Abstract:
BACKGROUND:Vedolizumab is a gut-selective humanized antibody that binds the α4β7 integrin. We evaluated efficacy and safety of vedolizumab in Japanese patients with moderate-to-severe Crohn's disease (CD). METHODS:In this Phase 3, double-blind study (NCT02038920), 157 patients were randomized to receive intravenous vedolizumab 300 mg (n = 79) or placebo (n = 78) at Weeks 0, 2, and 6 (induction phase). Patients with CD activity index (CDAI)-70 response at Week 10 were randomized to receive vedolizumab 300 mg (n = 12) or placebo (n = 12) at Week 14, then every 8 weeks until Week 54 (maintenance phase). Primary endpoints were ≥ 100-point reduction in CDAI (CDAI-100 response) at Week 10 for induction, and clinical remission (CR: CDAI ≤ 150) at Week 60 for maintenance. RESULTS:At Week 10, 26.6% of patients who received vedolizumab and 16.7% who received placebo achieved CDAI-100 response (odds ratio [OR] [95% confidence interval (CI)] 1.80 [0.82-3.96]; p = 0.145). At Week 60, 41.7% of vedolizumab-treated patients and 16.7% of placebo-treated patients achieved CR (OR [95% CI] 3.57 [0.53-23.95]; p = 0.178). The incidence of adverse events was similar in both treatment groups in both induction and maintenance phases. In patients without prior anti-TNFα exposure or with inadequate response to anti-TNFα, vedolizumab showed improved outcomes over placebo in the induction phase. Age might be a possible predictive factor of CR for future research. CONCLUSION:Vedolizumab showed a numerically greater efficacy versus placebo as induction therapy, but the difference was not statistically significant. Vedolizumab also showed a numerically greater efficacy in maintenance therapy, and was well tolerated.
journal_name
J Gastroenteroljournal_title
Journal of gastroenterologyauthors
Watanabe K,Motoya S,Ogata H,Kanai T,Matsui T,Suzuki Y,Shikamura M,Sugiura K,Oda K,Hori T,Araki T,Watanabe M,Hibi Tdoi
10.1007/s00535-019-01647-wsubject
Has Abstractpub_date
2020-03-01 00:00:00pages
291-306issue
3eissn
0944-1174issn
1435-5922pii
10.1007/s00535-019-01647-wjournal_volume
55pub_type
杂志文章abstract::Primary sclerosing cholangitis is very rare in Japan. The aim of the present study was to identify the characteristics of such patients in Japan. A questionnaire was sent to the members of the Japanese Society of Gastroenterology and responses for 192 cases were analyzed. There was male predominancy (61%), and two pea...
journal_title:Journal of gastroenterology
pub_type: 杂志文章
doi:10.1007/BF01213311
更新日期:1997-02-01 00:00:00
abstract:BACKGROUND:As biopsy sites may miss coexisting gastric mucosal high grade neoplasia (HGN) foci, making a diagnosis of gastric mucosal low grade neoplasia (LGN) based only on forceps biopsy specimens can be inaccurate. Therefore, to achieve an accurate diagnosis, endoscopic mucosal resection (EMR) of the entire lesion i...
journal_title:Journal of gastroenterology
pub_type: 杂志文章
doi:10.1007/s00535-010-0289-2
更新日期:2011-01-01 00:00:00
abstract::An extremely rare case of malignant schwannoma of the esophagus with lymph node metastasis is reported. A 49-year-old woman was found to have an abnormal shadow on a chest X-ray film taken during an annual checkup. Upper gastrointestinal series showed extrinsic pressure on the middle thoracic esophagus, without a muco...
journal_title:Journal of gastroenterology
pub_type: 杂志文章,评审
doi:10.1007/s005350170020
更新日期:2001-11-01 00:00:00
abstract::Preoperative biliary drainage (PBD) has been thought to be preferable regardless of the site of biliary strictures, e.g., distal or proximal strictures because PBD by endoscopy or interventional radiology decreases postoperative mortality and morbidity rates. However, recently, several studies have revealed that PBD s...
journal_title:Journal of gastroenterology
pub_type: 杂志文章,评审
doi:10.1007/s00535-015-1096-6
更新日期:2015-09-01 00:00:00
abstract:BACKGROUND:The model for end-stage liver disease (MELD) is useful for assessing the recipients of liver transplants, namely, deceased-donor transplantation. The application of MELD for living donor liver transplantation (LDLT) is under investigation. Thus, the aim of this study was to analyze the impact of the MELD sco...
journal_title:Journal of gastroenterology
pub_type: 杂志文章
doi:10.1007/s00535-006-1887-x
更新日期:2006-10-01 00:00:00
abstract:BACKGROUND:A new capsule endoscope has been developed by Olympus Medical Systems. The visualization and usefulness of its real-time image viewer for gastric transit abnormality were evaluated by using this new device. METHODS:Thirty-seven consecutive patients were enrolled. In cases of gastric transit abnormality (gas...
journal_title:Journal of gastroenterology
pub_type: 临床试验,杂志文章
doi:10.1007/s00535-007-2140-y
更新日期:2008-01-01 00:00:00
abstract:BACKGROUND:Linked color imaging (LCI) increases the visibility of early gastric cancers, which may be associated with characteristic findings including background purple mucosae. These lesions are found in areas of chronic gastritis and surrounding mucosa. The aim of this study is to objectively characterize these lesi...
journal_title:Journal of gastroenterology
pub_type: 杂志文章
doi:10.1007/s00535-018-1515-6
更新日期:2019-05-01 00:00:00
abstract:BACKGROUND:Gastric marker mucins (MUC5AC and MUC6) and intestinal marker molecules (MUC2 and CD10) have been used to determine the cell lineage of epithelial cell of gastric carcinoma (GC). METHODS:To clarify the characteristics of Epstein-Barr virus (EBV)-associated GC, 18 cases were immunohistochemically evaluated a...
journal_title:Journal of gastroenterology
pub_type: 杂志文章
doi:10.1007/s00535-006-1841-y
更新日期:2006-08-01 00:00:00
abstract::Positron emission tomography (PET) is widely available and its application with 2-[(18)F] fluoro-2-deoxy-D-glucose ((18)F-FDG) in oncology has become one of the standard imaging modalities in diagnosing and staging of tumors, and monitoring the therapeutic efficacy in hepatic malignancies. Recently, investigators have...
journal_title:Journal of gastroenterology
pub_type: 杂志文章,评审
doi:10.1007/s00535-013-0790-5
更新日期:2014-01-01 00:00:00
abstract::Helicobacter pylori infection has been found to decrease the expression of antral somatostatin and to increase the release of the acid-stimulating hormone gastrin. The reversal of these changes in gut hormones by the eradication of H. pylori, and in-vivo and in-vitro studies in animals either infected with H. pylori o...
journal_title:Journal of gastroenterology
pub_type: 杂志文章,评审
doi:10.1007/s005350200000
更新日期:2002-01-01 00:00:00
abstract::We encountered a patient with a ciliated hepatic foregut cyst with accompanying liver cirrhosis, which was hard to distinguish from well-differentiated hepatocellular carcinoma. A lesion 2 cm in diameter was found in the subcapsular region of the medial segment of the liver. It was slightly hypoechoic on ultrasonograp...
journal_title:Journal of gastroenterology
pub_type: 杂志文章
doi:10.1007/BF02355038
更新日期:1996-06-01 00:00:00
abstract:BACKGROUND:We recently reported the real-world changes in the etiologies of liver cirrhosis (LC) based on nationwide survey data and assessed the etiologies of LC with hepatocellular carcinoma (HCC). METHODS:Fifty-five participants from 68 institutions provided data on 23,637 patients with HCC-complicated LC. The chan...
journal_title:Journal of gastroenterology
pub_type: 杂志文章
doi:10.1007/s00535-020-01748-x
更新日期:2020-11-20 00:00:00
abstract::The gastrointestinal epithelium is a unique model for the study of mammalian stem cells. Not only does it have a highly stereotypical organization, its remarkable rate of self-renewal provides a daily readout of stem cell activity. The past decade has seen a major investment in developing technologies dedicated to rev...
journal_title:Journal of gastroenterology
pub_type: 杂志文章,评审
doi:10.1007/s00535-011-0424-8
更新日期:2011-09-01 00:00:00
abstract:BACKGROUND:Cytotoxin-associated gene A (CagA) product is a bacterial virulence factor contributing to the pathogenicity of Helicobacter pylori (HP) infection in humans. Host factors, which vary in different countries, interact with bacterial factors to determine the disease state. Our objective was to investigate the f...
journal_title:Journal of gastroenterology
pub_type: 临床试验,杂志文章
doi:10.1007/s00535-006-1788-z
更新日期:2006-06-01 00:00:00
abstract:PURPOSE:In patients chronically infected with hepatitis B virus, interferon has been used for the purpose of viral suppression by loss of hepatitis B e antigen (HBeAg) with or without seroconversion to antibody to HBeAg (anti-HBe). However, discussion about the effect of interferon on the development of hepatocellular ...
journal_title:Journal of gastroenterology
pub_type: 杂志文章,meta分析
doi:10.1007/s00535-009-0024-z
更新日期:2009-01-01 00:00:00
abstract:BACKGROUND:Patients with primary biliary cirrhosis (PBC) exhibit a variety of clinical manifestations and patterns of disease progression. The aim of this study was to identify genetic determinants of PBC progression. METHODS:A total of 52 tag single nucleotide polymorphisms (SNPs) of 11 candidate genes involved in re...
journal_title:Journal of gastroenterology
pub_type: 杂志文章
doi:10.1007/s00535-012-0730-9
更新日期:2013-10-01 00:00:00
abstract::Gastrointestinal symptoms such as abdominal pain, dyspepsia, and diarrhea are relatively nonspecific and a common cause for seeking medical attention. To date, it is challenging for physicians to differentiate between functional and organic gastrointestinal conditions and it involves the use of serological and endosco...
journal_title:Journal of gastroenterology
pub_type: 杂志文章,评审
doi:10.1007/s00535-016-1182-4
更新日期:2016-05-01 00:00:00
abstract:BACKGROUND:The clinical utility of relative and absolute grading criteria for submucosal invasion in T1 colorectal carcinomas has been controversial. METHODS:In 51 T1 colorectal carcinomas, depth of submucosal invasion was graded either according to a modified Haggitt's classification (a relative criterion) or by dire...
journal_title:Journal of gastroenterology
pub_type: 杂志文章
doi:10.1007/s005350300004
更新日期:2003-01-01 00:00:00
abstract:BACKGROUND:We carried out this study to evaluate the association between regulatory T cells (Treg) and prognosis and progression after cryoablation in patients with hepatitis-B virus-related hepatocellular carcinoma. METHODS:Peripheral Treg frequency in 111 patients with hepatocellular carcinoma (HCC) was detected by ...
journal_title:Journal of gastroenterology
pub_type: 杂志文章
doi:10.1007/s00535-010-0243-3
更新日期:2010-09-01 00:00:00
abstract:BACKGROUND:Few studies have investigated measures to prevent small bowel injuries induced by aspirin. Our aim was to evaluate the effect of probiotic treatment on the small bowel injuries induced by chronic low-dose aspirin use. METHODS:Thirty-five patients who took low-dose enteric-coated aspirin 100 mg daily (for mo...
journal_title:Journal of gastroenterology
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1007/s00535-011-0410-1
更新日期:2011-07-01 00:00:00
abstract::Cyclin D1 overexpression is remarkably frequent in several human carcinomas and is believed to be a critical event in oncogenesis. We examined cyclin D1 expression, p53 expression, and the Ki-67 labeling index by immunostaining in human gallbladder mucosa in conditions varying from normal to malignant tissue. We also ...
journal_title:Journal of gastroenterology
pub_type: 杂志文章
doi:10.1007/s005350050027
更新日期:2000-01-01 00:00:00
abstract:BACKGROUND:Only a few studies have longitudinally evaluated whether fatty pancreas increases the risk of type-2 diabetes (T2D), and their results were inconsistent. Fatty pancreas is closely linked to overweight and obesity, but previous studies did not exclude overweight or obese individuals. Therefore, in this cohort...
journal_title:Journal of gastroenterology
pub_type: 杂志文章
doi:10.1007/s00535-020-01683-x
更新日期:2020-07-01 00:00:00
abstract::Sixty-two colorectal adenomas 10 mm or less in diameter, resected endoscopically and fixed in formalin for 3 days or less, were evaluated with antiproliferating cell nuclear antigen/cyclin (PCNA) monoclonal antibody to investigate the cell proliferation kinetics. All lesions were tubular adenoma with low-grade atypia....
journal_title:Journal of gastroenterology
pub_type: 杂志文章
doi:10.1007/BF02358674
更新日期:1994-04-01 00:00:00
abstract:BACKGROUND:The Japan Society of Diabetes Mellitus reported that the leading cause of death in patients with diabetes mellitus (DM) was chronic liver disease; however, there are limited studies investigating the cause of liver injury in these patients. Our study aimed to clarify the clinicopathological features of liver...
journal_title:Journal of gastroenterology
pub_type: 杂志文章,多中心研究
doi:10.1007/s00535-012-0653-5
更新日期:2013-04-01 00:00:00
abstract::We report a case of squamous cell carcinoma (SCC) of the gastric cardia showing submucosal progression with direct invasion of the liver. A 71-year-old man was admitted with dysphagia. Esophagogastroscopy showed a protruding tumor covered with normal gastric mucosa in the anterior wall of the gastric cardia, although ...
journal_title:Journal of gastroenterology
pub_type: 杂志文章
doi:10.1007/s005350170113
更新日期:2001-04-01 00:00:00
abstract:BACKGROUND:Our preliminary study indicated that either a high hepatofugal flow velocity in the left gastric vein (LGV) or an anterior branch dominant pattern seen under color Doppler EUS (CD-EUS) were possible contributing risk factors for variceal recurrence after endoscopic treatment. However, the sample size was too...
journal_title:Journal of gastroenterology
pub_type: 杂志文章
doi:10.1007/s00535-006-1992-x
更新日期:2007-03-01 00:00:00
abstract:BACKGROUND:The efficacy, safety, and pharmacokinetics of the combination of three direct-acting antiviral (DAA) agents (adafosbuvir [also known as AL-335], odalasvir, and simeprevir) were investigated in DAA treatment-naïve Japanese patients with genotype (GT)1 or GT2 chronic hepatitis C virus (HCV) infection, with or ...
journal_title:Journal of gastroenterology
pub_type: 杂志文章
doi:10.1007/s00535-020-01672-0
更新日期:2020-06-01 00:00:00
abstract::A rare case of benign diaphragmatic schwannoma in a 38-year-old female is reported. Precontrast computed tomography (CT) showed an encapsulated well-defined round homogeneous tumor with central calcification, measuring approximately 5 cm in diameter, arising from the left diaphragm. Contrast-enhanced CT and gadolinium...
journal_title:Journal of gastroenterology
pub_type: 杂志文章,评审
doi:10.1007/BF02389529
更新日期:1996-04-01 00:00:00
abstract::We report a 54-year-old Japanese woman who developed liver tumors 102 months after hepatic resection for hepatocellular carcinoma (HCC) and percutaneous transluminal angioplasty (PTA) for membranous obstruction of the inferior vena cava (MOVC), which is one form of Budd-Chiari syndrome. In the present admission workup...
journal_title:Journal of gastroenterology
pub_type: 杂志文章
doi:10.1007/s00535-004-1365-2
更新日期:2004-07-01 00:00:00
abstract::An association between macrovascular thrombosis and idiopathic inflammatory bowel disease has been described, although very few well-documented cases have been published. We report on a 39-year-old woman who presented with right hemifacial and upper limb edema that was shown to be due to an extensive right brachioceph...
journal_title:Journal of gastroenterology
pub_type: 杂志文章
doi:10.1007/s005350300046
更新日期:2003-01-01 00:00:00