Mirikizumab, approved for the treatment of moderately to severely active ulcerative colitis (UC), may be prescribed in a similar placement to ustekinumab in second-line settings. Payers may compare the economic value when making formulary decisions. This study estimated and compared the cost per remission of the second-line therapies mirikizumab versus ustekinumab in patients with UC.

An Excel-based analytic model was developed to estimate the cost per additional patient achieving clinical remission at the end of one year in biologic/Janus kinase inhibitor (JAKi)-experienced patients (second-line therapy) with UC from a United States commercial payer perspective. A network meta-analysis of published pivotal randomized clinical trials was used to derive the number needed to treat (NNT) for clinical response, clinical remission, and endoscopic remission/endoscopic improvement/mucosal healing for ustekinumab and mirikizumab in the study population. The model included the treatment cost (wholesale acquisition costs [WAC] and treatment administration costs) during the induction and maintenance phases. A scenario involving the availability of a ustekinumab biosimilar was also evaluated, assuming the NNT remained the same as ustekinumab but with a WAC set at 50% lower than its current WAC.

The costs per patient achieving clinical remission for mirikizumab vs. ustekinumab as a second-line therapy were $461,096 vs. $67,273 during induction and $501,456 vs. $1,079,189 during maintenance. The cost per clinical remission in case of dose escalation during maintenance was lower for mirikizumab vs. ustekinumab ($501,456 vs. $1,569,127). Considering the ustekinumab 130 mg IV biosimilar, the scenario resulted in a lower cost per clinical remission for mirikizumab vs. a ustekinumab biosimilar during the maintenance phase ($501,456 vs. $539,594).

Mirikizumab is projected to have a lower cost per remission during maintenance therapy than ustekinumab. Given the need for long-term treatment for this chronic condition, mirikizumab appears to be a cost-efficient treatment option.

The appendix might have an immunomodulatory role in ulcerative colitis. Appendicectomy has been suggested as a potentially therapeutic intervention to maintain remission in ulcerative colitis. We aimed to evaluate the clinical effectiveness of laparoscopic appendicectomy in maintaining remission in patients with ulcerative colitis.

We did a pragmatic, open-label, international, randomised controlled superiority trial in 22 centres across the Netherlands, Ireland, and the UK. Patients with established ulcerative colitis who were in remission but had been treated for disease relapse within the preceding 12 months were randomly assigned (1:1) to undergo appendicectomy plus continued maintenance medical therapy (intervention group) or to continue maintenance medical therapy alone (control group). Randomisation was done with a central, computer-generated allocation concealment, stratified by disease extent. Patients and treating physicians were unmasked to group allocation. The prespecified primary outcome was the proportion of patients with a disease relapse within 1 year, predefined as a total Mayo score of 5 or higher with an endoscopic subscore of 2 or 3, or, in absence of endoscopy, based on a centrally independent masked review by a critical event committee as an exacerbation of abdominal symptoms (eg, elevated stool frequency subscore of ≥1 point from baseline) with a rectal bleeding subscore of ≥1 or faecal calprotectin level above 150 μg/g or necessitating treatment intensification other than mesalazine. Analyses were done on an intention-to-treat principle. This trial is complete and was registered with the Netherlands Trial Register (NTR2883) and ISRCTN (ISRCTN60945764).

Between Sept 20, 2012, and Sept 21, 2022, 1386 patients were screened. 201 patients were randomly assigned to the appendicectomy group (n=101) or the control group (n=100). After exclusion of four patients due to eligibility violations (three had active disease and one received biological agents at time of randomisation), 99 patients in the appendicectomy group and 98 patients in the control group were included in the intention-to-treat analyses. The 1-year relapse rate was significantly lower in the appendicectomy group than in the control group (36 [36%] of 99 patients vs 55 [56%] of 98 patients; relative risk 0·65 [95% CI 0·47-0·89]; p=0·005; adjusted p=0·002). Adverse events occurred in 11 (11%) of 96 patients in the appendicectomy group and 10 (10%) of 101 patients in the control group. The most frequently reported adverse events were postoperative temporary self-limiting abdominal pain in the appendicectomy group (three [3%] patients) and skin rash in the control group (three [3%] patients). Two cases (2%) of low-grade appendiceal mucinous neoplasm were incidentally found in resected appendix specimens in the appendicectomy group. Serious adverse events occurred in two (2%) of 96 patients who underwent appendicectomy and none in the control group. There were no deaths.

Appendicectomy is superior to standard medical therapy alone in maintaining remission in patients with ulcerative colitis.

Fonds Nuts-Ohra and National Institute for Health Research Efficacy and Mechanism Evaluation.

Inflammatory Bowel Disease (IBD), a chronic condition characterized by gastrointestinal inflammation, is influenced by genetic and environmental factors. Emerging evidence suggests a "mouth-gut axis," with the oral cavity reflecting extra-intestinal manifestations of IBD. This study evaluated the oral health status of IBD patients and the potential of salivary calprotectin (SCP) as a biomarker for assessing IBD activity and oral health.

Oral health was assessed in 100 IBD patients [60 with Crohn's disease (CD) and 40 with ulcerative colitis (UC)] and 14 controls. Evaluations included the Decayed, Missing, and Filled Teeth (DMFT) Score, Periodontal Diagnosis and the need for dental or prosthetic treatment. Saliva and stool samples were collected to measure SCP and faecal calprotectin (FCP) levels using the Elia Calprotectin 2 Test. IBD activity was evaluated with FCP, the Harvey-Bradshaw Index for CD, and the Partial Mayo Score for UC.

The DMFT index mean was comparable between IBD patients (mean 7.99, SD 7.73) and controls (mean 10.00, SD 6.49). However, periodontal disease was significantly more prevalent in IBD patients (57% in CD, 70% in UC) than in controls (29%), with severe cases (stages III/IV) more frequent in IBD. Additionally, 89% of IBD patients required dental treatment, and 39% needed prosthetic rehabilitation. SCP levels showed no significant correlation with disease activity or oral health status, while FCP correlated with C-reactive protein and erythrocyte sedimentation rate.

This study underscores the need for improved oral health management in IBD patients and suggests that SCP may not be a reliable biomarker for monitoring IBD or periodontal disease.

Not applicable.

Ulcerative colitis (UC) is significantly linked with gut microbiota, which is essential for maintaining gut health. Their metabolites mitigate gut inflammation and bolster barrier function. Among these metabolites, we focused on vitamin B3, which has been reported to improve the pathogenesis of UC in mice. This study aimed to compare fecal vitamin B3 and gut microbiota between non-UC and UC patients.

We assessed fecal metabolites and gut microbiota in 71 UC patients (UC group) and 72 non-UC patients (non-UC group) matched by sex and age in 10-year intervals. Fecal samples were collected and metabolites were analyzed using capillary electrophoresis time-of-flight mass spectrometry. Bacterial DNA was extracted for 16S rRNA gene sequencing. We analyzed fecal nicotinamide levels and gut microbiota composition, employing statistical adjustments for confounding factors.

We found that the UC group exhibited significantly lower fecal nicotinamide levels and α-diversity (Shannon index) compared to the non-UC group. The relative abundance of bacterial genera such as Treponema, UCG-002, and Fusicatenibacter was decreased, while Sellimonas, Fournierella, and Oscillospira were increased in the UC group. Moreover, a negative correlation was observed between Sellimonas abundance and fecal nicotinamide levels in the UC group. Additionally, the UC group showed higher expression of a bacterial gene encoding nicotinamidase compared to the non-UC group.

These findings suggest that gut microbiota dysbiosis contributes to reduced vitamin B3 metabolism in UC patients. The study highlights the potential of replenishing vitamin B3 metabolic pathways as a novel therapeutic approach for UC treatment.

To help navigate the complex treatment landscape of ulcerative colitis (UC), we quantified the benefit-risk trade-offs that patients were willing to make when choosing treatment.

Patients completed an online discrete choice experiment. Eligible patients had a UC diagnosis for ≥6 months, were aged ≥18 years, and resided in France, Germany, Italy, Spain, or the UK. Patients chose between 2 hypothetical treatments set up to ensure trade-offs were made. Clinical trial data, literature review, and patient interviews identified treatment attributes. Relative attribute importance (RAI) scores and maximum acceptable risks were generated. A patient-centric benefit-risk assessment of 200 mg of filgotinib was conducted as an example to show how measured trade-offs can be used.

Overall, 631 patients participated; patients had a mean age of 42.2 years and were predominantly male (75.3%). Achieving and maintaining clinical remission was the most important factor for patients (RAI 32.4%); to achieve this, patients were willing to accept slightly higher risks of blood clots, serious infections, and malignancies compared with lower risk treatment profiles. Patients also valued the convenience of oral treatments, avoiding steroids, and the ability to attend school/work. The patient-centric benefit-risk assessment suggested patients are significantly more likely to prefer Janus kinase 1 preferential inhibitor filgotinib over placebo.

Achieving clinical remission was the highest treatment priority for patients. To attain this, patients were willing to accept some slightly higher risk treatment profiles. Patient choices in the benefit-risk assessment suggested patients were significantly more likely to prefer filgotinib over placebo.

Inflammatory bowel diseases, Crohn's disease (CD) and ulcerative colitis (UC), are associated with reduced quality of life (QoL). By using questionnaire tools called patient-reported outcome measures (PROM), patients' well-being and health-status can be measured. The aim of this study was to identify subgroups at risk of being missed in questionnaire monitoring and assess QoL and variability of responses over time.

CD or UC, age ≥18 years, receiving biological treatment subcutaneously or intravenously, 01 August 2018 to 31 January 2020, at Karolinska University Hospital, were included. Patients completed standardised and validated questionnaires for QoL-measurements; Short Health Scale (SHS) and EuroQol 5-dimension-index (EQ5D).

412 patients, 287 (70%) Crohn's disease, 125 (30%) ulcerative colitis, 267 (65%) males, median age: 33 (range 18-85). Patients receiving subcutaneous treatment completed PROM questionnaires significantly less frequently compared with intravenous treatment (multiplicative factor 6.5, 5.7-7.5 95% CI). Reduced QoL was seen for intravenous treatment (multiplicative factor 2.0, 0.5-3.5 95% CI) and active disease (multiplicative factor -4.0, -6.1 to -1.9 95% CI). Greater variability in responses was seen in active disease, anaemia, faecal calprotectin ≥ 250 mg/kg.

Patients receiving subcutaneous treatment, equivalent to home-based treatment, completed significantly fewer PROM questionnaires and are therefore less monitored. It is therefore important to offer different modes of questionnaire administration when monitoring a heterogeneous patient population especially as we see a shift towards oral forms of therapy.

Exclusive Enteral Nutrition (EEN) and the Crohn's Disease Exclusion Diet (CDED) have been shown to induce remission in Crohn's disease. Low-sulphur, plant-based diets are being explored for ulcerative colitis, and wholefood, low-additive approaches are emerging as significant. Although Inflammatory Bowel Disease (IBD) patients modify their diet, evidence for tolerability and benefit outside clinical trials is limited. The DELECTABLE program aimed to assess satisfaction, adherence, and efficacy of dietary therapies as part of IBD care.

In this dietitian-led, open-label, prospective study, patients with Crohn's disease were offered the CDED or a whole-food, additive-free diet (WFD), and patients with ulcerative colitis were offered a low-sulphur, plant-based diet (UCD) or WFD. Primary outcomes were 12-week diet satisfaction (modified DSAT-28) and diet adherence, including food additive intake. Secondary outcomes were quality of life (QoL) (IBDQ-9), disease activity (CDAI for Crohn's disease, partial Mayo score for ulcerative colitis), and biochemical markers (CRP, faecal calprotectin). Analyses were conducted within, rather than between, diet arms due to the non-random nature of the study. Diet adherence and disease activity change across time points (baseline, week 6, week 12) were assessed using repeated measures ANOVA or Friedman's test, with pairwise paired t-test or Wilcoxon Signed-Rank test. Diet satisfaction and quality of life changes across time (baseline/week 1, week 12) were assessed using a paired t-test or Wilcoxon Signed-Rank test.

Of 165 referrals, 76 patients enrolled, with 64 completing the 12-week program (CDED: n = 15, WFD: n = 42, UCD: n = 7). Diet satisfaction was initially high and remained stable over time on CDED (p = 0.212) and improved on WFD (p = 0.03). Patient- and dietitian-rated adherence was high at baseline and did not significantly decrease on any diet arm (p > 0.349). Food additive intake decreased on WFD (p = 0.009). QoL improved on CDED and WFD (p < 0.001). CRP, calprotectin, and CDAI were reduced on CDED (p < 0.045), and CDAI and partial Mayo were reduced on WFD (p < 0.027).

Well-balanced therapeutic diets are feasible and well-accepted by patients with IBD, with a promising impact on disease activity.

Health literacy and digital health literacy are crucial for spreading information that enhances self-management and health outcomes. IBD patients have called for relevant and reliable information to enable self-management. However, mapping conditional capacities for adapting IBD health information remains unaddressed. This study examines IBD patients' health literacy and digital health literacy covariance with clinical, demographic and patient-reported outcomes.

This cross-sectional study recruited patients between April 2023 to February 2024 from a Norwegian university hospital. Canonical correlations identified maximum covariance between health literacy and digital health literacy dimensions against clinical, demographic and patient-reported characteristics. Hierarchical clustering of covariance patterns were compared on external variables using bivariate analyses and logistic regression.

Of 432 consents, 380 (87.96%) IBD patients ≥ 18 years were included. Mean age was 43.6 (14.9) years, 173 (45.5%) had UC, 207 (54.5%) had CD, and 108 (53%) were male. Self-efficacy, illness perception, health status and age correlated with several health literacy and digital health literacy dimensions. Of two identified patient clusters, cluster 1 embodied patients with lowest levels of health literacy, digital health literacy, self-efficacy, health status, illness perception and longest disease duration. Cluster 1 demonstrated significantly lower medication adherence and QoL, higher rates of unemployment, elevated disease activity and fewer receiving biological treatment. Disease activity and biological treatment were the strongest predictors of cluster membership.

The findings emphasize the necessity of addressing clinical characteristics alongside health literacy and digital health literacy in the dissemination of IBD health information.

The psychosocial effects of eating and drinking - summarized as food-related quality of life (FR-QoL) - are underexplored in inflammatory bowel disease (IBD). Currently, there is no German instrument to assess FR-QoL in IBD patients. This study aimed to translate the validated English FR-QoL-29 questionnaire into German and evaluate its validity and reliability.A monocentric, cross-sectional study was conducted at a tertiary referral center with IBD patients and healthy controls. Participants completed questionnaires on sociodemographics, disease history, the Malnutrition Universal Screening Tool (MUST), the German Short Health Scale (SHS), and the FR-QoL-29-German. The FR-QoL-29 was translated into German using a forward-backward method. Its reliability and validity was assessed using Pearson correlation coefficients, intraclass correlation coefficients, and Cronbach's α.N=200 IBD patients (Crohn's disease: 61.8%; women: 50.8%; remission: 56.2%) and n=10 healthy controls completed the questionnaires. Overall, 113 IBD patients repeated the questionnaires after an average of six weeks. Significant differences in FR-QoL-29-German sum scores were found between all levels of IBD disease activity, except for remission - mild disease (p = 0.423) and moderate - severe disease (p = 0.999). FR-QoL-29-German scores significantly correlated with age (p = 0.041), disease activity (p < 0.001), MUST (p = 0.015), fecal Calprotectin (p = 0.011) and SHS (p < 0.001). Overall, the FR-QoL-29-German showed excellent internal consistency (Cronbach's α = 0.965) and good test-retest reliability (ICC = 0.85 [95% CI: 0.78-0.89]).The FR-QoL-29-German is a valid and reliable tool for assessing food-related quality of life in German-speaking individuals with IBD.

Several studies have shown that infliximab and adalimumab ameliorate fatigue in inflammatory bowel disease. We investigated whether serum levels of these agents above or below a selected threshold influence fatigue severity. In this cross-sectional study, we measured serum concentrations (s-) of infliximab and adalimumab and corresponding anti-drug antibody levels. Therapeutic thresholds were defined as s-infliximab ≥ 5.0 mg/L and s-adalimumab ≥ 7.0 mg/L. Disease activity was assessed using the Harvey-Bradshaw Index for Crohn's disease, Partial Mayo Score for ulcerative colitis, and C-reactive protein (CRP) and faecal calprotectin levels for both conditions. Fatigue was assessed with the Fatigue Visual Analog Scale and Fatigue Severity Scale, and depression was evaluated with the Hospital Anxiety and Depression Scale, Depression subscale. Of 171 included patients (112 with Crohn's disease, 59 with ulcerative colitis), 66 (38.6%) were on infliximab and 105 (61.4%) were on adalimumab. Scores on the two fatigue scales were similar for serum values above versus below therapeutic thresholds for both drugs and did not differ with versus without anti-drug antibodies against either drug. CRP was numerically higher with infliximab levels below versus above the threshold (p = 0.06), whereas both CRP and faecal calprotectin were increased with adalimumab below versus above the threshold (p = 0.022, p = 0.0242). In patients with inflammatory bowel disease on maintenance therapy, s-infliximab and s-adalimumab levels below or above therapeutic thresholds or the presence of anti-drug antibodies did not affect fatigue severity. Trial Registration: ClinicalTrials.gov identifier: NCT02134054.

Amgevita is a licensed biosimilar to adalimumab, having demonstrated high pharmacokinetic and clinical similarity to Humira. Switching to a lower-cost medicine may elicit a nocebo effect, whereby expectations of poorer efficacy impact outcomes despite pharmacological similarity. This prospective cohort study examined clinical and economic outcomes and associated psychosocial variables in a group of patients undergoing a nonmedical switch to biosimilar adalimumab.

Patients with inflammatory bowel disease (IBD) were followed before and after switching from Humira to Amgevita. Objective disease activity was assessed pre- and post-switch using the Harvey-Bradshaw Index (Crohn's disease) or partial Mayo score (ulcerative colitis), faecal calprotectin and C-reactive protein. Subjective symptom burden was measured using the IBD Control Questionnaire (IBDCQ). Pre-switch, health anxiety was measured using the Health Anxiety Index (HAI).

In total, 64 patients aged 18-67 were enrolled. IBDCQ scores marginally improved post-switch (13.33 vs, 12.49, P = .043), with no significant changes in objective disease activity scores, faecal calprotectin or C-reactive protein. Sixteen patients reported 17 new adverse events within 4 weeks. Logistic regression revealed a significant relationship between HAI scores and adverse events (P = .0079); each unit increase in HAI score increased the odds of reporting an adverse event by 21%. Drug cost savings for the 64 patients over 8 weeks totalled €143 958.

Switching to biosimilar adalimumab did not affect disease control or quality of life. 25% of patients developed new side effects, particularly those with high levels of health anxiety. Significant cost savings were achieved.

One key area of interest in gastroenterology research is the relationship between Helicobacter pylori (H. pylori) and Inflammatory bowel disease (IBD). Several studies have shown varying results regarding the prevalence of H. pylori in IBD patients and its impact on disease progression, severity, and overall outcome.

This is a prospective cohort study conducted at King Fahad University Hospital in Al Khobar, Saudi Arabia from November 2023 to May 2024 to determine the prevalence of H. pylori in IBD patients and its association with severity. The study included 2 arms for comparison which are IBD patients and control group, IBD will be further classified to CD and UC. Prevalence of H. pylori infection and severity of the disease was compared between these groups.

A total of 360 patients were included in the study which were divided equally into IBD group and control group. The IBD was subdivided into CD with 91 cases and UC with 89 cases. H. Pylori was significantly higher in control group (23.3%) compared with UC cases (13.2%) p value: 0.048. H. pylori infection was significantly high in smokers p value = < 0.0001. The presence of autoimmune disease was significantly associated with H. Pylori infection (16.4%) p value: 0.023.

H. pylori infection was significantly higher in the control group in comparison to IBD group. In addition, smoking and autoimmune disease were significantly associated with H. pylori infection. Finally, the overall association between severity of CD, UC and medication use with H. Pylori were insignificant.

Inflammatory bowel disease (IBD) has an increased risk of venous thromboembolism (VTE), with factors such as hospitalization and surgery enhancing this risk. This study was aimed at evaluating rotational thrombo-elastometry (ROTEM) for assessing blood coagulation status in ulcerative colitis (UC) and determining its relationship with disease severity and response to treatment.

This was a prospective age and sex-matched study with 60 patients each in UC and irritable bowel syndrome groups, the latter being controls. Clinical details and blood investigations, including ROTEM (clotting time [CT], clot formation time [CFT], alpha angle [AA], maximum clot firmness [MCF], maximum lysis [ML]) and D-dimer, were collected, analyzed and compared between the two groups. A hypercoagulable state was defined by Kaufmann et al. as having two or more of the following: short CT and/or CFT time, increased AA and increased MA.

There were 60 patients with UC (age, 38.6 ± 11.64 years; 44 males). The UC group significantly had more patients with hypercoagulable ROTEM than the control group (66.7% vs. 36.7%, p = 0.001). In UC patients with hypercoagulable ROTEM, nine patients were in remission and 31 patients had active disease. Compared to controls, CT, CFT, AA, MCF and D-dimer levels were significantly abnormal in the UC group. Among UC patients with increasing severity, only CFT, AA and D-dimer differed significantly across the groups. There were no significant differences in ROTEM values and D-dimer in patients with severe UC at admission compared to one-week post-discharge. Only hemoglobin (OR, 0.61; 95% CI, 0.38-0.98; p = 0.04) was found to be a significant independent predictor of a hypercoagulable state of active UC, on multivariate analysis.

More patients with UC had hypercoagulable ROTEM compared to controls, which increased with disease severity. Low hemoglobin was predictive of a hypercoagulable state in active UC.

Background/Objectives: Metabolic dysfunction-associated steatotic liver disease (MASLD) is increasingly recognized in inflammatory bowel disease (IBD) patients due to chronic inflammation and metabolic disturbances. However, reliable non-invasive biomarkers for MASLD prediction in this population are lacking. This study evaluated the predictive value of metabolic scores and lipid ratios for MASLD onset in IBD patients. Methods: An observational retrospective study was conducted on 358 IBD patients at the "Renato Dulbecco" Teaching Hospital in Catanzaro, Italy, in a period between 1 January 2021 and 31 December 2024. Clinical and laboratory data, including metabolic scores and lipid ratios, were analyzed using the chi-square and Kruskal-Wallis tests as appropriate. Post hoc comparisons were conducted using Dunn's test. Receiver operating characteristic analysis assessed their predictive accuracy for MASLD. p < 0.05 was considered significant. Results: IBD-MASLD patients had a significantly higher body mass index (BMI, 27 ± 4 vs. 22 ± 2 kg/m2; p < 0.001), waist circumference (100 ± 11 vs. 85 ± 4 cm; p < 0.001), other anthropometric parameters, metabolic scores, and lipid ratios than IBD-only patients. The metabolic score for insulin resistance [METS-IR, area under curve (AUC = 0.754)] and waist circumference (AUC = 0.754) exhibited the highest predictive accuracy, followed by the lipid accumulation product (LAP, AUC = 0.737), BMI (AUC = 0.709), and triglyceride/high-density lipoprotein (TG/HDL, AUC = 0.701). Insulin resistance scores, including the homeostasis model assessment of insulin resistance (AUC = 0.680) and triglyceride-glucose index (AUC = 0.674), were of moderate predictive use. The visceral adiposity index (AUC = 0.664) and low-density lipoprotein/high-density lipoprotein (AUC = 0.656) showed lower discriminative ability, while the fibrosis-4 index (AUC = 0.562) had the weakest diagnostic performance. Conclusions: Our findings suggest that MASLD in IBD is primarily driven by cardiometabolic dysfunction. The introduction of the METS-IR, LAP, and TG/HDL into clinical assessments of IBD patients could prove useful in preventing liver and cardiovascular complications in this setting.

Background/Objectives: Patients with inflammatory bowel disease (IBD) face an increased risk of developing intestinal and extraintestinal cancers. This retrospective single-center study aimed to quantify cancer risk and identify potential risk factors associated with cancer in IBD patients. Methods: The epidemiological data, disease characteristics, treatment regimens, and occurrences of cancer following IBD diagnosis were collected between January 2021 and February 2022. Hazard ratios (HRs) and standardized incidence ratios (SIRs) were estimated. Results: 560 IBD patients were included; 37 patients developed cancer, with 5 patients developing two distinct cancers, resulting in 42 cancers overall. This translated into a twofold increased risk of developing any cancer compared to the general population (SIR 1.94, 95% CI 1.4-2.6). Colorectal (CRC, 29%), skin (19%), and breast cancer (17%) were the most common malignancies. Female patients showed an increased risk for all cancers (SIR 3.1, 95% CI 2.06-4.3), melanoma (SIR 5.6, 95% CI 1.14-16.2), and CRC (SIR 7.5, 95% CI 3-15.4). Conversely, male patients exhibited a significantly increased risk of lymphoma (SIR 26.2, 95% CI 3.2-95.7). Young age at IBD diagnosis and the use of immunomodulators, whether as monotherapy or in combination with biologics, were associated with an increased risk of cancer. Conclusions: The risk of CRC and lymphoma in IBD patients may be higher than previously reported, potentially due to the increasing use of combination therapy. Cancer risk in IBD should be regularly assessed and personalized throughout the disease course.

Ulcerative colitis (UC) is a chronic inflammatory bowel disease characterized by continuous inflammation of the colon and rectum. Accurate disease assessment is essential for effective treatment, with endoscopic evaluation, particularly the Mayo Endoscopic Score (MES), serving as a key diagnostic tool. However, MES measurement can be subjective and inconsistent, leading to variability in treatment decisions. Deep learning approaches have shown promise in providing more objective and standardized assessments of UC severity.

This study utilized publicly available endoscopic images of UC patients to analyze and compare the performance of state-of-the-art deep neural networks for automated MES classification. Several state-of-the-art architectures were tested to determine the most effective model for grading disease severity. The F1 score, accuracy, recall, and precision were calculated for all models, and statistical analysis was conducted to verify statistically significant differences between the networks.

VGG19 was found to be the best-performing network, achieving a QWK score of 0.876 and a macro-averaged F1 score of 0.7528 across all classes. However, the performance differences among the top-performing models were very small suggesting that selection should depend on specific deployment requirements.

This study demonstrates that multiple state-of-the-art deep neural network architectures could automate UC severity classification. Simpler architectures were found to achieve competitive results with larger models, challenging the assumption that larger networks necessarily provide better clinical outcomes.

Multi-omic and multimodal datasets with detailed clinical annotations offer significant potential to advance our understanding of inflammatory bowel diseases (IBD), refine diagnostics, and enable personalized therapeutic strategies. In this multi-cohort study, we performed an extensive multi-omic and multimodal analysis of 1,002 clinically annotated patients with IBD and non-IBD controls, incorporating whole-exome and RNA sequencing of normal and inflamed gut tissues, serum proteomics, and histopathological assessments from images of H&E-stained tissue sections. Transcriptomic profiles of normal and inflamed tissues revealed distinct site-specific inflammatory signatures in Crohn's disease (CD) and ulcerative colitis (UC). Leveraging serum proteomics, we developed an inflammatory protein severity signature that reflects underlying intestinal molecular inflammation. Furthermore, foundation model-based deep learning accurately predicted histologic disease activity scores from images of H&E-stained intestinal tissue sections, offering a robust tool for clinical evaluation. Our integrative analysis highlights the potential of combining multi-omics and advanced computational approaches to improve our understanding and management of IBD.

Background: Colonoscopy is crucial for diagnosing and monitoring inflammatory bowel disease (IBD), assessing disease activity, and detecting dysplasia. However, patient adherence to surveillance remains suboptimal due to discomfort, anxiety, and concerns about bowel preparation. Methods: This multicenter cross-sectional study assessed patient satisfaction with colonoscopy in IBD patients across three Italian centers. Participants completed pre- and post-examination questionnaires, including the Endoscopy Customer Satisfaction Questionnaire (ECSQ) and Perceived Stress Scale (PSS-10). Clinical factors, bowel preparation methods, and healthcare provider expertise were analyzed. Results: Among 444 enrolled patients, overall satisfaction was high (98.8%) but varied across procedural phases. Higher satisfaction was predicted by expert endoscopists (β = 2.11, p = 0.012), disease remission (β = 1.70, p = 0.020), and frequent endoscopic procedures in the last 24 months (β = 0.46, p = 0.041). Conversely, severe disease activity (β = -3.87, p < 0.001) was associated with lower satisfaction. Deep sedation and high-volume bowel preparation negatively impacted satisfaction. Conclusions: Optimizing bowel preparation, enhancing healthcare provider expertise, and implementing stress-reducing strategies could improve patient adherence to surveillance guidelines in IBD care.

In inflammatory bowel disease, protein misfolding in the endoplasmic reticulum (ER) potentiates epithelial barrier dysfunction and impairs mucosal healing. Tauroursodeoxycholic acid (TUDCA), a naturally occurring bile acid, acts as a chemical chaperone to reduce protein aggregation and colitis severity in preclinical models. We conducted an open label trial evaluating oral TUDCA as therapy in patients with active ulcerative colitis (UC).

Patients with moderate-to-severely active UC (Mayo score ≥6, endoscopic subscore ≥1) received oral TUDCA at 1.75 or 2 g/day for 6 weeks. Exclusion criteria included known hepatic disorders or change in UC therapy within 60 days. Clinical disease activity questionnaires, endoscopy with biopsy, blood, and stool were collected at enrollment and after 6 weeks. The primary outcome measure was change in ER stress markers while safety, tolerability and change in UC disease activity were secondary outcomes.

Thirteen participants completed the study with eleven evaluable for clinical response. TUDCA was well-tolerated with transient dyspepsia being the most common side effect. Mucosal biopsies revealed significant reductions in ER stress and inflammation as well as an increase in markers of epithelial restitution. Clinical, endoscopic, and histologic disease activity were significantly improved at week 6 (mean total Mayo Score: 9 to 4.5, p<0.001).

Six weeks of oral TUDCA treatment was well-tolerated in patients with active ulcerative colitis and promoted mucosal healing, lessened ER stress, and reduced clinical disease activity. A randomized controlled trial of adjunctive TUDCA therapy in patients with UC is warranted.

ClinicalTrials.gov (NCT04114292).

This study aimed to identify sexual satisfaction and related factors in Japanese patients with inflammatory bowel disease, as well as the characteristics of patients who refrained from responding to the sexual satisfaction question.

A questionnaire survey was administered to 499 patients, of whom 492 were available for the analysis. Sexual satisfaction was measured using 5-point scale derived from "I am satisfied with my sex life" item in the Functional Assessment of Chronic Illness Therapy-Fatigue. Patient characteristics (sex, age, marital status, and job status) were collected. Additionally, we obtained data from the scale regarding nonresponse to the sexual satisfaction, sleep deprivation status, emotional well-being, and fatigue subscales, and collected information on disease status from the medical records, including the partial Mayo Score and Crohn's Disease Activity Index.

Regarding sex life satisfaction, the most common response was somewhat (24.8%). There were 173 (35.2%) patients who refrained from answering the sexual satisfaction question. Females and those of older age tended to avoid answering the question. Impaired sexual satisfaction was also significantly associated with older age, sleep deprivation, low emotional well-being subscale scores, and greater effects of fatigue.

Sexual satisfaction is related to chronic conditions in such areas as emotional well-being, fatigue, and sleep deprivation in inflammatory bowel disease patients, even when they are in remission. These results suggest that patients with inflammatory bowel disease are sometimes reluctant to talk about sex. Therefore, it is important for medical staff to consider this issue, especially in Japan.

The burden of inflammatory bowel disease (IBD) is often reported on from a system or cost viewpoint. We created and explored a novel patient-perceived burden of disease (PPBoD) score in a large Australasian cohort.

To create and explore a novel patient-perceived burden of disease (PPBoD) score in a large Australasian cohort, and correlate PPBoD scores with demographics, disease and treatment factors.

The Crohn Colitis Care Registry was interrogated in October 2023. Data from adults with IBD with an outpatient care encounter in the last 14 months among 17 centres were included. A novel PPBoD score was designed for ulcerative colitis (UC), Crohn disease (CD) and IBD-unclassified (IBDU). Correlations between PPBoD scores and demographics, disease and treatment factors were examined.

Of those with adequate data, 46.7% (2653/5685) had no PPBoD, 34.6% (1969/5685) had mild, 11.3% (641/5685) had moderate and 7.4% (422/5685) had significant PPBoD. New Zealanders were more likely to have higher PPBoD compared to Australians (P = 0.047). Greater PPBoD was seen in patients with CD and IBDU compared to patients with UC (P < 0.001) and females were more likely to have significant PPBoD (8.7%) than males (6.1%) (P < 0.001). People with no or mild PPBoD were more likely to be on advanced therapies (55.7% and 59.5% respectively) than those with significant PPBoD (46.3%) (P < 0.001). The proportion of people on advanced therapies in Australia was higher than in New Zealand (61.2% vs 38.5% respectively, P < 0.001). Steroid usage was significantly higher in people with greater PPBoD (significant BoD 7.1% vs no BoD 1.1%; P < 0.001).

Most of this real-world care cohort had no or mild PPBoD. Data suggest that higher PPBoD levels may be resolved by appropriate therapeutic escalations.

Recent studies suggest that subcutaneous infliximab is effective and safe for treating patients with inflammatory bowel disease. Real-world studies with larger cohorts are needed to confirm the efficacy of subcutaneous treatment.

The aim was to assess real-world treatment persistence, clinical outcomes, infliximab concentrations, and treatment safety after switching from intravenous to subcutaneous infliximab treatment with patients with inflammatory bowel disease.

This retrospective register-based study included patients with inflammatory bowel disease who were in clinical remission and switched from intravenous infliximab maintenance therapy to subcutaneous infliximab in two tertiary centers.

A total of 274 patients (104 Crohn's disease and 170 ulcerative colitis) were included. After the switch, the treatment persistence at 12 months was 94.8% in patients with Crohn's disease and 88.8% in patients with ulcerative colitis. Only 11.3% (n = 31) of the patients discontinued the treatment during 79-week median follow-up. Compared to the baseline, no change occurred in clinical disease activity at the time points of 3, 6, and 12 months, based on the Harvey-Bradshaw Index or partial Mayo Score (p = 0.792 and p = 0.426, respectively). Infliximab median concentrations were higher (p < 0.0001) during subcutaneous treatment (16.75 µg/ml) compared to the intravenous treatment median trough levels before the switch (6.71 µg/ml). In total, 15.0% (n = 41) of the patients reported adverse events.

Switching to subcutaneous infliximab maintenance therapy was associated with high treatment persistence, a stable disease course, increased infliximab concentrations, and an acceptable safety profile.

This nationwide retrospective chart review study assessed ustekinumab treatment persistence and clinical outcomes of ustekinumab treatment in Finnish patients with ulcerative colitis in a real-world setting.

Data was collected retrospectively until April 2022 from patient charts for all patients with ulcerative colitis who started ustekinumab between September 2019 and December 2021 in 16 Finnish inflammatory bowel disease centers. The primary outcomes were persistence on ustekinumab and clinical remission/steroid-free clinical remission, defined as partial Mayo score <3 and a combined stool frequency and rectal bleeding subscore of ≤1 at 16 weeks and 1 year.

The study included 221 patients with an average follow-up of 14.7 months and a median disease duration of 5.5 years. Disease status was endoscopically evaluated as severely active in more than 91% of the patients at baseline. Treatment persistence was 87% at 16 weeks and 63% at 1 year. The clinical/steroid-free remission rate was 49%/46% at 16 weeks and 68%/62% at 52 weeks, respectively. Decreases in fecal calprotectin and partial Mayo scores were observed. Concomitant corticosteroid use decreased from 60% at baseline to 28% at 16 weeks and to 16% at 1 year during ustekinumab maintenance therapy. Antibodies to ustekinumab were detected in very few patients (<5, <21%), and discontinuation was observed due to adverse effects even less frequently (<5, <6%).

This real-world study demonstrated that ustekinumab has sustained efficacy in the treatment of ulcerative colitis in a real-world setting.

Ulcerative proctitis (UP) is a limited form of ulcerative colitis. While achieving endoscopic healing (EH) in ulcerative colitis improves long-term outcomes, the benefit of EH in UP is uncertain. This study aimed to assess the impact of EH on outcomes in UP.

This single-center retrospective study included adults with UP and ≥2 endoscopies, with active inflammation (Mayo endoscopic score [MES] 1-3) at index. EH was defined as MES 0-1 at follow-up procedure. The relationship of EH to inflammatory bowel disease (IBD)-related outcomes was assessed using univariate analysis and multivariable logistic regression assessed the effect of EH on IBD-related outcomes.

Among 200 UP patients, 109 (54.5%) had EH at follow-up endoscopy at median 19 months (interquartile range: 7, 32). EH was associated with fewer IBD-related emergency department (ED) visits (EH: 8.3%, no EH: 21%, P = .01), hospitalizations (5.5% vs 18%), and GI visits (mean: 1.47/year [SD: 1.40], vs 2.96/year [2.52], P < .001). Patients with EH were less likely to have iron deficiency anemia (23% vs 41%, P = .007), Clostridioides difficile (0.9% vs 6.6%, P = .048), or initiate new biologic therapy after relapse (15% vs 33%, P = .034). Patients with EH had a greater time to clinical relapse (21 [24] vs 9 months [14]; P = .006) and lower odds of an IBD-related ED visit (OR: 0.32, 95% CI: 0.13, 0.73) or hospitalization (0.26 [0.09, 0.67]). Baseline presence of a cecal patch did not impact outcomes.

UP patients with EH had less IBD-related healthcare utilization, fewer IBD-related complications, and were less likely to escalate therapy after relapse than patients without EH. Using a treatment target of EH may therefore be desirable in UP.

Inflammatory bowel disease (IBD), including ulcerative colitis (UC) and Crohn's disease (CD), consists of chronic gastrointestinal inflammation, with nutrition playing a significant role in its development. IBD patients often face dietary challenges affecting their quality of life (QoL), yet research on food-related QoL (FR-QoL) and sex-specific differences is limited. It was hypothesized that dietary patterns and choices impact food-related quality of life in IBD and that these effects vary by sex. The objective of this analysis was, therefore, to evaluate the impact of diet on food-related quality of life for men and women with IBD, respectively.

A monocentric, cross-sectional study at a tertiary referral center analyzed the food-related quality of life in 117 women and 116 men with IBD, with a particular focus on dietary choices and patterns. To achieve this, multiple assessment tools, including the German version of the IBD-specific Questionnaire for Food-Related Quality of Life (FR-QoL-29-German) and a validated Food Frequency Questionnaire (FFQ) for dietary behavior, were used. Clinical indices (Harvey-Bradshaw Index (HBI); Partial Mayo Score (PMS)) and biochemical markers (C-reactive protein; fecal calprotectin) were evaluated.

The FR-QoL-29-German sum score differed significantly between the sexes (p = 0.034; g = -0.3), with men showing a higher mean score. Distinct dietary patterns showed little correlation with FR-QoL for both sexes, except for a significant inverse correlation between FR-QoL and sQ-HPF scores for men (p = 0.021; r = -0.214) but not for women (p = 0.897; r = -0.012). In a logistic regression analysis that was adjusted for confounding, the impact of IBD-specific and diet-related factors on FR-QoL was assessed, and disease entity was identified as a significant influencing factor for men but not for women. In women, older age and lower body weight were associated with higher FR-QoL.

The findings of this study indicate that dietary choices and patterns do not exhibit uniform associations with IBD-related quality of life. In addition, sex differences have been identified as a substantial factor in IBD food-related quality of life.

Crohn's disease (CD) and ulcerative colitis (UC) are chronic inflammatory bowel diseases (IBD) that have a negative impact on patient quality of life (QOL).

To evaluate QOL, work productivity, use of healthcare resources, and medical costs in patients with IBD from the RISE-MX trial.

RISE-MX was a non-interventional, multicentric, cross-sectional, retrospective study conducted in a Mexican population with IBD.

The 36-item Short Form Health Survey (SF-36) and the Inflammatory Bowel Disease Questionnaire (IBDQ) were used to assess QOL. The burden of disease was analyzed using the Work Productivity and Activity Impairment Questionnaire (WPAI), healthcare resources use, and medical costs.

Of 326 subjects, 95 (29.1%) had CD, and 231 (70.8%) had UC. In patients with CD, 43 patients (45.3%) showed moderate-to-severe activity, and 42 (18.1%) had moderate-to-severe disease activity in patients with UC. In all SF-36 dimensions, a significant difference between moderate-to-severe and mild activity/in remission groups was observed in patients with UC, while in patients with CD, the difference between activity groups was significant only for physical functioning and social functioning dimensions. In patients with CD, a higher but non-significant IBDQ score difference between activity groups was observed while a statistical difference between activity groups was observed for all dimensions in UC patients. In WPAI, the total percentage for work impairment (absenteeism plus presenteeism) and the percentage of regular daily activity impairment were statistically significant between activity groups only for UC. The annual total costs (direct and indirect) per patient in CD were USD 19,757 (moderate-to-severe activity group) and USD 12,587 (mild activity/in remission group), while in patients with UC were USD 11,702 and USD 9144, respectively.

Moderate-to-severe activity of disease was associated with a substantial impact on QOL, work productivity, and medical costs in Mexican patients with IBD. Total costs were higher for patients with CD than for patients with UC.

Mitochondrial dysfunction is increasingly recognized as a shared feature of Alzheimer's disease (AD) and inflammatory bowel disease (IBD), linked through overlapping pathways of hypoxia and immune dysregulation. Our study integrated transcriptomic and genetic analyses to uncover mitochondria-related mechanisms underlying these diseases. By analyzing multiple AD and IBD datasets through differential expression gene (DEG) analyses, biological pathway enrichment, and co-expression module construction, we identified hypoxia-induced mitochondrial dysfunction as a central risk factor for both conditions. Key findings revealed several mitochondrial-related genes shared between AD and IBD, including BCL6, PFKFB3, NDUFS3, and COX5B, which serve as critical regulators bridging mitochondrial and immune pathways. Drug enrichment analyses using Drug Signatures Database (DsigDB) and the Connectivity Map (cMAP) identified promising therapeutic candidates, including decitabine, DMOG, and estradiol, targeting shared regulators such as BCL6, PFKFB3, MAFF, and TGFBI. These drugs demonstrated potential to modulate mitochondrial autophagy and oxidative phosphorylation (OXPHOS), pathways enriched in the constructed interaction network with BCL6 and PFKFB3 as central nodes. Mendelian randomization (MR) analysis further identified MAP1LC3A as significantly associated with increased risk for both AD and IBD, while NME1 emerged as strongly protective, suggesting their roles as therapeutic targets. Our findings underscore hypoxia-induced mitochondrial dysfunction as a unifying mechanism in AD and IBD, mediated by hypoxia-inducible factor-1α (HIF-1α). By identifying key mitochondria-associated genes and pathways, this study highlights innovative therapeutic targets and contributes to a deeper understanding of the gut-brain interplay in neurodegeneration and chronic inflammation. These insights pave the way for precision medicine strategies targeting mitochondrial dysfunction in AD and IBD.

Vedolizumab (VDZ), a novel biologic targeting α4β7 integrin, is safe and effective for the treatment of patients with ulcerative colitis (UC). The objective of this study was to compare the potential of the Platelet-to-lymphocyte ratio (PLR), neutrophil-to-lymphocyte ratio (NLR), and systemic immune-inflammation index (SII) in predicting clinical remission and treatment failure in patients with moderate-to-severe UC on VDZ therapy and to explore the risk factors for treatment failure.

Seventy-four UC patients treated with VDZ at our institution between December 1, 2020, and October 1, 2023, who had medical records were included in this study. We retrospectively collected baseline NLR, PLR, and SII values and assessed the predictive ability of the three indices for clinical remission and treatment failure using the receiver operating characteristic (ROC) curves.

Patients in the severe group (n = 47) had significantly higher baseline PLR and SII values than those in the moderate group (n = 27) (p < 0.05). Patients with MES3 had significantly higher PLR and SII values than patients with MES2 (p < 0.05). At 14 weeks after VDZ treatment, 28 patients obtained steroid-free clinical remission, whereas 46 did not. The area under the ROC curve (AUC) for SII was 0.659 for predicting clinical remission and exhibited the best predictive ability. Of the 52 patients who achieved long-term remission, 35 patients responded consistently to VDZ, whereas 17 patients experienced disease relapse. The SII, with an AUC of 0.793, showed the best predictive ability (sensitivity: 94.1%; specificity: 57.1%; cut-off value: 602.0). Cox regression analysis revealed that SII ≥602.0, was a potential predictor of relapse after VDZ treatment in UC patients (p = 0.048, hazard ratio: 8.651; 95% confidence interval: 1.017-73.593).

The SII performed better than NLR and PLR in predicting clinical remission and relapse for UC patients on VDZ therapy. Moreover, patients with high SII may relapse after VDZ treatment and should be treated with caution.

Background/Objectives: In the current era of tailored therapy, biologics such as vedolizumab (VDZ) and ustekinumab (UST) are increasingly administered to inflammatory bowel disease (IBD) patients. The decision to discontinue biologics after side effects or a lack of response is usually simple, but the decision to stop treatment in patients in remission is more difficult: to date, no study has been conducted to investigate the effects of VDZ or UST withdrawal. Our study aims to investigate the rates and predictors of relapse of IBD after the discontinuation of VDZ and UST during a well-controlled disease phase and to evaluate the response to retreatment. Methods: In this observational, multicenter, retrospective study, we included IBD patients who discontinued VDZ or UST during a well-controlled disease phase after at least 1 year of treatment. We collected demographic and clinical data for each patient at the time of discontinuation and at follow-up visits. Results: We included 36 IBD patients from 5 different centers; 80.0%, 58.5%, and 48.3% of patients maintained clinical remission at 12, 24, and 48 months after discontinuation, respectively. Crohn's disease (CD) patients were more likely to maintain remission than ulcerative colitis (UC) patients at 48 months (70.0% vs. 40.0%). No predictors of relapse were identified, but UC patients had a higher risk of early relapse than CD patients (HR = 3.23); 81.3% of retreated IBD patients achieved clinical remission after induction and at 12 months. Conclusions: No predictors of disease relapse after treatment discontinuation were identified. Half of the patients had a relapse within 48 months after discontinuation, but most of them achieved clinical remission after retreatment.

Ulcerative colitis (UC) is a chronic disease characterized by periods of inflammatory activity and remission, which vary from the rectum to the proximal colon. Currently, mucosal healing is a long-term goal in the management of inflammatory bowel disease, with colonoscopy and sigmoidoscopy being the recommended tools for evaluation.

To assess the effectiveness of both examinations in determining the presence of inflammatory activity in the follow-up of patients with UC.

Retrospective observational study analyzing colonoscopies performed as part of the follow-up of UC patients between January 2021 and July 2023 by gastroenterologists from the Inflammatory Bowel Disease Program at the Clínica Universidad de los Andes. The study compared endoscopic and histological activity observed in the rectosigmoid region with that found in the rest of the colon. Sensitivity and specificity were determined using concordance and correlations tests.

A very good concordance and correlation were observed regarding endoscopic findings, with a Kappa index of 0.97 and a Spearman coefficient of 0.97. The Positive Predictive Value (PPV) of sigmoidoscopy for endoscopic activity was 1, and the Negative Predictive Value (NPV) was 0.96. In relation to histological activity, the concordance had a Kappa index of 0.93 and a Spearman coefficient of 0.93, with a PPV of sigmoidoscopy for histological activity being 1 and an NPV of 0.91.

This cohort suggests that sigmoidoscopy is a cost-effective option for evaluating mucosal healing in UC patients in symptomatic and biomarker remission. However, complete colonoscopy should be considered in cases of discrepancies with the clinical picture or in colorectal cancer surveillance.

The performance of endoscopic evaluation of ulcerative colitis (UC) using conventional scoring, including Mayo endoscopic subscore (MES) and ulcerative colitis endoscopic index of severity (UCEIS), is not satisfactory. Recently, the usefulness of novel image-enhanced endoscopy (IEE) such as texture and color enhancement imaging (TXI) and red dichromatic imaging (RDI) has been reported in the endoscopic evaluation of UC. We evaluated the performance of IEEs in UC, particularly focusing on the correlation with MES and UCEIS, and prediction of relapse.

This is a prospective, observational study. UC patients in clinical remission who underwent colonoscopy with evaluation of IEEs and follow-up for > 3 months were analyzed. TXI and RDI were evaluated using the previously reported scoring system (TXI 0-2 and RDI 1-4). The IEE scores were compared with the conventional scoring, fecal calprotectin levels, and histological findings using Geboes score, and patient's clinical relapse rate stratified by each IEE score was examined.

Both TXI and RDI scores were well-correlated with MES and UCEIS (both p < 0.001), fecal calprotectin levels (p = 0.015 and p = 0.006), and histology evaluated with Geboes score. In the Geboes subscore, the subscore 2B (neutrophil infiltration in lamina propria) was the most correlated with each endoscopic scoring. RDI 3-4 was significantly correlated with subsequent relapse (hazard ratio 3.56, 95% confidence interval 1.13-11.24), but TXI scoring did not predict relapse significantly.

The assessment using RDI could be a convenient and useful endoscopic evaluation method for predicting the prognosis of UC.

Ulcerative colitis (UC) is a chronic inflammatory bowel disease (IBD) characterised by episodes of symptoms including rectal bleeding, increased stool frequency and abdominal pain, impacting quality of life significantly. Conventional treatments often come with potential side effects and may not be sufficient. Acupuncture is increasingly recognised for its potential benefits in UC. This study aims to assess the efficacy and safety of acupuncture for symptom relief in mild to moderate UC.

This single-centre, parallel-arm, randomised, sham-controlled, the two-step acupuncture (TSA)-UC trial, will involve 64 adults with mild to moderate UC, randomly assigned in a 1:1 ratio to either the acupuncture or sham acupuncture group. Participants will receive 20 sessions of two-step acupuncture or sham acupuncture therapy over 8 weeks. Blinding will be applied to participants, outcome assessors and statisticians. The primary outcome measure is the change in Patient-Reported Outcome 2 (PRO2) from baseline at week 8. Secondary outcomes include changes from baseline in the following scales: PRO2 at other time points, weekly average Numeric Rating Scale (NRS) for bowel urgency, weekly average NRS for abdominal pain (both associated and not associated with bowel movement), the 32-item Inflammatory Bowel Disease Questionnaire, Work Productivity and Activity Impairment Questionnaire-IBD, Pittsburgh Sleep Quality Index and Hospital Anxiety and Depression Scale. The Patient Global Impression of Change will also be assessed. Long-term effects of acupuncture will be explored. Adverse events and additional treatments will be monitored throughout the study. The modified intention-to-treat population including participants who complete baseline assessments and receive at least one treatment session will be analysed.

The study has received ethical approval from the Ethics Committee of Guang'anmen Hospital, China Academy of Chinese Medical Sciences (2024-190-KY). The results will be published in a peer-reviewed medical journal.

NCT06615765.

Disease activity scores are efficacy endpoints in clinical trials of inflammatory bowel disease (IBD) therapies. Crohn's disease activity index (CDAI), Mayo endoscopic score (MES) and Mayo score are frequently used in clinical trials. They rely on either the physician's observation of the inflammatory state of the patient's gastrointestinal tissue alone or combined with the patient's subjective evaluation of general wellbeing. Given the importance of these scores in evaluating the efficacy of drug treatment and disease severity, there has been interest in developing a computational approach to reliably predict these scores. A promising approach is using mechanistic models such as quantitative systems pharmacology (QSP) which simulate the mechanisms of the disease and its modulation by the drug pharmacology. However, extending QSP model simulations to clinical score predictions has been challenging due to the limited availability of gut biopsy measurements and the subjective nature of some of the evaluation criteria for these scores that cannot be described using mechanistic relationships. In this perspective, we examine details of IBD disease activity scores and current progress in building predictive models for these scores (such as biomarkers for disease activity). Then, we propose a method to leverage simulated markers of inflammation from a QSP model to predict IBD clinical scores using a machine learning algorithm. We will demonstrate how this combined approach can be used to (1) explore mechanistic insights underlying clinical observations; and (2) simulate novel therapeutic strategies that could potentially improve clinical outcomes.

Ulcerative colitis (UC) is an inflammatory bowel disease in which one-quarter of patients are at risk of developing a severe form of the disease known as acute severe UC (ASUC). This condition exposes patients to serious complications, including toxic megacolon, surgical intervention, and even death. The current therapeutic strategy relies on time-dependent, multi-step algorithms that integrate systemic corticosteroids, calcineurin inhibitors, and biologic agents (specifically infliximab) as medical therapy aimed at avoiding colectomy. Despite this approach, a significant proportion of patients fail to respond to either corticosteroids or infliximab and may require alternative therapeutic options if there is no urgent surgical necessity. These alternatives include other biologics or emerging small molecules, although the evidence supporting these treatments remains extremely low, even considering their well-documented and promising efficacy and safety in moderate-to-severe UC. Conversely, it is necessary to investigate whether infliximab can be effectively replaced or surpassed by other approved biological agents and small molecules as first-line therapy after steroid resistance. This review aims to summarise the available evidence on small molecules, specifically Janus kinase inhibitors and sphingosine-1-phosphate receptor modulators.

Inflammatory bowel disease (IBD) is characterized by periods of remission and relapses, and treatment is based on phenotype, risk factors, and disease severity. Treatments include 5-aminosalicylates (5-ASA), thiopurines, methotrexate, calcineurin inhibitors, corticosteroids (CS), biological therapy (BxT), and, more recently, small molecules.

To determine the baseline demographics and clinical characteristics, treatment patterns, and disease status of patients in Mexico with a history of moderate/severe IBD returning for hospital follow-up (Index Day).

This was a non-interventional, cross-sectional study.

Socio-demographics, clinical characteristics, and prescribed treatments were collected from a retrospective review (3 years) of each patient's medical records.

A total of 326 patients with a diagnosis of moderate/severe IBD at least 6 months before the Index Day were included in the analysis: 95 patients (29.2%) had Crohn's disease (CD) and 231 (70.9%) ulcerative colitis (UC). In the CD group, 45.3% (n = 43) had a Harvey Bradshaw Index score ⩾8 or Crohn's Disease Activity Index ⩾220; 10 patients had a B1-non-stenosing, non-penetrating phenotype and 17 had stenosis (B2). In the UC group, 18.2% (n = 42) had moderate/severe disease and the most frequent presentation was pancolitis (n = 56). Regarding treatment over the previous 3 years: for CD, 62 (65.3%) received CS and 20.0% (n = 19) were CS-dependent; 30.5% received 5-ASA + IMS; 27.4% BxT + IMS; and 38.9% 5-ASA + IMS + BxT. In the case of UC, 74.9% (n = 173) received CS and 32.9% (n = 76) were CS-dependent; 64.5% received 5-ASA + IMS; 2.2% BxT + IMS; and 31.6% 5-ASA + IMS + BxT.

In Mexico, 45.3% of CD patients and 18.1% with UC presented with moderate/severe disease activity. Conventional therapy was used to treat the majority of patients, and the availability of more advanced therapies and a personalized treatment approach is needed to improve clinical outcomes in the future.