Introduction

The Endoscopical Submucosal Dissection (ESD) is an advanced resection technique for removing “en bloc” gastrointestinal (GI) lesions, bigger than 20 mm and with macroscopic features of no deep infiltration (limited to the submucosal). It is a complex procedure and, therefore, with risk of complications (early and/or delayed), first of all bleeding, then perforation.

Aims & Methods

Our aim is to confirm the pivotal role of Over-The-Scope Clip (OTSC) for menagement of perforation occurred during the ESD. Our Centre started the ESD techinque from March 2023 by an expert endoscopist, with a collegue in training, and we have included in a database the information of all procedures carried out from that period to September 2023.

Results

Were included 34 adult patient (M/F: 19/15) with an age mean of 69 years. The mean lesions size was of 31 mm ± 20 for the upper-GI, 25 mm ± 15 for the lower-GI. Histological findings were reported in the tab. 1. All procedures were performed under general anesthetic care. Lesions were succesfully resected “en bloc” in all patients (100%) by ESD procedure using minimal CO2 insufflation. The overall intraprocedure perforation occured in 3 out of 34 (8,8%): 1 out of 18 was located in the upper-GI tract (fundus); 2 out of 16 lesions were located in the lower-GI tract (1 in the ascending colon and 1 in the discending colon, respectively). According to clinical and medical stability of the patients, all the parietal defect were treated successfully, at the end of the complete ESD, by positioning OTSC, allowing a full-thickness closure of the GI tract defect, avoiding emergency surgery. The R0 rate was of 94.1%, with two cases that underwent to surgery beacause of “pT2” at the final histological report.

Conclusion

OTSC is a known safe and efficacy device for closing perforation occured during ESD, in the course of the same endosocpic procedure. More and larger studies are needed to further validate these findings.

Introduction

Inflammatory Bowel Diseases (IBD), including Crohn's Disease (CD) and Ulcerative Colitis (UC), pose significant global health challenges. Nutrient deficiencies and malnutrition are common in both forms of the disease. Dietary supplementation with TGF-β has been suggested to enhance patients’ nutritional status, quality of life, and improvement of the symptoms. However, comprehensive evaluations of its clinical impact are needed.

Aims & Methods

This study aims to assess the efficacy of nutritional supplementation in improving clinical outcomes, nutritional status, quality of life, fatigue, disability, and body image among IBD patients.
Methods: Multicenter longitudinal study, enrolling 42 IBD patients in clinical activity and/or at nutritional risk. Patients received the nutritional supplement enriched with TGF-β and underwent assessments before supplementation (M0), at 30 days (M30), and at 60 days (M60) of supplement use. Clinical parameters, disease activity (Harvey-Bradshaw score for CD and partial Mayo score for UC), nutritional evaluation, body composition, presence of fatigue, anxiety and depression, disability, and body image were evaluated. Statistical analyses included descriptive statistics and ANOVA (p<0.05).

Results

42 patients were included: 30 (71%) with CD and 12 (29%) with UC; 48% women, age of 35.1 ± 15.65 years. Among CD patients, 30% were in remission, 16.67% had mild, 43.33% moderate, and 10% severe activity. According to Montreal classification, 36.67% presented ileocolonic disease, 36.67% fistulizing behavior, 26.67% stenosing behavior, 33.33% perianal disease. For UC patients, 41.67% had mild and 58.33% moderate activity; 41.67% presented pancolitis. All patients presented malnutrition or nutritional risk at enrollment. Significant improvements were observed in HBI score comparing M0 (7.97±5.70) vs M30 (4.61±3.16) vs M60 (3.27±1.75), p=0.0055. There was also an improvement of the number of bowel movements (5.45±4.65 vs 2.90±2.02 vs 2.65±1.55). Nutritional assessment revealed a significant increase in brachial circumference (24.23±3.68 vs 25.37±3.51 vs 26.03±4.10, p=0.0182). Fatigue decreased (40.58±14.07 vs 33.12±15.72 vs 30.38±14.88, p=0.0293), as well as disability (51.14±25.34 vs 36±20.89 vs 30.33±22.64, p=0.0032). It was observed an improvement of IBD score (135.08±38.88 vs 145.20±48.27 vs 152.71±58.96; p=0.3737) and body image (10.78±7.37 vs 9.68±8.42 vs 5.57±6.04; p=0.1395), with no significance.

Conclusion

Nutritional supplementation demonstrated notable improvements in clinical and nutritional parameters, as well as reduction in fatigue and disability, underscoring its potential as an adjunctive therapy for IBD management

Introduction

Long-term real-life data on vedolizumab (VDZ) are scarce. In this study, we aim to evaluate the long-term outcomes of patients (pts) with inflammatory bowel disease (IBD) who received VDZ.

Aims & Methods

The LONG-LIVE is the long-term extension (LTE) of the LIVE study, including IBD pts who had started VDZ from 04 to 06/2017 at 47 Italian centres affiliated with IG-IBD, prospectively followed-up to 06/2019. For this study, data on therapy withdrawal, clinical and endoscopic activity, need for surgery/hospitalizations, deaths, and serious adverse events (SAEs) were retrospectively extracted from 07/2019 up to the last available follow-up (fup).

Results

Seven hundred eighty-two (70% of the original cohort) pts were enrolled in the LTE (394 CD, 388 UC), 316 (40%) of whom had already definitively discontinued VDZ; 43% were female, mean age was 53±16 years, mean disease duration was 17±9 years, 76% of patients were bioexposed to anti-TNFα therapy. Among the remaining 466 still receiving VDZ, 204 (44%) subsequently suspended VDZ permanently and 9 (2%) temporarily: mean VDZ therapy duration was 113±92 weeks and 311±60 weeks among those who suspended and those who continued VDZ, respectively. Mean therapy duration was 177±124 weeks (172±124 weeks for CD and 182±125 weeks for UC, with no significant differences); longer mean persistence was observed in bionaive vs bioexposed CD pts (197±123 vs 182±122 weeks, p<0.05), while no such difference was observed in UC pts (193.1±126 vs 190±122. week, p=ns). Among CD pts who continued VDZ throughout the entire LTE, 74% and 54% were in clinical and endoscopic remission, respectively, at the last fup; among UC pts who continued VDZ throughout the entire LTE, 79% and 50% were in clinical and endoscopic remission, respectively, at the last fup. During the LTE, CD pts had a higher risk of IBD-related hospitalizations (Hazard Ration, HR, 1.37, 95% Confidence Interval, CI, 1.04-1.72, p=0.027). Specifically, 153 (20%) pts (83 CD, 70 UC) were hospitalized to receive IBD-related surgery after a mean time of 136±87 weeks from VDZ start (for CD vs UC comparison, HR 1.17, 95% CI 0.85-1.60, p=ns); 85 (11%, 54 CD, 31 UC) pts underwent IBD-related hospitalization for non-surgical reasons (CD vs UC, HR 1.71, 95% CI 1.21-2.62, p=0.015). New or recurrent cancers were reported in 17 pts (the most common localization being 4 breast cancers and 3 gastrointestinal cancers): mean interval between first VDZ administration and cancer diagnosis was 214 (±95) weeks; 20 non-oncological SAEs were recorded in pts receiving VDZ, the most common being infections (n=7), mostly pneumonia (n=4). Finally, 15 deaths were reported (of which 9 occurred in patients still receiving VDZ); the most common causes of death were infections (n=5), cardiovascular diseases (n=5) and cancer (n=3).

Conclusion

About one-third of pts were still receiving VDZ after a fup of more than 6 years, with the majority of them being in clinical remission and more than 50% also having quiescent endoscopic activity at the last observation; bionaive CD patients had longer persistence compared to bioexposed ones. During the LTE, CD pts had higher rates of IBD-related hospitalizations; most hospitalizations were due to the necessity of surgery. SAEs were observed in a minority of patients and predominantly consisted of infections; the rates of cancer diagnosis are seemingly in line with those of the general population. Overall, our study strengthens the notion that vedolizumab is associated with a long-term real-life durability in terms of both effectiveness and safety.

Disclosure

Daniela Pugliese received speaker fees and/or advisory board from AbbVie, Galapagos, MSD, Takeda and Janssen, Pfizer. Giuseppe Privitera received consultancy fees from Alphasigma and Janssen. Alessandro Armuzzi: consulting and/or advisory board fees from AbbVie, Amgen, Biogen, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Celltrion, Eli-Lilly, Ferring, Galapagos, Gilead, Janssen, MSD, Mylan, Pfizer, Protagonist Therapeutics, Roche, Samsung Bioepis, Sandoz, Takeda; lecture and/or speaker bureau fees from AbbVie, Amgen, Arena, Biogen, Bristol-Myers Squibb, Eli-Lilly, Ferring, Galapagos, Gilead, Janssen, MSD, Mitsubishi-Tanabe, Novartis, Pfizer, Roche, Sandoz, Samsung Bioepis, Takeda; and research grants from MSD, Pfizer, Takeda and Biogen.

Introduction

Anti-TNF agents play a significant role in the induction and maintenance therapy of moderate to severe ulcerative colitis. However, at least 30% of patients experience loss of response within the first year of treatment.

Aims & Methods

This study aims to compare Tofacitinib versus Vedolizumab in patients with ulcerative colitis in the setting of previous anti-TNF failure. We performed a systematic review in PubMed, Embase and Cochrane databases, searching for randomized and non-randomized studies comparing Tofacetinib versus Vedolizumab in this population. The primary outcome was colectomy rate. The secondary outcomes were thromboembolic event rate and infectious incidence. The odds ratio (OR) was used for binary outcomes with their respective 95% confidence interval (CI). Heterogeneity was assessed using the Cochran Q test and I² statistics.

Results

The meta-analyses included 6 studies and 2,241 patients. There was a significant difference favoring Vedolizumab in colectomy rate (OR 2.03; 95% CI 1.30 to 3.16, p=0.002; I2=0%). There were no difference in thromboembolic event rate (OR 0.90; 95% CI 0.39 to 2.06; p=0.798; I2=0%) and infection incidence (OR 0.83; 95% CI 0.56 to 1.25; p=0.378; I2=0%).

Conclusion

In patients with ulcerative colitis with prior anti-TNF failure, tofacitinib showed higher colectomy rate compared to vedolizumab, with no difference in thromboembolic and infectious events between both groups. Considering this, vedolizumab seems to be a reasonable option in this population.

References

1. Straatmijer T, Biemans V, Visschedijk MC, Hoentjen F, De Vries A, Van Bodegraven AA, et al. SUPERIOR EFFECTIVENESS OF TOFACITINIB COMPARED TO VEDOLIZUMAB IN ANTI-TNF EXPERIENCED ULCERATIVE COLITIS PATIENTS: A NATIONWIDE DUTCH REGISTRY STUDY. United Eur Gastroenterol J. 2022;10((Straatmijer T., t.straatmijer@amsterdamumc.nl; De Boer K.H.N.) Amsterdam UMC, Amsterdam, Netherlands):390–1.
2. Buisson A, Serrero M, Altwegg R, Guilmoteau T, Bouguen G, Nachury M, et al. Real-world comparison of effectiveness between tofacitinib and ustekinumab in patients with ulcerative colitis exposed to at least one anti-TNF agent: Results from the TORUS study. J Crohns Colitis. 2023;17((Buisson A.; Guilmoteau T.) CHU Clermont-Ferrand, IBD Unit, Clermont-Ferrand, France):i707.
3. Adimadhyam S, Lewis JD, Simon AL, Wolfe AE, Smith S, Hou L, et al. Real-world Evidence Comparing Tofacitinib and Vedolizumab in Anti-TNF-experienced Patients With Ulcerative Colitis. Inflamm Bowel Dis. 2024 Apr 3;30(4):554–62.
4. Hyun HK, Zhang HS, Yu J, Kang EA, Park J, Park SJ, et al. Comparative effectiveness of second-line biological therapies for ulcerative colitis and Crohn’s disease in patients with prior failure of anti-tumour necrosis factor treatment. BMC Gastroenterol. 2022 Mar 27;22(1):143.