Intestinal Research最新文献

{"title":"Comparative effectiveness of ustekinumab versus infliximab in the management of perianal fistulizing Crohn's disease: a retrospective study in China.","authors":"Mengqi Chen, Zihan Chen, Jianming Lin, Linxin Liu, Tong Tu, Xiaoling Li, Baili Chen, Yao He, Minhu Chen, Zhirong Zeng, Xiaojun Zhuang","doi":"10.5217/ir.2024.00168","DOIUrl":"https://doi.org/10.5217/ir.2024.00168","url":null,"abstract":"<p><strong>Background/aims: </strong>Ustekinumab (UST) and infliximab (IFX) are both effective in the treatment of perianal fistulizing Crohn's disease (CD), but limited research has focused on comparing the efficacy of UST versus IFX in this field. This study aimed to compare the effectiveness of UST or IFX in treating perianal fistula of CD patients naive to biological agents in a real-world setting.</p><p><strong>Methods: </strong>A retrospective cohort study included patients with perianal fistulizing CD treated with UST or IFX was conducted to evaluate the rates of luminal and perianal fistula response and remission at 6 months after treatment.</p><p><strong>Results: </strong>Ninety-seven patients (49 UST and 48 IFX) were enrolled. Compared to IFX, UST exhibited significantly higher rates of treatment success (89.8% vs. 50.0%, P< 0.001) and intestinal clinical response (85.7% vs. 68.8%, P= 0.048), but no significant differences in fistula remission, fistula response, fistula closure, intestinal clinical remission, endoscopic remission and endoscopic response was observed. Furthermore, multivariate analyses demonstrated complexity of fistula was conversely associated with fistula remission between the UST and IFX groups. Finally, the rates of disease relapse and operation in the IFX group were higher as compared to the UST group during follow-up.</p><p><strong>Conclusions: </strong>UST may serve as a promising alternative to IFX for the treatment of perianal fistulizing CD.</p>","PeriodicalId":14481,"journal":{"name":"Intestinal Research","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2025-06-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144274870","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}

{"title":"Clinical spectrum of acute severe ulcerative colitis in the biologic era: a prospective cohort study from India.","authors":"Arshdeep Singh, Mayur Luthra, Arshia Bhardwaj, Ramit Mahajan, Riya Sharma, Dharmatma Singh, Devanshi Jain, Omesh Goyal, Varun Mehta, Kirandeep Kaur, Yogesh Kumar Gupta, Vandana Midha, Ajit Sood","doi":"10.5217/ir.2024.00189","DOIUrl":"https://doi.org/10.5217/ir.2024.00189","url":null,"abstract":"<p><strong>Background/aims: </strong>Acute severe ulcerative colitis (ASUC) is a time-critical situation requiring urgent intervention. Limited data exist on the evolving clinical spectrum of ASUC in the era of advanced therapies.</p><p><strong>Methods: </strong>This prospective real-world observational cohort study included 145 adult patients hospitalized with ASUC between January 2020 and June 2024. ASUC was defined by the modified Truelove and Witts criteria. Demographics and disease characteristics, including disease severity, probable precipitating factors, and corticosteroid failure rates, were recorded.</p><p><strong>Results: </strong>The median age of patients was 36 years (interquartile range, 26-48.5 years) with 63 females (43.4%). Most patients had left-sided colitis (53.1%). The median disease duration was 1 year (IQR, 0.5-3 years), with 91 patients (62.7%) presenting with ASUC within the first year of diagnosis of ulcerative colitis. One-third of the patients had previous exposure to biologics and small molecules. The most commonly reported probable precipitants of ASUC were poor compliance with treatment (n = 43, 29.6%), antibiotic use (n = 35, 24.1%), high perceived stress (n = 32, 22.1%), and Clostridioides difficile infection (n = 19, 13.1%). Forty patients (27.5%) were non-responders to intravenous corticosteroids (IVCS). Twenty-nine patients (20%) received medical rescue therapy (infliximab, n = 14 [48.27%], cyclosporine A, n = 6 [20.68%], and tofacitinib, n = 9 [31.03%]). Seven patients (4.82%; 4 after non-response to IVCS and 3 after non-response to medical rescue therapy) underwent colectomy.</p><p><strong>Conclusions: </strong>In this cohort of ASUC patients, poor treatment compliance, antibiotic use, stress, and C. difficile infection were common precipitants of flare-ups. Nearly one-third of patients required medical rescue therapy, and a small proportion ultimately underwent colectomy.</p>","PeriodicalId":14481,"journal":{"name":"Intestinal Research","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2025-06-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144247860","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}

{"title":"Upadacitinib and vedolizumab combination therapy for the management of refractory ulcerative colitis and Crohn's disease.","authors":"Robert Gilmore, Amrutha Murali, Amirah Etchegaray, Ei Swe, Yoon-Kyo An, Jakob Begun","doi":"10.5217/ir.2024.00174","DOIUrl":"https://doi.org/10.5217/ir.2024.00174","url":null,"abstract":"<p><strong>Background/aims: </strong>Inflammatory bowel disease (IBD) is characterised by chronic inflammation of the gastrointestinal tract, and encompasses both ulcerative colitis (UC) and Crohn's disease (CD). Refractory disease is common, a combination of advanced drug therapies may be required to obtain maximal efficacy. We describe the use of upadacitinib therapy in combination with vedolizumab therapy for the management of refractory UC and CD.</p><p><strong>Methods: </strong>In this retrospective observational study, patients who received upadacitinib in combination with vedolizumab were identified at a tertiary IBD center between November 2022 and March 2024. Patients were followed for 6 months with clinical, biochemical, endoscopic and intestinal ultrasound outcomes.</p><p><strong>Results: </strong>Sixteen patients (7 with UC, 9 with CD) were identified. Median age was 44 years (range, 25-58 years), 11 (69%) were male, and median number of prior biologic exposures was 3 (range, 2-5). Twelve patients (75%) achieved clinical response, clinical remission, biochemical remission, corticosteroid-free clinical remission, and transmural remission by intestinal ultrasound. Eleven patients (69%) achieved endoscopic remission, with 4 (25%) achieving histological remission. Adverse events were seen in 8 patients (50%), but the majority were mild and did not require interruption of therapy.</p><p><strong>Conclusions: </strong>Upadacitinib in combination with vedolizumab may have a role in refractory UC and CD patients who have previously failed to respond to standard therapy, with a favorable safety profile. Prospective studies are required to determine the safety and efficacy of this combination in larger cohorts before routine use can be recommended.</p>","PeriodicalId":14481,"journal":{"name":"Intestinal Research","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2025-06-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144258110","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}

{"title":"The duration of prior anti-tumor necrosis factor agents is associated with the effectiveness of vedolizumab in patients with ulcerative colitis: a real-world multicenter retrospective study.","authors":"Taku Kobayashi, Tadakazu Hisamatsu, Satoshi Motoya, Minoru Matsuura, Toshimitsu Fujii, Reiko Kunisaki, Tomoyoshi Shibuya, Ken Takeuchi, Sakiko Hiraoka, Hiroshi Yasuda, Kaoru Yokoyama, Noritaka Takatsu, Atsuo Maemoto, Toshiyuki Tahara, Keiichi Tominaga, Masaaki Shimada, Nobuaki Kuno, Mary Cavaliere, Kaori Ishiguro, Jovelle L Fernandez, Toshifumi Hibi","doi":"10.5217/ir.2024.00126","DOIUrl":"https://doi.org/10.5217/ir.2024.00126","url":null,"abstract":"<p><strong>Background/aims: </strong>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.</p><p><strong>Methods: </strong>This was a multicenter, retrospective, observational chart review of records from 16 hospitals in Japan (December 1, 2018, to February 29, 2020). Included patients who had ulcerative colitis, were aged ≥ 20 years, and received at least 1 dose of vedolizumab. Outcomes included clinical remission rates from weeks 2 to 54 according to prior biologic exposure status and factors associated with clinical remission up to week 54.</p><p><strong>Results: </strong>A total of 370 eligible patients were included. Clinical remission rates were significantly higher in biologic-naïve (n=197) than in biologic-non-naïve (n=173) patients for weeks 2 to 54 of vedolizumab treatment. Higher clinical remission rates up to week 54 were significantly associated with lower disease severity (partial Mayo score ≤ 4, P= 0.001; albumin ≥ 3.0, P= 0.019) and the duration of prior anti-tumor necrosis factor α (anti-TNFα) therapy (P= 0.026). Patients with anti-TNFα therapy durations of < 3 months, 3 to < 12 months, and ≥ 12 months had clinical remission rates of 28.1%, 32.7%, and 60.0%, respectively (P= 0.001 across groups).</p><p><strong>Conclusions: </strong>The effectiveness of vedolizumab in biologic-non-naïve patients was significantly influenced by duration of prior anti-TNFα therapy. (Japanese Registry of Clinical Trials: jRCT-1080225363).</p>","PeriodicalId":14481,"journal":{"name":"Intestinal Research","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2025-06-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144215807","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}

{"title":"Impact of stool transplantation and metformin on polyp reduction and inflammation in an APC Min mouse model.","authors":"Yeon Ji Kim, Jiwon Lee, Eunmi Lee, Seun Ja Park, Jae Hyun Kim","doi":"10.5217/ir.2025.00011","DOIUrl":"https://doi.org/10.5217/ir.2025.00011","url":null,"abstract":"<p><strong>Background/aims: </strong>Familial adenomatous polyposis is a hereditary condition characterized by numerous adenomatous polyps in the colon and rectum, significantly increasing colorectal cancer risk. Current management strategies, such as prophylactic colectomy, are invasive and have long-term consequences, highlighting the need for alternative therapies. This study aimed to evaluate whether stool transplantation and metformin therapy synergistically reduce polyp formation and inflammation.</p><p><strong>Methods: </strong>APC Min mice were divided into 4 groups: control, anti-control (antibiotic pretreatment), stool (stool transplantation), and stool+metformin. Polyp burden, bacterial abundance, inflammatory cytokines (interleukin [IL]-6, tumor necrosis factor [TNF]-α, IL-10), and tumorigenic markers (NF-κB, Cox2, c-myc, β-catenin) were assessed using messenger RNA (mRNA) and protein analyses of intestinal tissues, along with serum and fecal microbiota evaluations.</p><p><strong>Results: </strong>Stool transplantation combined with metformin significantly reduced bacterial abundance and polyp burden. The anti-control group showed similar reductions, suggesting suppression of gut microbiota re-establishment. TNF-α and IL-10 levels remained unchanged, but a significant increase in IL-6 was observed in the stool+metformin group's intestinal tissues, indicating localized immune activation. Intestinal Cox2 mRNA expression was reduced in the combination group, correlating with polyp suppression. Protein levels of NF-κB, Cox2, and β-catenin showed no significant changes in vivo, while in vitro experiments revealed a decrease in NF-κB and an increase in Cox2, suggesting complex regulation of inflammation-related pathways.</p><p><strong>Conclusions: </strong>Stool transplantation combined with metformin reduces polyp burden in APC Min mice through gut microbiota modulation and localized immune activation. These findings support the therapeutic potential of this combination treatment for familial adenomatous polyposis.</p>","PeriodicalId":14481,"journal":{"name":"Intestinal Research","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2025-05-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144093883","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}

{"title":"Decoding genetic divergence: TPMT and NUDT15 polymorphisms in north India mirror Caucasian ancestry.","authors":"Arshdeep Singh, Renu Moti Pandita, Manjeet Kumar Goyal, Barjinderjit K Dhillon, Vandana Midha, Ajit Sood","doi":"10.5217/ir.2024.00027","DOIUrl":"https://doi.org/10.5217/ir.2024.00027","url":null,"abstract":"","PeriodicalId":14481,"journal":{"name":"Intestinal Research","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2025-05-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144093880","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}

{"title":"Lifestyle restrictions are associated with impaired quality of life but not reduction in relapse in ulcerative colitis.","authors":"Hajime Yamazaki, Masakazu Nagahori, Tadakazu Hisamatsu, Taku Kobayashi, Teppei Omori, Jimmy K Limdi, John T McLaughlin, Shu-Chen Wei, Jovelle Fernandez, Shunichi Fukuhara, Katsuyoshi Matsuoka","doi":"10.5217/ir.2024.00199","DOIUrl":"https://doi.org/10.5217/ir.2024.00199","url":null,"abstract":"<p><strong>Background/aims: </strong>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.</p><p><strong>Methods: </strong>This multicenter, prospective cohort study was conducted in Japan (2018-2021) via the YOURS registry, enrolling patients with UC in clinical remission. Patients were followed for 2 years. A baseline questionnaire evaluated lifestyle restrictions in diet, work/study/housework, and physical exercise. QOL was assessed by Disease Impact Scale every 3 months during the first year of follow-up. Associations of lifestyle restrictions with relapse and QOL were assessed by Cox regression analysis and linear mixed-effects models, respectively.</p><p><strong>Results: </strong>Among 911 patients in clinical remission for > 90 days, 63% had adopted dietary avoidance; 47%, work/study/housework avoidance; and 8%, physical exercise avoidance. Overall, 216 patients relapsed. Lifestyle restrictions were not associated with reduced risk of relapse (multivariableadjusted hazard ratios [95% confidence interval]: dietary avoidance, 1.08 [0.81-1.44]; and work/study/housework avoidance, 1.14 [0.87-1.50]); physical exercise avoidance was associated with increased relapse (multivariable-adjusted hazard ratio, 1.58; 95% confidence interval, 1.02-2.44). All lifestyle restrictions were associated with impaired QOL (P <0.01).</p><p><strong>Conclusions: </strong>Lifestyle restrictions were not associated with relapse reduction in patients with UC; however, they were associated with impaired QOL. Clinicians should engage in evidence-based discussions with patients with UC in remission regarding lifestyle restrictions (UMIN Clinical Trials Registry; UMIN000031995).</p>","PeriodicalId":14481,"journal":{"name":"Intestinal Research","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2025-05-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143967268","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}

{"title":"Gut, bone, and muscle: the triad of osteosarcopenia in inflammatory bowel disease.","authors":"Shilpa Sharma","doi":"10.5217/ir.2024.00185","DOIUrl":"https://doi.org/10.5217/ir.2024.00185","url":null,"abstract":"<p><p>Inflammatory bowel disease (IBD) is a group of chronic inflammatory conditions affecting the gastrointestinal tract that can lead to multiple systemic complications. Among these, osteosarcopenia has emerged as a significant concern, characterized by the concurrent deterioration of bone density and muscle mass, strength, and function. This dual deterioration significantly elevates the risk of falls and fractures, thereby exacerbating morbidity and diminishing quality of life. The pathogenesis of IBD-associated osteosarcopenia is multifactorial, with chronic intestinal inflammation serving as a central driver. Pro-inflammatory cytokines simultaneously disrupt bone homeostasis and muscle metabolism, creating a catabolic environment that impacts both tissues. Nutritional deficiencies, common in IBD due to malabsorption and decreased dietary intake, further compromise both bone mineralization and muscle protein synthesis. Management requires a comprehensive approach combining nutritional optimization, structured physical therapy, and lifestyle modifications. Pharmacological interventions integrate diseasespecific treatments with targeted therapies including vitamin D supplementation, hormonal treatments, and bisphosphonates when indicated. This review synthesizes current evidence regarding the prevalence, pathogenesis, and clinical impact of osteosarcopenia in IBD, highlighting areas requiring further investigation.</p>","PeriodicalId":14481,"journal":{"name":"Intestinal Research","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2025-04-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144015674","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}

{"title":"Anti-integrin αvβ6 autoantibody in patients with ulcerative colitis after proctocolectomy: a cross-sectional study in Japan.","authors":"Tsuyoshi Yanagida, Yu Nishida, Yumie Kobayashi, Rieko Nakata, Shuhei Hosomi, Hirotsugu Maruyama, Masaki Ominami, Yuji Nadatani, Shusei Fukunaga, Koji Otani, Fumio Tanaka, Yasuhiro Fujiwara","doi":"10.5217/ir.2024.00170","DOIUrl":"https://doi.org/10.5217/ir.2024.00170","url":null,"abstract":"<p><strong>Background/aims: </strong>Pouchitis is a common complication in patients with ulcerative colitis (UC) following colectomy with ileal pouch-anal anastomosis (IPAA). Recent studies have identified a novel autoantibody against integrin αvβ6 in patients with UC, correlated with disease activity. This study aimed to assess the association between serum anti-integrin αvβ6 antibody levels and pouch inflammation in patients with postoperative UC.</p><p><strong>Methods: </strong>Serum anti-integrin αvβ6 antibodies were measured using enzyme-linked immunosorbent assay in patients after IPAA, patients with UC, and controls.</p><p><strong>Results: </strong>We examined sera from 71 subjects, including 28 patients who underwent IPAA, 23 controls, and 20 patients with mild and moderate-to-severe UC. Post-IPAA, patients with UC had higher median anti-integrin αvβ6 levels than that of controls (P<0.001) but lower than that of patients with active UC (P=0.001). Patients with pouchitis had higher antibody levels than those without (P=0.047). The receiver operating characteristics curve for anti-integrin αvβ6 showed an area under the curve of 0.724. The pouchitis activity index endoscopic sub-score was correlated with antibody levels (r= 0.48, P=0.011).</p><p><strong>Conclusions: </strong>Serum anti-integrin αvβ6 antibody levels remain elevated in patients with UC even after total colectomy, and were significantly higher in patients with pouchitis than in those without. This antibody could be a novel and useful biomarker for the diagnosis of pouchitis and assessment of disease activity.</p>","PeriodicalId":14481,"journal":{"name":"Intestinal Research","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2025-04-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144024357","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}

{"title":"Efficacy and safety of etrasimod in Japanese patients with ulcerative colitis: results from a phase 2 dose-ranging study.","authors":"Ken Takeuchi, Hiroshi Nakase, Tadakazu Hisamatsu, Katsuyoshi Matsuoka, Shoko Arai, Hirotoshi Yuasa, Motoki Oe, Ryosuke Ono, Michael Keating, Guibao Gu, Krisztina Lazin, Aoibhinn McDonnell, Koki Fukuta, Toshifumi Hibi","doi":"10.5217/ir.2024.00213","DOIUrl":"https://doi.org/10.5217/ir.2024.00213","url":null,"abstract":"<p><strong>Background/aims: </strong>Etrasimod is an oral, once-daily, selective sphingosine 1-phosphate1,4,5 receptor modulator for the treatment of moderately to severely active ulcerative colitis (UC). However, its efficacy, safety, and the appropriate dosage have not been extensively investigated in the Japanese population.</p><p><strong>Methods: </strong>This phase 2, multicenter, randomized, double-blind, placebo-controlled dose-ranging, 12-week trial was carried out among Japanese patients with moderately to severely active UC. Patients were randomized 1:1:1 to receive etrasimod 1 mg once daily (QD), etrasimod 2 mg QD, or placebo. The primary efficacy endpoint was the proportion of patients achieving clinical remission at week 12. Secondary efficacy endpoints and treatmentemergent adverse events (TEAEs) were also investigated. Efficacy endpoints were presented as proportions of patients achieving each outcome.</p><p><strong>Results: </strong>Overall, 17, 19, and 18 patients received etrasimod 1 mg QD, etrasimod 2 mg QD, and placebo, respectively. One patient receiving etrasimod 1 mg (6.7%), 5 patients receiving etrasimod 2 mg (26.3%), and no patients receiving placebo (0%) achieved clinical remission. More patients receiving etrasimod versus placebo achieved secondary endpoints, except endoscopic normalization, at week 12. TEAEs were experienced by 9 patients receiving etrasimod 1 mg (52.9%), 13 patients receiving etrasimod 2 mg (68.4%), and 10 patients receiving placebo (55.6%). None of the TEAEs were serious and none experienced by patients receiving etrasimod led to treatment discontinuation.</p><p><strong>Conclusions: </strong>Overall, etrasimod 2 mg QD for up to 12 weeks appeared efficacious and safe in these Japanese patients with moderately to severely active UC. All TEAEs were mild to moderate in severity. (ClinicalTrials.gov: NCT05061446).</p>","PeriodicalId":14481,"journal":{"name":"Intestinal Research","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2025-04-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144024891","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}