Journal of Crohn's & colitis最新文献

Background and aims: Risankizumab, a selective interleukin-23 p19 inhibitor, is approved to treat moderately to severely active Crohn's disease (CD) in adults. We report interim results from part 2 of the ongoing SEQUENCE trial evaluating long-term efficacy and safety of risankizumab in patients with active CD and previous anti-tumor necrosis factor failure.

Methods: Patients randomized to risankizumab who completed the part 1 Week 48 visit could continue receiving open-label subcutaneous risankizumab 360 mg every 8 weeks (part 2). Patients with inadequate response could receive rescue therapy (intravenous risankizumab 600 mg) before continuing regular treatment. This interim analysis assessed efficacy at Weeks 52, 76, and 100 of treatment; safety was evaluated throughout.

Results: Overall, 224 patients who received risankizumab 600 mg intravenous induction therapy and 360 mg subcutaneous maintenance therapy entered part 2. Clinical remission rates remained stable through Week 100 (as observed, ≥74.5%; nonresponder and modified non-responder imputation analyses showed similar trends). Most patients (>99%) achieving clinical remission were corticosteroid-free at the corresponding visit. CD-related hospitalization and surgery incidence were low (≤0.03 n/patient year), and Inflammatory Bowel Disease Questionnaire and 36-Item Short Form Health Survey improvements were sustained. Safety data were consistent with the known risankizumab safety profile; the exposure-adjusted serious adverse event rate was 11.8/100 patient-years.

Conclusions: This interim analysis of continuous open-label risankizumab therapy showed durable long-term clinical efficacy and no new safety signals in patients with moderately to severely active CD. Future analyses will evaluate longer-term clinical and endoscopic outcomes and safety.

Clinical trial registration number: NCT04524611.

Background and aims: Timely treatment of inflammatory bowel disease (IBD) flares improves outcomes, but quick differentiation from other symptom causes is challenging. We implemented a clinical care pathway (CCP) using protocolized nurse-led triage and rapid access intestinal ultrasound (RAIUS) for early flare management, aiming to improve patient outcomes and satisfaction, and reduce healthcare utilization.

Methods: Prospective observational study from November 2022 until June 2023. IBD nurse triaged patients using a symptom severity-based protocol. Based on clinical urgency, patients were discussed with their specialist, referred for RAIUS, or planned for hospitalization. Data collected included outcomes, healthcare utilization impact, clinical coding data, patient surveys.

Results: There were 211 episodes of care (EOCs), most (78%, 165/211) for flare symptoms, with medication optimization in 36% (59/165), reassurance of remission in 41% (67/165), aperients for fecal loading in 12% (19/165), and further investigations in 5% (8/165). RAIUS utilized in 27% EOCs (56/211), confirming active disease in 32% (18/56), response/remission in 43% (24/56), and fecal loading in 23% (13/56). Of the EOCs, 10% (20/211) avoided unplanned hospitalizations, 58% (123/211) avoided urgent clinic reviews, and 32% (68/211) had no direct impact, with AUD$146,418 estimated net savings over 30 weeks. There were lower numbers of Emergency Department presentations (14 vs 44) and hospital admissions (10 vs 38). Six unplanned hospital presentations occurred within 30 days of CCP engagement (five after-hours). More patients were "satisfied" or "very satisfied" (32/60 pre- and 51/60 post-CCP).

Conclusion: Our novel CCP reduced hospital resource utilization, with high patient satisfaction and significant cost-savings.

Background: We aimed to assess to what extent socioeconomic status (SES) and elevated symptoms of anxiety and depression predict low physical activity (PA) and high fatigue among individuals with inflammatory bowel disease (IBD).

Methods: Participants from the University of Manitoba IBD Research Registry completed a cross-sectional survey pertaining to fatigue, IBD symptoms, PA, and mental health. The International Physical Activity Questionnaire, Modified Fatigue Impact Scale (MFIS), Generalized Anxiety Disorders-7, and Patient Health Questionnaire scales were used. Disease activity was defined by the Inflammatory Bowel Disease Symptom Inventory.

Results: Among those who were fatigued (MFIS > 38) more were <63 years of age (63% vs 49%, P < .001), reported education of highschool level or less (34% vs 27%, P = .03), had low household income <$50 000 (24% vs. 16%, P < .01), were not in a relationship (25% vs 18%, P < .001), and were current smokers (16% vs 7%, P < .0001). The odds of low SES were greater for those who participated in low PA (OR = 2.75, 95% CI = 1.8-4.3), low PA and were fatigued (OR = 3.05, 95% CI = 1.7-5.3), and low PA excluding fatigue (OR = 2.28, 95% CI = 1.3-3.9). Low SES was not significantly associated with fatigue (P = .08), particularly after removing PA observations (OR = 1.00, 95% CI = 0.47-1.97). After adjusting for demographic and clinical factors, the odds of being fatigued were greater among those with elevated anxiety (aOR = 14.4, 95% CI = 9.4-22.4), depression (aOR = 39.6, 95% CI = 24.1-67.2), and active disease (aOR = 6.9, 95% CI = 4.8-9.97). The results did not change when removing low PA from the analysis.

Conclusions: Low SES was a main driver of engaging in low PA (and not high fatigue). Anxiety and/or depression and active disease were drivers of high fatigue (and not low PA).

Background: Intestinal ultrasound (IUS) is increasingly valuable in inflammatory bowel disease (IBD) management.

Objective: This study aimed to determine the learning curve for basic and advanced IUS parameters and establish the minimum number of examinations required for diagnostic proficiency.

Design: We conducted a prospective, multicenter study across eight Italian tertiary IBD centers. Eight gastroenterology trainees with extensive abdominal ultrasound experience but limited IUS exposure completed standardized training comprising theoretical education, 30 supervised examinations, and 99 independent assessments. Expert sonographers independently and blindly reassessed all independent examinations using identical protocols. Interobserver agreement was quantified using Cohen's kappa coefficients across 12 predefined categories, stratified into basic (bowel wall thickness, vascularity, stratification) and advanced (fistulas, collections, strictures) findings.

Results: : Following initial training, trainees demonstrated substantial baseline competency. Basic parameters achieved consistently high performance throughout the study period (κ = 0.792 to κ = 0.842), while advanced findings showed more pronounced learning curves, improving from κ = 0.728 to κ = 0.854. Small bowel dilation exhibited the steepest learning trajectory (κ = 0.674 to κ = 0.921, 36.6% improvement, P = 0.204). Sustained primary competence (κ ≥ 0.8) was achieved by 37.5-62.5% of trainees for basic parameters within 99 examinations, with bowel wall stratification proving most challenging (37.5% success rate).

Conclusion: This study establishes the first comprehensive, parameter-specific learning thresholds for IUS competency in IBD. Our findings demonstrate that structured training enables basic IUS proficiency within 75-112 examinations for experienced ultrasonographers, while advanced skills require extended practice. These data represent an important step toward defining evidence-based benchmarks for IUS training, supporting the development of standardized international curricula and safe clinical implementation.

Background: Obesity is increasingly recognized as a common comorbidity in patients with inflammatory bowel disease (IBD). Glucagon-like peptide-1 receptor agonists (GLP-1RAs) are widely used for weight reduction and cardiometabolic risk management. However, their safety and effectiveness in individuals with IBD remain uncertain.

Methods: We conducted a systematic review through June 2025 to identify studies involving adult patients with IBD treated with GLP-1RAs. Primary outcomes included hospitalization, corticosteroid use, treatment escalation, risk of flare, and IBD-related surgery. Secondary outcomes were changes in weight and body mass index (BMI).

Results: Ten observational studies, comprising 10 362 patients with IBD (3479 receiving GLP-1RAs and 6883 receiving placebo or other anti-obesity medications) were included. The pooled incidences of hospitalization, corticosteroid use, treatment escalation, flare, and surgery among patients receiving GLP-1RAs were 11%, 11%, 8%, 14%, and 3%, respectively. Use of GLP-1RAs in IBD patients was not associated with an increased risk of corticosteroid use (OR: 0.93; 95% CI: 0.17-5.16; I2 = 11.4%), treatment escalation (OR: 0.70; 95% CI: 0.06-7.62; I2 = 0%), or IBD-related surgery (OR: 0.32; 95% CI: 0.00-313.88; I2 = 92.5%) compared to non-GLP-1 users. Patients treated with GLP-1RAs achieved a percentage total body weight loss of 6.67% (95% CI: 2.93%-10.40%; I2 = 0%), a mean absolute weight loss of 7.33 kg (95% CI: 6.03-8.63; I2 = 0%) and a BMI reduction of 2.48 kg/m2 (95% CI: 0.79-4.17; I2 = 0%) compared to baseline.

Conclusion: GLP-1RAs appear to be safe and effective in patients with IBD.

Background and aims: Individuals with inflammatory bowel disease (IBD) and related low-grade dysplasia (LGD) have an elevated risk of developing high-grade dysplasia (HGD) or colorectal cancer (CRC). The magnitude of this risk and the influence of risk factors, such as the calendar year of diagnosis and exposure to medical therapy, remain uncertain. We therefore investigated the 15-year cumulative incidence of HGD or CRC and the impact of potential risk factors using Danish healthcare registers.

Methods: We conducted a nationwide cohort study of all Danish individuals diagnosed with IBD-related LGD between 1997 and 2023. Individuals with prior colectomy, HGD, CRC, or familial adenomatous polyposis were excluded. The cumulative incidence of subsequent HGD or CRC was estimated, treating death and colectomy as competing risks. Multivariable Cox regression assessed hazard ratios (HRs) for potential risk factors.

Results: Among 7455 individuals, the 15-year cumulative incidence of HGD and/or CRC following IBD-related LGD was 6.3% (95% confidence interval CI: 5.5-7.2). The risk declined over time, with lower hazards in 2017-2020 (HR: 0.45 [95% CI: 0.30-0.67]) and 2020-2023 (HR: 0.24 [95% CI: 0.14-0.43]) compared with 1997-2010. Anti-TNF-α therapy (≥5 doses) showed a non-significant trend toward reduced risk (HR: 0.32 [95% CI: 0.09-1.11]). Identified risk factors included: age (per 5 years: HR: 1.11 [95% CI: 1.06-1.17]), IBD duration (per 5 years: HR: 1.13 [95% CI: 1.07-1.19]), having a first-degree relative with CRC (HR: 1.73 [95% CI: 1.12-2.68]), episodes of elevated fecal calprotectin (per episode in the 5 years prior to inclusion: HR: 1.14 [95% CI: 1.02-1.27]), and high-dose prednisone use in the year prior to inclusion (HR: 1.53 [95% CI: 1.01-2.31]).

Conclusion: Among Danish individuals with IBD-related LGD, the overall 15-year cumulative incidence of subsequent HGD or CRC was 6.3% and has declined markedly over time. In addition to established risk factors, including age, IBD duration, family history of CRC, and elevated fecal calprotectin, we found that high-dose prednisone use was associated with an increased risk.