Kazuya Kitamura’s research while affiliated with Kanazawa University and other places

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Publications (10)


Nationwide multicenter study on adverse events associated with a patency capsule: Additional survey of appropriate use of patency capsule study
  • Article

October 2023

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16 Reads

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7 Citations

Journal of Gastroenterology and Hepatology

Teppei Omori

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Naoki Ohmiya

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[...]

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Background and Aim The PillCam patency capsule (PC) without a radio frequency identification tag was released to preclude retention of the small bowel capsule endoscope (CE) in Japan in 2012. We conducted a multicenter study to determine tag‐less PC‐related adverse events (AEs). Methods We first conducted a retrospective survey using a standardized data collection sheet for the clinical characteristics of PC‐related AEs among 1096 patients collected in a prospective survey conducted between January 2013 and May 2014 (Cohort 1). Next, we retrospectively investigated additional AEs that occurred before and after Cohort 1 within the period June 2012 and December 2014 among 1482 patients (Cohort 2). Results Of the 2578 patients who underwent PC examinations from both cohorts, 74 AEs occurred among 61 patients (2.37%). The main AEs were residual parylene coating in 25 events (0.97%), PC‐induced small bowel obstruction, suspicious of impaction, in 23 events (0.89%), and CE retention even after patency confirmation in 10 events (0.39%). Residual parylene coating was significantly associated with Crohn's disease ( P < 0.01). Small bowel obstruction was significantly associated with physicians with less than 1 year of experience handling the PC and previous history of postprandial abdominal pain ( P < 0.01 and P < 0.03, respectively). CE retention was ascribed to erroneous judgment of PC localization in all cases. Conclusions This large‐scale multicenter study provides evidence supporting the safety and efficiency of a PC to preclude CE retention. Accurate PC localization in patients without excretion and confirmation of previous history of postprandial abdominal pain before PC examinations is warranted (UMIN000010513).


Novel adsorptive type Apheresis Device Immunopure for Ulcerative colitis -from clinical perspectives based on clinical trial of Japan/Europe
  • Article
  • Full-text available

April 2021

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70 Reads

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1 Citation

Therapeutic apheresis and dialysis: official peer-reviewed journal of the International Society for Apheresis, the Japanese Society for Apheresis, the Japanese Society for Dialysis Therapy

Several adsorptive type devices for Ulcerative colitis are used for the induction of remission in patients with active severe disease in worldwide. In 2020 the novel apheresis device Immunopure for Ulcerative colitis was launched in Japan Immunopure, like the polyethylene terephthalate column, uses polyarylate, a type of polyester resin, as the adsorbent. similar to the cellulose acetate column, Immunopure is filled with adsorbent beads and expected to provide ease of use, with minimal risk of column clogging. Immunopure adsorbs leukocytes and platelets, especially activated platelets and platelet-leukocyte aggregates. In this article, the capability of Immunopure is evaluated from clinical perspective based on clinical trial in Japan/Europe. As a result, Immunopure is comparable to other products in clinical effectiveness and indicated for the treatment of patients with refractory moderate ulcerative colitis, making it highly useful in clinical practice. This article is protected by copyright. All rights reserved.

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Summary of demographic factors and baseline characteristics by group in the full analysis set (FAS)
Discontinuation of infliximab in patients with ulcerative colitis in remission (HAYABUSA): a multicentre, open-label, randomised controlled trial

April 2021

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1,027 Reads

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41 Citations

The Lancet Gastroenterology & Hepatology

Background Anti-tumour necrosis factor (TNF) agents are the mainstay of long-term treatment for refractory ulcerative colitis. However, long-term use of anti-TNF therapy might lead to an increased risk of malignancy or infection. To date, no randomised controlled trial has evaluated whether anti-TNF agents can be safely discontinued in patients with ulcerative colitis in remission. We therefore aimed to compare outcomes in these patients who continued infliximab with those who discontinued infliximab. Methods We did a multicentre, open-label randomised controlled trial at 24 specialist centres in Japan. We enrolled patients with ulcerative colitis who were in remission, had been treated with intravenous infliximab (5 mg/kg) every 8 weeks, and had started infliximab at least 14 weeks before study enrolment. No restrictions regarding age and comorbidities were used to exclude participation. Patients who were confirmed to be in remission for more than 6 months, to be corticosteroid-free, and to have a Mayo Endoscopic Subscore (MES) of 0 or 1 were centrally randomised. An independent organisation randomly assigned patients (1:1) into either the infliximab-continued group or infliximab-discontinued group, using a computer-generated stratified randomisation procedure. The stratified factors were the use of immunomodulators (yes or no) and MES (0 or 1). Neither patients nor health-care providers were masked to the randomisation. The primary endpoint was the remission rate at week 48 in the full analysis set, which was based on the intention-to-treat principle and excluded participants with no efficacy data after randomisation. This study was registered with the University Hospital Medical Information Network Center Trials registry, UMIN000012092. Findings Between June 16, 2014, and July 28, 2017, 122 patients were eligible for screening and a total of 95 patients were randomly assigned to the infliximab-continued group (n=48) or the infliximab-discontinued group (n=47). 92 patients (n=46 for both groups) were included in the full analysis set. 37 (80·4% [95% CI 66·1–90·6]) of 46 patients in the infliximab-continued group and 25 (54·3% [39·0–69·1]) of 46 patients in the infliximab-discontinued group were in remission at week 48. The between-group difference was 26·1% (95% CI 7·7–44·5; p=0·0076) before adjustment and 27·3% (95% CI 8·0–44·1; p=0·0059) after adjustment for stratification factors. Eight (17%) of 48 patients in the infliximab-continued group and six (13%) of 47 in the infliximab-discontinued group developed adverse events (between-group difference 3·9% [95% CI −10·3 to 18·1]; p=0·59). In the infliximab-continued group, one patient had an infusion reaction and two patients had psoriatic skin lesions. Eight (66·7%, 95% CI 34·9–90·1) of the 12 patients in the infliximab-discontinuation group who were re-treated with infliximab after relapsing were in remission within 8 weeks of re-treatment; none had infusion reactions. Interpretation Maintenance of remission was significantly more common in patients who continued infliximab than in those who discontinued. Discontinuing infliximab should therefore be discussed with caution, taking both risk of relapse and efficacy of re-treatment into account. Funding Mitsubishi Tanabe Pharma Corporation and the Intractable Disease Project of the Ministry of Health, Labour and Welfare of Japan. Translation For the Japanese translation of the abstract see Supplementary Materials section.


Patients’ enrolment
Proportion of patients self-reporting good adherence (solid line), and physician estimated adherence (dotted line) with mesalamine (a) and thiopurines (b).#< 0.05 compared to trimester 1
Comparison of cumulative incidences of relapse between good- or non-adherent patients. (a) Cumulative incidence of overall relapse among the UC pregnant women. (b)Those who were non-adherent to their treatment (dotted line) had a significantly higher risk of relapse than those with good adherence (bold line) (p < 0.01)
The effect of non-adherence was significant in patients treated only with high-dose mesalamine. The proportion of patients with relapse was affected significantly by adherence in higher dose group. No relapse was observed in lower dose group with good adherence.#< 0.05 compared to good adherence in higher dose group
Non-adherence to Medications in Pregnant Ulcerative Colitis Patients Contributes to Disease Flares and Adverse Pregnancy Outcomes

February 2021

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103 Reads

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25 Citations

Digestive Diseases and Sciences

Background Adherence to medications is important to maintain disease under control and to prevent complications in pregnant patients with ulcerative colitis (UC). To evaluate the incidence of non-adherence during pregnancy and its effect on relapse and pregnancy outcomes, we conducted a multicenter prospective study using a patient self-reporting system without physician interference.Methods Sixty-eight pregnant UC women were recruited from 17 institutions between 2013 and 2019. During the course of pregnancy, questionnaires were collected separately from patients and physicians, to investigate the true adherence to medications, disease activity, and birth outcomes. Multivariable logistic regression analysis was performed to identify the risk factors for the relapse or adverse pregnancy outcomes.ResultsOf 68 pregnancy, 15 adverse pregnancy outcomes occurred in 13 patients. The rate of self-reported non-adherence was the greatest to mesalamines in the first trimester, which was significantly higher than physicians’ estimate (p = 0.0116), and discontinuation was observed in 42.1% of non-adherent group. Logistic regression analysis revealed non-adherence as an independent risk factor for relapse [odds ratio (OR) 7.659, 95% CI 1.928–30.427, p = 0.038], and possibly for adverse pregnancy outcome (OR 8.378, 95% CI 1.350–51.994, p = 0.023). Among the subgroup of patients treated with oral mesalamine alone, the non-adherence was confirmed to be an independent risk factor for relapse (p = 0.002).Conclusion Non-adherence to mesalamine was underestimated by physicians in pregnant UC patients and contributed to disease relapse and possibly on pregnancy outcomes. Preconceptional education regarding safety of medications and risk of self-discontinuation is warranted.


Fig. 1. Concept of primary nonresponders (PNR) and partial responders (PR) after the induction of TNF-α inhibitors.
Management of Primary Nonresponders and Partial Responders to Tumor Necrosis Factor-α Inhibitor Induction Therapy among Patients with Crohn’s Disease

March 2020

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105 Reads

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7 Citations

Inflammatory Intestinal Diseases

Induction therapy with tumor necrosis factor-α (TNF-α) inhibitors is highly effective for the treatment of Crohn’s disease. However, there are primary nonresponders (PNR) of TNF-α inhibitors without clinical response during the induction period. In addition, there are partial responders (PR), who show some efficacy, but clinical remission is not achieved by induction therapy. To date, the definition and clinical management of PNR and PR have not been established. This report summarizes the opinions of 36 Japanese experts attending the Japan Round Table Discussion on IBD Meeting regarding how to determine PNR and PR of TNF-α inhibitors and how to manage these patients in clinical practice. PNR, who do not show any initial improvement of clinical symptoms and serum C-reactive protein (CRP) levels, require re-assessment of intestinal complications. PR can be determined either by clinical symptoms, serum CRP levels, or imaging results. PR need intensification of the treatment with TNF-α inhibitors either with or without optimization of immunomodulators. Optimization of initial TNF-α inhibitor therapy may improve long-term outcomes, but more evidence is required to improve the use of TNF-α inhibitors for the prevention and management of PNR and PR.


A nationwide, multi-center, retrospective study of symptomatic small bowel stricture in patients with Crohn’s disease

January 2020

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54 Reads

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19 Citations

Journal of Gastroenterology

Background Small bowel stricture is one of the most common complications in patients with Crohn’s disease (CD). Endoscopic balloon dilatation (EBD) is a minimally invasive treatment intended to avoid surgery; however, whether EBD prevents subsequent surgery remains unclear. We aimed to reveal the factors contributing to surgery in patients with small bowel stricture and the factors associated with subsequent surgery after initial EBD.Methods Data were retrospectively collected from surgically untreated CD patients who developed symptomatic small bowel stricture after 2008 when the use of balloon-assisted enteroscopy and maintenance therapy with anti-tumor necrosis factor (TNF) became available.ResultsA total of 305 cases from 32 tertiary referral centers were enrolled. Cumulative surgery-free survival was 74.0% at 1 year, 54.4% at 5 years, and 44.3% at 10 years. The factors associated with avoiding surgery were non-stricturing, non-penetrating disease at onset, mild severity of symptoms, successful EBD, stricture length < 2 cm, and immunomodulator or anti-TNF added after onset of obstructive symptoms. In 95 cases with successful initial EBD, longer EBD interval was associated with lower risk of surgery. Receiver operating characteristic analysis revealed that an EBD interval of ≤ 446 days predicted subsequent surgery, and the proportion of smokers was significantly high in patients who required frequent dilatation.Conclusions In CD patients with symptomatic small bowel stricture, addition of immunomodulator or anti-TNF and smoking cessation may improve the outcome of symptomatic small bowel stricture, by avoiding frequent EBD and subsequent surgery after initial EBD.



Differential diagnosis for ulcerative colitis in the elderly patients Infection-related diseases Clostridium difficile (Clostridioides difficile)-associated diarrhea (CDAD)
Management of elderly ulcerative colitis in Japan

April 2019

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94 Reads

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36 Citations

Journal of Gastroenterology

Japan has the largest aging society, where many elderly people have intractable diseases including ulcerative colitis (UC). Along with the increasing total number of UC patients, the number of elderly UC patients has also been increasing and will continue to do so in the future. Although the clinical features and natural history of UC in the elderly have many similarities with UC in the non-elderly population, age-specific concerns including comorbidities, immunological dysfunction, and polypharmacy make the diagnosis and management of elderly UC challenging compared to UC in non-elderly patients. Based on increasing data related to elderly UC patients from Japan, as well as other countries, we reviewed the epidemiology, clinical course, differential diagnosis, management of comorbidities, surveillance, medical therapy, and surgery of UC in the elderly.



Citations (8)


... While avoiding retention is laudable, it is well accepted that there is a need to adhere to the appropriate use of patency capsules to prevent the excessive exclusion of patients from undergoing capsule endoscopy [24]. While in the majority, patency capsule use is safe, there are reports of AEs, including transient obstructive symptoms and patency capsule retention [25]. ...

Reference:

Performance measures for small-bowel endoscopy: a European Society of Gastrointestinal Endoscopy (ESGE) Quality Improvement Initiative -Update 2025
Nationwide multicenter study on adverse events associated with a patency capsule: Additional survey of appropriate use of patency capsule study
  • Citing Article
  • October 2023

Journal of Gastroenterology and Hepatology

... The available data comparing de-escalation of treatment versus continuation is mainly for the agents that have been in use longer such as TNFi [150,151]. Studies of TNFi dose reduction showed feasibility in patients who have been doseescalated and achieved deep remission. In TAXIT RCT, IBD patients who had stable responses to infliximab were randomized to dose escalation or de-escalation aimed at achieving target trough concentrations, based on either clinical features or trough concentrations. ...

Discontinuation of infliximab in patients with ulcerative colitis in remission (HAYABUSA): a multicentre, open-label, randomised controlled trial

The Lancet Gastroenterology & Hepatology

... Recent studies investigating the relationship between pregnancy outcomes and medications for IBD, such as thiopurine and biologics, have concluded that most of these medications had no significant risk to babies (3)(4)(5). Given these findings, it is believed that IBD patients should continue IBD medications during pregnancy; nonetheless, the medications are often stopped due to fear of adverse effects on babies (6,7). ...

Non-adherence to Medications in Pregnant Ulcerative Colitis Patients Contributes to Disease Flares and Adverse Pregnancy Outcomes

Digestive Diseases and Sciences

... Partial primary response is where despite symptomatic and biochemical remission, imaging results demonstrate continued active inflammation. 65 Clinical indications of partial response must be assessed at timepoints defined by the specific induction therapy administered. The partial response may be improved through medication dose escalation or a switch to an alternative therapy. ...

Management of Primary Nonresponders and Partial Responders to Tumor Necrosis Factor-α Inhibitor Induction Therapy among Patients with Crohn’s Disease

Inflammatory Intestinal Diseases

... Anti-tumor necrosis factor-α theoretically has a risk of stricture formation. 24 However, several studies reported a positive impact of biologics clinical course following EBD 25 and the healing process of small bowel ulcers. 26 We believe that further investigations with more participants are necessary to evaluate the impact of biologics on the restenosis-free period following RIC. ...

A nationwide, multi-center, retrospective study of symptomatic small bowel stricture in patients with Crohn’s disease
  • Citing Article
  • January 2020

Journal of Gastroenterology

... The proportion of patients with elderly onset IBD varies from 3 to 21% for CD and 7 to 29% for UC [169]. Elderly patients with long-standing IBD who were diagnosed in younger adulthood may be clinically distinct from those with elderly onset IBD [170]. ...

Correction to: Management of elderly ulcerative colitis in Japan

Journal of Gastroenterology

... The comparison of the disease severity between elderly and non-elderly patients with UC varies among studies. [23,24] Aging is reported to induce a significant decrease in the number and function of antibody-producing B cells and senescence of B cells [25]. These factors may have affected their V6 Ab titers. ...

Management of elderly ulcerative colitis in Japan

Journal of Gastroenterology

... Fractalkine regulates crawling monocytes in colitis 301 or TNF-α inhibitors (56,57). Therefore, blockade of the FKN-CX3CR1 pathway and inhibition of monocyte functions may prove particularly effective in IBD patients. ...

Mo1890 Safety, Tolerability and Efficacy of E6011, Anti-Human Fractalkine Monoclonal Antibody, in the First-in-Patient Study for Crohn's Disease
  • Citing Article
  • April 2016

Gastroenterology