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Real-world efficacy and safety of upadacitinib in difficult-to-treat Crohn's disease: a 24-week multicenter study from China. upadacitinib治疗难治性克罗恩病的实际疗效和安全性:来自中国的一项为期24周的多中心研究
IF 4.7
Intestinal Research Pub Date : 2026-09-04 DOI: 10.5217/ir.2026.00114
Zile Zhang, Shuowen Zhang, Wensong Ge, Yue Li, Ruidong Chen, Wen Tang, Qunying Wang, Yihong Fan, Linyan Zhou, Feng Tian, Chunxiao Chen, Yubei Gu, Duowu Zou
{"title":"Real-world efficacy and safety of upadacitinib in difficult-to-treat Crohn's disease: a 24-week multicenter study from China.","authors":"Zile Zhang, Shuowen Zhang, Wensong Ge, Yue Li, Ruidong Chen, Wen Tang, Qunying Wang, Yihong Fan, Linyan Zhou, Feng Tian, Chunxiao Chen, Yubei Gu, Duowu Zou","doi":"10.5217/ir.2026.00114","DOIUrl":"https://doi.org/10.5217/ir.2026.00114","url":null,"abstract":"<p><strong>Background/aims: </strong>Real-world evidence for upadacitinib use in strictly defined difficult-to-treat Crohn's disease (DTT-CD), particularly in Asian populations, remains limited. Herein, we aimed to evaluate the efficacy and safety of upadacitinib in Chinese patients with DTT-CD.</p><p><strong>Methods: </strong>This multicenter, bidirectional cohort study was conducted at 8 Chinese inflammatory bowel disease centers. Patients received upadacitinib 45 mg once daily for 12 weeks induction, followed by 15 mg daily for maintenance. The coprimary endpoints were clinical remission at week 12 and week 24.</p><p><strong>Results: </strong>Among the 151 DTT-CD patients enrolled, the clinical remission rates were 47.0% at week 12 and 62.9% at week 24, with endoscopic remission achieved in 28.1% of patients at week 24. Adverse events occurred in 42 (27.8%) during induction and in 33 (21.9%) during maintenance, with 3 serious events (venous thrombosis, perforation, and hemorrhage) reported during the maintenance phase. Notably, 2 male reproductive system-related adverse events were observed, including blue semen in 2 patients and a suspected case of paternal teratogenicity with fetal anomalies and pregnancy loss. The drug persistence at week 24 was 93.4%.</p><p><strong>Conclusions: </strong>Upadacitinib demonstrated robust efficacy in Chinese patients with DTT-CD, with a manageable safety profile and high treatment persistence.</p>","PeriodicalId":14481,"journal":{"name":"Intestinal Research","volume":" ","pages":""},"PeriodicalIF":4.7,"publicationDate":"2026-09-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148887372","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Gut microbiome: a key driver and therapeutic target of intestinal fibrosis in Crohn's disease. 肠道微生物组:克罗恩病肠道纤维化的关键驱动因素和治疗靶点。
IF 4.7
Intestinal Research Pub Date : 2026-08-10 DOI: 10.5217/ir.2026.00013
Jee Hyun Kim, Yoon Jeong Choi, Jun Hwan Yoo
{"title":"Gut microbiome: a key driver and therapeutic target of intestinal fibrosis in Crohn's disease.","authors":"Jee Hyun Kim, Yoon Jeong Choi, Jun Hwan Yoo","doi":"10.5217/ir.2026.00013","DOIUrl":"https://doi.org/10.5217/ir.2026.00013","url":null,"abstract":"<p><p>Intestinal fibrosis is a debilitating complication of Crohn's disease that often leads to stricture formation, requiring surgical intervention. Despite its clinical significance, effective anti-fibrotic therapies remain an unmet need. Emerging evidence highlights the gut microbiome as a central orchestrator of fibrogenesis, beyond its role in inflammation. This review provides a comprehensive overview of how microbial dysbiosis, which is marked by the expansion of pathobionts such as adherent-invasive Escherichia coli and Clostridium innocuum, drives intestinal fibrosis through multifaceted pathways. We delineate the direct activation of fibroblasts via pattern recognition receptors and indirect mechanisms involving macrophage polarization, T helper 17 cell responses, and the emerging role of the \"creeping fat\" axis. Furthermore, we discuss how microbial translocation into the mesenteric adipose tissue triggers a profibrotic environment. By synthesizing these mechanistic insights, we suggest that targeting the microbiome-fibrosis axis, through precision modulation of the microbiome or metabolite-based interventions, represents a promising frontier for preventing and reversing fibrostenotic Crohn's disease.</p>","PeriodicalId":14481,"journal":{"name":"Intestinal Research","volume":" ","pages":""},"PeriodicalIF":4.7,"publicationDate":"2026-08-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148706513","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Real-world data on the effectiveness of risankizumab as induction therapy for ustekinumab-refractory ulcerative colitis. 利桑单抗作为ustekinumab难治性溃疡性结肠炎诱导治疗有效性的真实世界数据。
IF 4.7
Intestinal Research Pub Date : 2026-08-10 DOI: 10.5217/ir.2025.00338
Ryo Morikawa, Toshimitsu Fujii, Akiko Tamura, Ami Kawamoto, Shuji Hibiya, Kento Takenaka, Hiromichi Shimizu, Kazuo Ohtsuka, Ryuichi Okamoto
{"title":"Real-world data on the effectiveness of risankizumab as induction therapy for ustekinumab-refractory ulcerative colitis.","authors":"Ryo Morikawa, Toshimitsu Fujii, Akiko Tamura, Ami Kawamoto, Shuji Hibiya, Kento Takenaka, Hiromichi Shimizu, Kazuo Ohtsuka, Ryuichi Okamoto","doi":"10.5217/ir.2025.00338","DOIUrl":"https://doi.org/10.5217/ir.2025.00338","url":null,"abstract":"","PeriodicalId":14481,"journal":{"name":"Intestinal Research","volume":" ","pages":""},"PeriodicalIF":4.7,"publicationDate":"2026-08-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148706483","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Chinese expert consensus on extraintestinal manifestations of inflammatory bowel disease. 中国专家对炎性肠病肠外表现的共识。
IF 4.7
Intestinal Research Pub Date : 2026-08-10 DOI: 10.5217/ir.2026.00147
Jie Liang, Liuqing Zhao, Jun Shen, Hong Yang, Yao He, Ling Liu, Yufang Wang, Kaichun Wu, Minhu Chen
{"title":"Chinese expert consensus on extraintestinal manifestations of inflammatory bowel disease.","authors":"Jie Liang, Liuqing Zhao, Jun Shen, Hong Yang, Yao He, Ling Liu, Yufang Wang, Kaichun Wu, Minhu Chen","doi":"10.5217/ir.2026.00147","DOIUrl":"https://doi.org/10.5217/ir.2026.00147","url":null,"abstract":"<p><p>Inflammatory bowel disease (IBD) is a chronic, relapsing, inflammatory condition of the gastrointestinal tract that primarily includes Crohn's disease and ulcerative colitis. Beyond the typical gastrointestinal symptoms, IBD is frequently associated with various extraintestinal manifestations (EIMs) affecting organs such as joints, skin, eyes, and the hepatobiliary system. As the prevalence of IBD rises in China, the identification and management of EIMs have become increasingly important. However, there is currently variation among Chinese physicians in their attention to, comprehensive assessment of, and management of EIMs in IBD. Therefore, this consensus aims to provide guidance for the systematic evaluation and multidisciplinary management of IBD-associated EIMs.</p>","PeriodicalId":14481,"journal":{"name":"Intestinal Research","volume":" ","pages":""},"PeriodicalIF":4.7,"publicationDate":"2026-08-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148701404","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Long-term efficacy and safety of vedolizumab compared with infliximab in biologic-naive ulcerative colitis: a systematic review and meta-analysis. 与英夫利昔单抗相比,vedolizumab治疗生物源性溃疡性结肠炎的长期疗效和安全性:一项系统评价和荟萃分析
IF 4.7
Intestinal Research Pub Date : 2026-07-27 DOI: 10.5217/ir.2026.00100
Akhil Deepak Vatvani, Timotius Ivan Hariyanto, Daniel Gonzalez Mosquera, Stephanie Stephanie
{"title":"Long-term efficacy and safety of vedolizumab compared with infliximab in biologic-naive ulcerative colitis: a systematic review and meta-analysis.","authors":"Akhil Deepak Vatvani, Timotius Ivan Hariyanto, Daniel Gonzalez Mosquera, Stephanie Stephanie","doi":"10.5217/ir.2026.00100","DOIUrl":"https://doi.org/10.5217/ir.2026.00100","url":null,"abstract":"<p><strong>Background/aims: </strong>Vedolizumab and infliximab are widely used biologic agents for ulcerative colitis (UC), yet their comparative long-term effectiveness and safety in biologic-naive patients remain uncertain. This meta-analysis evaluated long-term efficacy and safety outcomes of vedolizumab versus infliximab in this population.</p><p><strong>Methods: </strong>A systematic search of MEDLINE, Scopus, the Cochrane Library, and ClinicalTrials.gov was conducted. Studies enrolling biologic-naive UC patients with a minimum follow-up of 12 months and reporting comparative outcomes between vedolizumab and infliximab were included. Random-effects meta-analyses were performed to pool odds ratios with 95% confidence intervals.</p><p><strong>Results: </strong>Twenty-five studies met the inclusion criteria. Vedolizumab was associated with significantly greater treatment persistence than infliximab at 12, 24, 36, and 48 months, while no significant difference was observed at 60 months. Patients receiving vedolizumab were more likely to achieve clinical remission and endoscopic remission at 12 months. Rates of steroid-free remission at 12 months were comparable between groups. Vedolizumab was linked to lower hospitalization rates at 12 and 36 months, with no difference at 24 months, and showed similar risks of inflammatory bowel disease-related surgery. The need for dose optimization was lower with vedolizumab at 12 months. Regarding safety, vedolizumab was associated with a lower incidence of serious adverse events compared with infliximab.</p><p><strong>Conclusions: </strong>In biologic-naive UC patients with long-term follow-up, vedolizumab demonstrates favorable treatment persistence, remission, and safety profiles compared with infliximab. Given the predominance of observational evidence, these findings should be interpreted cautiously and warrant confirmation in prospective comparative studies.</p>","PeriodicalId":14481,"journal":{"name":"Intestinal Research","volume":" ","pages":""},"PeriodicalIF":4.7,"publicationDate":"2026-07-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148603170","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Transabdominal ultrasonography for small-bowel lesions in Crohn's disease: a prospective comparison with balloon-assisted enteroscopy. 克罗恩病小肠病变的经腹超声检查:与气球辅助肠镜检查的前瞻性比较。
IF 4.7
Intestinal Research Pub Date : 2026-07-27 DOI: 10.5217/ir.2026.00015
Masahiro Takahara, Sakiko Hiraoka, Keiko Takeuchi, Kensuke Takei, Toshihiro Inokuchi, Yuki Aoyama, Shoko Igawa, Mikako Ishiguro, Junki Toyosawa, Yasushi Yamasaki, Hideaki Kinugasa, Hideki Onishi, Motoyuki Otsuka
{"title":"Transabdominal ultrasonography for small-bowel lesions in Crohn's disease: a prospective comparison with balloon-assisted enteroscopy.","authors":"Masahiro Takahara, Sakiko Hiraoka, Keiko Takeuchi, Kensuke Takei, Toshihiro Inokuchi, Yuki Aoyama, Shoko Igawa, Mikako Ishiguro, Junki Toyosawa, Yasushi Yamasaki, Hideaki Kinugasa, Hideki Onishi, Motoyuki Otsuka","doi":"10.5217/ir.2026.00015","DOIUrl":"https://doi.org/10.5217/ir.2026.00015","url":null,"abstract":"<p><strong>Background/aims: </strong>Transabdominal ultrasonography (TUS) is increasingly used to assess small-bowel lesions in Crohn's disease (CD); however, the diagnostic performance of prospective segment-specific data relative to balloon-assisted enteroscopy (BAE) remains limited.</p><p><strong>Methods: </strong>In this prospective, single-center study, 94 patients with CD underwent TUS the day before BAE. The diagnostic accuracy of TUS for mucosal inflammation and stenosis was evaluated separately for the terminal ileum and proximal small bowel, using BAE as the reference standard and endoscopic criteria based on the Simple Endoscopic Score for Crohn's Disease. We performed exploratory analyses of clinical factors associated with TUS detectability, including multivariable logistic regression for inflammatory lesions and exploratory comparisons for stenosis.</p><p><strong>Results: </strong>For mucosal inflammation, TUS sensitivity and specificity were 69% and 94% in the terminal ileum (accuracy, 90%) and 91% and 82% in the proximal small bowel (accuracy, 84%), respectively. For stenosis, the sensitivity and specificity were 78% and 98% in the terminal ileum (accuracy, 96%) and 63% and 89% in the proximal small bowel (accuracy, 84%), respectively. In exploratory analyses of BAEconfirmed inflammatory lesions, anastomotic involvement, history of bowel resection, and small-bowel resection were associated with TUS detectability in univariate analyses. No independent predictors were identified in the multivariable logistic regression.</p><p><strong>Conclusions: </strong>Compared to BAE as the reference standard, TUS showed high specificity and segment-dependent sensitivity for detecting small-bowel inflammation and stenosis. These findings support TUS as a complementary, practiceinforming, and noninvasive assessment tool, indicating that additional evaluation may be needed when clinical suspicion persists despite negative or equivocal TUS findings.</p>","PeriodicalId":14481,"journal":{"name":"Intestinal Research","volume":" ","pages":""},"PeriodicalIF":4.7,"publicationDate":"2026-07-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148603178","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Environmental pollutants and the rising burden of inflammatory bowel disease in East Asia: a narrative review. 环境污染物与东亚地区炎症性肠病负担的增加:叙述性回顾。
IF 4.7
Intestinal Research Pub Date : 2026-07-27 DOI: 10.5217/ir.2026.00108
Shabari Shenoy, Mansi Chaubey, Eun Soo Kim, Jean-Frederic Colombel, Manasi Agrawal
{"title":"Environmental pollutants and the rising burden of inflammatory bowel disease in East Asia: a narrative review.","authors":"Shabari Shenoy, Mansi Chaubey, Eun Soo Kim, Jean-Frederic Colombel, Manasi Agrawal","doi":"10.5217/ir.2026.00108","DOIUrl":"https://doi.org/10.5217/ir.2026.00108","url":null,"abstract":"<p><p>Inflammatory bowel disease (IBD) is rising at an alarming rate in parallel with rapid urbanization in newly industrialized parts of the world, including East Asia. Simultaneously, environmental pollutants are also an escalating problem in these regions. Recent studies have reported on associations between environmental pollutants and IBD, however, data on this topic specific to East Asia are limited. In this review, we summarize available data on environmental pollutants and related exposures in East Asia and their relationship with IBD. Motor vehicle emissions and industrial wastes are key sources of air pollution, while drinking water, seafood and vegetable produce constitute main sources of heavy metal and pesticide exposure. Microplastics are even more ubiquitous and pervasive toxicants. Mechanistic data suggest that environmental pollutants may influence IBD risk and outcomes through microbial dysbiosis and intestinal barrier disruption, ultimately leading to intestinal inflammation. Understanding the impact of environmental exposures and outcomes is key to potentially identify modifiable factors and inform strategies to predict, prevent and mitigate the rising burden of IBD in East Asia.</p>","PeriodicalId":14481,"journal":{"name":"Intestinal Research","volume":" ","pages":""},"PeriodicalIF":4.7,"publicationDate":"2026-07-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148591653","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Efficacy and safety of ustekinumab in Asian patients with moderately to severely active Crohn's disease: a small subpopulation analysis of UNITI/IM-UNITI long-term extension through 5 years. ustekinumab在亚洲中度至重度活动性克罗恩病患者中的疗效和安全性:一项为期5年的UNITI/IM-UNITI长期扩展的小亚群分析
IF 4.7
Intestinal Research Pub Date : 2026-07-10 DOI: 10.5217/ir.2025.00285
Byong Duk Ye, Ken Sugimoto, Jae Hee Cheon, Christopher Gasink, Yuya Imai, Bryan Wahking, Jianmin Zhuo, Shiho Kawamura, Toshifumi Hibi
{"title":"Efficacy and safety of ustekinumab in Asian patients with moderately to severely active Crohn's disease: a small subpopulation analysis of UNITI/IM-UNITI long-term extension through 5 years.","authors":"Byong Duk Ye, Ken Sugimoto, Jae Hee Cheon, Christopher Gasink, Yuya Imai, Bryan Wahking, Jianmin Zhuo, Shiho Kawamura, Toshifumi Hibi","doi":"10.5217/ir.2025.00285","DOIUrl":"https://doi.org/10.5217/ir.2025.00285","url":null,"abstract":"<p><strong>Background/aims: </strong>This final long-term extension (LTE) analysis assessed the long-term efficacy and safety of ustekinumab (UST) in the Asian patient subpopulation of the UNITI/IM-UNITI study.</p><p><strong>Methods: </strong>Patients completing safety and efficacy evaluations at Week 44 of the maintenance study were eligible to participate in the LTE and continued their UST treatment. Unblinding occurred after Week 44 analyses were completed, and patients still receiving placebo were discontinued; no placebo data were reported beyond Week 44 in this report. Efficacy assessments were performed every 12 weeks (q12w) until unblinding and at dosing visits thereafter through Week 252. Safety events (per 100 patient-years [PY]) were assessed through Week 272.</p><p><strong>Results: </strong>Sixty-three Asian patients entered the LTE. At Week 44, clinical response/clinical remission rates in the UST 90 mg subcutaneous (SC) q12w and every 8 weeks (q8w) arms were 75.0%/58.3% and 61.5%/53.8%, respectively. At Week 252, clinical response/clinical remission rates in the UST 90 mg SC q12w and q8w arms were 58.3%/41.7% and 23.1%/15.4%, respectively. Normalized C-reactive protein levels were maintained over 252 weeks of UST treatment. Among patients who entered the LTE, the number of treatment-emergent adverse events and serious infections in the UST 90 mg SC combined group was 267.2/100 PY and 4.5/100 PY, respectively.</p><p><strong>Conclusions: </strong>Maintenance therapy with UST 90 mg SC was well tolerated and efficacious in maintaining clinical remission and response rates through 5 years in Asian patients with Crohn's disease, consistent with the global population. (ClinicalTrials.gov Identifier: UNITI-1 [NCT01369329], UNITI-2 [NCT01369342], and IM UNITI [NCT01369355]).</p>","PeriodicalId":14481,"journal":{"name":"Intestinal Research","volume":" ","pages":""},"PeriodicalIF":4.7,"publicationDate":"2026-07-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148421155","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Efficacy and safety of ozanimod in Japanese patients with moderately to severely active ulcerative colitis naive to immunomodulators or advanced therapies: post hoc analysis of the phase 2/3 J-True North study. ozanimod在未接受免疫调节剂或先进疗法的日本中度至重度活动性溃疡性结肠炎患者中的疗效和安全性:J-True North 2/3期研究的事后分析
IF 4.7
Intestinal Research Pub Date : 2026-07-10 DOI: 10.5217/ir.2026.00031
Tadakazu Hisamatsu, Toshimitsu Fujii, Hiroshi Nakase, Katsuyoshi Matsuoka, Masayuki Saruta, Taku Kobayashi, Seika Inoue, Kazuhiro Toriyama, Dong Wang, Yoko Uchikawa, Go Fujimoto, Toshifumi Hibi
{"title":"Efficacy and safety of ozanimod in Japanese patients with moderately to severely active ulcerative colitis naive to immunomodulators or advanced therapies: post hoc analysis of the phase 2/3 J-True North study.","authors":"Tadakazu Hisamatsu, Toshimitsu Fujii, Hiroshi Nakase, Katsuyoshi Matsuoka, Masayuki Saruta, Taku Kobayashi, Seika Inoue, Kazuhiro Toriyama, Dong Wang, Yoko Uchikawa, Go Fujimoto, Toshifumi Hibi","doi":"10.5217/ir.2026.00031","DOIUrl":"https://doi.org/10.5217/ir.2026.00031","url":null,"abstract":"<p><strong>Background/aims: </strong>There is limited evidence for ozanimod, an oral sphingosine 1-phosphate receptor modulator, in patients with ulcerative colitis (UC) before treatment is escalated to an immunomodulator (IM) or advanced therapy (AT), including biologics and Janus kinase inhibitors.</p><p><strong>Methods: </strong>We performed post hoc analyses to examine the efficacy and safety of ozanimod 0.92 mg versus placebo in a subgroup of Japanese IM-/AT-naive patients with moderately to severely active UC, without concomitant corticosteroids (CS), enrolled in the randomized J-True North study.</p><p><strong>Results: </strong>The analyses comprised 29 and 30 patients treated with ozanimod 0.92 mg and placebo, respectively. The clinical response rate was significantly greater in the ozanimod group at Week 12 (75.9% vs. 40.0%; P=0.0103) and Week 52 (62.1% vs. 16.7%; P=0.0010). Clinical remission, endoscopic improvement, and histologic remission rates at Weeks 12 and 52 were significantly better in the ozanimod group. Changes in the rectal bleeding subscore, stool frequency subscore, symptomatic response, and symptomatic remission were apparent by Week 2 in both groups, and tended to be better in the ozanimod group from Week 5 onward. Treatment-emergent adverse events occurred in 79.3% and 63.3% of patients in the ozanimod and placebo groups, respectively; the most frequent were nasopharyngitis (ozanimod vs. placebo: 17.2% vs. 13.3%) and pyrexia (13.8% vs. 10.0%, respectively).</p><p><strong>Conclusions: </strong>This subgroup analysis demonstrated that ozanimod 0.92 mg was significantly more effective than placebo in Japanese IM-/AT-naive UC patients without concomitant CS therapy, consistent with the results of global trials. The safety profile of ozanimod 0.92 mg was consistent with prior studies. ClinicalTrials.gov (NCT03915769) and the Japan Registry of Clinical Trials (jRCT2080224654).</p>","PeriodicalId":14481,"journal":{"name":"Intestinal Research","volume":" ","pages":""},"PeriodicalIF":4.7,"publicationDate":"2026-07-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148421099","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Long-term clinical and endoscopic efficacy of vedolizumab and therapeutic persistence in patients with ulcerative colitis in China: a multicenter observational study. vedolizumab在中国溃疡性结肠炎患者的长期临床和内镜疗效和治疗持久性:一项多中心观察性研究
IF 4.7
Intestinal Research Pub Date : 2026-07-06 DOI: 10.5217/ir.2025.00049
Zhaopeng Huang, Lingya Yao, Yun Qiu, Kang Chao, Qing Li, Lang Lin, Jing Liu, Ren Mao, Qian Cao, Minhu Chen, Xiang Gao
{"title":"Long-term clinical and endoscopic efficacy of vedolizumab and therapeutic persistence in patients with ulcerative colitis in China: a multicenter observational study.","authors":"Zhaopeng Huang, Lingya Yao, Yun Qiu, Kang Chao, Qing Li, Lang Lin, Jing Liu, Ren Mao, Qian Cao, Minhu Chen, Xiang Gao","doi":"10.5217/ir.2025.00049","DOIUrl":"https://doi.org/10.5217/ir.2025.00049","url":null,"abstract":"<p><strong>Background/aims: </strong>Limited data are available on the long-term efficacy of vedolizumab (VDZ) in Asian patients with ulcerative colitis (UC), particularly regarding endoscopic outcomes.</p><p><strong>Methods: </strong>In this multicenter, retrospective, real-world study, UC patients treated with VDZ were evaluated for steroid-free remission, endoscopic remission (Mayo endoscopic score ≤ 1), and mucosal healing (Mayo endoscopic score = 0) at weeks 52, 104, and 156. Treatment persistence was analyzed using Kaplan-Meier curves.</p><p><strong>Results: </strong>Among 239 patients, steroid-free remission was achieved in 59.4%, 52.9%, and 40.3% at weeks 52, 104, and 156, respectively. Endoscopic remission and mucosal healing rates were 53.3% and 32.2% at week 52, 39.8% and 27.5% at week 104, and 34.8% and 26.2% at week 156. The probability of treatment persistence was 76.8%, 63.3%, and 56.4% at these time points. Anti-tumor necrosis factor (anti-TNF) exposure was independently associated with a higher risk of failing to achieve long-term VDZ persistence (hazard ratio [HR], 2.754; 95% confidence interval [CI], 1.478-5.135; P= 0.001), whereas achieving early steroid-free remission after induction was an independent protective factor (HR, 0.480; 95% CI, 0.235-0.978; P= 0.043). VDZ-related adverse events occurred in 7.1% of patients, with no serious events reported.</p><p><strong>Conclusions: </strong>VDZ demonstrated long-term clinical and endoscopic efficacy with a high safety profile in Chinese UC patients. Notably, anti-TNF-naive patients with early steroid-free remission were more likely to maintain long-term treatment persistence.</p>","PeriodicalId":14481,"journal":{"name":"Intestinal Research","volume":" ","pages":""},"PeriodicalIF":4.7,"publicationDate":"2026-07-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148390876","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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