Background and Aims: In patients with non-severe acute or chronic autoimmune hepatitis (AIH) without cirrhosis, clinical practice guidelines recommend indistinct use of prednisone or budesonide. However, budesonide is infrequently used in clinical practice. We aimed to describe its use and compare its efficacy and safety with prednisone as first-line options. Approach and Results: This was a retrospective, multicenter study of 105 naive AIH patients treated with budesonide as the first-line drug. The control group included 276 patients treated with prednisone. Efficacy was assessed using logistic regression and validated using inverse probability of treatment weighting propensity score. The median time to biochemical response (BR) was 3.1 months in patients treated with budesonide and 4.9 months in those with prednisone. The BR rate was significantly higher in patients treated with prednisone (87% vs. 49% of patients with budesonide, p < 0.001). The probability of achieving BR, assessed using the inverse probability of treatment weighting propensity score, was significantly lower in the budesonide group (OR = 0.20; 95% CI: 0.11–0.38) at any time during follow-up, and at 6 (OR = 0.51; 95% CI: 0.29–0.89) and 12 months after starting treatment (0.41; 95% CI: 0.23–0.73). In patients with transaminases <2 × upper limit of normal, BR was similar in both treatment groups. Prednisone treatment was significantly associated with a higher risk of adverse events (24.2% vs. 15.9%, p = 0.047). Conclusions: In the real-life setting, the use of budesonide as first-line treatment is low, and it is generally prescribed to patients with perceived less disease activity. Budesonide was inferior to prednisone as a first-line drug but was associated with fewer side effects.

Background and Aims: Immunotherapy-based regimes have changed the management of HCC. However, evidence of efficacy in patients with impaired liver function is unknown. This systematic review and meta-analysis assesses survival of HCC patients and liver dysfunction treated with immunotherapy-based regimens. Methods: Systematic review and meta-analysis of original articles or abstracts reporting survival of HCC patients treated with immunotherapy according to liver function between 2017 and 2022. Overal survival (OS) according to restricted mean survival time (RMST) and median OS, and hazard ratio (HR) of Child-Pugh B or B/C versus Child-Pugh A were assessed while considering the line of treatment. Results: Of the 2218 articles considered, 15 articles recruiting 2311 patients were included. Of these, 639 (27.7%) were Child-Pugh B and 34 (1.5%) C. RMST was 8.36 (95% CI, 6.15–10.57; I ²=93%) months, estimated from 8 studies. The HR was reported in 8 studies for survival between Child-Pugh B versus Child-Pugh A and metanalysis disclosed a 1.65 HR (95% CI,1.45–1.84; I ²=0% heterogeneity; p = 0.45). Treatment line data were available for 47% of the patients and 3 studies included patients treated with atezolizumab-bevacizumab in the first line. Conclusions: The high heterogeneity across studies reflects the incapacity of the current evidence to support the indication of immunotherapy in HCC patients with relevant liver dysfunction. It is mandatory to report complementary information to Child-Pugh classification such as prior liver decompensation, use of concomitant medication to control ascites, or signs of clinically significant portal hypertension to allow better patient stratification in future studies.

Background: The impact of biologics on the risk of postoperative complications (PC) in inflammatory bowel disease (IBD) is still an ongoing debate. This lack of evidence is more relevant for ustekinumab and vedolizumab. Aims: To evaluate the impact of biologics on the risk of PC. Methods: A retrospective study was performed in 37 centres. Patients treated with biologics within 12 weeks before surgery were considered “exposed”. The impact of the exposure on the risk of 30-day PC and the risk of infections was assessed by logistic regression and propensity score-matched analysis. Results: A total of 1535 surgeries were performed on 1370 patients. Of them, 711 surgeries were conducted in the exposed cohort (584 anti-TNF, 58 vedolizumab and 69 ustekinumab). In the multivariate analysis, male gender (OR: 1.5; 95% CI: 1.2–2.0), urgent surgery (OR: 1.6; 95% CI: 1.2–2.2), laparotomy approach (OR: 1.5; 95% CI: 1.1–1.9) and severe anaemia (OR: 1.8; 95% CI: 1.3–2.6) had higher risk of PC, while academic hospitals had significantly lower risk. Exposure to biologics (either anti-TNF, vedolizumab or ustekinumab) did not increase the risk of PC (OR: 1.2; 95% CI: 0.97–1.58), although it could be a risk factor for postoperative infections (OR 1.5; 95% CI: 1.03–2.27). Conclusions: Preoperative administration of biologics does not seem to be a risk factor for overall PC, although it may be so for postoperative infections.

Background Antireflux mucosal ablation (ARMA) is a novel endoscopic technique for gastroesophageal reflux disease (GERD) but has only been assessed in noncontrolled studies. The objective of this randomized controlled study was to evaluate its efficacy in patients with proton pump inhibitor (PPI)-responsive GERD. Methods We conducted a double-blind, sham endoscopy-controlled, randomized trial across 12 Spanish hospitals. Adults with PPI-responsive GERD and abnormal esophageal acid exposure time (AET > 6 %) were randomly assigned (1:1) to receive ARMA or sham endoscopy. The primary outcome was clinical success at 12 months, defined as a ≥ 50 % reduction in the GERD-Health-Related Quality of Life score. Inability to discontinue PPIs to allow symptom assessment was considered treatment failure. Secondary outcomes included PPI discontinuation, AET, manometric parameters, mucosal healing, and adverse events. Results Of 186 patients screened, 60 were included (ARMA 31; sham 29). At 12 months, clinical success was achieved in 16 patients (51.6 %) in the ARMA group and in 11 (37.9 %) in the sham group (P = 0.29; risk ratio 1.36, 95 %CI 0.76 to 2.42). No significant differences were observed in PPI discontinuation, AET, manometric findings, or mucosal healing. Postprocedural pain (27.3 % vs. 3.3 %) and dysphagia (45.5 % vs. 10.0 %) occurred more frequently in the ARMA group. No severe adverse events were recorded. Conclusions ARMA was not superior to sham endoscopy in improving GERD-related quality of life at 12 months in patients with PPI-responsive GERD, and was associated with a higher incidence of adverse events. These findings do not support its implementation in routine clinical practice.

INTRODUCTION: Esophageal motility disorders (EMDs) are common in clinical practice, with a high symptomatic burden and significant impact on the patients' quality of life. High-resolution esophageal manometry (HREM) is the gold standard for the evaluation of functional esophageal disorders. The Chicago Classification offers a standardized approach to HREM. However, HREM remains a complex procedure, both in data analysis and in accessibility. This study aimed to develop and validate machine learning (ML) models to detect EMDs according to the Chicago Classification. METHODS: We retrospectively analyzed 618 HREM examinations from 3 centers (Spain and the United States) using 2 recording systems. Labels were assigned by expert consensus as either disorder present or absent for 2 categories: esophagogastric junction outflow disorders and peristalsis disorders. Several ML models were trained and evaluated. ML classifiers were developed using an 80/20 patient-level stratified split for training/validation and testing. Model selection was guided by internal evaluation through repeated 10-fold cross-validation. Model performance was assessed by accuracy and area under the receiver-operating characteristic curve (AUC-ROC). RESULTS: The GradientBoostingClassifier model outperformed the remaining ML models with an accuracy of 0.942 ± 0.015 and an AUC-ROC of 0.921 ± 0.041 for identifying disorders of esophagogastric junction outflow. The xGBClassifier model detected disorders of peristalsis with an accuracy of 0.809 ± 0.029 and an AUC-ROC of 0.871 ± 0.027. Performance was consistent across repeated validations, demonstrating model robustness and generalization. DISCUSSION: This multicenter, multidevice study demonstrates that ML models can accurately detect EMDs in HREM. Artificial intelligence-driven HREM may improve diagnosis by standardizing interpretation and reducing interobserver variability.