Inflammatory Bowel Diseases最新文献

{"title":"Stricture dynamics and prognosis during biologic therapy in ileal Crohn's disease: a real-world cohort.","authors":"Kento Takenaka, Ami Kawamoto, Shuji Hibiya, Akiko Tamura, Ryo Morikawa, Hiromichi Shimizu, Toshimitsu Fujii, Kazuo Ohtsuka, Ryuichi Okamoto","doi":"10.1093/ibd/izag012","DOIUrl":"10.1093/ibd/izag012","url":null,"abstract":"<p><strong>Background and aims: </strong>Clinicians need data on the responsiveness of ileal strictures of Crohn's disease (CD) to biologic therapy, yet most trials prioritize mucosal healing. We quantified short‑term changes in ileal strictures under biologic treatment and evaluated their prognostic relevance.</p><p><strong>Patients and methods: </strong>In a post hoc analysis of a prospective cohort, consecutive patients with ileal or ileocolonic CD initiating or switching a biologic (anti‑tumor necrosis factor [TNF], ustekinumab [UST], or vedolizumab [VDZ]) underwent segment‑specific endoscopic assessment at baseline and 6 months. The primary outcome was resolution or progression of strictures at 6 months. Secondary outcomes included time‑to‑event analyses for hospitalization and surgery.</p><p><strong>Results: </strong>Among the 170 patients, the 6‑month stricture resolution and progression rates were 30.9% and 15.7%, respectively. There were no significant differences in stricture dynamics between anti‑TNF agents, UST, and VDZ (P = .443 for resolution and P = .167 for progression). Baseline strictures did not predict outcomes; however, strictures present at 6 months were associated with higher risks of hospitalization (P = .006) and surgery (P = .024), particularly when located in the non-terminal ileum. Clinical, biochemical, and endoscopic activity improved overall during follow‑up.</p><p><strong>Conclusions: </strong>The 6‑month stricture status, especially non-terminal ileal disease, carried prognostic significance. Because stricture dynamics did not differ across biologic classes, the presence of strictures alone should not constrain agent selection.</p>","PeriodicalId":13623,"journal":{"name":"Inflammatory Bowel Diseases","volume":" ","pages":"1211-1218"},"PeriodicalIF":5.5,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146149628","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Matrix metalloproteinases in intestinal fibrosis and fibrostenosing Crohn's disease: Current evidence, mechanistic hypotheses, and translational challenges.","authors":"Thierry Kochkarian, Kevin M Lopez, Rongliwen Ou, Don W Powell, Qingjie Li","doi":"10.1093/ibd/izag088","DOIUrl":"10.1093/ibd/izag088","url":null,"abstract":"<p><p>Fibrostenosing complications in Crohn's disease arise from mixed transmural remodeling that includes inflammation, fibrosis, and muscular hypertrophy/hyperplasia. Matrix metalloproteinases (MMPs) are implicated in extracellular matrix turnover and inflammatory remodeling, but their precise role in stricture evolution remains incompletely defined. We review current evidence (2020-2026) on MMP biology in intestinal fibrosis and fibrostenosing disease, emphasizing assay limitations, tissue-layer heterogeneity, and the predominance of cross-sectional rather than longitudinal human data. This review examines current evidence on MMP classification and substrate specificities, current evidence on cytokine-MMP interactions and proposed spatial and contextual patterns of remodeling, MMP contributions to fibrosis and smooth muscle cell proliferation, assay caveats and interpretation guardrails that distinguish expression from activity across gut layers, candidate biomarkers (such as PRO-C3/-C6 and fecal or serum MMP-9, which remain investigational), and emerging but unproven therapeutic strategies highlighting clinical trials and optimization strategies. We propose a state- and layer-aware conceptual framework to organize these findings, while acknowledging that the proposed states likely overlap and have not been prospectively validated. Despite recent advances, clinical trials of anti-MMP agents such as andecaliximab have yielded limited efficacy, likely attributable to challenges in timing, drug specificity, and outcome assessment. Candidate biomarkers and emerging therapeutic strategies remain investigational, and no MMP-directed approach has yet demonstrated clinical utility for routine fibrosis staging or stricture prevention. Future research directions should prioritize longitudinal human studies, mechanistic elucidation of how MMPs influence fibrosis and/or smooth muscle hyperplasia, improved linkage between tissue biology and imaging, fibrosis-specific endpoints, and rigorous validation before clinical trial translation can be justified.</p>","PeriodicalId":13623,"journal":{"name":"Inflammatory Bowel Diseases","volume":" ","pages":"1386-1405"},"PeriodicalIF":5.5,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13337219/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148015390","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Soluble transferrin receptor as a reliable inflammation-independent marker of iron deficiency in Crohn's disease and ulcerative colitis.","authors":"Francisco Portela, Paula Ministro, Helena Tavares de Sousa, Joana Roseira, Samuel Fernandes, Ricardo Crespo, Beatriz Domingues, Mafalda Santiago, Rita Melo-Miranda, Sandra Dias, Cláudia Camila Dias, Fernando Magro","doi":"10.1093/ibd/izag057","DOIUrl":"10.1093/ibd/izag057","url":null,"abstract":"<p><strong>Background: </strong>Iron deficiency is a common complication in inflammatory bowel disease (IBD), including ulcerative colitis (UC) and Crohn's disease (CD). However, standard iron markers are influenced by inflammation, complicating the diagnosis of true iron deficiency. Soluble transferrin receptor (sTfR) has been proposed as a more reliable, inflammation-independent marker of iron demand. This study aimed to assess the utility of sTfR in identifying iron deficiency without anemia (IDWA).</p><p><strong>Methods: </strong>The ID_IBD study was a multicenter, cross-sectional study. Iron status was classified using two approaches: the ECCO consensus definition, focusing on ferritin thresholds adjusted for inflammatory markers (C-reactive protein [CRP] and fecal calprotectin [FCAL]), and a stricter definition that adds transferrin saturation to the ECCO criteria. sTfR levels were compared across groups, and ROC curve analysis was used to identify optimal diagnostic cut-offs.</p><p><strong>Results: </strong>This analysis included 411 IBD patients (130 UC, 281 CD) and 178 controls. sTfR showed no correlation with CRP or FCAL. In UC, patients with IDWA had significantly higher sTfR levels (median 1.20 mg/L, IQR 1.02-1.42) compared to non-IDWA patients (median 1.05 mg/L, IQR 0.92-1.22; P = .013). Anemic UC patients also showed elevated sTfR levels (median 1.27 mg/L, IQR 1.14-1.59) compared to non-IDWA individuals (P < .001). In CD, sTfR did not significantly differ between IDWA and non-IDWA patients but was significantly higher in anemic patients (P = .003).</p><p><strong>Conclusions: </strong>sTfR appears to be an inflammation-independent marker of iron status in IBD. It showed greater potential for identifying IDWA in UC, while in CD it mainly reflected increased iron demand in anemia. Overall, sTfR may be useful as a complementary parameter to conventional iron markers. Further longitudinal studies are warranted to validate these findings and assess their clinical utility in IBD.</p>","PeriodicalId":13623,"journal":{"name":"Inflammatory Bowel Diseases","volume":" ","pages":"1321-1332"},"PeriodicalIF":5.5,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147864073","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Clinical characteristics of isolated perianal Crohn's disease and validation of the TOpClass criteria: a retrospective cohort pilot study.","authors":"Wasuwit Wanchaitanawong, Varut Lohsiriwat, Sitthipong Srisajjakul, Marianee Salaemae, Phichayut Phinyo, Julajak Limsrivilai","doi":"10.1093/ibd/izag028","DOIUrl":"10.1093/ibd/izag028","url":null,"abstract":"<p><strong>Background: </strong>Isolated perianal Crohn's disease (ipCD) is characterized by recurrent or refractory complex perianal fistulas without luminal inflammation. This study aimed to compare clinical characteristics among ipCD, perianal Crohn's disease (pCD) with luminal involvement, and refractory/recurrent cryptoglandular disease (CGD), assess the diagnostic performance of the TOpClass criteria, and evaluate treatment outcomes in ipCD.</p><p><strong>Methods: </strong>This retrospective cohort pilot study included patients with complex perianal fistula confirmed by pelvic magnetic resonance imaging. ipCD was defined as recurrent or refractory complex perianal fistula persisting beyond 6 months post-surgery, absence of luminal inflammation, and at least a clinical response to biologics.</p><p><strong>Results: </strong>Among 33 patients (ipCD = 9, pCD = 9, CGD = 15), ipCD patients were older than pCD (38 vs 27 years, P = .020), had lower fecal calprotectin (268 vs 2498 mg/kg, P = .014), and more complex fistula types (P = .029). Compared to CGD, ipCD patients were younger (38 vs 47 years, P = .032), more likely to have anal stenosis (55.6% vs 0%, P = .003), branched fistula (100.0% vs 46.7%, P = .009), multiple internal openings (44.4% vs 6.7%, P = .047), horseshoe extensions (77.8% vs 20.0%, P = .010), and deeper internal opening (3.8 vs 2.7 cm, P = .006). The TOpClass criteria demonstrated 75.0% sensitivity and 100% specificity for diagnosing ipCD. Fistula remission at 6 months was significantly lower in ipCD than pCD (11.1% vs 100%, P = .007).</p><p><strong>Conclusion: </strong>ipCD represents a distinct phenotype with advanced fistula complexity and limited response to biologics. Younger age, anal stenosis, and more advanced fistula characteristics favor ipCD over CGD. Applying TOpClass criteria showed high specificity but moderate sensitivity; incorporating additional fistula features may improve sensitivity.</p>","PeriodicalId":13623,"journal":{"name":"Inflammatory Bowel Diseases","volume":" ","pages":"1289-1297"},"PeriodicalIF":5.5,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146258208","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Correction to: Early Top-Down Treatment With Biologics Improves the Rates of Transmural Remission in Crohn's Disease-A Risk-Adjusted Propensity Score Matched Analysis.","authors":"","doi":"10.1093/ibd/izag084","DOIUrl":"10.1093/ibd/izag084","url":null,"abstract":"","PeriodicalId":13623,"journal":{"name":"Inflammatory Bowel Diseases","volume":" ","pages":"1430"},"PeriodicalIF":5.5,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147928835","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Fecal calprotectin is an accurate noninvasive screening tool for pouchitis.","authors":"Sérgio Bronze, Susanne Ibing, Darwin Jimenez, Pamela Reyes Mercedes, Maia Kayal","doi":"10.1093/ibd/izag029","DOIUrl":"10.1093/ibd/izag029","url":null,"abstract":"<p><strong>Background: </strong>Pouchitis is the most common complication after ileal pouch anal anastomosis (IPAA), yet symptoms are non-specific, and diagnosis typically requires pouchoscopy. Fecal calprotectin (FC) is an established inflammatory bowel disease biomarker, but optimal thresholds and diagnostic performance across distinct pouch phenotypes remain unclear.</p><p><strong>Methods: </strong>We performed an analysis of a prospectively maintained IPAA registry (2022-2025) at Mount Sinai Hospital. Adults with ulcerative colitis who had underwent total proctocolectomy with IPAA and had FC testing within ±90 days of pouchoscopy were included. Phenotypes were categorized as normal pouch (NP), acute pouchitis (AP), chronic pouchitis (CP), or Crohn's disease-like pouch inflammation (CDLPI). FC was compared across phenotypes and tested for associations with endoscopic Pouchitis Disease Activity Index (PDAI) sub-score, histologic activity, and symptoms using non-parametric tests, Spearman correlation, log-linear regression, and receiver operating characteristic analysis.</p><p><strong>Results: </strong>Among 163 patients, FC differed significantly across pouch phenotypes (P <.01) with a median value of 50.5 µg/g in NP, 244 µg/g in AP, 370.5 µg/g in CP, and 231.5 µg/g in CDLPI. FC distinguished between inflammatory and normal pouches with an area under the curve (AUC) of 0.82, with an optimal threshold of ∼167 µg/g (specificity, 94%). FC correlated significantly with endoscopic PDAI sub-scores (Spearman ρ = 0.45, P <.001), and predicted severe endoscopic activity with an AUC of 0.82 and an optimal cutoff of 280 µg/g.</p><p><strong>Conclusion: </strong>FC is accurate for detecting and grading pouch inflammation. Thresholds near 167 and 280 µg/g reliably discriminate normal from inflamed pouches and mild from severe endoscopic disease, respectively.</p>","PeriodicalId":13623,"journal":{"name":"Inflammatory Bowel Diseases","volume":" ","pages":"1298-1303"},"PeriodicalIF":5.5,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147389854","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Artificial intelligence and the future of inflammatory bowel disease trial recruitment: from bottleneck to breakthrough.","authors":"Rohan Kakkar, Michael F Byrne","doi":"10.1093/ibd/izag036","DOIUrl":"10.1093/ibd/izag036","url":null,"abstract":"","PeriodicalId":13623,"journal":{"name":"Inflammatory Bowel Diseases","volume":" ","pages":"1418-1420"},"PeriodicalIF":5.5,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147456842","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Recovery of response and long-term outcomes following loss of response and dose escalation of subcutaneous infliximab: a post hoc analysis of the LIBERTY-CD & LIBERTY-UC trials.","authors":"Marla C Dubinsky, Stefan Schreiber, Andres J Yarur, Bruce E Sands, Stephen B Hanauer, Silvio Danese, Hyunseong Yu, Dong-Hyeon Kim, Young Nam Lee, Jean-Frédéric Colombel","doi":"10.1093/ibd/izag017","DOIUrl":"10.1093/ibd/izag017","url":null,"abstract":"<p><strong>Background: </strong>Rapidity of onset of efficacy following dose escalation of subcutaneous infliximab after loss of response remains unclear in Crohn's disease (CD) and ulcerative colitis (UC). This post hoc analysis of the LIBERTY-CD and LIBERTY-UC trials evaluated time to response recovery following dose escalation of subcutaneous infliximab after loss of response, and characterized patients who experienced early recovery.</p><p><strong>Methods: </strong>This analysis included week 10 responders to intravenous infliximab induction who were randomized to receive subcutaneous infliximab 120 mg every other week (Q2W) and underwent dose escalation to 240 mg Q2W following loss of response. Time to response recovery was assessed, and outcomes pre-/post-dose escalation were analyzed by recovery timing (early [≤8 weeks], late [>8 weeks], non-recovery). Week 102 outcomes and factors associated with early recovery were evaluated.</p><p><strong>Results: </strong>Response recovery was achieved in 85.1% (40/47) with CD and 82.3% (51/62) with UC, with early recovery in 66.0% (31/47) and 69.4% (43/62), respectively. Early recovery groups in CD and UC showed greater serum infliximab increases than late or non-recovery groups. At week 102, numerically higher rates of clinical response and clinical remission in CD, and endoscopic remission in UC, were observed in early versus late recovery group. Factors associated with early recovery differed between CD and UC: systemic inflammatory and pharmacokinetic parameters were linked to early recovery in CD, while mucosal and gut-specific factors predominated in UC.</p><p><strong>Conclusion: </strong>Dose escalation of subcutaneous infliximab led to rapid response recovery in most patients with CD and UC. Early recovery was associated with favorable long-term outcomes.</p><p><strong>Clinical trial registration numbers: </strong>NCT03945019 and NCT04205643.</p>","PeriodicalId":13623,"journal":{"name":"Inflammatory Bowel Diseases","volume":" ","pages":"1235-1247"},"PeriodicalIF":5.5,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13337220/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147480393","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Preoperative anorectal manometry is associated with cuffitis but not proximal pouch inflammation after IPAA creation.","authors":"Emma Dester, Joseph Carter Powers, Mark Zemanek, Riley Smith, Zeeyong Kwong, Anna Spivak, Benjamin L Cohen, Katherine Falloon, Tracy Hull, Bret Lashner, Cheryl Cameron, Taha Qazi","doi":"10.1093/ibd/izag027","DOIUrl":"10.1093/ibd/izag027","url":null,"abstract":"<p><strong>Background: </strong>Patients undergoing ileal pouch-anal anastomosis (IPAA) for inflammatory bowel disease (IBD) commonly experience postoperative inflammatory complications, including pouchitis and cuffitis. While pelvic floor dysfunction has been associated with these complications, the predictive value of preoperative anorectal manometry (ARM) remains unclear. We evaluated the association between abnormal preoperative ARM and postoperative inflammatory outcomes in IPAA patients.</p><p><strong>Methods: </strong>In this historical cohort study we assessed IPAA patients who underwent preoperative ARM with ileostomy closure during the period from January 2009 to December 2024. Patients were divided into 2 groups-normal vs abnormal pelvic floor function-based on ARM. Primary outcomes were a composite measure of endoscopic inflammatory pouch disease (EIPD) and endoscopic evidence of rectal cuffitis after the perioperative period. Secondary outcomes included individual components of the composite primary outcome. Multivariable logistic regression was used to assess associations while controlling for covariates.</p><p><strong>Results: </strong>We included 179 patients in this study, 46 (25.7%) with abnormal ARM and 133 (74.3%) with normal ARM. In multivariable regression, abnormal ARM was associated with modestly increased odds of cuffitis (odds ratio [OR], 2.136; 95% CI, 1.050-4.345; P = .037) but was not associated with EIPD (OR, 1.490; 95% CI, 0.710-3.104; P = .287). Secondary outcomes were similar between groups, except for diffuse pouch inflammation, which was more frequently observed among patients with abnormal ARM (P = .024).</p><p><strong>Conclusions: </strong>Abnormal preoperative ARM was associated with increased odds of postoperative cuffitis but not composite endoscopic pouch inflammation in IPAA patients. Given the modest effect size and limited precision, these findings warrant confirmation in larger, prospective studies.</p>","PeriodicalId":13623,"journal":{"name":"Inflammatory Bowel Diseases","volume":" ","pages":"1248-1255"},"PeriodicalIF":5.5,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147456793","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Targeting the transcription factor GATA3 by the DNAzyme formulation SB012 in patients with moderately-to-severely active ulcerative colitis: a multicenter, randomized, placebo-controlled, phase 2a induction trial.","authors":"Raja Atreya, Tanja Kühbacher, Michael Vieth, Andre Jefremow, Simon Hirschmann, Maximilian J Waldner, Sarah Fischer, Marcel Vetter, Oliver Drvarov, Benno Weigmann, Michael Meyer, Tanja Mühl, Ursula Homburg, Georgios Sarigiannis, Holger Garn, Harald Renz, Markus F Neurath","doi":"10.1093/ibd/izag046","DOIUrl":"10.1093/ibd/izag046","url":null,"abstract":"<p><strong>Objective: </strong>Augmented mucosal expression of the transcription factor GATA3 has been implicated in the pathogenesis of ulcerative colitis (UC). Here, we evaluated the efficacy and safety of SB012, an enema formulation of the DNAzyme hgd40 that specifically inactivates GATA3 messenger RNA, for induction therapy in patients with active UC.</p><p><strong>Design: </strong>In this randomized, double-blind, placebo-controlled, multicenter, phase 2a study, patients with moderately-to-severely active UC were randomized to either receive SB012 enema (225 mg hgd40) or placebo once daily for 4 weeks. The primary endpoint was change in the Total Mayo Score at week 4 compared to baseline values in the SB012 versus placebo group.</p><p><strong>Results: </strong>Patients were randomized 2:1 to the SB012 (n = 13) or placebo (n = 7) group. The treatment difference between the SB012 and placebo group was not statistically significant at week 4 (P = .286). In patients not treated with glucocorticoids, the Total Mayo score in the SB012 group improved on day 28 by -2.2 (P = .027; 95%CI: -4.1 to -0.3) compared to placebo, whereas no improvement was seen in patients using corticosteroids. Further, the median Total Mayo Score in the SB012 group dropped significantly from 9.0 (Q1-Q3 6.5-10) at baseline to 7.0 (4.0-8.5) at week 4 (P = .004), while there were no significant changes in the placebo group. Endoscopic improvement was reached by 17% (2/12) and 57% (4/7) in the SB012 and 17% (1/6) and 50% (3/6) in the placebo group at weeks 4 (P = 1.0) and 8 (P = 1.0), respectively. SB012 application was well tolerated.</p><p><strong>Conclusion: </strong>Overall, topical application of the GATA3-specific DNAzyme formulation SB012 was well tolerated, but did not reach the defined primary endpoint of treatment difference at week 4 between the SB012 and placebo group in active moderate-to-severe UC patients, unless confounding by glucocorticoids was taken into account.</p>","PeriodicalId":13623,"journal":{"name":"Inflammatory Bowel Diseases","volume":" ","pages":"1354-1365"},"PeriodicalIF":5.5,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147929024","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}