Journal of Gastroenterology最新文献

{"title":"Prevalence and risk factors for lymph node metastasis in duodenal neuroendocrine tumors: a systematic review and meta-analysis.","authors":"Yohei Ogata, Waku Hatta, Takeshi Kanno, Yutaka Hatayama, Masahiro Saito, Xiaoyi Jin, Tomoyuki Koike, Akira Imatani, Yuhong Yuan, Atsushi Masamune","doi":"10.1007/s00535-025-02247-7","DOIUrl":"https://doi.org/10.1007/s00535-025-02247-7","url":null,"abstract":"<p><strong>Background: </strong>Although the status of lymph node metastasis (LNM) is crucial in determining treatment strategy for duodenal neuroendocrine tumors (D-NETs), robust evidence for their potential LNM risk remains lacking. This systematic review aimed to summarize the prevalence and risk factors of LNM in D-NETs.</p><p><strong>Methods: </strong>This systematic review of electronic databases identified eligible case-control and cohort studies for D-NET resected either endoscopically or surgically, published from 1990 to 2023. The primary outcome was the pooled prevalence of LNM in D-NETs. Secondary outcomes included the pooled prevalence of LNM according to tumor location and functionality, as well as identifying pathological risk factors for LNM. Meta-analysis was performed.</p><p><strong>Results: </strong>We identified 36 studies that involved 1,396 patients with D-NETs, including 326 with LNM. The pooled prevalence of LNM in D-NETs was 22.7% (95% confidence interval [CI] 17.3-29.2%). The prevalence was high in ampullary/peri-ampullary D-NETs and functional D-NETs (46.8 and 53.3%, respectively), whereas it was low in non-functional, non-ampullary D-NETs (NAD-NETs) (9.5%). Pathological risk factors for LNM in NAD-NETs included tumor size > 10 mm (odds ratio [OR] 7.31 [95% CI 3.28-16.31]), tumor invasion into the muscularis propria or deeper (OR 7.79 [3.65-16.61]), lymphovascular invasion (OR 5.67 [2.29-14.06]), and World Health Organization grading of G2 (OR 2.47 [1.03-5.92]).</p><p><strong>Conclusion: </strong>Approximately one-fourth of the patients with D-NETs had LNM. Endoscopic resection might be acceptable for non-functional NAD-NETs with diameters of 10 mm or less, but additional surgical resection with lymphadenectomy may be recommended for cases exhibiting pathological risk factors.</p>","PeriodicalId":16059,"journal":{"name":"Journal of Gastroenterology","volume":" ","pages":""},"PeriodicalIF":6.9,"publicationDate":"2025-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143772416","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Circulating miR-485-3p as a biomarker for VEGF-associated therapeutic response to atezolizumab plus bevacizumab in hepatocellular carcinoma.","authors":"Kyoko Oura, Asahiro Morishita, Rie Yano, Takushi Manabe, Kei Takuma, Mai Nakahara, Tomoko Tadokoro, Koji Fujita, Shima Mimura, Joji Tani, Miwa Tatsuta, Takashi Himoto, Tsutomu Masaki, Hideki Kobara","doi":"10.1007/s00535-025-02239-7","DOIUrl":"https://doi.org/10.1007/s00535-025-02239-7","url":null,"abstract":"<p><strong>Background: </strong>In atezolizumab/bevacizumab (atezo/bev) therapy for unresectable hepatocellular carcinoma (HCC), the tumor immune environment is regulated through vascular endothelial growth factor A (VEGFA) inhibition to maximize immune checkpoint blockade; however, evidence for VEGFA as a biomarker is limited. This study aimed to investigate serum VEGFA and associated microRNAs (miRNAs) as rapid biomarkers and their regulatory mechanisms in the microenvironment of HCC.</p><p><strong>Methods: </strong>Fifty-four patients with unresectable HCC who were treated with atezo/bev therapy were enrolled and assigned into objective response (OR) and non-OR groups according to the best therapeutic response in 12 weeks using the modified response evaluation criteria in solid tumors. Serum VEGFA levels and associated miRNA expression were compared. Furthermore, the effect of cell transfection with specific miRNA was investigated.</p><p><strong>Result: </strong>There was no significant difference in the pre-treatment serum VEGFA levels between the groups; however, the 3-week/pre-treatment ratio of serum VEGFA levels was significantly lower in the OR group than in the non-OR group. The pre-treatment serum levels of 10 miRNAs, especially miR-485-3p involved in VEGFA expression, were higher in the OR group than in the non-OR group and were further elevated after 1-7 days and 3 weeks. MiR-485-3p suppressed HuH-7 migration, enhanced the expression of protein inhibitor of activated (PIA) signal transducer and activator of transcription 3 (STAT3) (PIAS3), and suppressed the expression of phosphorylated STAT3/VEGFA.</p><p><strong>Conclusion: </strong>Circulating miR-485-3p is a more sensitive biomarker than VEGFA for the early prediction of therapeutic response in atezo/bev therapy for HCC.</p>","PeriodicalId":16059,"journal":{"name":"Journal of Gastroenterology","volume":" ","pages":""},"PeriodicalIF":6.9,"publicationDate":"2025-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143780333","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Serum Mac2-binding protein glycosylated isomer (M2BPGi) as a prognostic biomarker in pancreatic ductal adenocarcinoma: iCAFs-derived M2BPGi drives tumor invasion.","authors":"Naotaka Kugiyama, Katsuya Nagaoka, Rin Yamada, Takehisa Watanabe, Hajime Yamazaki, Shinya Ushijima, Fumiya Otsuka, Yukiko Uramoto, Hajime Iwasaki, Motohiro Yoshinari, Shunpei Hashigo, Hiromitsu Hayashi, Takatsugu Ishimoto, Yoshihiro Komohara, Yasuhito Tanaka","doi":"10.1007/s00535-024-02195-8","DOIUrl":"10.1007/s00535-024-02195-8","url":null,"abstract":"<p><strong>Background: </strong>Pancreatic ductal adenocarcinoma (PDAC) is an aggressive malignancy with a poor prognosis. Mac2-binding protein glycosylated isomer (M2BPGi), a known biomarker for liver fibrosis, is also elevated in other fibrotic tissues. However, its role in PDAC remains unexplored. This study investigates the potential of M2BPGi as a prognostic biomarker for PDAC and elucidates its role in cancer progression.</p><p><strong>Methods: </strong>We analyzed serum M2BPGi levels in 83 PDAC patients and 60 healthy controls, examining the relationship with clinical outcomes. Tissue immunostaining and in vitro experiments were conducted to investigate M2BPGi-secreting cells and its role.</p><p><strong>Results: </strong>Serum M2BPGi levels were significantly higher in PDAC patients than in controls (0.98 vs. 0.59, p < 0.0001). Notably, elevated serum M2BPGi was associated with worse progression-free survival (144 days vs. 260 days, p = 0.017) and overall survival (OS) (245 days vs. 541 days, p < 0.001) following chemotherapy. Multivariable Cox regression analysis further confirmed that a high serum M2BPGi level is an independent risk factor for OS (HR: 2.44, 95% CI 1.26-4.74, p = 0.008). Immunostaining revealed that M2BPGi is secreted by both cancer cells and cancer-associated fibroblasts (CAFs), with high M2BP expression in CAFs correlating with poor prognosis. Furthermore, M2BPGi-secreting CAFs exhibited characteristics of inflammatory CAFs. M2BPGi directly activated mTOR signaling and epithelial-mesenchymal transition in PDAC cells, enhancing their invasive and migratory capabilities.</p><p><strong>Conclusions: </strong>Our findings identify M2BPGi as a promising prognostic biomarker for PDAC. Moreover, we demonstrate that inflammatory CAFs promote tumor invasion and contribute to poor outcomes by secreting M2BPGi, revealing a novel mechanism of PDAC progression.</p>","PeriodicalId":16059,"journal":{"name":"Journal of Gastroenterology","volume":" ","pages":"479-495"},"PeriodicalIF":6.9,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142807435","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Can personalized optimization of acid suppression dosage and duration improve the management of artificial ulcers after gastric endoscopic submucosal dissection?","authors":"Eikichi Ihara, Yoshitaka Hata, Haruei Ogino","doi":"10.1007/s00535-025-02227-x","DOIUrl":"10.1007/s00535-025-02227-x","url":null,"abstract":"","PeriodicalId":16059,"journal":{"name":"Journal of Gastroenterology","volume":" ","pages":"526-527"},"PeriodicalIF":6.9,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143382222","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Importance of rectal over colon status in ulcerative colitis remission: the role of microinflammation and mucosal barrier dysfunction in relapse.","authors":"Kei Nishioka, Haruei Ogino, Eikichi Ihara, Takatoshi Chinen, Yusuke Kimura, Mitsuru Esaki, Xiaopeng Bai, Yosuke Minoda, Yoshimasa Tanaka, Masafumi Wada, Yoshitaka Hata, Yoko M Ambrosini, Yoshihiro Ogawa","doi":"10.1007/s00535-024-02199-4","DOIUrl":"10.1007/s00535-024-02199-4","url":null,"abstract":"<p><strong>Background: </strong>Ulcerative colitis (UC) is a refractory inflammatory disease that affects the rectum and colon, with pivotal involvement of the rectal environment in relapse initiation. This study was conducted in two phases to examine the differences in gene expression between the rectum and colon and to identify relapse factors.</p><p><strong>Methods: </strong>In ***Study 1, RNA sequencing was performed on biopsies from the colon and rectum of patients with active UC, those with remission UC, and controls. In Study 2, the mucosal impedance (MI) values reflecting mucosal barrier function and the mRNA expression of tight junction proteins and inflammatory cytokines were examined in 32 patients with remission UC and 22 controls. Relapse was monitored prospectively.</p><p><strong>Results: </strong>In Study 1, comprehensive genetic analysis using RNA sequencing revealed distinct gene profiles in the rectum and sigmoid colon of patients with remission UC. The rectum of these patients exhibited an enriched immune response and apical junction phenotype with persistent upregulation of CLDN2 gene expression. In Study 2, even in patients with remission UC, the MI values in the rectum, but not in the sigmoid colon, were significantly decreased, whereas they were negatively correlated with CLDN2, IL-1β, and IL-6 expressions.</p><p><strong>Conclusion: </strong>The status of the rectum in patients with remission UC differs from that of the colon, with microinflammation and impaired mucosal barrier function, which are associated with the upregulation of CLDN2, playing a role in relapse.</p>","PeriodicalId":16059,"journal":{"name":"Journal of Gastroenterology","volume":" ","pages":"416-429"},"PeriodicalIF":6.9,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142822103","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Usefulness of serum HBV RNA levels for predicting antiviral response to entecavir treatment in patients with chronic hepatitis B.","authors":"Masanari Kosaka, Hatsue Fujino, Masataka Tsuge, Kenji Yamaoka, Yasutoshi Fujii, Shinsuke Uchikawa, Atsushi Ono, Eisuke Murakami, Tomokazu Kawaoka, Daiki Miki, Clair Nelson Hayes, Seiya Kashiyama, Sho Mokuda, Shinichi Yamazaki, Shiro Oka","doi":"10.1007/s00535-025-02211-5","DOIUrl":"10.1007/s00535-025-02211-5","url":null,"abstract":"<p><strong>Background: </strong>Hepatitis B virus (HBV) RNA is an important serum biomarker of hepatic covalently closed circular DNA (cccDNA) transcriptional activity; however, its clinical characteristics remain unclear. This study evaluated the clinical utility of HBV RNA levels in patients with chronic hepatitis B (CHB).</p><p><strong>Methods: </strong>We studied 87 CHB patients with serum HBV DNA levels ≥ 5.0 log IU/mL who initiated entecavir (ETV) treatment between 2000 and 2018. Serum HBV RNA levels were measured at three-time points: before ETV treatment, at 12 weeks, and at 48 weeks after starting ETV treatment. Clinical markers associated with the antiviral effects of ETV treatment were analyzed.</p><p><strong>Results: </strong>Serum HBV RNA levels decreased in both HBeAg-positive and -negative patients during the observation period. In HBeAg-positive patients, multivariable analysis showed that lower HBV RNA levels at 48 weeks of ETV treatment were independently associated with HBeAg seroconversion. Additionally, lower baseline HBV RNA levels significantly predicted virologic response in those patients. In contrast, among HBeAg-negative patients, lower HBV core-related antigen (HBcrAg) levels and the FIB-4 index were independently associated with virologic response. In HBeAg-positive patients, those with higher baseline HBV RNA levels showed a more significant reduction in hepatitis B surface antigen levels.</p><p><strong>Conclusion: </strong>Serum HBV RNA levels predicted HBeAg seroconversion and early HBV DNA reduction in HBeAg-positive patients, while HBcrAg was significantly associated with virologic response in HBeAg-negative patients. These findings highlight the different predictive roles of HBV RNA and HBcrAg based on HBeAg status, which may provide individualized treatment strategies.</p>","PeriodicalId":16059,"journal":{"name":"Journal of Gastroenterology","volume":" ","pages":"469-478"},"PeriodicalIF":6.9,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11922970/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143006620","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effect of tumor microenvironment in pancreatic cancer on the loss of β-cell mass: implications for type 3c diabetes.","authors":"Ke Hu, Xuelian Zhao, Na Zhang, Jing Ma, Ruonan Zhang, Zhiqiang Lu, Wenchuan Wu, Yuan Ji, Xiaomu Li","doi":"10.1007/s00535-024-02204-w","DOIUrl":"10.1007/s00535-024-02204-w","url":null,"abstract":"<p><strong>Background: </strong>To explore the complex interactions between the tumor microenvironment (TME) of pancreatic ductal adenocarcinoma (PDAC) and the loss of β-cell mass, further elucidating the mechanisms of type 3c diabetes mellitus (T3cDM) onset.</p><p><strong>Methods: </strong>Single-cell RNA sequencing was employed to analyze the PDAC TME, identifying cell interactions and gene expression changes of endocrine cells. Pathological changes and paraneoplastic islets were assessed in the proximal paratumor (PP) and distal paratumor (DP). Fractional β-cell area and islet density were compared among normal pancreas from donors and paraneoplastic tissues from non-diabetes mellitus (NDM) and T3cDM patients. TUNEL staining, RT-qPCR and CCK8 assay were applied to demonstrate the β-cell apoptosis.</p><p><strong>Results: </strong>Tumor cells, immune cells and fibroblasts could interact with endocrine cells, and apoptotic pathways were activated in endocrine cells of the PP. The PDAC TME was characterized by marked inflammation, sever fibrosis and atrophy. The islets in the PP had lower fractional β-cell area (0.68 ± 0.65% vs. 0.86 ± 1.02%, P = 0.037) and islet density (0.54 ± 0.42 counts/mm² vs. 0.83 ± 0.90 counts/mm², P = 0.001) compared to those in the DP. The PDAC TME in T3cDM exerted a more significant impact on the paraneoplastic islets compared to NDM. Moreover, β-cell apoptosis was markedly increased in the PP compared to the DP in PDAC patients without diabetes, particularly in smaller islets. Apoptosis-related genes were highly expressed in INS-1E cells exposed to PANC-1 medium.</p><p><strong>Conclusion: </strong>Our research revealed that the PDAC TME is usually accompanied by some pathological changes, including inflammation, fibrosis, and atrophy. These pathological changes are related to a reduction in β-cell mass and trigger the development of T3cDM.</p>","PeriodicalId":16059,"journal":{"name":"Journal of Gastroenterology","volume":" ","pages":"512-525"},"PeriodicalIF":6.9,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142931866","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Multistage deep learning for classification of Helicobacter pylori infection status using endoscopic images.","authors":"Guang Li, Ren Togo, Katsuhiro Mabe, Shunpei Nishida, Yoshihiro Tomoda, Fumiyuki Shiratani, Masashi Hirota, Takahiro Ogawa, Miki Haseyama","doi":"10.1007/s00535-024-02209-5","DOIUrl":"10.1007/s00535-024-02209-5","url":null,"abstract":"<p><strong>Background: </strong>The automated classification of Helicobacter pylori infection status is gaining attention, distinguishing among uninfected (no history of H. pylori infection), current infection, and post-eradication. However, this classification has relatively low performance, primarily due to the intricate nature of the task. This study aims to develop a new multistage deep learning method for automatically classifying H. pylori infection status.</p><p><strong>Methods: </strong>The proposed multistage deep learning method was developed using a training set of 538 subjects, then tested on a validation set of 146 subjects. The classification performance of this new method was compared with the findings of four physicians.</p><p><strong>Results: </strong>The accuracy of our method was 87.7%, 83.6%, and 95.9% for uninfected, post-eradication, and currently infected cases, respectively, whereas that of the physicians was 81.7%, 76.5%, and 90.3%, respectively. When including the patient's H. pylori eradication history information, the classification accuracy of the method was 92.5%, 91.1%, and 98.6% for uninfected, post-eradication, and currently infected cases, respectively, whereas that of the physicians was 85.6%, 85.1%, and 97.4%, respectively.</p><p><strong>Conclusion: </strong>The new multistage deep learning method shows potential for an innovative approach to gastric cancer screening. It can evaluate individual subjects' cancer risk based on endoscopic images and reduce the burden of physicians.</p>","PeriodicalId":16059,"journal":{"name":"Journal of Gastroenterology","volume":" ","pages":"408-415"},"PeriodicalIF":6.9,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143006617","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Impact of preceding treatment for head and neck squamous cell carcinoma on synchronous superficial esophageal squamous cell carcinoma.","authors":"Tomoya Ueda, Ryu Ishihara, Yasuhiro Tani, Yoshiaki Ando, Gentaro Tanabe, Yuta Fujimoto, Noriaki Ito, Nobutoshi Tsukuda, Kazuki Matsuyama, Muneshin Morita, Minoru Kato, Shunsuke Yoshii, Satoki Shichijo, Takashi Kanesaka, Sachiko Yamamoto, Koji Higashino, Noriya Uedo, Tomoki Michida, Takashi Fujii","doi":"10.1007/s00535-024-02201-z","DOIUrl":"10.1007/s00535-024-02201-z","url":null,"abstract":"<p><strong>Background: </strong>Patients with esophageal squamous cell carcinoma (ESCC) frequently develop synchronous head and neck squamous cell carcinoma (HNSCC). With advances in endoscopic technology and widespread screening of synchronous cancers, the detection of synchronous HNSCC and superficial ESCC (SESCC) is increasing. We aimed to evaluate the impact of preceding HNSCC treatment on synchronous SESCC.</p><p><strong>Methods: </strong>This single-center retrospective study enrolled patients with synchronous HNSCC and SESCC who were treated between January 2010 and December 2023. Tumor size and depth of SESCC before and after HNSCC treatment were evaluated. The factors associated with SESCC progression were investigated.</p><p><strong>Results: </strong>Of the 299 patients with synchronous HNSCC and SESCC, 134 who underwent preceding HNSCC treatment with follow-up esophagogastroduodenoscopy (EGD) for SESCC were evaluated. Chemoradiotherapy was the most common treatment for HNSCC (56.0%), followed by surgery (17.2%), radiotherapy (14.9%), local resection (7.5%), and chemotherapy (4.5%). The tumor size of SESCC increased after HNSCC treatment in 18 patients (13.4%). Multivariate analysis revealed that an EGD interval of ≥ 120 days was significantly associated with increased tumor size in SESCC (odds ratio, 6.64; 95% confidence interval, 1.91-23.1). Tumor regrowth was observed in 70.6% of SESCCs that shrank with HNSCC treatment, mostly within six months. Tumor depth aggravation was rare (2.2%), but progression to advanced ESCC was observed in two patients.</p><p><strong>Conclusions: </strong>Timely endoscopic follow-up, preferably within 120 days, is crucial for managing synchronous SESCC after HNSCC treatment to prevent tumor progression. Tumor regrowth should be monitored when SESCC shrinks with HNSCC treatment.</p>","PeriodicalId":16059,"journal":{"name":"Journal of Gastroenterology","volume":" ","pages":"397-407"},"PeriodicalIF":6.9,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142807430","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"First-line biologics as a treatment for ulcerative colitis: a multicenter randomized control study.","authors":"Makoto Naganuma, Hisashi Shiga, Masayuki Shimoda, Minoru Matsuura, Kento Takenaka, Toshimitsu Fujii, Shojiro Yamamoto, Mao Matsubayashi, Taku Kobayashi, Nobuo Aoyama, Daisuke Saito, Kaoru Yokoyama, Kei Moriya, Kiichiro Tsuchiya, Shunsuke Shibui, Ami Kawamoto, Hiromichi Shimizu, Ryuichi Okamoto, Kazuki Sakamoto, Katsuki Yaguchi, Reiko Kunisaki, Shintaro Akiyama, Ryohei Hayashi, Keisuke Hasui, Shuji Kanmura, Shigeki Bamba, Yoshiyuki Mishima, Kazuki Kakimoto, Shinya Sugimoto, Atsushi Nakazawa, Takayuki Abe, Haruhiko Ogata, Tadakazu Hisamatsu","doi":"10.1007/s00535-025-02216-0","DOIUrl":"10.1007/s00535-025-02216-0","url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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).</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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/ ).</p>","PeriodicalId":16059,"journal":{"name":"Journal of Gastroenterology","volume":" ","pages":"430-441"},"PeriodicalIF":6.9,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143066183","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}