Intestinal Research最新文献

Background/aims: Standard withdrawal time (SWT) is a recognized colonoscopy quality metric but may not capture mucosal examination quality. We developed an artificial intelligence (AI)-derived metric, effective withdrawal time (EWT), to quantify clear mucosal visualization. This study prospectively evaluated EWT versus SWT on adenoma detection rate (ADR) and other metrics.

Methods: In this prospective single-center study, patients undergoing colonoscopy were enrolled. EWT was calculated in real-time using an AI system with endoscopists blinded to results. Multivariable analyses assessed the association of EWT and SWT with binary (e.g., ADR) and count outcomes (e.g., adenoma or polyp per colonoscopy [APC or PPC]), adjusting for patient and procedural characteristics.

Results: We analyzed 193 colonoscopies by 16 endoscopists. After adjustment, each 1-minute EWT increase was associated with higher odds of adenoma detection (ADR: odds ratio [OR], 1.38; 95% confidence interval [CI], 1.15-1.67) and a > 2-fold increase in adenomas detected per procedure (APC: incidence rate ratio [IRR], 2.14; 95% CI, 1.97-2.32). Both parameters were significantly better with EWT than SWT (OR, 1.38 vs. 1.06; P< 0.01 for ADR; IRR, 2.14 vs. 1.15; P= 0.02 for APC). EWT demonstrated stronger correlation with APC (R2 = 0.97) and PPC (R2 = 0.96) than SWT (R2 = 0.67 and 0.68, respectively; P< 0.01).

Conclusions: AI-derived EWT is a novel quality indicator reflecting mucosal examination thoroughness, serving as a stronger, more independent predictor of ADR than SWT. (Clinical Trials.gov identifier: NCT06063720).

Diet is increasingly recognized not as a passive exposure but as a dynamic determinant of inflammatory bowel disease (IBD) pathogenesis, progression, and treatment response. This review article redefines diet as a multidimensional modifier acting through complex interactions with genetics, microbiota, intestinal barrier function, and environmental exposures. Beyond nutrient composition, we highlight how age, sex, habitual diet, cooking methods, contaminants, and lifestyle collectively shape disease trajectories. We also identify key research priorities: incorporation of long-term, mechanistically anchored trials; development of digital, biomarker-informed dietary assessment tools; and integration of polygenic, microbial, and metabolic data to inform individualized therapy. Emerging evidence also calls for culturally tailored and patient-centered frameworks that ensure real-world adherence and equity in dietary interventions. Reframing diet as a biological, behavioral, and environmental nexus shifts it from the periphery to the forefront of IBD care, transforming it from a confounder in research to a therapeutic frontier in clinical practice.

Background/aims: This post hoc analysis of the phase 2b/3 SELECTION (NCT02914522) study and its long-term extension (SELECTIONLTE; NCT02914535) evaluated the impact of filgotinib 200 mg (FIL200) on health-related quality of life (HRQoL) and work productivity in Japanese patients with ulcerative colitis over 3 years.

Methods: Patients in SELECTION were randomized to FIL200, filgotinib 100 mg, or placebo (PBO) during the induction phase. Week-10 responders were re-randomized to continue assigned treatment or PBO in the 47-week maintenance phase. Patients who completed the SELECTION induction and maintenance phases (completers) and week-10 non-responders could enter SELECTIONLTE. HRQoL and work productivity were assessed using EQ 5-dimension (EQ-5D), EQ visual analog scale, Inflammatory Bowel Disease Questionnaire (IBDQ), 36-item Short Form Health Survey (SF-36), and Work Productivity and Activity Impairment (WPAI) questionnaires at week 10 (FIL200 vs. PBO), and at week 10 and years 1-3 (completers and non-responders who received only FIL200 in SELECTION+SELECTIONLTE).

Results: Proportions of patients with minimal clinically important differences (MCIDs) at week 10 were higher with FIL200 versus PBO for IBDQ total score (77% vs. 54%), SF-36 mental component summary (58% vs. 21%), and SF-36 physical component summary (54% vs. 36%). All measures (except WPAI absenteeism) showed mean score changes from baseline at week 10 in the direction of improved HRQoL with FIL200 versus PBO. MCID rates were maintained in completers up to 3 years and increased notably in non-responders (except WPAI absenteeism and EQ-5D) from week 10 to years 1-3.

Conclusions: FIL200 treatment was associated with sustained improvements in HRQoL and work productivity over 3 years in Japanese patients with ulcerative colitis, consistent with the overall SELECTION and SELECTIONLTE trial populations.

Background/aims: Very early-onset inflammatory bowel disease (VEO-IBD), defined as IBD diagnosed before 6 years of age, is highly influenced by genetic factors. Monogenic IBD is a type of enterocolitis caused by a single pathogenic variant. However, information on Asian patients with VEO-IBD and monogenic IBD is limited. This study investigated real-world data on VEOIBD and monogenic IBD in Japan.

Methods: We evaluated patients with VEO-IBD registered in the Japanese Pediatric Inflammatory Bowel Disease Registry, a multicenter prospective registry study conducted between 2012 and 2021. We categorized patients into monogenic and non-monogenic IBD groups and compared their clinical characteristics and outcomes.

Results: Among 703 pediatric patients with IBD, 68 (9.7%) had VEO-IBD. Of these, 26 (38.2%) had ulcerative colitis, 16 (23.5%) had Crohn's disease, 23 (33.8%) had unclassified IBD (IBD-U), and 3 (4.4%) had Behçet's disease. Genetic testing was performed in 25 patients (36.8%), and monogenic IBD was identified in 5 of the 23 patients with IBD-U (7.4% of the VEO-IBD cohort). All 5 monogenic cases presented with an IBD-U phenotype. Monogenic IBD included A20 haploinsufficiency, interleukin-10 receptor subunit alpha deficiency, chronic granulomatous disease, Wiskott-Aldrich syndrome, and Hermansky-Pudlak syndrome. Monogenic IBD was significantly associated with IBD-U phenotype (P= 0.015) and severe infections before 1 year of age (P= 0.004).

Conclusions: Patients with VEO-IBD who present an IBD-U phenotype and have a history of severe infections during infancy should be prioritized for genetic analysis to investigate the possibility of monogenic IBD.

Background/aims: Scant population-based data are available for inflammatory bowel disease (IBD)-related hospitalization rates in Asian countries. We investigated the epidemiological trends of hospitalization rate and lengths of hospital stay of the IBD population in Taiwan.

Methods: Data for the period from 2001 to 2017 were retrieved from the National Health Insurance database. The average annual percentage change (AAPC) was analyzed by summarizing the trend with an underlying Joinpoint regression model. Data for the prebiologics era (2001-2010) and postbiologics era (2011-2017) were compared using regression discontinuity design.

Results: A total of 4,376 patients with IBD were analyzed (1,167 Crohn's disease [CD] and 3,209 ulcerative colitis [UC]). Between 2001 and 2017, the all-cause hospitalization rates per 100,000 person-years increased significantly in those with IBD (AAPC, 10.5%; 95% confidence interval [CI], 9.6% to 11.4%), CD (AAPC, 14.1%; 95% CI, 10.0% to 18.5%), and UC (AAPC, 10.1%; 95% CI, 8.3% to 11.8%). However, hospitalization rates per 100 patients with IBD decreased for IBD (AAPC, -2.6%; 95% CI, -4.0% to -1.2%) and UC (AAPC, -1.8%; 95% CI, -2.8% to -0.7%) but not for CD (AAPC, -1.6%; 95% CI, -3.5% to 0.4%). Significant downward trends in length of hospital stay were identified for patients with IBD. Hospitalization, surgical, and mortality rates associated with IBD were significantly lower in the postbiologic than in the prebiologic eras.

Conclusions: We observed an upward hospitalization trend relative to the general population but a downward trend within the IBD population in Taiwan. The declining hospitalization, surgical, and mortality rates might be attributed to advances in clinical management.

Background/aims: To date, some large language models (LLMs), such as Chat Generative Pre-trained Transformer 4-omni (ChatGPT-4o), can process images through visual transformer patching. An LLM analysis was conducted to assess the ability of ChatGPT-4o to assign the Mayo endoscopic score (MES).

Methods: A selection set of high-quality endoscopic frames was identified to compare 4 input models to select the most performant, confirmed in an extended set of 304 frames. Concordance with the evaluation by expert endoscopists was assessed.

Results: Only one of the pre-tested models demonstrated significant concordance (κ = 0.232, 95% confidence interval [CI] = 0.167 to 0.296, P= 0.003; ρ = 0.36, P= 0.011), with a mean bias of -0.26 ± 1.192 (95% CI, -2.596 to 2.076). This was confirmed in the extended set (κ = 0.260, 95% CI = 0.195 to 0.324, P< 0.001; ρ = 0.288, P< 0.001). The absolute concordance for the selected model was 44% and 45.3% in the selection and extended sets, respectively. For the identification of moderately-to-severely active disease, a sensitivity of 73% (95% CI, 60% to 82%), specificity of 60% (95% CI, 54% to 66%), positive predictive value of 32% (95% CI, 25% to 40%), and negative predictive value of 90% (95% CI, 84% to 93%) were identified.

Conclusions: ChatGPT-4o shows a mild potential in evaluating MES in endoscopic frames, but further refinements are mandatory.

Background/aims: The GRAVITI (NCT05197049) study demonstrated efficacy and safety of guselkumab, a dual-acting interleukin- 23p19 subunit inhibitor, as subcutaneous (SC) induction and maintenance therapy in participants with moderate to severely active Crohn's disease (CD). We report post hoc subgroup analyses in East Asian participants.

Methods: Seventy-one East Asian participants were randomized 1:1:1 to guselkumab 400 mg SC every 4 weeks (q4w) (x3) followed by 100 mg SC every 8 weeks (q8w) starting at Week 16 (n = 23), guselkumab 400 mg SC q4w (x3) followed by 200 mg SC q4w starting at Week 12 (n = 20), or placebo (n = 28) in the Phase 3 double-blind, placebo-controlled, treat-through GRAVITI study. From Week 16, placebo participants meeting rescue criteria were eligible for rescue treatment with guselkumab. Clinical remission at Week 12 and endoscopic response at Week 12 were co-primary endpoints, additional endpoints included Patient-Reported Outcome-2 remission (Week 12), clinical response (Week 12), clinical remission (Week 24 and Week 48), and endoscopic response (Week 48), and safety through Week 48.

Results: Greater proportions of East Asian participants receiving guselkumab 400 mg SC achieved clinical remission versus placebo (41.9% vs. 14.3%) and endoscopic response versus placebo (39.5% vs. 21.4%) at Week 12. At Week 48, greater proportions of participants in both guselkumab groups (100 mg SC q8w, 69.6%; 200 mg SC q4w, 60.0%) achieved clinical remission versus placebo (10.7%) and endoscopic response versus placebo (43.5%, 60.0%; vs. placebo 0.0%). The adverse event profile was generally consistent with the global population.

Conclusions: Efficacy and safety results of SC guselkumab in East Asian participants with moderately to severely active CD reflect findings from the global study.

Background/aims: Ulcerative colitis (UC)-associated colorectal neoplasia (UCAN) in patients with UC and primary sclerosing cholangitis (PSC) has not been studied well in Japan. This retrospective study examined the clinicopathological features and prognosis of UCAN in patients with PSC-UC.

Methods: A total of 808 patients with UCAN were enrolled from 1983 to 2020 and categorized into PSC (PSC-UCAN, n = 26) and no PSC (UCAN-alone, n = 782) groups. Clinicopathological features were compared between the 2 groups, and the 10-year overall survival (OS) and cancer-specific survival (CSS) were analyzed.

Results: The PSC-UCAN group had a shorter UC duration before UCAN diagnosis (12.8 years vs. 16.9 years, P= 0.044), were younger at UCAN diagnosis (47.8 years vs. 53.3 years, P= 0.046), and developed UCAN more frequently in the right-sided colon (34.6% vs. 15.9%, P= 0.028) than the UCAN-alone group. The PSC-UCAN group showed a trend toward a lower proportion of high-grade dysplasia (19.2% vs. 30.7%) and a higher proportion of early-stage cancers (53.9% vs. 31.2%). The 10-year OS (64.6% vs. 79.3%, P=0.080) and CSS (80.8% vs. 83.9%, P=0.60) were comparable.

Conclusions: Patients with PSC-UCAN showed earlier and younger development of UCAN than patients with only UCAN, with a high prevalence in the right-sided colon. Early-stage cancer was more frequently observed in the PSC-UCAN group, despite the shorter duration of UC. Patients with PSC-UC probably benefit from early initiation of surveillance colonoscopy.

Background/aims: Budesonide rectal foam was approved in Japan in 2017 for mild to moderate active ulcerative colitis (UC). This is the final report of post-marketing surveillance to evaluate real-world safety and effectiveness.

Methods: This Japanese large-scale, prospective, multicenter, open-label observational study included patients with active-phase mild to moderate UC newly started on budesonide 2 mg rectal foam. Safety was evaluated by adverse drug reactions (ADRs). Effectiveness was evaluated using clinical remission rates and partial Mayo scores. Effectiveness by background (disease phenotype, severity, clinical course, age, prior topical therapy, baseline advanced therapy [biologicals/Janus kinase inhibitors]) was also assessed.

Results: There were 633 and 503 patients in the safety and effectiveness analyses, respectively. ADRs occurred in 4.3% (27/633) of patients. Eight glucocorticoid-related ADRs occurred in 7 patients (1.1%). Clinical remission rates were 44.2% (165/373), 72.1% (191/265), and 69.8% (333/477) at week 2, week 6, and the final evaluation, respectively. There were statistically significant changes from baseline in partial Mayo scores at all timepoints (all P< 0.0001 vs. baseline). At 2, 4, 6, and 6-12 weeks, mean± standard deviation changes from baseline in partial Mayo scores were -2.1 ± 1.9, -2.7 ± 2.1, -3.1 ± 2.3, and -3.4 ± 2.3 points, respectively. Statistically significant improvements were maintained at all timepoints in subgroup analyses by background (disease phenotype, severity, clinical course, age, prior topical therapy, baseline advanced therapy).

Conclusions: No new safety concerns were identified. Partial Mayo score improved in a variety of patient background factors. Health condition improvements were confirmed in this Japanese post-marketing surveillance. (Japan Registry of Clinical Trials, identifier jRCT1080223802).

Background/aims: Randomized controlled trials have confirmed the efficacy and safety of mirikizumab, an anti-interleukin-23p19 monoclonal antibody, for moderate-to-severe active ulcerative colitis (UC). However, there are no real-world data on the efficacy and safety of mirikizumab for UC as maintenance therapy, especially in difficult-to-treat inflammatory bowel disease (DTT-IBD). This study aimed to evaluate the long-term efficacy and safety of mirikizumab in patients with UC of DTT-IBD.

Methods: This was a single-center retrospective observational study involving adult patients with UC who received mirikizumab between January 2023 and April 2025 and met the criteria for DTT-IBD (e.g., failure of biologics and advanced small molecule drugs with at least 2 different mechanisms of action). The primary outcome was the clinical response at week 52. Secondary outcomes included steroid-free clinical remission within 52 weeks and the persistency of mirikizumab use. Adverse events were also recorded.

Results: Thirty-two patients were included in this study. The median 2-item patient-reported outcome score at baseline was 3 (interquartile range, 2-4). The proportion of patients with a clinical response at week 52 was 33.3% (95% confidence interval, 14.6%-57.0%). Steroid-free clinical remission was achieved in 26.7% (95% confidence interval, 12.3%-45.9%) of the patients. The cumulative continuous rate of mirikizumab use at week 52 was approximately 60%. Only 1 patient developed a serious adverse event requiring hospitalization (pneumonia), and mirikizumab was successfully resumed after recovery.

Conclusions: The present study demonstrated real-world data regarding maintenance therapy with mirikizumab for UC among patients with DTT-IBD.