Hsu-Heng Yen

Background: Real-world data on ustekinumab (UST) in Asian inflammatory bowel disease (IBD) populations remain limited. The T-RUST (Taiwan Multicenter Real-world Ustekinumab Study) study evaluated the effectiveness, durability, and safety of UST in patients with Crohn’s disease (CD) and ulcerative colitis (UC). Methods: This retrospective multicenter study utilized data from the Taiwan Association for the Study of Intestinal Diseases IBD Registry between September 2019 and April 2025. Patients with CD or UC treated with UST were evaluated for clinical response and remission at weeks 4, 8, and 52. Subgroup analyses examined drug persistence according to biologic treatment history (biologic naive vs biologic experienced), prior advanced therapies, and difficult-to-treat IBD status. Fistula closure, endoscopic, radiologic, and histological remission, as well as safety outcomes, were assessed. Results: A total of 379 patients were included, comprising 301 (79.4%) with CD and 78 (20.6%) with UC. Among patients with available week 52 data, clinical response was achieved in 183 (90.1%) of 203 CD patients and 40 (97.6%) of 41 UC patients. Corresponding clinical remission was achieved in 172 (84.7%) of 203 and 37 (90.2%) of 41 patients, respectively. Fistula closure was achieved in 17 (45.9%) of 37 patients with active fistulizing CD, including 10 (45.5%) of 22 patients with perianal fistulas. One-year UST persistence exceeded 80% in both cohorts, with persistence observed in 273 (91.0%) of 300 CD patients and 67 (85.9%) of 78 UC patients. UST was generally well tolerated, with no new safety signals identified. Conclusions: UST demonstrated sustained effectiveness, meaningful fistula healing, and a favorable safety profile in this real-world IBD cohort. These findings support its role as a durable and well-tolerated therapeutic option in Asian clinical practice.

Background: Gallbladder (GB) abnormalities are frequently observed in critically ill patients, but their clinical relevance remains uncertain. This study aimed to evaluate the prevalence of GB abnormalities and their association with clinical outcomes in patients admitted to a medical intensive care unit (ICU). Methods: We conducted a retrospective study of adult patients admitted to the medical ICU of Changhua Christian Hospital from February to September 2023 who underwent abdominal ultrasound. Patients with prior cholecystectomy or diagnosed acute cholecystitis were excluded. Clinical variables, ultrasound findings, and 30-day outcomes were analyzed. Results: A total of 59 patients were included (mean age 68.9 ± 14.7 years; 69.5% male). GB abnormalities were identified in 33 patients (55.9%), with wall thickening (35.6%) and pericholecystic fluid (30.5%) being most common. GB abnormalities were significantly associated with lower serum albumin (2.8 ± 0.5 vs. 3.3 ± 0.8 g/dL, P = 0.018) and prolonged nil per os status ( P = 0.002), but not with age, sex, acute physiology and chronic health evaluation II score, or 30-day mortality ( P = 0.980). Sludge was more frequent in patients with ICU stays ≥48 h (30.0% vs. 5.1%, P = 0.008). Conclusion: GB abnormalities are common among medical ICU patients and are associated with hypoalbuminemia and prolonged fasting, but not with increased short-term mortality. These findings may help guide clinical management and avoid unnecessary interventions.

Background: Biologic safety during pregnancy in patients with inflammatory bowel disease (IBD) remains a clinical concern, particularly with the increasing use of novel agents such as ustekinumab (UST) and vedolizumab (VDZ). Objectives: A network meta-analysis (NMA) was performed to compare pregnancy-related outcomes among various biological agents and nonbiologic-exposed patients. Design: Systematic review and frequentist random-effects NMA of comparative observational studies. Data Sources and Methods: This study systematically searched from inception to 23 March 2025 for comparative studies reporting pregnancy outcomes in biologics or conventional therapies (CT)-exposed patients with IBD. Outcomes included preterm birth, congenital malformation (CM), low birth weight (LBW), and spontaneous abortion. An NMA model was applied. Subgroup analysis was conducted for studies with comparable baseline disease activity between the treatment groups. Results: This NMA included 12 studies. Anti-tumor necrosis factor alpha (TNF-α) agents were not associated with an increased risk of any adverse pregnancy outcomes. UST and VDZ were associated with increased CM risks (UST: odds ratio [OR]: 2.32 [1.31–4.10]; VDZ: OR: 1.98 [1.11–3.52]), and VDZ was associated with LBW (OR: 2.17 [1.15–4.11]). These associations were not significant in the subgroup analyses limited to studies with similar disease activity. Sensitivity analysis revealed that a single important study influenced the CM risk of UST/VDZ, whereas the LBW risk with VDZ remained consistent. Conclusions: This is the first NMA to comprehensively assess the pregnancy-related safety of biologic therapies, including the novel biologics VDZ and UST, in patients with IBD. Anti-TNF agents have the most robust pregnancy safety evidence and were not associated with an increased risk of adverse pregnancy outcomes in this analysis. The findings for UST and VDZ should be framed as exploratory and potentially affected by residual confounding, as the observed risk signals were not consistently maintained in the additional analyses. Registration: INPLASY202540012.

A subset of patients with inflammatory bowel disease (IBD) remains refractory to treatment despite multiple lines of advanced therapies. These patients are often categorized as having difficult-to-treat (DTT) IBD. We retrospectively analyzed 354 patients with IBD (including 112 with Crohn’s disease [CD] and 242 with ulcerative colitis [UC]) from a real-world cohort. Baseline demographic and disease characteristics, treatment history, and outcomes were compared between the DTT-IBD and non-DTT-IBD groups. Logistic regression analysis was performed to identify factors associated with DTT-IBD in CD and UC cohorts. Approximately 10.6% of the patients exposed to advanced therapy fulfilled the definition of DTT-IBD (CD: 9.8%, UC: 11.4%). Compared with patients with non-DTT-IBD, those with DTT-IBD exhibited a significantly higher exposure to multiple biologic classes, including antitumor necrosis factor (94.1% vs. 59.0%), anti-integrin (94.1% vs. 47.2%), anti-interleukin-12/23 (88.2% vs. 19.4%), and Janus kinase inhibitors (35.3% vs. 0.7%). The DTT-IBD group had a significantly lower clinical remission rate at the last follow-up than the non-DTT-IBD group (52.9% vs. 85.4%, p = 0.001). A longer interval from diagnosis to the initiation of advanced therapy was independently associated with DTT-IBD in CD (OR: 1.014 per month, 95% CI: 1.001–1.026, p = 0.026). No significant predictors for UC were identified. In conclusion, DTT-IBD, characterized by extensive biologic exposure and suboptimal long-term remission rates, accounts for approximately 10% of patients with IBD receiving advanced therapy. In CD, delayed initiation of advanced therapy may contribute to refractoriness. These findings emphasize the unmet need for earlier therapeutic intervention, better predictive markers of treatment response, and novel therapeutic mechanisms.

Background: Colonoscopy plays a vital role in assessing disease activity in ulcerative colitis (UC), and biopsy via colonoscopy helps to evaluate its histological activity. Endoscopists must report the endoscopic activity and rely on the biopsy results to predict the histological activity. Methods: We aimed to develop a deep learning-based algorithm to evaluate the disease and histological activities of UC based on white-light endoscopic images obtained during the procedure in this research. A deep learning system for classifying the colonoscopic images for assessing the endoscopic and histological activities of UC patients was developed. Its performance was evaluated with an independent dataset. The system was utilized to analyze the captured video segments, and the results were compared with those of human endoscopists. Results: A total of 375 video segments from 82 patients were utilized to develop the endoscopic and histological activity prediction assurance algorithm. Among the 375 video segments, 60%, 20%, and 20% were used for training, validation, and testing the proposed vision transformer (ViT) model, respectively. Moreover, four senior and six young endoscopists reviewed and scored the endoscopic and histological activities based on 77 testing video clips. The accuracies were 77.92%, 71.00%, and 83.12% for histological healing; and 74.35%, 72.51%, and 92.21% for complete mucosal healing (Mayo Endoscopic Score 0 vs 1–3), among senior endoscopists, junior endoscopists, and the ViT model, respectively. Conclusions: Our novel deep learning-based model, based on endoscopic videos, was comparable to that of experienced endoscopists and surpassed that of young endoscopists in predicting histological remission and complete mucosal healing.

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