Minoru Matsuura’s research while affiliated with Kyorin University and other places

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Publications (241)


First-line biologics as a treatment for ulcerative colitis: a multicenter randomized control study
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January 2025

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11 Reads

Journal of Gastroenterology

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Masayuki Shimoda

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Despite the availability of several biologics for ulcerative colitis (UC), there remains a critical need to identify first-line treatment biologics. The superiority of infliximab (IFX) over vedolizumab (VED) and ustekinumab (UST) was evaluated as initial UC treatments in patients with biologic-naïve UC. This multicenter, randomized control trial was conducted across 20 Japanese medical institutions. An independent center randomly allocated patients with UC (Mayo score ≥ 6) who had not previously used biologics to three treatment groups (IFX, VED, UST). The primary endpoint was the clinical remission (CR) rate at week 12, with other endpoints including the treatment continuation rate at week 26 and adverse events (AEs). From May 2021 to June 2023, 107 cases were registered, including 104 for safety and 97 for efficacy evaluation. CR rate at week 12 was 36.4% (95%CI:20.4–54.9), 32.4% (95%CI:17.4–50.5) and 43.3% (95%CI:25.5–62.6) in IFX, VED, and UST group, respectively. Continuation rates at week 26 were 50.0%(IFX), 58.3% (VED), and 82.4% (UST). AEs related to study medication were 14.7% (IFX), 16.7% (VED), and 5.9% (UST). Predictors for CR at week 12 were thiopurine use in IFX (p = 0.04), lower baseline Mayo score (p = 0.007), and lower Patient report outcome 2 (p = 0.003) at week 2 in VED. Due to small sample size, it is challenging to make conclusions for main endpoints from this study while our study suggested that use of thiopurines in IFX group and lower activity at enrollment in VED group may enhance treatment efficacy. (jRCT1031200329; available at https://jrct.niph.go.jp/).



P0358 The effects of reading experience on small intestine capsule endoscopy scoring of Crohn’s disease

January 2025

Journal of Crohn s and Colitis

Background Small bowel capsule endoscopy (SBCE) is a less invasive modality for the evaluation of small bowel lesions in Crohn’s disease (CD). The CD small bowel lesions that are visualized include inflammation and stenosis, and standardized scores are used for objective assessment of activity. On the other hand, it is not clear whether experience or individual differences influence the scoring. We assessed the correlation of each investigator and interobserver agreement in the SBCE scores. Methods Retrospective study including 15 CD patients who underwent SBCE from 2015 to 2022 after confirming patency with a patency capsule. The patient information was blinded and assessed independently by three physicians, with no experience reading SBCE (Beginner A), less than 10 years of experience (Intermediate B), and more than 10 years of experience (Expert C). The activity of inflammation was calculated independently by individual physicians according to Lewis score (LS), capsule endoscopy Crohn’s disease activity index (CECDAI), and Crohn’s disease activity in capsule endoscopy (CDACE). The correlation was compared between the scores for each investigator individually. The interobserver agreement of scores between physicians (A to C) and those with at least 10 years of reading experience and at least 500 SBCE scoring experiences (Expert D as standard control) for LS > 350 and CDACE > 420 scores, which have been reported to predict relapse outcome, were compared using kappa coefficients for each. The correlation between LS, CECDAI, and CDACE scores and Harvey-Bradshaw index (HBI) and CRP was assessed by Expert D as the standard. Results Seven male patients, median age (min-max) 21 (14-72) years, disease duration 4 (2-38) months, HBI 3 (0-9), Montreal Classification B1: 14 (93.3%), B2: 1 (6.7%), L1: 4 (26.7%), L3: 11 (73.3%). Reading time differed significantly among readers, with the beginner taking the longest (median reading time of 60 minutes for the beginner, p<0.0001). The correlation between each score per investigator regardless of experience was good, with the highest correlation between CECDAI and CDACE (Beginner A: ρ=0.87, Intermediate B: ρ=0.90, Expert C: ρ=0.93, Expert D: ρ=0.91, Spearman’s rank correlation coefficient). All physicians (A to C) showed moderate to high concordance (kappa coefficient 0.47 to 0.84) with Expert D for CDACE > 420. However, all physicians (A to C) did not show agreement with Expert D (kappa coefficient -0.05 to 0.11) for LS>350. There is no correlation was found between each score and HBI or CRP. Conclusion Reading time was affected by experience of SBCE, but the intraobserver correlation of each score was observed regardless of years of experience. Interobserver agreement was higher in CDACE compared to LS.


P1333 Trajectory analyses to optimise third booster COVID-19 vaccination in patients with Inflammatory Bowel Disease: final analyses of the J-COMBAT trial

January 2025

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5 Reads

Journal of Crohn s and Colitis

Background Even after resolving pandemic, the verification of COVID-19 vaccination is important to optimise vaccination against next crisis.1,2 Methods Data at 39 institutes were prospectively acquired at eight predetermined timepoints before and after three manufacturers’ recommended vaccine doses including 3rd booster vaccination in a multicentre observational controlled study (UMIN000043545).3 Blood sample collections to measure anti-SARS-CoV-2 spike IgG antibody titers were planned prior to each vaccination, and at 4 weeks, 3 months and 6 months post-2nd and 3rd vaccination. We performed trajectory analysis to identify the degree of immune response and associated factors including baseline characteristics and immunomodulatory drug treatments in IBD patients compared with controls. Results Overall, 679 IBD patients and 203 controls were enrolled, and 473 IBD patients who were treated with immunomodulatory drugs that were well-balanced for each mode of action and 169 controls were analysed through three vaccine doses. 63 IBD patients and 16 controls affected by COVID-19 breakthrough infection. Trajectory analyses indicated four distinct patterns of change in immune response to 3rd vaccination in IBD patients: high (4.9%), moderately high (52.3%), moderately low (36.9%) and low responders (5.9%), and none stepped up the degree from low (Figure). Older age, anti-TNFα (odds ratio, 0.16; 95% CI, 0.06-0.45) and combined with thiopurine (0.02; 0-0.22) were negative factors associated with high response (Table). Combined anti-TNFα and thiopurine (p<0.001), and tofacitinib (p<0.001) was significantly associated with a different trajectory pattern from the control. Among each drug, only tofacitinib (fold change relative to the control 0.4, 0.21-0.76; p=0.005) was significantly associated with weakened elevation of the antibody titer at 4 weeks post-3rd vaccination referred to pre-3rd vaccination. Compared to 2nd vaccination, this relative suppression of immune response in other immunomodulatory drugs shrank 0.32 to 0.62 in patients treated with anti-TNFα with thiopurines, and 0.69 to 0.88 with systemic steroids. 15.4 % of breakthrough-infected IBD patients were infected at the status less than fourfold rise of genomic mean titer (GMT), especially half of them (7.7%) were infected at the status of almost negative GMT. Moreover, 27.8% of infected IBD patients didn’t show the increasing GMT after breakthrough infection. Conclusion Assessment of changes over time is essential to optimise COVID-19 vaccination, especially in low responders. Additional booster vaccination should be considered for these low responders. Trajectory analysis is a useful approach to identify the degree of immune response sufficiency according to individual differences. References 1.Nakase H, Hayashi Y, Yokoyama Y, et al. Final Analysis of COVID-19 Patients With Inflammatory Bowel Disease in Japan (J-COSMOS): A Multicenter Registry Cohort Study.Gastro Hep Adv. 2023;2(8):1056-1065. 2.Nakase H, Wagatsuma K, Nojima M, et al. Anxiety and behavioral changes in Japanese patients with inflammatory bowel disease due to COVID-19 pandemic: a national survey. J Gastroenterol. 2023;58(3):205-216. 3.Watanabe K, Nojima M, Nakase H, et al. Trajectory analyses to identify persistently low responders to COVID-19 vaccination in patients with inflammatory bowel disease: a prospective multicentre controlled study, J-COMBAT. J Gastroenterol. 2023;58(10):1015-1029.


Factors affecting 1-year persistence with vedolizumab for ulcerative colitis: a multicenter, retrospective real-world study

January 2025

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12 Reads

Intestinal Research

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.


Publisher Correction: Anti-integrin αvβ6 antibody as a biomarker for diagnosing ulcerative colitis: a nationwide multicenter validation study
  • Article
  • Full-text available

December 2024

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11 Reads

Journal of Gastroenterology

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Fig. 1 Patient flowchart
Fig. 2 Serum anti-integrin αvβ6 antibody titers in patients with UC, CD, and OGDs. V6 Ab titers were measured using an enzyme-linked immunosorbent assay kit. The cut-off value of 1.64 U/mL, defined as the mean + 3SDs of 83 serum samples from healthy volunteers as determined by the manufacturer, is indicated by a dashed line. n total number of patients in each group. UC ulcerative colitis, CD Crohn's disease, OGDs other gastrointestinal diseases
Anti-integrin αvβ6 antibody as a biomarker for diagnosing ulcerative colitis: a nationwide multicenter validation study

November 2024

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27 Reads

Journal of Gastroenterology

Background A serum biomarker for diagnosing ulcerative colitis (UC) remains to be established. Although we recently reported an anti-integrin αvβ6 antibody (V6 Ab) for diagnosing UC with high sensitivity and specificity, no large-scale validation study exists. This study aimed to validate the diagnostic value of V6 Ab for UC using a nationwide multicenter cohort study. Methods We measured V6 Ab titers in patients definitively diagnosed with UC, Crohn’s disease (CD), or other gastrointestinal disorders (OGDs). The primary outcome was the diagnostic value of V6 Ab. Secondary outcomes were factors associated with false-negative results in patients with UC and false-positive results in patients without UC and the heterogeneity of the diagnostic value of V6 Ab among the participating facilities. Results We enrolled 1241, 796, and 206 patients with UC, CD, and OGD, respectively, from 28 Japanese high-volume referral centers. The diagnostic sensitivity of V6 Ab for UC was 87.7%, and its specificities for CD and OGDs were 82.0% and 87.4%, respectively. Multivariable logistic regression analysis showed that false-negative results were associated with older age at the time of sample collection, current smokers, lower partial Mayo score, and not receiving advanced therapies in patients with UC, and false-positive results were associated with colonic CD in patients with CD. No factor was associated with false-positive results in patients with OGDs. There were no significant differences in the diagnostic value of V6 Ab among the centers. Conclusions The diagnostic value of V6 Ab for UC was validated in the large-scale nationwide multicenter study.


Determination of optimal cutoff value of ulcerative colitis intestinal ultrasound index to estimate endoscopic improvement in ulcerative colitis

November 2024

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3 Reads

Journal of Gastroenterology

The ulcerative colitis intestinal ultrasound (UC-IUS) index (UII) has been reported as a sonographic scoring system correlating with the Mayo endoscopic subscore (MES). Endoscopic improvement (EI) of UC (MES ≤ 1) is a crucial therapeutic target in clinical practice. However, the cutoff value for estimating EI using the UII has not been established. We established test and validation cohorts comprising patients with UC undergoing IUS and endoscopy within a 15-day interval at our institution. IUS findings (bowel wall thickness, bowel blood flow, bowel wall structure, haustrations, and inflammatory fat) and endoscopic activity (MES) of each colon segment (ascending, transverse, descending, and sigmoid colon) were assessed. In the test cohort (74 segments), UII was correlated with MES (r = 0.645, p < 0.0001). The median UII was 1.0 and 6.0 among participants with MES ≤ 1 and MES ≥ 2, respectively. A UII of 2 was identified as the threshold for estimating MES ≤ 1 with receiver operating characteristic analysis. In the validation cohort (122 segments), UII was correlated with MES (r = 0.675, p < 0.0001) and the estimation ability of UII ≤ 2 for EI had a positive predictive value of 85.4% and negative predictive value of 79.0%. This estimation ability of UII for EI was numerically lower but not statistically different from the previously reported Milan Ultrasound Criteria and Kyorin Ultrasound Criterion for UC. UII ≤ 2 can be a simple, feasible criterion for estimating EI. Correlation with MES is an advantage of the UII compared with other criteria. Proper use of various sonographic criteria is important.


Citations (53)


... Machine learning methods leveraging clinical data hold great promise for developing drug-specific prediction models, including those for anti-IL-23 agents. For example, Morikubo et al. recently presented an ustekinumab-specific treatment response prediction model for ulcerative colitis, achieving a positive predictive value of 68.8% and a negative predictive value of 71.4% [92]. Future research should focus on evaluating treatment response prediction models that incorporate multiple clinical features to optimize patient selection for anti-IL-23 therapies in asthma. ...

Reference:

Advances in Biologic Therapies for Allergic Diseases: Current Trends, Emerging Agents, and Future Perspectives
Machine learning using clinical data at baseline predicts the medium-term efficacy of ustekinumab in patients with ulcerative colitis

... Other markers of inflammation include color Doppler signal, loss of bowel wall stratification, swollen lymph nodes, and peri-intestinal mesenteric fat [137]. Recent studies have demonstrated the potential of IUS scoring systems to predict disease course [136,138,139]. Milan ultrasound criteria ([1.4 × BWT] + [2 × bowel wall flow]) is the wellknown validated score, with score > 6.2 at baseline was significantly associated with negative disease course (HR 3.87; 95%CI 2.25-6.64; ...

A combination of bowel wall thickness and submucosa index is useful for estimating endoscopic improvement in ulcerative colitis: external validation of the Kyorin Ultrasound Criterion
  • Citing Article
  • January 2024

Journal of Gastroenterology

... 8 Since the publication of the abovementioned report, similar papers on the significance of MEFV mutations in patients with IBD have been published. [9][10][11] These clinical reports suggest the existence of a subset of patients with IBDU and mutated MEFV who show improvement in their colitis with colchicine treatment. This study aimed to elucidate the clinical characteristics and responsiveness to colchicine in Japanese patients with IBDU carrying MEFV mutations. ...

Single Nucleotide Polymorphisms of the MEFV Gene E148Q Are Highly Associated With Disease Phenotype in Crohn's Disease

Inflammatory Bowel Diseases

... Our PSM analysis showed that the risk of herpes zoster infection was comparable among the three JAK inhibitors, suggesting that providers need to explain the infectious risk and the importance of herpes zoster virus vaccination when prescribing any JAK inhibitor for patients with UC. Although herpes zoster virus or COVID-19 is preventable by vaccines [32,33], recent studies have shown that JAK inhibitors or TNF inhibitors may inhibit vaccineinduced immune responses [34][35][36][37], suggesting that patients taking JAK inhibitors may have an increased risk of vaccinepreventable infectious diseases. Therefore, more real-world data are needed to understand the actual risks of such viral infections in JAK inhibitor-treated UC patients exposed to vaccines. ...

Trajectory analyses to identify persistently low responders to COVID-19 vaccination in patients with inflammatory bowel disease: a prospective multicentre controlled study, J-COMBAT
  • Citing Article
  • August 2023

Journal of Gastroenterology

... This therapeutic effect likely results from dual mechanisms: anti-inflammatory action and regulation of the microbiota. MSZ could inhibit pro-inflammatory mediators such as leukotrienes, prostaglandin, IL-1, NF-κB, and TNF-α, along with a PPAR-γ receptor agonist (Wada, 2023). Previous studies in our group have shown that MSZ inhibits pro-inflammatory factors and peroxides, demonstrating therapeutic efficacy in periodontitis. ...

5-Aminosalicylic acid alters the gut microbiota and altered microbiota transmitted vertically to offspring have protective effects against colitis

... The prevalence of IBD is 0.12-0.25‰ in western regions and is estimated to progress up to 1% by 2030 [1], which brings about a heavy economic burden on the global healthcare system [3]. UC typically manifests with persistent or repetitive abdominal pain and diarrhea with pus-blood, accompanied by systemic symptoms including rectal tenesmus and fever, which can disrupt a normal life [4,5]. Despite the unclear mechanism of UC, recent studies suggested that gut dysbiosis, ferroptosis, and dietary patterns play an important role in the pathogenesis of UC [6][7][8]. ...

Association of ulcerative colitis symptom severity and proctocolectomy with multidimensional patient-reported outcomes: a cross-sectional study

Journal of Gastroenterology

... For the Australian cohorts, 59% of the entire DB population had no designated sex, hence sex composition of the IBD population is unknown. The average age at diagnosis across most cohorts in our study is higher than previously reported [12,13], likely due to the distinctive patient demographics under examination and, specifically, the small proportion of pediatric populations within certain cohorts (e.g., MDCR and, to a lesser extent, CCAE). Indeed, our findings show that the average age at diagnosis is highly correlated with the average age of the covered population in each database (Supplemental Table 1; R 2 = 0.86 and 0.8, P-value < 0.001 for Crohn's disease and ulcerative colitis, respectively). ...

Correction: Characteristics of adult patients newly diagnosed with Crohn's disease: interim analysis of the nation-wide inception cohort registry study of patients with Crohn's disease in Japan (iCREST-CD)
  • Citing Article
  • May 2023

Journal of Gastroenterology

... 40 years, and it decreased with age. Perianal fistulas (59.9%) and abscesses (30.6%) were the most common perianal lesions [11]. ...

Diagnosis and Clinical Features of Perianal Lesions in Newly Diagnosed Crohn's Disease: Subgroup Analysis from Inception Cohort Registry Study of Patients with Crohn's Disease (iCREST-CD)

Journal of Crohn s and Colitis

... The discordance between the symptoms and the mucosal inflammation is more significant in CD patients compared to UC [17]. Given the poor correlation between symptoms and inflammatory activity, it is usually advised that treatment escalation be corroborated by objective evidence of intestinal inflammation [18]. Although widely recommended, there have been few studies specifically assessing the role and frequency of endoscopic evaluation before starting an advanced therapy, and even fewer studies examining the longer-term benefit from routine endoscopic monitoring in terms of likelihood of remission or prevention of complications [19]. ...

Treatment escalation and de-escalation decisions in Crohn's disease: Delphi consensus recommendations from Japan, 2021

Journal of Gastroenterology

... Although there is little evidence to suggest the efficacy of 5-ASA for CD patients, especially for the maintenance of remission [30,31], in this study, >80% of patients were treated with 5-ASA. Recent study reported that cumulative proportion of CD patients prescribed 5-ASA was approximately 70% in Japan [32,33] with a regionary bias. Also, the efficacy of 5-ASA for CD patients in remission to mild activity is reported [34]. ...

P775 Disease activity and treatment patterns of newly diagnosed adult patients with Crohn's disease in Japan: Interim analysis of inception cohort registry study of patients with Crohn's disease (iCREST-CD)
  • Citing Article
  • January 2023

Journal of Crohn s and Colitis