Tadakazu Hisamatsu

Tadakazu Hisamatsu
Kyorin University · Department of Gastroenterology and Hepatology

Professor, Department of Gastroenterology and Hepatology, Kyorin University School of Medicine

About

574
Publications
57,441
Reads
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12,683
Citations
Introduction
pathogenesis, diagnosis, therapeutics, endoscopy, education, interview skill innate immunity, intestinal macrophage, mucosal plasma cell, flora, epithelial cell amino acid metabolism in chronic inflammatory disorders
Additional affiliations
May 2000 - September 2003
Harvard Medical School
Position
  • Research Associate
November 2014 - March 2015
Keio University
Position
  • Professor (Associate)

Publications

Publications (574)
Article
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 wa...
Article
Background The Phase 3 double-blind, placebo-controlled, treat-through GRAVITI study evaluated the efficacy and safety of subcutaneous (SC) induction and maintenance treatment with guselkumab (GUS), a dual-acting IL-23p19 subunit inhibitor that binds to IL-23 and CD64 (a receptor on cells that produce IL-23), in participants (pts) with Crohn’s dise...
Article
Background Guselkumab (GUS) is a dual-acting interleukin-23 p19 subunit inhibitor that was efficacious in phase 3 trials of participants (pts) with Crohn’s disease (CD) using either intravenous (IV; GALAXI 2/3) or subcutaneous (SC; GRAVITI) induction and SC maintenance.1,2 We evaluated the efficacy and safety of GUS SC induction and SC maintenance...
Article
Background Obefazimod is an investigational, oral, once-daily (QD), small molecule which enhances expression of microRNA-124 and demonstrated efficacy and safety in patients with moderately to severely active ulcerative colitis (UC) in a placebo-controlled, Phase 2b induction trial and the subsequent 96-week open-label maintenance (OLM) study [1, 2...
Article
Background Guselkumab (GUS) is a dual-acting IL-23 inhibitor that potently neutralizes IL-23 and binds to CD64, a receptor on cells that produce IL-23. Induction with both intravenous (IV) and subcutaneous (SC) GUS was effective in phase 2/3 clinical trials of participants (pts) with moderately to severely active Crohn’s disease (CD). To characteri...
Article
Background The GRAVITI study established the efficacy and safety of subcutaneous (SC) induction with guselkumab (GUS), a dual-acting IL-23p19 subunit inhibitor, in participants (pts) with moderately to severely active Crohn’s disease (CD) through 48 weeks of treatment.1 Here, we evaluated the efficacy of GUS SC induction in GRAVITI subgroups based...
Article
Background Obefazimod is an oral, once-daily (QD), small molecule which enhances expression of microRNA-124 and is currently in phase 3 clinical trials for the treatment of patients with moderately to severely active ulcerative colitis (UC) [1]. Obefazimod demonstrated efficacy and safety in patients with UC across 4 clinical studies: two placebo-c...
Article
Background The FORTIFY maintenance open-label extension (OLE) is an ongoing phase 3 substudy evaluating the long-term efficacy and safety of risankizumab (RZB), a p19 interleukin-23 inhibitor, in patients (pts) with moderate to severe Crohn’s disease (CD). Previously, we presented the 2-year (Y) results from the OLE assessed through MAR2023, at whi...
Article
Background Guselkumab (GUS) is a selective dual-acting IL-23p19 subunit inhibitor that potently blocks IL-23 and binds to CD64, a receptor on cells that produce IL-23. GUS demonstrated efficacy in patients (pts) with ulcerative colitis (UC) who received GUS intravenous (IV) induction and subcutaneous (SC) maintenance (QUASAR). We evaluated the effi...
Article
Background The global QUASAR studies demonstrated efficacy and safety of guselkumab (GUS), a dual-acting interleukin-23p19 subunit inhibitor, as induction and maintenance therapy in participants (pts) with moderately to severely active ulcerative colitis (UC).1-3 We report a subgroup analysis in East Asian pts. Methods The QUASAR Ph 2b/3 clinical...
Article
Background Etrasimod is an oral, once-daily, selective sphingosine 1-phosphate (S1P)1,4,5 receptor modulator for the treatment of moderately to severely active ulcerative colitis (UC). The efficacy and safety of etrasimod 1 mg and 2 mg have been assessed in a global population,1 but not in a Japanese population. We evaluated the efficacy and safety...
Article
Background Guselkumab (GUS), a dual-acting interleukin-23p19 subunit inhibitor, demonstrated efficacy and safety in participants (pts) with moderately to severely active Crohn’s disease (CD) in the global Phase 3 GALAXI 2 & 3 (G2 & G3) studies.1 We report a subgroup analysis of GUS efficacy and safety in East Asian pts from G2 & G3. Methods G2 & G...
Article
Background GALAXI 2 & GALAXI 3 (G2 & G3) are identical 48-week (Wk), randomized, double-blind, head-to-head, placebo- and active-comparator (ustekinumab; UST) treat-through trials assessing the efficacy and safety of guselkumab (GUS), a dual-acting IL-23p19 subunit inhibitor, in participants (pts) with Crohn’s disease (CD). Here we report the corti...
Article
Background Obefazimod is an investigational, oral, once-daily (QD), small molecule that enhances expression of microRNA-124 and is currently in phase 3 clinical trials for the treatment of patients with UC [1]. Obefazimod demonstrated efficacy and safety at Week 8 in two double-blind, placebo-controlled induction trials and ensuing open-label maint...
Article
Background The GRAVITI study established the efficacy and safety of subcutaneous (SC) induction with guselkumab, a dual-acting IL-23p19 subunit inhibitor, in participants with moderately to severely active Crohn’s disease through 48 weeks of treatment.1 Here, we evaluated the efficacy of guselkumab SC induction in GRAVITI subgroups based on baselin...
Article
Background Guselkumab (GUS) is a dual-acting IL-23p19 subunit inhibitor that was efficacious in phase 3 trials (GALAXI 2/3) of pts with CD using IV induction and SC maintenance. We evaluated the efficacy and safety of GUS SC induction/maintenance in GRAVITI, a phase 3 treat-through trial in pts with moderately to severely active CD. Methods Eligib...
Article
Background VIVID-2 (NCT04232553) is an ongoing open-label long-term extension study of efficacy and safety of mirikizumab (MIRI), a selective interleukin-23p19 inhibitor, in patients with moderately to severely active Crohn’s disease (CD). We present efficacy and safety results from patients randomised to MIRI in the phase 3 VIVID-1 study (NCT03926...
Article
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 multicentr...
Article
Background Guselkumab (GUS), a dual-acting IL-23 inhibitor that potently neutralizes IL-23 and binds to CD64 (a receptor on cells that produce IL-23), is currently approved in the United States for treatment of ulcerative colitis (UC) and worldwide for the treatment of plaque psoriasis and psoriatic arthritis. While GUS has been shown to be safe in...
Article
Background Risankizumab (RZB), a high-affinity humanised IgG1 monoclonal antibody targeting interleukin-23 p19, has shown sustained efficacy and an acceptable safety profile for patients (pts) with ulcerative colitis (UC).1 This interim analysis reports efficacy data at week (wk) 0 and wk 96, as well as safety data of the COMMAND (NCT03398135) open...
Article
Background Results from the phase 3 VIVID-1 study, NCT03926130, showed efficacy of mirikizumab (miri), a p19-directed antibody against IL-23, in patients with moderately-to-severely active Crohn’s disease (CD). VIVID-1 co-primary and gated endpoints, including comparison with ustekinumab (uste), are already reported1, 2. Immunogenicity is recognise...
Article
Background Histologic inflammation persists in up to 1/4 of patients with Crohn’s disease (CD) despite endoscopic mucosal healing. Histologic and combined endoscopic-histologic endpoints are evolving measures of treatment efficacy in CD; however, the impact of histologic healing on long-term outcomes and disease progression is unknown. Week (W) 52...
Article
Background Obefazimod is an investigational, oral, once-daily (QD), small molecule which enhances expression of microRNA-124. Obefazimod demonstrated efficacy and safety in patients with moderate to severe active UC at week-8 in two double-blind, placebo-controlled induction trials and in subsequent open-label maintenance (OLM) studies [1-3], and a...
Article
Full-text available
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 mult...
Article
Full-text available
Background The involvement of Mediterranean fever (MEFV) gene mutations in patients with inflammatory bowel disease unclassified (IBDU) remains unclear. This study aimed to determine the clinical characteristics and responsiveness to colchicine in Japanese patients with IBDU carrying MEFV mutations. Methods In this retrospective cohort study, we e...
Article
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....
Article
Background and Aims Normalization of high-sensitivity C-reactive protein [hs-CRP] and fecal calprotectin [FCP] are suggested Crohn’s disease [CD] intermediate treatment targets. This analysis evaluates achievement of biomarker normalization and the relationship between improvements in biomarker concentrations and clinical and endoscopic outcomes am...
Article
Introduction: Etrasimod is an oral, once-daily (QD), selective sphingosine 1-phosphate (S1P)1,4,5 receptor modulator for the treatment of moderately to severely active ulcerative colitis (UC). Here, we report the primary analysis of a phase 3 trial evaluating the efficacy and safety of etrasimod in patients from Japan with moderately to severely a...
Article
Full-text available
Recent evidence indicates that liver cirrhosis (LC) is a reversible condition, but there is no established intervention against liver fibrosis. Although the gut microbiota is considered involved in the pathogenesis of LC, the underlying mechanisms remain unclear. Although the antibiotic, rifaximin (RFX), is effective for hepatic encephalopathy (HE)...
Article
Importance The clinical effects of risankizumab (a monoclonal antibody that selectively targets the p19 subunit of IL-23) for the treatment of ulcerative colitis are unknown. Objective To evaluate the efficacy and safety of risankizumab when administered as an induction and a maintenance therapy for patients with ulcerative colitis. Design, Setti...
Article
Full-text available
Objectives Although color information is important in gastrointestinal endoscopy, there are limited studies on how endoscopic images are viewed by people with color vision deficiency. We aimed to investigate the differences in the visibility of blood vessels during endoscopic submucosal dissection (ESD) among people with different color vision char...
Article
Full-text available
Although sequence-based studies show that basal-like features lead to worse prognosis and chemotherapy-resistance compared to the classical subtype in advanced pancreatic ductal adenocarcinoma (PDAC), a surrogate biomarker distinguishing between these subtypes in routine diagnostic practice remains to be identified. We aimed to evaluate the utility...
Conference Paper
Objective Here we compared mirikizumab (miri), a p19-directed anti-IL-23 antibody, to ustekinumab (uste), a p40 directed anti-IL-12/IL-23 inhibitor, from the Phase 3, randomised, double-blind, double-dummy, active- and PBO-controlled, treat-through (TT) study, VIVID-1 (NCT03926130). Methods Adult pts (N=1065) were randomised 6:3:2 to miri (N=579)...
Conference Paper
Aim To evaluate long-term efficacy and safety of mirikizumab (miri), a p19-directed IL-23 antibody, in moderately to severely active ulcerative colitis (UC). Methods In LUCENT-3, patients received 200 mg miri Q4W subcutaneously. Results Among W52 miri responders (N=239), 74.5% demonstrated clinical response at W104. Remission rates at W104 for W5...
Conference Paper
Introduction C-reactive protein (CRP) and fecal calprotectin (FeCal) are non-invasive inflammatory biomarkers used to assess disease activity in ulcerative colitis (UC). The Phase 3 QUASAR induction study evaluated guselkumab’s (GUS) efficacy and safety in patients (pts) with moderately to severely active UC. Here, we analyze the effect of GUS trea...
Conference Paper
Introduction The QUASAR study evaluated GUS safety and efficacy in moderately to severely active ulcerative colitis (UC) with inadequate/loss of response or intolerance to corticosteroids, immunosuppressants, and/or advanced therapies. We present GUS induction effects on histologic and combined histologic and endoscopic outcomes at Week (W)12. Met...
Conference Paper
Objective Here we present primary efficacy and safety of mirikizumab (miri), a selective IL23p19 monoclonal antibody, compared to placebo (PBO) up to Week 52 (W52) in patients with moderate to severe Crohn’s disease from the Phase 3, randomised, double-blind, double-dummy, active- and PBO-controlled, treat-through VIVID-1 study. Methods Adult pts...
Article
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, dou...
Article
Full-text available
Background This study evaluated the effectiveness of NUDT15 codon 139 genotyping in optimizing thiopurine treatment for inflammatory bowel disease (IBD) in Japan, using real-world data, and aimed to establish genotype-based treatment strategies. Methods A retrospective analysis of 4628 IBD patients who underwent NUDT15 codon 139 genotyping was con...
Article
Introduction: We examined the associations among disease-related symptoms, health-related quality of life (HRQOL), and sense of coherence (SOC) in Japanese patients with ulcerative colitis (UC). Methods: This cross-sectional survey involved patients and physicians at 23 hospitals specializing in UC treatment in Japan (December 2019-December 2020...
Article
Background Mirikizumab, a p19-directed interleukin-23 monoclonal antibody, is efficacious in inducing clinical remission at week 12 (W12) and maintaining clinical remission at W52 in patients with moderately to severely active ulcerative colitis. Results are presented from the open-label extension study through W104. Methods Clinical, symptomatic,...
Article
Full-text available
Predicting the therapeutic response to biologics before administration is a key clinical challenge in ulcerative colitis (UC). We previously reported a model for predicting the efficacy of vedolizumab (VDZ) for UC using a machine-learning approach. Ustekinumab (UST) is now available for treating UC, but no model for predicting its efficacy has been...
Article
Hospitalization for ulcerative colitis (UC) is potentially life-threatening. Severe disease in the Japanese criteria which modifies the Truelove–Witts’ criteria might encompass more fulminant cases than the definition for acute severe UC. However, few studies have investigated the predictive factors for clinical remission (CR) after medical treatme...
Article
INTRODUCTION While the therapeutic armamentarium for Crohn’s disease (CD) is rapidly expanding, direct evidence on comparative efficacy of various treatments is lacking. CT-P13 subcutaneous (SC) provides patients with a new opportunity for maintenance treatment of their disease. METHODS A network meta-analysis (NMA) was conducted to evaluate compa...
Article
Background Tofacitinib is an oral Janus kinase inhibitor for the treatment of ulcerative colitis (UC). We present the final analysis of a 60-week post-marketing surveillance (PMS) study of tofacitinib in patients (pts) with UC in Japan. Methods A final analysis of safety and effectiveness data from a PMS study was conducted (final data as of 30 Se...
Article
Background Etrasimod is an oral, once-daily (QD), selective sphingosine 1-phosphate (S1P)1,4,5 receptor modulator for the treatment of moderately to severely active ulcerative colitis (UC). We evaluated efficacy and safety among Japanese patients with moderately to severely active UC with contextualisation to the global population. Methods ELEVATE...
Article
Background Ozanimod is an oral, small molecule sphingosine 1-phosphate (S1P) receptor modulator that selectively targets the S1P1 and S1P5 receptor subtypes. Ozanimod is approved in multiple countries outside Japan for the treatment of moderately to severely active ulcerative colitis (UC) and/or relapsing forms of multiple sclerosis. We herein repo...
Article
Background Fistulising perianal diseases (FPD) are common in patients with Crohn's disease (CD) in Asia, but the treatment pattern and the proportion of patients who develop new FPD after diagnosis are not clear. An interim analysis of a large registry study was performed to evaluate the difference in prognosis between patients with and without FPD...
Article
Background Ustekinumab (UST), an anti-IL12/23p40 monoclonal antibody, is now widely used for ulcerative colitis (UC). Meanwhile, there are no established models to predict the efficacy of UST for UC. We previously demonstrated that the machine-leaning approach was useful for finding predictors and developing a prediction tool in vedolizumab (VDZ) t...
Article
Background Vedolizumab (VDZ) is a gut-selective monoclonal antibody approved for ulcerative colitis (UC). This real-world study aimed to evaluate the effectiveness of VDZ in the treatment of UC, with the goal of further treatment optimization. Methods In this multicenter, retrospective, observational chart review, 370 patients with UC who received...
Article
Background Endoscopic improvement (EI), Mayo endoscopic subscore of 0 or 1, is considered a therapeutic target in ulcerative colitis (UC) treatment. The potential to estimate EI non-invasively is an advantage of intestinal ultrasound (IUS). In a former study, we developed a new ultrasound parameter, the submucosal index (SMI), calculated as the rat...
Article
Background Today molecular-targeted medications (MTMs) are widely used for ulcerative colitis (UC). Predicting the efficacy of MTMs early after induction remains a crucial clinical challenge. Intestinal ultrasound (IUS) is now considered a non-invasive, promising monitoring tool for UC. It can assess the disease activity of UC in the whole colon sa...
Article
Endoscopic improvement (EI; a Mayo endoscopic subscore of 0 or 1) is considered a therapeutic target in ulcerative colitis (UC) treatment. The potential to estimate EI non-invasively is an advantage of intestinal ultrasound (IUS). In a previous study, we developed a new sonographic parameter, the submucosa index (SMI), calculated as the ratio of th...
Article
Full-text available
A 19-year-old man with a history of Peutz-Jeghers syndrome (PJS) and two previous partial small bowel resections because of intussusception presented with lower abdominal pain. Computed tomography (CT) showed concentric multilayer and cord-like structures in the transverse colon. Colo-colonic intussusception was suspected and he was hospitalized. A...
Article
Full-text available
Ulcerative colitis is an inflammatory bowel disease that is intractable and causes chronic inflammation in the colon and rectum. Although the cause is unknown, an excessive immune response associated with disruption of intestinal immune homeostasis is involved in the pathology. 5-ASA preparations, corticosteroids, and thiopurines have been used as...