Publications by authors named "Taku Kobayashi"

Background And Aims: Cross sectional imaging is an integral part of evaluating disease activity and complications in Crohn's disease. There remains a need to develop guidance that may be for both clinical trials and clinical practice. This initiative aimed to develop consensus statements for definitions of response and remission, transmural healing, optimal timing for assessing, and evaluation of treatment efficacy in patients with Crohn's disease using magnetic resonance enterography (MRE) in clinical trials and clinical practice.

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Background: Mucosal histological activity is increasingly valued as a treatment endpoint in inflammatory bowel diseases (IBD). In the Asia Pacific region, the utility and acceptability of IBD histology as a treatment endpoint are uncertain due to the heterogeneity of IBD prevalence, resourcing and level of knowledge among practitioners. There is an opportunity to engage clinicians to harmonise histology reporting and collaborate with pathologists in this field.

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Introduction: Intestinal ultrasound (IUS) is a valuable tool for assessing short-term responses to treatment of ulcerative colitis (UC). Nevertheless, no prior reports on IUS use, earlier than week 6-14, are known for predicting long-term endoscopic responses. This study evaluated whether IUS (transabdominal and transperineal) at week 1 can predict long-term clinical-endoscopic remission (CER) and histo-endoscopic mucosal improvement (HEMI) following advanced therapies.

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Background & Aims: Tofacitinib and upadacitinib are Janus kinase (JAK) inhibitors that are increasingly used for the treatment of acute severe ulcerative colitis (ASUC). However, comparative analyses of safety and effectiveness have not been performed for their use in this setting.

Methods: This multicenter, retrospective study enrolled hospitalized adult patients treated with tofacitinib or upadacitinib for ASUC between January 2019 and June 2024.

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Background/aims: Vedolizumab (VDZ), a gut-selective monoclonal antibody for ulcerative colitis (UC) treatment, has no established biomarkers or clinical features that predict long-term remission. Week 2 remission, a potential predictor of long-term remission, could inform maintenance treatment strategy.

Methods: This retrospective, observational chart review included patients with UC in Japan who initiated VDZ between December 2018 and February 2020.

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Background And Aims: Concurrent achievement of symptomatic, endoscopic, and histologic remission, known as disease clearance, has been proposed as a treatment target in ulcerative colitis. Mirikizumab, an anti-interleukin-23 p19 antibody, has demonstrated long-term efficacy and safety, as reported in the LUCENT Phase 3 trials (NCT03518086, NCT03524092, and NCT03519945). The current analysis evaluates the impact of mirikizumab on disease clearance and the association with other clinical and patient-reported outcomes (PROs).

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Background: Fecal calprotectin (FC) and C-reactive protein (CRP) are noninvasive biomarkers used in ulcerative colitis (UC) clinical trials; however, thresholds defined as "normal" in trials may be higher than "normal" thresholds typically used in clinical practice. We assessed the relationship between FC and CRP improvement in the "normal" range across different cutoff thresholds for patients with moderately to severely active UC treated with mirikizumab.

Methods: Patients achieving clinical response to mirikizumab in LUCENT-1 (Weeks 0-12) proceeded to LUCENT-2 (Weeks 12-52 [52 weeks of continuous mirikizumab]).

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Background & Aims: JAK inhibitor-associated acne is a common but poorly understood adverse event. This study aimed to investigate the epidemiology, clinical characteristics, and treatment outcomes of this condition in patients with inflammatory bowel disease (IBD).

Methods: This international, multicenter, retrospective cohort study consecutively enrolled JAK-inhibitor-treated patients with IBD who subsequently developed acne.

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Background/aims: Previous literature suggests that the response of patients with ulcerative colitis to vedolizumab may be affected by previous biologic therapy exposure. This real-world study evaluated vedolizumab treatment effectiveness in biologicnon- naïve patients.

Methods: This was a multicenter, retrospective, observational chart review of records from 16 hospitals in Japan (December 1, 2018, to February 29, 2020).

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The gut microbiome early in life plays a crucial role in development of the host and affects health throughout life. The definition of a healthy microbiome early in life has not been established, and the underlying mechanism of how a young host selects appropriate microbes for colonization remains unclear. Understanding the mechanism may provide insights into novel preventive and therapeutic strategies by correcting dysbiosis early in life.

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Background & Aims: The diagnosis and management of ileocolonic Crohn's disease are well-established. In contrast, standardized guidance pertaining to the diagnosis and management of upper gastrointestinal Crohn's disease (UGICD) is lacking, despite its potentially severe consequences. This comprehensive systematic review describes the prevalence, clinical presentation, and medical and surgical management of involvement of the upper GI tract in adult patients with Crohn's disease.

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Background And Aim: Vedolizumab (VDZ) is often used in older patients with ulcerative colitis (UC) in clinical practice; however, real-world evidence is still limited, including in those with late-onset UC.

Methods: This post hoc analysis of a multicenter, retrospective, observational chart review, enrolling 370 patients with UC receiving VDZ between December 2018 and February 2020, compared effectiveness and safety of VDZ among patients ≥ 70 (n = 40) versus < 70 years (n = 330), and among patients ≥ 70 years with and without late-onset UC (age at disease onset: ≥ 70 [n = 13] versus < 70 years [n = 26]).

Results: There were no differences between patients ≥ 70 and < 70 years in clinical remission rates (week 6: 57.

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Background/aims: Patients with ulcerative colitis (UC) in remission commonly restrict thir lifestyle to prevent relapse; however, the effectiveness and impact on quality of life (QOL) is unclear. This study investigated whether lifestyle restrictions are associated with relapse reduction and assessed their impact on QOL.

Methods: This multicenter, prospective cohort study was conducted in Japan (2018-2021) via the YOURS registry, enrolling patients with UC in clinical remission.

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Background And Aims: Tyrosine kinase 2 is a downstream intracellular mediator of interleukin-23 signaling, which has a key role in the pathogenesis of inflammatory bowel disease. Deucravacitinib is a novel, oral, selective, allosteric tyrosine kinase 2 inhibitor currently approved for the treatment of adults with moderate to severe plaque psoriasis.

Methods: Here we describe 3 randomized, double-blind, placebo-controlled phase 2 studies of deucravacitinib in patients with moderately to severely active Crohn's disease (LATTICE-CD [NCT03599622]) or ulcerative colitis (LATTICE-UC [NCT03934216] and IM011-127 [NCT04613518]).

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During the twentieth century, inflammatory bowel disease (IBD) was considered a disease of early industrialized regions in North America, Europe and Oceania. At the turn of the twenty-first century, IBD incidence increased in newly industrialized and emerging regions in Africa, Asia and Latin America, while the prevalence in early industrialized regions continued to grow steadily. Changes in the incidence and prevalence denote the evolution of IBD across four epidemiologic stages: stage 1 (emergence), characterized by low incidence and prevalence; stage 2 (acceleration in incidence), marked by rapidly rising incidence and low prevalence; and stage 3 (compounding prevalence), where the incidence decelerates, plateaus or declines while the prevalence steadily increases.

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Introduction: While previous reports have suggested an association between Wilson's disease (WD) and ulcerative colitis (UC), we present the first case of asymptomatic WD diagnosed during the treatment course of UC.

Case Presentation: A 14-year-old male receiving treatment for UC developed elevated liver enzymes without any related symptoms. After ruling out drug-induced liver toxicity and other possible causes of hepatitis, further investigation was initiated due to his sister's subsequent diagnosis of WD.

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Background: In randomised controlled trials, mirikizumab achieved clinical remission and improved outcomes of patients with moderate to severe ulcerative colitis (UC). However, there is currently no real-world evidence for mirikizumab.

Aim: To evaluate the real-world effectiveness and safety of mirikizumab.

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Introduction: The global Communicating Needs and Features of Inflammatory Bowel Disease Experiences (CONFIDE) study aimed to evaluate the impact of ulcerative colitis (UC)- and Crohn's disease (CD)-related symptoms on patients' lives and elucidate communication gaps between patients and health care professionals (HCPs). We report the findings from the study in patients with UC or CD and HCPs in Japan.

Methods: Online, quantitative, cross-sectional surveys were conducted in Japan for patients with moderate-to-severe UC or CD and HCPs responsible for the care of patients with UC and/or CD.

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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.

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Background: 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.

Methods: This multicenter, randomized control trial was conducted across 20 Japanese medical institutions.

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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.

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The relationship between D-AA metabolic enzymes and cancer development remains unclear. We aimed to investigate this relationship using mice deficient in D-AA-related metabolic enzymes. We examined mice lacking these enzymes for approximately 900 days and the effects of altered D-AA metabolism on cancer development based on lifespan, pathological findings, and gene expression.

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