gaps in assessing and managing moderate UC. The Asia-Pacific, Middle East, and Africa Inflammatory Bowel Disease Coalition comprised 24 experts who convened to share, discuss and vote electronically on management recommendations for moderate UC. Experts emphasized that the goal of treating UC is to attain clinical, biomarker, and endoscopic remission using cost-effective strategies such as 5-aminosalicylates (5-ASAs), well-tolerated therapy that can be optimized to improve outcomes. Experts agreed that 5-ASA therapy could be optimized by maximizing dosage (4 g/day for induction of remission), combining oral and topical administration, extending treatment duration beyond 8 weeks, and enhancing patient adherence through personalized counselling and reduced pill burden. Treatment escalation should ideally be reserved for patients with predictors of aggressive disease or those who do not respond to 5-ASA optimization. Premature treatment escalation to advanced therapies (including biologics and oral small molecules) may have long-term health and financial consequences. This paper provides consensus-based expert recommendations and a treatment algorithm, based on current evidence and practices, to assist decision-making in real-world settings.
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Original Articles
Patient preferences for advanced therapies in ulcerative colitis using conjoint analysis
Taku Kobayashi, Naomi Mizuno, Noriko Sato, Yutaka Kawaguchi, Yoshiko Ikawa, Naruyasu Komorita, Hirono Ishikawa
Received June 28, 2024  Accepted July 22, 2024  Published online October 14, 2024  
DOI: https://doi.org/10.5217/ir.2024.00101    [Epub ahead of print]
AbstractAbstract PDFPubReaderePub
Background/Aims
Selecting an optimal advanced therapy for ulcerative colitis (UC) is difficult because of the increasing number of available therapies. This study assessed UC patients’ preferences for drug profiles in decision-making regarding advanced therapies using conjoint analysis.
Methods
A web-based survey was conducted from October to November 2023 in patients with UC aged ≥ 18 years with prior oral 5-aminosalicylic acid treatment (UMIN000052327). We quantified the importance of drug attributes (location of administration, route/frequency of administration, speed of onset-of-action, maintenancesustainability, risk of serious adverse events within 1 year, and novelty of the drug) and the part-worth utility of attribute levels in mild and severe symptom scenarios, including among employed versus unemployed patients.
Results
Of 372 patients who completed the survey, 365 were evaluated. Patient preferences were generally highly individualized. The route/frequency of administration was the most important attribute in both the mild and severe symptom scenarios. Oral administration was preferred in the mild symptom scenario, whereas no specific preference was observed in the severe symptom scenario. The route/ frequency of administration was more valued in the mild symptom scenario than in the severe one, whereas speed of onset of action was more valued in the severe symptom scenario. No significant difference was found in the preference for drug profiles between employed and unemployed patients.
Conclusions
Patient preferences for the route/frequency of administration, as well as other drug profiles, change with disease severity but demonstrate substantial interindividual variability. Therefore, shared decision-making is important to incorporate patients’ perspectives into the selection of advanced therapies.
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Early resolution of bowel urgency by budesonide foam enema results in improved quality of life in patients with ulcerative colitis: a multicenter prospective observational study
Taku Kobayashi, Kei Moriya, Toshimitsu Fujii, Shigeki Bamba, Shinichiro Shinzaki, Akihiro Yamada, Takashi Hisabe, Shintaro Sagami, Shuji Hibiya, Takahiro Amano, Noritaka Takatsu, Katsutoshi Inagaki, Ken-ichi Iwayama, Toshifumi Hibi
Received January 11, 2024  Accepted April 29, 2024  Published online July 15, 2024  
DOI: https://doi.org/10.5217/ir.2024.00005    [Epub ahead of print]
AbstractAbstract PDFSupplementary MaterialPubReaderePub
Background/Aims
Bowel urgency is an important symptom for quality of life determination in patients with ulcerative colitis (UC). Few clinical studies have focused on bowel urgency as an efficacy endpoint. Budesonide foam enema has shown efficacy for clinical and endoscopic improvement in mild-to-moderate UC. We evaluated the improvement of clinical symptoms (bowel urgency), safety, and treatment impact of twice-daily budesonide foam enema on the quality of life in patients with UC.
Methods
This open-label, multicenter, prospective observational study comprised a 4-week observation period assessing the effectiveness and safety of twice-daily budesonide foam enema. Mild-to-moderate UC patients who had bowel urgency were included. Patients collected data daily in an electronic patient-reported outcome system or logbooks. The primary endpoint was the rate of resolution of bowel urgency at the end of the 4-week observation period. The rate of bowel incontinence was also assessed.
Results
Sixty-one patients were enrolled. Of patients with a final evaluation, the rate of resolution of bowel urgency was 58.5% (31/53; 95% confidence interval, 44.1%–71.9%). Bowel urgency decreased over time, with a significant difference observed on day 7 versus day 0. Bowel incontinence showed a decreasing trend from day 5, with a significant difference confirmed on day 12 versus day 0. The clinical remission rate was 64.4% (38/59; 95% confidence interval, 50.9%–76.4%). One adverse event not related to budesonide rectal foam occurred.
Conclusions
The findings suggest that bowel urgency can be improved early with twice-daily budesonide foam enema. No new safety signals were observed.
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IBD
Filgotinib induction-study baseline characteristics of patients with ulcerative colitis who achieve sustained corticosteroid-free remission: post hoc analysis of the phase 2b/3 SELECTION study
Taku Kobayashi, Axel Dignass, Xavier Roblin, Yoshie Takatori, Toshihiko Kaise, Alessandra Oortwijn, Corinne Jamoul, Toshifumi Hibi
Intest Res 2025;23(1):65-75.   Published online June 14, 2024
DOI: https://doi.org/10.5217/ir.2024.00007
AbstractAbstract PDFSupplementary MaterialPubReaderePub
Background/Aims
Obtaining and maintaining corticosteroid-free remission are important goals of treatment for ulcerative colitis (UC). Characteristics associated with achieving corticosteroid-free remission were assessed in filgotinib-treated patients in SELECTION, a 58-week, phase 2b/3 trial in moderately to severely active UC.
Methods
This post hoc analysis used data from filgotinib-treated patients receiving corticosteroids at maintenance baseline in SELECTION. Univariate logistic regression was performed to assess induction baseline characteristics associated with 6 months of corticosteroid-free remission at week 58, defined as clinical remission without using corticosteroids for at least 6 months.
Results
At maintenance baseline, 92 and 81 patients were receiving corticosteroids in the filgotinib 200 mg and filgotinib 100 mg groups, respectively. Age, body mass index, history of pancolitis, disease duration, fecal calprotectin levels, C-reactive protein levels, Mayo Clinic Score, concomitant corticosteroids, immunomodulators, and aminosalicylates had no statistically significant effect on the likelihood of achieving corticosteroid-free remission. Baseline characteristics associated with increased odds of corticosteroid-free remission were Mayo Clinic Endoscopic Subscore of 2 (vs. 3) in the filgotinib 200 mg and filgotinib 100 mg groups, and female (vs. male) sex, current (vs. former or never) smoking, and being biologic‑naive (vs. experienced) in the filgotinib 200 mg group.
Conclusions
Steroid tapering can be achieved in patients with UC receiving filgotinib 200 mg independently of baseline characteristics such as clinical activity and duration of illness. However, the likelihood of achieving corticosteroid-free remission was higher among patients who were biologic-naive, current smokers, had low endoscopic inflammatory burden and who were female.

Citations

Citations to this article as recorded by  
  • In which patients with ulcerative colitis would filgotinib be effective?
    Jihye Park
    Intestinal Research.2025; 23(1): 1.     CrossRef
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IBD
Early change in serum leucine-rich α-2-glycoprotein predicts clinical and endoscopic response in ulcerative colitis
Ryo Karashima, Shintaro Sagami, Yoko Yamana, Masa Maeda, Aya Hojo, Yusuke Miyatani, Masaru Nakano, Takahisa Matsuda, Toshifumi Hibi, Taku Kobayashi
Intest Res 2024;22(4):473-483.   Published online June 5, 2024
DOI: https://doi.org/10.5217/ir.2023.00135
AbstractAbstract PDFPubReaderePub
Background/Aims
Leucine-rich α-2-glycoprotein (LRG) is a new serum biomarker reflecting the disease activity of ulcerative colitis (UC), but its change during the acute phase has not been enough investigated.
Methods
Patients with UC who initiated the induction therapy with steroid or advanced therapy (biologics or Janus kinase inhibitors) were prospectively enrolled. Associations of LRG, C-reactive protein (CRP) and fecal calprotectin (FC) at baseline, week 1, and week 8 with clinical remission at week 8 and subsequent endoscopic improvement within 1 year (Mayo endoscopic subscore of 0 or 1) were assessed.
Results
A total of 143 patients with UC were included. LRG and CRP at week 1 were significantly lower in the clinical remission group than in the non-remission group (LRG, 20.6 μg/mL vs. 28.4 μg/mL, P< 0.001; CRP, 0.9 mg/dL vs. 2.3 mg/dL, P< 0.001) while FC demonstrated the difference between groups only at week 8. The area under the curves of week 1 LRG, CRP, and FC for week 8 clinical remission using the receiver operating characteristic curves analysis were 0.68, 0.71, and 0.57, respectively. Furthermore, LRG and CRP predicted subsequent endoscopic improvement as early as week 1, while FC was predictive only at week 8.
Conclusions
LRG can be an early-phase biomarker predicting subsequent clinical and endoscopic response to induction therapy.

Citations

Citations to this article as recorded by  
  • The diagnostic accuracy of plasma and serum calprotectin is inferior to C-reactive protein in patients with suspected Crohn’s disease
    M. H. Rasmussen, J. B. Brodersen, C. L. Brasen, J. S. Madsen, T. Knudsen, J. Kjeldsen, M. D. Jensen
    Scandinavian Journal of Gastroenterology.2025; : 1.     CrossRef
  • Changes of leucine-rich alpha 2 glycoprotein could be a marker of changes of endoscopic and histologic activity of ulcerative colitis
    Yuki Aoyama, Sakiko Hiraoka, Eriko Yasutomi, Toshihiro Inokuchi, Takehiro Tanaka, Kensuke Takei, Shoko Igawa, Keiko Takeuchi, Masahiro Takahara, Junki Toyosawa, Yasushi Yamasaki, Hideaki Kinugasa, Jun Kato, Hiroyuki Okada, Motoyuki Otsuka
    Scientific Reports.2025;[Epub]     CrossRef
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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
AbstractAbstract PDFSupplementary MaterialPubReaderePub
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.

Citations

Citations to this article as recorded by  
  • 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
Performing colonoscopy before steroid induction is associated with shorter steroid use in patients with ulcerative colitis
Taku Kobayashi, Eri Udagawa, Lisa Hirose, Toshifumi Hibi
Intest Res 2023;21(2):205-215.   Published online December 15, 2022
DOI: https://doi.org/10.5217/ir.2021.00164
AbstractAbstract PDFPubReaderePub
Background/Aims
Risks of long-term steroid use in patients with ulcerative colitis (UC) outweigh the benefits, thus dosing should be tapered once a response is achieved. Colonoscopy is a key technique for assessing disease severity and optimizing treatment involving steroids. This retrospective longitudinal cohort study of patients with UC explored factors associated with the duration of systemic steroid use.
Methods
The Japan Medical Data Center database, an employer-based insurance claims database, was used to select individuals initiating prednisolone, with a prescription issued between January 1, 2010, and January 31, 2018. The study included adults with a confirmed diagnosis of UC, who had received ≥1 year of continuous treatment with 5-aminosalicylic acid, biologics, or thiopurine. Factors associated with prednisolone duration were assessed using a multivariate regression model.
Results
Median duration of prednisolone treatment was 98 days, and colonoscopy was performed ≤1 month before or at the first prescription of prednisolone (index date) in 32.8% of patients (607/1,853). Shorter durations of prednisolone treatment were associated with colonoscopy ≤1 month before or at the index date and higher prednisolone dose at index date, with incidence rate ratios (IRRs) of 0.776 (95% confidence interval [CI], 0.682–0.884; P<0.001) and 0.998 (95% CI, 0.996–1.000; P=0.018), respectively. Charlson Comorbidity Index scores of 1 and ≥2 predicted longer prednisolone treatment (IRR, 1.332; 95% CI, 1.174–1.511; P<0.001 and IRR, 1.599; 95% CI, 1.357–1.885; P<0.001, respectively).
Conclusions
Performing colonoscopy before or at the time of initiating steroid was associated with a shorter duration of steroid use in patients with UC.
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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
AbstractAbstract PDFSupplementary MaterialPubReaderePub
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.

Citations

Citations to this article as recorded by  
  • Efficacy and safety of filgotinib for ulcerative colitis: A real‐world multicenter retrospective study in Japan
    Shintaro Akiyama, Kaoru Yokoyama, Soichi Yagi, Shinichiro Shinzaki, Kozo Tsuruta, Shinichiro Yoshioka, Minako Sako, Hiromichi Shimizu, Mariko Kobayashi, Toshiyuki Sakurai, Kei Nomura, Tomoyoshi Shibuya, Masahiro Takahara, Sakiko Hiraoka, Kyohei Sugai, Shu
    Alimentary Pharmacology & Therapeutics.2024; 59(11): 1413.     CrossRef
  • Real-World Data on the Effectiveness and Safety of Filgotinib for Ulcerative Colitis in Japanese Patients: A Single-Center Experience
    Takahito Toba, Ryo Karashima, Kodai Fujii, Keiichi Inoue, Nanako Inoue, Yurie Ogawa, Aya Hojo, Ai Fujimoto, Takahisa Matsuda
    Cureus.2024;[Epub]     CrossRef
  • Safety and effectiveness of tofacitinib in Korean adult patients with ulcerative colitis: post-marketing surveillance study
    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
  • Patients’ Preference on Advanced Therapy and Follow-Up Procedure for Inflammatory Bowel Disease in Japan: A Web-Based 3A Survey
    Toshifumi Morishita, Shunichi Yanai, Yosuke Toya, Takayuki Matsumoto
    Inflammatory Intestinal Diseases.2024; 9(1): 174.     CrossRef
  • The role and prospect of tofacitinib in patients with ulcerative colitis
    Jun Lee
    Intestinal Research.2023; 21(1): 168.     CrossRef
  • Advances in pharmacotherapy for ulcerative colitis: a focus on JAK1 inhibitors
    Alexander Goetsch, Ferdinando D’Amico, Mariangela Allocca, Gionata Fiorino, Federica Furfaro, Alessandra Zilli, Tommaso Lorenzo Parigi, Simona Radice, Laurent Peyrin-Biroulet, Silvio Danese
    Expert Opinion on Pharmacotherapy.2023; 24(7): 849.     CrossRef
  • Understanding the efficacy of individual Janus kinase inhibitors in the treatment of ulcerative colitis for future positioning in inflammatory bowel disease treatment
    Hiroshi Nakase
    Immunological Medicine.2023; 46(3): 121.     CrossRef
  • Inflammation-Driven Colorectal Cancer Associated with Colitis: From Pathogenesis to Changing Therapy
    Olga Maria Nardone, Irene Zammarchi, Giovanni Santacroce, Subrata Ghosh, Marietta Iacucci
    Cancers.2023; 15(8): 2389.     CrossRef
  • Extraintestinal Cancers in Inflammatory Bowel Disease: A Literature Review
    Alessandro Massano, Luisa Bertin, Fabiana Zingone, Andrea Buda, Pierfrancesco Visaggi, Lorenzo Bertani, Nicola de Bortoli, Matteo Fassan, Marco Scarpa, Cesare Ruffolo, Imerio Angriman, Cristina Bezzio, Valentina Casini, Davide Giuseppe Ribaldone, Edoardo
    Cancers.2023; 15(15): 3824.     CrossRef
  • Integrated safety analysis of filgotinib for ulcerative colitis: Results from SELECTION and SELECTIONLTE
    Stefan Schreiber, Gerhard Rogler, Mamoru Watanabe, Séverine Vermeire, Christian Maaser, Silvio Danese, Margaux Faes, Paul Van Hoek, Jeremy Hsieh, Ulrik Moerch, Yan Zhou, Angela de Haas, Christine Rudolph, Alessandra Oortwijn, Edward V. Loftus
    Alimentary Pharmacology & Therapeutics.2023; 58(9): 874.     CrossRef
  • Recent advances in anti-inflammatory active components and action mechanisms of natural medicines
    Zhimin Wu, Tao Zhang, Xiaofei Ma, Shuai Guo, Qingqing Zhou, Arshad Zahoor, Ganzhen Deng
    Inflammopharmacology.2023; 31(6): 2901.     CrossRef
  • Filgotinib for moderately to severely active ulcerative colitis
    Alessandro Mannucci, Ferdinando D’Amico, Ahmad El Saadi, Laurent Peyrin-Biroulet, Silvio Danese
    Expert Review of Gastroenterology & Hepatology.2022; 16(10): 927.     CrossRef
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Inflammatory Bowel Diseases
Efficacy and safety of a new vedolizumab subcutaneous formulation in Japanese patients with moderately to severely active ulcerative colitis
Taku Kobayashi, Hiroaki Ito, Toshifumi Ashida, Tadashi Yokoyama, Masakazu Nagahori, Tomoki Inaba, Mitsuhiro Shikamura, Takayoshi Yamaguchi, Tetsuharu Hori, Philippe Pinton, Mamoru Watanabe, Toshifumi Hibi
Intest Res 2021;19(4):448-460.   Published online August 18, 2020
DOI: https://doi.org/10.5217/ir.2020.00026
AbstractAbstract PDFSupplementary MaterialPubReaderePub
Background/Aims
A subgroup analysis was conducted in Japanese patients with moderate to severe ulcerative colitis (UC) enrolled in the phase 3 VISIBLE 1 study, which evaluated the safety and efficacy of a new vedolizumab subcutaneous (SC) formulation.
Methods
Eligible patients received open-label infusions of vedolizumab 300 mg intravenous (IV) at weeks 0 and 2 in the induction phase. Patients with clinical response by complete Mayo score at week 6 entered the double-blind maintenance phase and were randomized to vedolizumab 108 mg SC every 2 weeks, placebo, or vedolizumab 300 mg IV every 8 weeks. The primary endpoint was clinical remission (complete Mayo score ≤ 2 points; no individual subscore > 1 point) at week 52.
Results
Of 49 patients who entered the induction phase, 22 out of 49 patients (45%) had clinical response at week 6 and were randomized to vedolizumab 108 mg SC (n = 10), placebo (n = 10), or vedolizumab 300 mg IV (n = 2). At week 52, 4 out of 10 patients (40%) who received vedolizumab SC had clinical remission versus 2 out of 10 patients (20%) who received placebo (difference: 20% [95% confidence interval, –27.9 to 61.8]). Two patients (2/10, 20%) who received vedolizumab SC experienced an injection-site reaction versus none who received placebo.
Conclusions
Our results indicate that the efficacy of vedolizumab SC in a subgroup of Japanese patients with UC are similar with those in the overall VISIBLE 1 study population, and with those established with vedolizumab IV. The safety and tolerability of vedolizumab SC were generally similar to that established for vedolizumab IV. (ClinicalTrials.gov ID NCT02611830; EudraCT 2015-000480-14)

Citations

Citations to this article as recorded by  
  • Evaluation of the transition from intravenous to subcutaneous vedolizumab in patients with inflammatory bowel disease
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Corrigendum
Corrigendum: Randomized, crossover questionnaire survey of acceptabilities of controlled-release mesalazine tablets and granules in ulcerative colitis patients
Keiji Yagisawa, Taku Kobayashi, Ryo Ozaki, Shinji Okabayashi, Takahiko Toyonaga, Miki Miura, Mari Hayashida, Eiko Saito, Masaru Nakano, Hajime Matsubara, Tadakazu Hisamatsu, Toshifumi Hibi
Intest Res 2020;18(3):343-344.   Published online July 20, 2020
DOI: https://doi.org/10.5217/ir.2018.00078-c1
Corrects: Intest Res 2019;17(1):87
PDFPubReaderePub
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Review
Inflammatory bowel diseases
Capsule endoscopy in inflammatory bowel disease: when and how
Ida Hilmi, Taku Kobayashi
Intest Res 2020;18(3):265-274.   Published online July 7, 2020
DOI: https://doi.org/10.5217/ir.2019.09165
AbstractAbstract PDFPubReaderePub
Capsule endoscopy (CE) is emerging as an important investigation in inflammatory bowel disease (IBD); common types include the standard small bowel CE and colon CE. More recently, the pan-enteric CE was developed to assess the large and small bowel in patients with Crohn’s disease (CD). Emerging indications include noninvasive assessment for mucosal healing (both in the small bowel and the colon) and detection of postoperative recurrence in patients with CD. Given the increasing adoption, several CE scoring systems have been specifically developed for IBD. The greatest concern with performing CE, particularly in CD, is capsule retention, but this can be overcome by performing cross-sectional imaging such as magnetic resonance enterography and using patency capsules before performing the procedure. The development of software for automated detection of mucosal abnormalities typically seen in IBD may further increase its adoption.

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    World Journal of Gastroenterology.2023; 29(18): 2717.     CrossRef
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    A. A. Likutov, T. A. Vlasko, V. V. Veselov
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Original Articles
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
AbstractAbstract PDFPubReaderePub
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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  • Efficacy and safety of biosimilar infliximab in bio-naïve patients with Crohn’s disease
    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
  • Impact of Infliximab-dyyb (Infliximab Biosimilar) on Clinical and Patient-Reported Outcomes: 1-Year Follow-up Results from an Observational Real-World Study Among Patients with Inflammatory Bowel Disease in the US and Canada (the ONWARD Study)
    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
    Journal of Gastroenterology and Hepatology.2021; 36(8): 2091.     CrossRef
  • Current utilization patterns for long-acting insulin analogues including biosimilars among selected Asian countries and the implications for the future
    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
    Advances in Therapy.2021; 38(8): 4366.     CrossRef
  • The Great Debate With IBD Biosimilars
    Jimmy K Limdi, Francis A Farraye
    Crohn's & Colitis 360.2021;[Epub]     CrossRef
  • Treatment of inflammatory bowel diseases: focusing on biologic agents and new therapies
    Hyo Yeop Song, Geom Seog Seo
    Journal of the Korean Medical Association.2021; 64(9): 605.     CrossRef
  • Effectiveness of Switching from Reference Product Infliximab to Infliximab-Dyyb in Patients with Inflammatory Bowel Disease in an Integrated Healthcare System in the United States: A Retrospective, Propensity Score-Matched, Non-Inferiority Cohort Study
    Stephanie L. Ho, Fang Niu, Suresh Pola, Fernando S. Velayos, Xian Ning, Rita L. Hui
    BioDrugs.2020; 34(3): 395.     CrossRef
  • Post-Marketing Pooled Safety Analysis for CT-P13 Treatment of Patients with Immune-Mediated Inflammatory Diseases in Observational Cohort Studies
    Sang Joon Lee, KyungMin Baek, Sujin Lee, Yoon Jee Lee, Jeong Eun Park, Seul Gi Lee
    BioDrugs.2020; 34(4): 513.     CrossRef
  • Hepatotoxicty of Agents Used in the Management of Inflammatory Bowel Disease: a 2020 Update
    Michele S. Barnhill, Joshua M. Steinberg, Joseph J. Jennings, James H. Lewis
    Current Gastroenterology Reports.2020;[Epub]     CrossRef
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IBD
Individualized treatment based on CYP3A5 single-nucleotide polymorphisms with tacrolimus in ulcerative colitis
Shinji Okabayashi, Taku Kobayashi, Eiko Saito, Takahiko Toyonaga, Ryo Ozaki, Shintaro Sagami, Masaru Nakano, Junichi Tanaka, Keiji Yagisawa, Satoshi Kuronuma, Osamu Takeuchi, Toshifumi Hibi
Intest Res 2019;17(2):218-226.   Published online February 7, 2019
DOI: https://doi.org/10.5217/ir.2018.00117
AbstractAbstract PDFPubReaderePub
Background/Aims
The pharmacokinetics of tacrolimus (TAC) is known to be largely influenced by single-nucleotide polymorphisms (SNPs) in CYP3A5. Patients starting TAC require careful dose adjustment, owing to the wide range of optimal dosages, depending on their CYP3A5 expression status. Here, we evaluated whether individualization of TAC dosages based on CYP3A5 SNPs would improve its therapeutic efficacy in ulcerative colitis.
Methods
Twenty-one patients were prospectively treated, with their initial dosage adjusted according to their CYP3A5 status (0.1, 0.15, and 0.2 mg/kg/day for CYP3A5*3/*3, CYP3A5*1/*3, and CYP3A5*1/*1, respectively). Their clinical outcomes were compared with those of patients treated with a fixed dose (0.1 mg/kg/day).
Results
The first blood trough level of CYP3A5 expressors, CYP3A5*1/*3 or CYP3A5*1/*1, and the overall rate in achieving the target blood trough level within a week in the individualized-dose group were significantly higher than those in the fixed-dose group (5.15±2.33 ng/mL vs. 9.63±0.79 ng/mL, P=0.035 and 12.5% vs. 66.7%, P=0.01). The remission rate at 2 weeks in the expressors was as high as that in the nonexpressors, CYP3A5*3/*3, in the individualized-dose group.
Conclusions
Individualized TAC treatment is effective against ulcerative colitis regardless of the CYP3A5 genotype.

Citations

Citations to this article as recorded by  
  • The impact of cytochrome P450 3A genetic polymorphisms on tacrolimus pharmacokinetics in ulcerative colitis patients
    Maizumi Furuse, Shuhei Hosomi, Yu Nishida, Shigehiro Itani, Yuji Nadatani, Shusei Fukunaga, Koji Otani, Fumio Tanaka, Yasuaki Nagami, Koichi Taira, Noriko Kamata, Toshio Watanabe, Kenji Watanabe, Yasuhiro Fujiwara, Erika Cecchin
    PLOS ONE.2021; 16(4): e0250597.     CrossRef
  • Advances in research of tacrolimus for treatment of inflammatory bowel disease
    Jing-Jing Wang, Yi-Hong Fan
    World Chinese Journal of Digestology.2019; 27(13): 842.     CrossRef
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  • 149 Download
  • 1 Web of Science
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IBD
Randomized, crossover questionnaire survey of acceptabilities of controlled-release mesalazine tablets and granules in ulcerative colitis patients
Keiji Yagisawa, Taku Kobayashi, Ryo Ozaki, Shinji Okabayashi, Takahiko Toyonaga, Miki Miura, Mari Hayashida, Eiko Saito, Masaru Nakano, Hajime Matsubara, Tadakazu Hisamatsu, Toshifumi Hibi
Intest Res 2019;17(1):87-93.   Published online December 14, 2018
DOI: https://doi.org/10.5217/ir.2018.00078
Correction in: Intest Res 2020;18(3):343
AbstractAbstract PDFPubReaderePub
Background/Aims
Oral mesalazine is an important treatment for ulcerative colitis (UC), and non-adherence to mesalazine increases the risk of relapse. Controlled-release (CR) mesalazine has 2 formulations: tablets and granules. The relative acceptabilities of these formulations may influence patient adherence; however, they have not been compared to date. This study aimed to evaluate the acceptabilities of the 2 formulations of CR mesalazine in relation to patient adherence using a crossover questionnaire survey.
Methods
UC patients were randomly assigned to 2 groups in a 1:1 ratio. Patients in each group took either 4 g of CR mesalazine tablets or granules for 6 to 9 weeks, and then switched to 4 g of the other formulation for a further 6 to 9 weeks. The acceptability and efficacy were evaluated by questionnaires, and adherence was assessed using a visual analog scale. The difference in acceptabilities between the 2 formulations and its impact on adherence were assessed.
Results
A total of 49 patients were prospectively enrolled and 33 patients were included in the analysis. Significantly more patients found the tablets to be less acceptable than the granules (76% vs. 33%, P=0.0005). The granules were preferable to the tablets when the 2 formulations were compared directly (73% vs. 21%, P=0.004), for their portability, size, and numbers of pills. The adherence rate was slightly better among patients taking the granules (94% vs. 91%) during the observation period, but the difference was not significant (P=0.139).
Conclusions
CR mesalazine granules are more acceptable than tablets, and may therefore be a better option for long-term medication.

Citations

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    Jeongkuk Seo, Seonok Kim, Seung Wook Hong, Sung Wook Hwang, Sang Hyoung Park, Dong‐Hoon Yang, Jeong‐Sik Byeon, Seung‐Jae Myung, Suk‐Kyun Yang, Ye‐Jee Kim, Byong Duk Ye
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    Khater AL-Japairai, Samah Hamed Almurisi, Abd Almonem Doolaanea, Syed Mahmood, Fawaz Alheibshy, Ahmed Alobaida, Nadiya Abdul-Halim, Bappaditya Chatterjee
    International Journal of Pharmaceutics.2023; 632: 122571.     CrossRef
  • Medication Formulation Preference of Mild and Moderate Ulcerative Colitis Patients: a European Survey
    Xavier Hébuterne, Stephan R Vavricka, Helen C Thorne, Lara MacKenzie-Smith, Raphaël Laoun, Johan Burisch
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    Xinyi Guo, Changxing Liu, Yahui Huang, Naeem Jan
    Computational and Mathematical Methods in Medicine.2022; 2022: 1.     CrossRef
  • Factors Associated with Self-reported Medication Adherence in Japanese Community-dwelling Elderly Individuals: The Nakajima Study
    Natsuko Ishida, Yurina Tokumoto, Yukio Suga, Moeko Noguchi-Shinohara, Chiemi Abe, Sohshi Yuki-Nozaki, Ayaka Mori, Mai Horimoto, Koji Hayashi, Kazuo Iwasa, Masami Yokogawa, Mai Ishimiya, Hiroyuki Nakamura, Kiyonobu Komai, Ryo Matsushita, Junko Ishizaki, Ma
    YAKUGAKU ZASSHI.2021; 141(5): 751.     CrossRef
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    You Sun Kim
    Journal of the Korean Medical Association.2021; 64(9): 596.     CrossRef
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    Ji Young Chang, Jae Hee Cheon
    Precision and Future Medicine.2021; 5(4): 151.     CrossRef
  • Association of Self-Reported Medication Adherence with Potentially Inappropriate Medications in Elderly Patients: A Cross-Sectional Pilot Study
    Motoyasu Miyazaki, Masanobu Uchiyama, Yoshihiko Nakamura, Koichi Matsuo, Chika Ono, Miwa Goto, Ayako Unoki, Akio Nakashima, Osamu Imakyure
    International Journal of Environmental Research and Public Health.2020; 17(16): 5940.     CrossRef
  • Mesalazine granule formulation improves clinical data in Crohn's disease compared with tablet formulation
    Satoshi Tamura, Natsuki Ishida, Takahiro Miyazu, Shunya Onoue, Shinya Tani, Mihoko Yamade, Yasushi Hamaya, Moriya Iwaizumi, Satoshi Osawa, Takahisa Furuta, Ken Sugimoto
    Scientific Reports.2020;[Epub]     CrossRef
  • 8,926 View
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  • 9 Web of Science
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IBD
Seven days triple therapy for eradication of Helicobacter pylori does not alter the disease activity of patients with inflammatory bowel disease
Shinichiro Shinzaki, Toshimitsu Fujii, Shigeki Bamba, Maiko Ogawa, Taku Kobayashi, Masahide Oshita, Hiroki Tanaka, Keiji Ozeki, Sakuma Takahashi, Hiroki Kitamoto, Kazuhito Kani, Sohachi Nanjo, Takeshi Sugaya, Yuko Sakakibara, Toshihiro Inokuchi, Kazuki Kakimoto, Akihiro Yamada, Hisae Yasuhara, Yoko Yokoyama, Takuya Yoshino, Akira Matsui, Misaki Nakamura, Taku Tomizawa, Ryosuke Sakemi, Noriko Kamata, Toshifumi Hibi
Intest Res 2018;16(4):609-618.   Published online October 10, 2018
DOI: https://doi.org/10.5217/ir.2018.00044
AbstractAbstract PDFSupplementary MaterialPubReaderePub
Background/Aims
The influences of Helicobacter pylori eradication therapy on the disease course of inflammatory bowel disease (IBD) are still unclear. We therefore conducted a multicenter, retrospective cohort study to evaluate the safety of H. pylori eradication therapy for IBD patients.
Methods
IBD patients with H. pylori eradication from 2005 to 2015 (eradication group) and control patients (non-eradication group; 2 paired IBD patients without H. pylori eradication matched with each eradicated patient) were included. IBD exacerbation (increased/additional IBD drug or IBD-associated hospitalization/surgery) and disease improvement based on the physicians’ global assessment were investigated at baseline, and at 2 and 6 months after eradication or observation.
Results
A total of 429 IBD (378 ulcerative colitis, 51 Crohn’s disease) patients, comprising 144 patients in the eradication group and 285 patients in the non-eradication group, were enrolled at 25 institutions. IBD exacerbation was comparable between groups (eradication group: 8.3% at 2 months [odds ratio, 1.76; 95% confidence interval, 0.78–3.92; P=0.170], 11.8% at 6 months [odds ratio, 1.60; 95% confidence interval, 0.81–3.11; P=0.172]). Based on the physicians’ global assessment at 2 months, none of the patients in the eradication group improved, whereas 3.2% of the patients in the non-eradication group improved (P=0.019). Multivariate analysis revealed that active disease at baseline, but not H. pylori eradication, was an independent factor for IBD exacerbation during 2 months’ observation period. The overall eradication rate was 84.0%–comparable to previous reports in non-IBD patients.
Conclusions
H. pylori eradication therapy does not alter the short-term disease activity of IBD.

Citations

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  • Factors Associated With Decision to Treat or Not to Treat Helicobacter pylori Infection in Children: Data From the EuroPedHp Registry
    Thu Giang Le Thi, Katharina Werkstetter, Kallirroi Kotilea, Patrick Bontems, José Cabral, Maria Luz Cilleruelo, Michal Kori, Josefa Barrio, Matjaž Homan, Nicolas Kalach, Rosa Lima, Marta Tavares, Pedro Urruzuno, Zrinjka Misak, Vaidotas Urbonas, Sibylle Ko
    Helicobacter.2024;[Epub]     CrossRef
  • Impact of Helicobacter pylori Eradication on Inflammatory Bowel Disease Onset and Disease Activity: To Eradicate or Not to Eradicate?
    Antonietta Gerarda Gravina, Raffaele Pellegrino, Veronica Iascone, Giovanna Palladino, Alessandro Federico, Rocco Maurizio Zagari
    Diseases.2024; 12(8): 179.     CrossRef
  • Bibliometric analysis of the correlation between H. pylori and inflammatory bowel disease
    Yantong Li, Limin Li, Wenmeng Yin, Juyi Wan, Xiaolin Zhong
    JGH Open.2024;[Epub]     CrossRef
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    Hang Yang, Yi Mou, Bing Hu
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  • Helicobacter pylori and Inflammatory Bowel Disease: An Unresolved Enigma
    Juris Pokrotnieks, Stanislav Sitkin
    Inflammatory Bowel Diseases.2023; 29(3): e5.     CrossRef
  • Helicobacter Pylori and Autoimmune Diseases: Involving Multiple Systems
    Li Wang, Zheng-Min Cao, Li-Li Zhang, Xin-can Dai, Zhen-ju Liu, Yi-xian Zeng, Xin-Ye Li, Qing-Juan Wu, Wen-liang Lv
    Frontiers in Immunology.2022;[Epub]     CrossRef
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    Ekram W. Abd El-Wahab, Ebtessam I. Youssef, Ehab Hassouna
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  • Is the Presence of Helicobacter Pylori in the Colonic Mucosa, Provocative of Activity in Ulcerative Colitis?
    Javad Ranjbar, Bita Geramizadeh, Kamran Bagheri Lankarani, Zahra Jowkar, Mitra Mirzai, Elham Moazamian
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    Yu. P. Uspenskiy, N. V. Baryshnikova, A. N. Suvorov, A. V. Svarval
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  • Effect of sequential eradication therapy on serum osteoprotegerin levels in patients with Helicobacter pylori infection and co-existing inflammatory bowel disease
    Hussam Murad, Misbahuddin Rafeeq, Mahmoud Mosli, Mamdouh Gari, Mohammed Basheikh
    Journal of International Medical Research.2021;[Epub]     CrossRef
  • Extra-Gastric Manifestations of Helicobacter pylori Infection
    Antonietta G. Gravina, Kateryna Priadko, Paola Ciamarra, Lucia Granata, Angela Facchiano, Agnese Miranda, Marcello Dallio, Alessandro Federico, Marco Romano
    Journal of Clinical Medicine.2020; 9(12): 3887.     CrossRef
  • Comparison of new and classical point mutations associated with clarithromycin resistance in Helicobacter pylori strains isolated from dyspeptic patients and their effects on phenotypic clarithromycin resistance
    Bekir Kocazeybek, Merve Kutlu Sakli, Pelin Yuksel, Mehmet Demirci, Reyhan Caliskan, Tevhide Ziver Sarp, Suat Saribas, Suleyman Demiryas, Fatma Kalayci, Huseyin Cakan, Hayriye Kirkoyun Uysal, Nesrin Gareayaghi, Sevgi Ergin, Yusuf Ziya Erzin, Kadir Bal, İhs
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    Helicobacter.2019;[Epub]     CrossRef
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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
AbstractAbstract PDFPubReaderePub

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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    Inflammatory Intestinal Diseases.2024; 9(1): 260.     CrossRef
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    Annals of Pharmacotherapy.2023; 57(9): 1053.     CrossRef
  • Residual Short-Segment Distal Inflammation Has No Significant Impact on the Major Relapse of Extensive Ulcerative Colitis
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Case Report
Steroid-refractory extensive enteritis complicated by ulcerative colitis successfully treated with adalimumab
Shinji Okabayashi, Taku Kobayashi, Tomohisa Sujino, Ryo Ozaki, Satoko Umeda, Takahiko Toyonaga, Eiko Saito, Masaru Nakano, Maria Carla Tablante, Shojiroh Morinaga, Toshifumi Hibi
Intest Res 2017;15(4):535-539.   Published online October 23, 2017
DOI: https://doi.org/10.5217/ir.2017.15.4.535
AbstractAbstract PDFPubReaderePub

Extracolonic involvement of the gastrointestinal tract is extremely uncommon in ulcerative colitis (UC) and rarely found in the upper gastrointestinal tract or in postoperative cases since it typically responds to steroids. Here we report a case of UC complicated by extensive ileal inflammation that was refractory to steroids. A 20-year-old man was diagnosed with UC of typical pancolitis without ileal involvement and started treatment with pH-dependent mesalazine and oral prednisolone. Although his symptoms transiently resolved, the condition flared when the steroid dose was tapered down. Computed tomography revealed marked thickening of the ileal wall, and capsule endoscopy and balloon-assisted enteroscopy found diffuse mucosal inflammation with ulcers in the ileum. On the contrary, the inflammation in the colon and rectum was improving. Since the response to the second steroid course was inadequate, treatment with adalimumab and 6-mercaptopurine was initiated and finally achieved clinical and endoscopic remission. The investigation of small intestinal lesions is necessary in patients with UC whose clinical deterioration cannot be explained by colonic lesions.

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  • Clinical Features and Therapeutic Outcomes of Post-colectomy Enteritis with Ulcerative Colitis
    Yuki Horio, Motoi Uchino, Kazutoshi Hori, Kurando Kusunoki, Tomohiro Minagawa, Ryuichi Kuwahara, Kozo Kataoka, Naohito Beppu, Masataka Ikeda, Hiroki Ikeuchi
    Journal of the Anus, Rectum and Colon.2021; 5(4): 405.     CrossRef
  • 8,219 View
  • 68 Download
  • 1 Web of Science
  • 1 Crossref
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