Background/Aims: Current literature is lacking in studies comparing the incidence of adverse events (AEs) in patients with inflammatory bowel diseases (IBD) treated with adalimumab (ADA) or vedolizumab (VDZ) in a real-life scenario. Therefore, our primary aim was to compare the AEs occurring in patients taking ADA to those of patients taking VDZ. Methods: In this single center study, data on AEs from IBD patients who underwent treatment with ADA and VDZ were retrospectively collected. AE rates per 100 person-years were calculated. A Cox regression model was used to estimate the hazard ratios of the AEs between the 2 drugs. Results: A total of 16 ADA patients (17.2%) and 11 VDZ patients (7.6%) had AEs causing drug interruption during the study period (P=0.02). Most of the AEs were noninfectious extraintestinal events (50% in ADA and 54.5% in VDZ) while infections accounted for 31.2% of the AEs in patients treated with ADA and 27.3% in those treated with VDZ. The incidence rate of AEs causing withdrawal of therapy was 13.2 per 100 person-years for ADA and 5.3 per 100 person-years for VDZ, corresponding to a 76% lower risk in patients in VDZ. Considering the first year of treatment, we observed 34 subjects treated with ADA (36.5%) having at least 1 AEs and 57 (39.3%) among those taking VDZ (P=0.67). Conclusions: VDZ has a lower incidence rate of AEs causing withdrawal of treatment compared to ADA but a similar risk of AEs not causing drug interruption. Real-life head-to-head studies are still necessary to further explore the safety profile of these drugs.

Background: Ustekinumab (UST) has demonstrated effectiveness in treating patients with Crohn’s disease. Monitoring treatment response can improve disease management and reduce healthcare costs. We investigated whether UST trough levels (TLs), serum IL22, and Oncostatin M (OSM) levels could be early indicators of non-response by analysing their correlation with clinical and biochemical outcomes in CD. Methods: Patients with CD initiating UST treatment from October 2018 to September 2020 were enrolled at six Italian centres for inflammatory bowel disease (IBD). Clinical and biochemical data were collected at four time points: baseline, second subcutaneous (SC) dose, fourth SC dose, and 52 weeks. TLs were measured during maintenance, at the second SC dose, and at the fourth SC dose. IL-22 and OSM serum levels were assessed at baseline and the second SC dose. We analysed whether TLs, IL22 levels, and OSM serum levels were associated with clinical response, clinical remission, biochemical remission, and endoscopic remission using the appropriate statistical tests. Results: Out of eighty-four initially enrolled patients, five were lost to follow-up, and eleven discontinued the drug before 52 weeks. At the 52-week time point, 47% achieved biochemical remission based on faecal calprotectin levels, and 61.8% achieved clinical remission. TLs at the second SC dose significantly correlated with biochemical remission at the same time point (p = 0.011). However, TLs did not correlate with clinical remission. Baseline OSM levels did not correlate with biochemical or clinical remission or response. IL22 levels notably decreased during UST therapy (p = 0.000), but its values did not correlate with biochemical or clinical remission. Conclusions: UST is an effective therapy for patients with CD. TLs measured at the second SC dose significantly correlated with biochemical remission, emphasising their potential role in treatment monitoring. Levels of OSM and IL-22, despite a significant decrease in the latter during therapy, did not exhibit correlations with clinical or biochemical outcomes in our study. Further studies are needed to confirm these findings.

Aims ESD (endoscopic submucosal dissection) and EFTR (endoscopic full-thickness resection) are treatments of choice in the endoscopic resection of small and submucosal invasive GI lesions. It is often challenging to assess the best curative option in this setting. Methods We retrospectively analyzed all gastrointestinal pT1 lesions < 30 mm resected by either ESD or EFTR in our Unit from 2016 and 2022. As primary endpoints we assessed en bloc resection, R0 resection (clear margins) and curative resection (no further need for surgery) rate. As secondary endpoints we analyzed mean procedural time, cost and adverse events. Statistical analysis was performed with Pearson chi-square test. Results 30 ESD and 28 EFTR were enrolled. En bloc resection was achieved in, respectively, 90 % (27/30) and 96% (27/28), with no statistical difference (RR 0.93, p= 0.9), likewise R0 resection (25/30, 83% vs 27/28, 96%, RR 0.86, p=0.7) and curative resection (20/30, 66% vs 18/28, 64%, RR 1.03, p= 0.7). Mean procedural time was lower in EFTR, although not significantly (67 ± 37 min vs 50 ± 15.6 min, p=0.7), while adverse events rate was similar (4/30, 13% vs 3/28, 10%). Eventually, mean procedural cost per hospitalization day was lower in ESD than EFTR (1603 ± 360 € vs 2160 ± 210€). Conclusions ESD and EFTR turned out to be equally successful in achieving R0 and curative resection in pT1 small lesions, so that ESD should remain gold standard in an experienced setting, even though EFTR could allow easier and faster en bloc resection in most challenging ESD, albeit more expensive. Article published online: 14 April 2023 © 2023. European Society of Gastrointestinal Endoscopy. All rights reserved. Georg Thieme Verlag KG Rüdigerstraße 14, 70469 Stuttgart, Germany