The mesentery might be involved in the pathogenesis of Crohn’s disease (CD). As a result of scarce and conflicting data, it is debatable whether removal during intestinal resections could influence postsurgical outcome. We aimed to investigate the association between the extent of mesenteric excision during intestinal resections and postoperative complications and recurrence. We conducted a systematic search in five databases on 29 July 2024 for studies reporting outcomes in patients with CD who underwent intestinal resections with extended mesenteric excision (EME) compared with limited mesenteric excision (LME). Pooled odds ratios (ORs) with 95

Abstract Background Crohn’s disease (CD) complicated with intra-abdominal abscess often requires surgical intervention. Image guided percutaneous drainage (PD) can help to avoid surgical interventions, however there is limited evidence on the optimal management after PD. Our study aimed to analyze the long-term outcomes of CD complicated with intra-abdominal abscess after intervention. Methods In this multicenter, multinational retrospective trial penetrating CD patients with simplex intra-abdominal abscess were enrolled and followed. Baseline was defined as the day of the first detection of simplex abdominal abscess, while follow-up period of 12-24 months was set. Patients with urgent resection were excluded. Patients were grouped based on elective surgical need during follow-up after a successful PD, while a control group of patients after resection without PD is created. Primary outcome was the abscess recurrence, while stoma rate, post procedural complications rate (<30 days), and postoperative luminal recurrence were analyzed as secondary outcomes. Logistic regression and Cox-regression models were created, while descriptive statistics, Welch’s test, and Fisher’s exact test were used to compare groups, with p-values <0.05 considered significant. Results A total of 131 CD patients from 7 countries were recruited (Table 1., 58% were male, the median age at inclusion was 31.4 [IQR25-40] years) and 74/131 patients had PD due to simplex abdominal abscess during a median follow-up of 104 (74-104) weeks. Abscess recurrence rates did not differ between groups (p=0.155, Figure 1.); however baseline SES-CD score was coupled with increased risk of recurrence (HR=1,17, 95% CI 0.993-1.389). Need for re-drainage was more common amongst PD patients (OR=0.092, 95% CI=0.012-0.732), while new stoma was created more frequently in patients without prior PD (OR=2.50, 95% CI=1.034-6.034). Postoperative luminal recurrence was similar between groups based on PD. Surgical complications were coupled with increased odds in patients without prior PD (OR=8.609, 95% CI=1.825-40.616), septic complications, perforation and new fistula formation were reported the most, while PD associated complication did not occur. Conclusion However, abscess recurrence did not differ between groups, PD prior to surgery strongly correlated with less stoma creature. Furthermore, surgical treatment of intra-abdominal abscess alone may be coupled with post procedural complications.

Abstract Background Perianal fistulas of Crohn’s disease (CD) create a significant burden on patient lives. However, the efficacy and safety of adipose-derived mesenchymal stem cell treatment are contradicting, and real-world evidence is lacking. We aimed to examine the usability of darvadstrocel therapy in managing perianal CD. Methods In this retrospective multicenter study CD patients with perianal fistulas were enrolled and followed. The primary outcome was perianal clinical remission (all treated fistulas have closed) at weeks 26 and 52, while the secondary outcomes were clinical response rates (≥ 1 fistulas have closed), perianal activity (PDAI), patient satisfaction, and adverse events. The data was recorded at the baseline and weeks 12, 26, and 52. Prediction of primary outcomes was performed by logistic regression. Results Overall, based on the data of 223 patients (Table 1., male/female ratio: 0.48), perianal clinical remission was achieved in 78.2% and 62.3% until week 26 and 52 (Figure 1.), whereas baseline PDAI score (OR 0.75), number of fistulas (OR 0.28), and the number of weeks after preparation for surgery (OR 0.98) were associated with treatment failure. The clinical response rates were 84.8% and 79.8% at week 26 and 52. Moreover, the improvement of subjective perianal symptoms was achieved in 77.8% and 78.4% of the patients, respectively. Adverse events occurred in 13.5% of the patients, with perianal abscesses and proctalgia reported the most. Conclusion Effectiveness data are higher than the clinical trials. The safety profile is reassuring, and patients’ satisfaction is high. Appropriate patient selection, fistula preparation and expertise may help to achieve treatment success.

Abstract Background The prevalence of ulcerative colitis (UC) is around 200/100 000 people. Colectomy is required in 7.5%–40% of patients and 58.8%–94% of these operations are elective. Approximately one in two adults with UC are overweight or obese. Objective Our aim was to compare postoperative complications between obese (defined by a body mass index (BMI) over 30 kg/m2) and non‐obese UC patients who underwent total proctocolectomy with ileal pouch‐anal anastomosis (IPAA). Methods Our preregistered protocol can be found on PROSPERO (CRD42022377761). We conducted our search in three databases on the 26th of November 2022. PRISMA 2020 guideline and the Cochrane Handbook were applied. We used the GRADEpro program and the QUIPS tool. We applied a random‐effects model to pool effect sizes. We included cohort and case–control studies investigating UC patients undergoing colectomy with IPAA and reported information on postoperative complications in obese and non‐obese patients. We used mean difference (MD) for continuous variables and calculated odds ratio (OR) with a 95% confidence interval (CI) for dichotomous variables. Results Of the 6870 hits of our systematic search, we included three retrospective cohort studies for analyses involving 4929 patients in our research. Neither the incidence of complications at 30 days after surgery [OR = 1.08; CI: 0.65–1.79] nor the incidence of septic complications [OR = 1.11; CI: 0.85–1.46] had any clinical relevance, except for the length of hospital stay [MD = 0.36; CI:0.04–0.69]. When we assessed the risk of bias, we found that most of the aspects examined had a moderate overall risk. Our results have very low certainty of evidence. Conclusions and Relevance Our findings suggest that obesity defined as BMI over 30 kg/m2 may not associated with an increased risk of higher rates of overall postoperative complications compared to non‐obese patients. Obesity with a cut‐off value of 30 kg/m2 does not appear to be a primary reason for prehabilitation.

Abstract Background The development of anti-TNFs has brought major advances in the treatment of ulcerative colitis (UC). Yet, a significant proportion of patients do not respond favorably to first-line anti-TNF therapy, which may require the use of second-, third-, or fourth-line biologics or small molecules. Treatment selection and sequencing, however, remains a major unmet need. Methods We conducted a multicenter, retrospective study including patients with moderate-to-severe UC who failed first-line anti-TNFs, and received sequential therapy with biologics or small-molecules. The effectiveness of sequential therapy, more specifically second-line agents was determined and compared by treatment persistence and colectomy-free survival up to 3 years post-initiation, and assessed using Kaplan-Meier analyses. Multivariate Cox regression analysis was performed to identify the predictive value of various factors for colectomy and persistence. Results 683 UC patients were included. The median follow-up time was 62 months (IQR: 36-98), during which 14.2% of patients required colectomy. The probability of colectomy-free survival was 97.5%, 93.9% and 92.3% at 1, 2, and 3 years. Persistence rates increased significantly with the number of therapy lines (P<.0001). The presence of deep ulcers at diagnosis (HR: 0.45; P=.009), prior cyclosporine use (CYA; HR: 0.41; P=.028), and low serum albumin at first-line therapy (HR: 0.92; P=.002) appeared to be predictive for colectomy. Following anti-TNF failure, significantly higher colectomy-free survival rates were observed over 3 years with ustekinumab (UST; P=.014; Figure 1a.), than with vedolizumab or tofacitinib. Second-line UST also showed superior persistence at 3, 6, 12, and 24 months (P=.049; Figure 1b.), but not at 36 months. Neither the risk of colectomy (P=.343), nor the rate of persistence with second-line therapy (P=.19) was influenced by the reason of first-line anti-TNF discontinuation. Prior CYA use (HR: 0.42; P=.047) negatively influenced persistence with second-line therapy. Conclusion Despite multiple lines of sequential biological and small molecule therapy we found a low incidence of colectomy and a high rate of persistence. Following anti-TNF failure, regardless of its cause, UST might be the preferred second-line agent in moderate-to-severe UC.

Abstract Background Primary sclerosing cholangitis (PSC) is a chronic progressive cholestatic liver disease often necessitating liver transplantation (LTX). Approximately 70% of PSC patients have a concomitant diagnosis of inflammatory bowel disease (IBD) and could need treatment with biological therapy on top of the immunosuppression to prevent transplant rejection. Vedolizumab (VDZ) and ustekinumab (UST), both agents with a favorable safety profile, are often used in this population despite lack of data concerning safety and effectiveness in the post-LTX setting. Methods A retrospective multicenter case series was performed as a part of the European Crohn's and Colitis Organisation [ECCO] Collaborative Network of Exceptionally Rare case reports [CONFER] project. Primary endpoints were clinical and endoscopic remission at week 52, occurrence of infectious complications, occurrence of malignancy, hospitalizations, and death after liver transplantation. Results In this retrospective study, 58 patients (male n= 34 (59%), median age 42 (interquartile range (IQR) 32-52) were included across 16 participating centers of which 24 (38%) were treated with UST and 40 (63%) with VDZ. Twelve patients (20%) were diagnosed with Crohn’s disease (CD), 44 (76%) with ulcerative colitis (UC), 2 (3%)- with unclassified IBD (IBD-U) and in 12 (20%) patients had an ileal pouch anal anastomosis (IPAA). Median disease duration was 16 years (IQR 13-26) and 33 (56%) had received biological therapy prior to LTX (33% anti-TNF, 11% VDZ, 5% UST). Median disease duration for PSC was 15.5 years (IQR 11-25) and median time since LTX was 6 years (IQR 4-10). Clinical remission, assessed according to physician global assessment, at week 52 was achieved in 44% of VDZ compared to 38% of UST treated patients (p=0.17), while endoscopic remission was seen in 17% of patients in the VDZ group versus 33% in the UST treated patients (p=0.87). Clinical effectiveness was similar across CD (respectively 33% and 20%), UC (33% and 37%) and IPAA patients (36% vs 60%). Infectious complications occurred in 21 patients (29%; 27% VDZ vs 33% UST) post LTX on biological therapy (p=0.66), malignancy occurred in 10 patients (14.1%, 12.8% VDZ vs 16.7% UST, p=0.66), hospitalizations in 32 (45%; 51% VDZ vs 34% UST, p=0.15), and death in 2 patients (3.4%; 2.1% VDZ vs 4.2% UST, p=0.66) (see table). Conclusion In IBD-PSC patients who underwent LTX both UST and VDZ show similar effectiveness with clinical remission rates of respectively 44% and 38% after 1 year. Safety profiles are similar although infectious complications and occurrence of malignancy remains an important concern in this patient group.

Abstract Background While randomized controlled trials have shown ustekinumab (UST) as an effective therapeutic option for Crohn’s disease (CD), there is a lack of long-term observational data in real-world CD patient settings. This prospective study seeks to evaluate the clinical effectiveness, sustainability, and safety of UST in a nationwide multicentre cohort of CD patients over three years. The aim is to bridge the gap in our understanding of UST's real-world implications for long-term CD management. Methods CD patients undergoing ustekinumab (UST) treatment were consecutively enrolled at nine Hungarian Inflammatory Bowel Disease centers from January 2019 to May 2020. Over a three-year period, comprehensive data on patient demographics, disease characteristics, treatment history, clinical disease activity (measured by the Harvey Bradshaw Index (HBI)), biomarkers, and endoscopic activity (evaluated using the Simple Endoscopic Score for Crohn’s Disease (SES-CD)) were systematically collected. Results Involving 148 patients, the cohort comprised 48.9% with complex behavior of CD and 97.2% with previous anti-TNF exposure. Pre-induction remission rates were observed at 12.2% (HBI) and 5.1% (SES-CD). Clinical remission rates (HBI) at the end of the first, second, and third years were 52.2%, 55.6%, and 50.9%, respectively. Criteria for endoscopic remission were met in 14.3%, 27.5%, and 35.3% of subjects at the end of the first, second, and third years. Dose intensification was notable, with 84.0% of patients on an 8-weekly and 29.9% on a 4-weekly regimen by the end of year 3. Throughout the follow-up period, drug sustainability stood at 76.9%, and no serious adverse events were observed. Conclusion Our study confirms that ustekinumab is a sustainable, effective, and safe long-term treatment for Crohn's disease patients with a severe disease phenotype and a history of high anti-TNF failure, with the need for frequent dose adjustments.

Abstract Background Anti-tumor necrosis factor alpha treatments are effective and safe as first line therapy, however, their long-term efficacy is limited by primary (PNR) and secondary non-response (LOR) resulting in treatment discontinuation in approximately, 40–50% of cases. Vedolizumab (VDZ) and ustekinumab (UST) therapy could be good alternative in patient with anti-TNF failure, however, no direct comparison has been made. This study aimed to assess treatment persistence and long-term efficacy of VDZ and UST as second- and third line biological therapies in Crohn’s disease (CD) patients refractory to anti-TNF therapy. Methods In this multicentre study, CD patients on VDZ or UST maintenance therapy were enrolled. We analysed data of medical history retrospectively in case of both agents. Demographic and clinical data at baseline and one-year were obtained. Clinical (CDAI<150) and biochemical (CRP<10) activities and steroid-free remission were assessed while concomitant medications, hospitalisations and surgeries were recorded during the follow-up. We performed Kaplan–Meier analyses of persistence on treatment including age, CRP, CDAI at baseline, localisation, disease duration, treatment level as possible predictors. Results 200 UST and, 96 VDZ-treated patients were included in the study. After exclusion of confounders, 162 UST and, 77 VDZ-treated patients were completed the follow-up. Mean age was, 41,1 (±16,5) and, 37,9 (±11,3) years at both agents at baseline. Steroid-free clinical and biochemical remission rates did not differ between VDZ and UST groups at one year (73% vs, 73% and, 67% vs., 51%). Kaplan-Meyer analysis revealed superiority of UST during follow up (86,5% vs., 62,9%, p<0,0001). At both agents, second-line therapy was superior to third line in drug persistence (p=0,019,Exp(B)=, 0,314). None of the further examined parameters predicted treatment outcome. Therapies were terminated due to PNR in, 14 (18%) vs., 8 (5%) cases, while LOR appeared at, 13 (17%) vs., 12 (7,4%) cases at VDZ and UST treatment. One patient discontinued UST therapy due to adverse drug reaction at w20. Other drug-associated adverse reactions didn’t occur during the follow-up. During the follow-up surgery was indicated in, 6 and, 4 cases on VDZ, and, 8 and, 1 cases on UST treatment due to activity and perianal disease (8 and, 5%;, 5 and, 1%, p=0,39, p=0,04). Conclusion We confirmed that VDZ and UST are effective and safe alternatives to CD patients who have failed to anti-TNF therapy. UST has a superiority in drug persistence compared to VDZ. Second compared to third line of sequential therapy results in better outcome in drug persistence in case of both agents, however, head-to-head comparison of both agents are needed to verify our data.

Abstract Background The use of biosimilar adalimumab (ADA) is effective and safe in inflammatory bowel disease (IBD), although clinical data on switching between ADA biosimilars is still rare. At the end of 2020, a non-medical switch to biosimilar ADA became mandatory in Hungary due to reimbursement policy changes of the National Health Insurance Fund of Hungary (NEAK). The aim of the present study was to evaluate short- and medium term clinical efficacy, drug sustainability and safety comparing non-medical switches from the originator to biosimilar ADA, and between ADA biosimilars. Methods 246 consecutive patients on maintenance ADA therapy (n=181 Crohn’s disease [CD] and n=65 ulcerative colitis [UC], male/female: 44%/56%, median disease duration: 10years(y) (IQR: 10–16)) were included from 4 IBD centers between September 2019 and December 2020. Data on clinical efficacy, using Crohn’s Disease Activity Index (CDAI) and partial Mayo Score (pMayo), laboratory parameters (C-reactive protein – CRP) and adverse events were collected at 8–12 weeks prior switch, at baseline, and 8–12 weeks, 20–24 weeks after switch. Drug sustainability following the switch was evaluated after a median of 41 weeks (IQR: 35–42) follow-up time. Results A total of 246 IBD patients (n=153 patients [115CD/38UC, median age: 38y(IQR: 27–45)] and n=93 patients [66CD/27UC, 32y(IQR: 26–40.5)] underwent a non-medical switch from the originator to a biosimilar, and biosimilar to biosimilar. Clinical disease activity based on CDAI and pMayo scores are presented in Figures 1 and 2. No significant difference was found in the proportion of patients in clinical remission at week 8–12 prior switch / switch / week 8–12 and week 20–24 in either patients switched from originator to biosimilar (86.8% / 88.2% / 86.0% / 85.0%; p=0.87 among groups) or biosimilar to biosimilar (72.0% / 77.4% / 84.9% / 77.6%; p=0.21). 89.2% and 83.1% of patients who were in clinical remission at switch/baseline sustained clinical remission up to week 20–24 in the first and second cohorts. Mean CRP levels were also unchanged during follow-up in both cohorts (p=0.71 and p=0.94). Drug survival was similar between originator to biosimilar and biosimilar to biosimilar switch cohorts, with a probability of 90.6% (SE: 2.4) and 85.8% (SE:3.7) to stay on drug after 40 weeks (log-rank: p=0.271). Figure 3. Two cases of skin reactions were registered as adverse events, one leading to treatment discontinuation. Conclusion Clinical remission was sustained following non-medical switch from originator or biosimilar adalimumab to a biosimilar in IBD patients. Medium-term drug sustainability following the switch was high, and comparable between patients with an originator to biosimilar and a biosimilar to biosimilar switch.

It is unclear whether biological antipsoriatic therapies affect seroconversion after messenger ribonucleic acid (mRNA)-based antisevere acute respiratory syndrome coronavirus 2 (anti-SARS-CoV-2) vaccinations. To assess antibody formation and the incidence of side effects after anti-SARS-CoV-2 mRNA vaccinations in psoriatic patients receiving different biologicals compared to healthy controls. 102 moderate-to-severe psoriatic patients (56.2 [±13.5] years) and 55 age-matched healthy (56.4 ± 13.6 years) volunteers were included in our study. Ten to 21 days after the administration of the second dosage of BNT162b2 or mRNA-1273 vaccine, antibody levels specific to the SARS-CoV-2 spike (S) protein receptor binding domain were monitored. The incidence of postvaccination side effects was recorded and compared to real-life data in the literature. Of the 102 patients, 57 (55.88%) received tumor necrosis factor (TNF), 28 (27.45%) received interleukin (IL)-12/23, 16 (15.68%) received IL-17, and 1 (0.99%) received IL-23 inhibitors. No significant differences in the median serum level of anti-SARS-CoV-2S antibody were observed between the study population and the control group (median IQR range: 1681.0 U/mL (600.0-4844.0) versus 1984.0 U/mL (1000.0-3136.0; p = 0.82). The most frequent side effects of the mRNA vaccines within 7 days after the administration of both dosages were arm pain on the side of injection (23.53% and 23.53%), fatigue (9.80% and 13.72%), headache (4.9% and 5.88%), and chills or shivering (4.9% and 8.82%). Detectable antibodies against SARS-CoV-2S protein appear 10-21 days after the administration of the second dosage of BNT162b2 or mRNA-1273 vaccines in moderate-to-severe psoriatic patients receiving biologicals, similar to those of healthy controls.

Abstract Background Inflammatory bowel disease potentially elevates the risk of infections, furthermore, disease activity and medical treatment(s) can increase the risk as well. However, both international data and recent studies do not confirm these preliminary conceptions regarding the SARS-CoV-2 infection. In addition, a number of studies have reported that less antibodies are produced against the virus in IBD patients. In January, 2021, the vaccination campaign has begun in Hungary as well, however, questions have been raised about the effectiveness and safety of the vaccine. Methods In this multicentre study, we assessed the prevalence and risk factors of COVID-19 infection, the willingness to receive COVID-19 vaccine and the efficacy of vaccination among IBD patients receiving biological therapy, based on a cross-sectional questionnaire-based study. To assess safety and antibody response to COVID-19 vaccines, we conducted a prospective study in the same Hungarian IBD centers. IgG antibody was quantified to SARS-CoV-2 spike protein and nucleocapsid, 1 week before and after the first vaccine and, 4 and, 8 weeks after the second vaccinane, respectively. Results 472 patients were enrolled in the first part of our study. SARS-CoV-2 infection was confirmed in, 16.9% of patients. Wearing gloves and masks were found to be effective in preventing infection (p=0.02; p=0.005), avoidance of communal areas had no effect on infection rates. Male sex increased the risk (p=0.008) of viral infection. Based on subjective complaints, UC patients had a worse disease course (p=0.002). Biological therapies did not increase the risk of infections. Patients vaccinated with mRNA vaccine had a significantly higher spike protein antibody titer one month after the second vaccination (p=0.004) compared to other vaccine types (Sinopharm©, Sputnik V©, Astra Zeneca©). Seropositivity was detected in, 98% of patients. Sinopharm© vaccination triggered the lowest number of side effect (p<0.001). SARS-CoV-2 infection induced relapses more frequently than vaccinations. Conclusion Face mask was the most effective preventive tool. The risk of infection was not increased by biological therapy, therefore therapy discontinuation is not justified. Almost every vaccinated patient developed seropositivity two month after vaccination independently from the type of the vaccine, however, spike protein antibody was significantly higher following mRNA vaccinations.

It is unclear whether biological antipsoriatic therapies affect seroconversion after messenger ribonucleic acid (mRNA)-based anti-severe acute respiratory syndrome coronavirus 2 (anti-SARS-CoV-2) vaccinations. 102 moderate-to-severe psoriatic patients (56.2 (±13.5) years) and 55 age-matched healthy (56.4±13.6 years) volunteers were included in our study. Ten to 21 days after the administration of the second dosage of BNT162b2 or mRNA-1273 vaccine, antibody levels specific to the SARS-CoV-2 spike (S) protein receptor binding domain were monitored. The incidence of postvaccination side effects was recorded and compared to real-life data in the literature. Of the 102 patients, 57 (55.88%) received tumor necrosis factor (TNF), 28 (27.45%) received interleukin (IL)-12/23, 16 (15.68%) received IL-17, and 1 (0.99%) received IL-23 inhibitors. No significant differences in the median serum level of the specific antibody were observed between the study population and the control group (median IQR range: 1681.0 U/ml (600.0-4844.0) vs. 1984.0 U/ml (1000.0-3136.0; p=0.82). The most frequent side effects within 7 days after the administration of both dosages were arm pain (23.53% and 23.53%), fatigue (9.80% and 13.72%), headache (4.9% and 5.88%) and chills or shivering (4.9% and 8.82%). Detectable antibodies against SARS-CoV-2S protein appear 10-21 days after the administration of the second dosage of mRNA vaccines in moderate-to-severe psoriatic patients receiving biologicals, similar to those of healthy controls.

Aims EUS is the most accurate imaging modality for evaluation of different types of pancreatic cystic lesions; however, distinguishing between malignant and benign lesions remains challenging. Our aim was to analyse EUS images of pancreatic cystic lesions using an image processing software.

Abstract Background Although efficacy and safety of ustekinumab (UST) in the treatment of inflammatory bowel disease have been demonstrated through randomized trials, data from real-life prospective cohorts are still of great interest. Our aim was to evaluate the clinical efficacy, drug sustainability, frequency of dose intensification, and results from therapeutic drug monitoring in UST treated Crohn’s disease (CD) patients using a prospective, nationwide, multicenter cohort from Hungary. Methods Patients were consecutively enrolled in this cohort between 2019 January and 2020 May from 5 academic centers and 5 county hospitals. Data from patient demographics, disease phenotype, treatment history (surgical history, prior and present medical therapies), clinical disease activity (using the Crohn’s Disease Activity Index (CDAI), Harvey Bradshaw Index (HBI)), biomarkers (C-reactive protein – CRP), and therapeutic drug monitoring were captured. Evaluations were performed at week8 (post-induction), w16-20, w32-36, and w52-56 follow-up visits. Results N=142 CD patients were included with a median follow-up time of 60 weeks (IQR:47.5–79.5w) [57.4% female; age 38.4±13.0 years]. Based on the Montreal classification, complicated disease behavior (B2orB3) was 48.2%, whereas ileocolonic disease location(L3) 55.7%. Perianal manifestation was present in 46.8% of the patients. Previous anti-TNF exposition was 97.2%, while previous vedolizumab failure was 25.5%. 66.2%/ 66.9% of the patients had moderate-to-sever clinical disease activity at baseline (CDAI>220/HBI>7). Clinical response and remission rates were 78.1% and 57.7% using CDAI, and 82.5% and 51.8% based on HBI scores after induction treatment (w8). One year clinical remission rates were 58% / 57.3% (CDAI/HBI) Composite clinical and biomarker remission (CDAI<150 and CRP<10mg/L) rates were 35.4%; 33.3%; 38.6% and 36.6% at w8/w16-20/w32-36 and w52-56. Parallel corticosteroid use was 34%/26.3%/16.5%/21%/16.9% at baseline and w8/w16-20/w32-36/w52-56. Drug sustainability was high with 81.9% (SD: 3.4) of patients remaining on treatment at one year.(Figure1) Probability of dose intensification was high and introduced early in the treatment, 42.2% (SD: 4.2) at ~w32 and 51.9% (SD: 4.4%) at 1y.(Figure2) Patients with complex disease phenotype (B2/B3) had higher probability for dose intensification (log-rank: p=0.042). Mean serum trough levels of UST were 4,28±3,35/ 1,35±1,42/ 0,82±0,65 and 1,13±0,74µg/mL measured at w8/w16-20/w32-36 and w52-56. ADAs were exceeding 1AU/mL in only 2 patients. Conclusion Ustekinumab showed good drug sustainability and clinical efficacy in a population with severe disease phenotype and high rates of previous anti-TNF failure, however frequent and early dose intensification was required.

Aims Multidisciplinary step-up approach is recommended in the management of symptomatic pancreatic necrotic collections (PNC). Application of lumen-apposing metal stents (LAMS) facilitates the transmural endoscopic ultrasound (EUS)-guided drainage. Subsequent debridement of necrotic material can be performed in a form of irrigation by naso-cavital drain and/or direct endoscopic necrosectomy (DEN). Whether to apply irrigation or DEN is unclear. Furthermore, when and “on-demand” or scheduled DEN should be carried out is also unknown. Delayed removal of the LAMS has been associated with increased risk of complications, accordingly timing of removal is also in evolution. Our aim was to fine-tune the recommendations in a form of a local protocol to improve safety and clinical efficacy of the step-up approach using LAMS.

Introduction: Although efficacy of ustekinumab (UST) has been demonstrated through randomized trials, data from real-life prospective cohorts are still limited. Our aim was to evaluate clinical efficacy, drug sustainability, dose intensification and results from therapeutic drug monitoring in UST treated patients with Crohn's disease (CD) using a prospective, nationwide, multicenter cohort. Methods: Patients from 10 Inflammatory Bowel Disease centers were enrolled between 2019 January and 2020 May. Patient demographics, disease phenotype, treatment history, clinical disease activity (Crohn's Disease Activity Index(CDAI), Harvey Bradshaw Index(HBI)), biomarkers, and serum drug levels were obtained. Evaluations were performed at week8 (post-induction), w16-20, w32-36, and w52-56 follow-up visits. Results: A total of 142 patients were included [57.4% female; complex disease behavior (B2/B3):48%, previous anti-TNF exposition:97%]. Clinical response and remission rates after induction(w8) were 78.1% and 57.7% using CDAI, and 82.5% and 51.8% based on HBI scores. The one-year clinical remission rate was 58%/57.3%(CDAI/HBI). Composite clinical and biomarker remission (CDAI < 150 and C-reactive protein < 10 mg/L) rates were 35.4%; 33.3%; 38.6% and 36.6% at w8/w16-20/w32-36 and w52-56. Drug sustainability was 81.9%(standard deviation(SD): 3.4) at 1 year(1y). Probability of dose intensification was high and introduced early, 42.2%(SD:4.2) at similar to w32 and 51.9%(SD:4.4%) at 1y. Conclusion: Ustekinumab showed favorable drug sustainability and clinical efficacy in a patient population with severe disease phenotype and previous anti-tumor necrosis factor (anti-TNF) failure, however frequent dose intensification was required. (C) 2021 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.

Abstract Background Inflammatory bowel diseases (IBD) patients are at increased risk for mental health problems. Managing IBD patients requires cooperation between gastroenterologists and psychologists and psychiatrists. We would like to assess the frequency of depression and suicidal thoughts among Hungarian IBD patients. Methods Multicentre, questionnaire-based survey among inflammatory bowel diseases patients. Demographic data and patient’s medical history was obtained with self-filling questionnaires. Patients’ psychic status was measured with Patient’s Health Questionnaire (PHQ-9), Beck Hopelessness Scale (short version). The survey was conducted in 3 IBD centres in Hungary, First Department of Medicine, University of Szeged, First Department of Surgery, University of Semmelweis and First Department of Medicine, University of Pécs. Results Three hundred IBD patients filled the questionnaires from the 3 IBD centres. Female-male ratio was 57% - 47%. Mean age at the time of the study was 38.8 years (SD 12.5) and mean disease duration was 11.5 years (SD 8.2). Sixty-two point three% was diagnosed with Crohn’s disease, 37.7% with ulcerative colitis, one patients reported IBD unclassified and three patients did not know the type of IBD. Sixty-nine point three% of the patients self-reported the remission state of IBD, while 30.7% self-reported to have active IBD. Proportion of patients on each category of PHQ-9 scale were the followings: severe 2%, moderate to severe 5.3%, moderate 21.3%, mild 33.6% and 37.6% had normal score. Nine point three% of the patients had elevated suicidal risk. More severe PHQ-9 category was associated with elevated risk for suicide. Significant difference was shown in the Hopelessness Scale’s results among the two genders, female patients had higher risks for suicidal thoughts. Those IBD patients in remission have lower probability for moderate or severe depression. Conclusion We have to be aware of that every IBD patient has increased risk for depression and suicide. Among our patients the rate of moderate to severe and severe depression was relatively low. Every tenth of our patients had elevated risk of suicide.

Introduction: In times of crisis such as the SARS-CoV-2 pandemic, health care workers represent a valuable social resource Health protection of each individual staff member must be essential From previous health crises such as the outbreak of Ebola, SARS/MERS-coronaviruses we know that mental pressure and anxiety of physicians, nurses and other professional categories of the health care system play a critical role in coping with an acute crisis situation They cannot only affect the health of health care professionals on long term, but also determine how fast the health care system can recover from such an extraordinary challenge The world health organization (WHO) published guidelines concerning handling and reduction of stress to preserve mental health (WHO, Geneva, 2020)), pointing out interprofessional collaboration to be pivotal for the management of stressful situations and the retention of psychologic resources We hypothesized that by means of intensified interprofessional exchange the impact of psychosocial stressors on health care professionals would be impaired Thus, this study investigated whether subjectively perceived interprofessional collaboration is in measurable context with mental health factors such as stress, anxiety or resilience Aims \u0026 Methods: This observational study consists of four different, but complemental lines of questioning based on an extensive questionnaire The study included staff with different health care professionals (physicians and nurses as well as volunteer workers, such as medical students, from diverse fields (intensive care, internal medicine, anesthesia, virology), working in variable extent of interprofessional collaboration Some of the teams intensified interprofessional communication by means of shared morning briefings, instructions and implementation of interprofessional working routines The questionnaire assessed demographic data such as gender, age group, marital status and workload, aiming at identifying primary groups at risk Based on pandemic specific stressors (Petzold et al 2020), in depth questioning determined the main stressors within the study population PHQ-9 and GAD-7 questionnaires screened for suspected depression and generalized anxiety disorder Fears directly associated with SARS-CoV-2 were also assessed Finally, the questionnaire focused on interprofessional collaboration experienced in everyday working routine Analyses were performed using IBM SPSSR software Results: A total of N=293 healthcare professionals (22 physicians, 159 nurses, 112 others completed the questionnaires (response rate 47%) This sample is part of an ongoing study and represents interim results Considering professional categories, gender and direct contact to patients infected with SARS-CoV-2 we present the following findings: Perception of both, poor interprofessional communication and insufficient crisis management, is associated with higher pressure caused by the pandemic, depression and anxiety The worse interprofessional collaboration within the team was evaluated, the higher were pressure score and anxiety caused by SARS-CoV-2 Conclusion: These results highlight the importance of intensified interprofessional collaboration for medical health care workers, improving coping mechanisms and contributing to alleviating stress and pressure caused by working under the state of emergency Our findings thus contribute to improve psycho-protective tasks in clinical health care during the ongoing SARS-CoV-2 pandemic and enforce the importance of developing preventive concepts for future challenges

Inflammatory bowel diseases (IBD – Crohn’s disease (CD); ulcerative colitis (UC)) are associated with an increased risk of colorectal cancer (CRC). Other extraintestinal malignancies have shown variable incidence rates. The aim of our nationwide registry was to prospectively collect IBD-related malignancies diagnosed in the Hungarian IBD population. Data on all malignancies developed between January 2015 and November 2018 in IBD patients were recorded. Each members of the Hungarian Society of Gastroenterology were prospectively interviewed three monthly by personal emails to report malignancies observed in their patient population. Demographic and clinical data including adherence, tumour stage, previous immunosuppressive and biological therapy were also collected. 106 newly diagnosed malignancies were reported. Half of the cancers were colorectal cancers. Mean disease duration at the time of the diagnosis of CRC was 18.7 (1–43) years, mean age was 52.4 (33–87) years. 69.8% of the CRC cases were associated with UC, 51% with pancolitis, 24% with left-sided colitis. From the CD’s patients the ileocolonic and colonic localisation were observed in 41.6% and 50% of the patients, respectively. According to our results CRC was more common in male patients (66%). The most common CRC localisation was the rectosigmoidal part of the colon (58.5%). Only 1/3 of the CRC’s cases were diagnosed in early stage. 20.1% of the patients died during the observation period. Other frequent malignancies were haematological malignancies (7.5%), lung cancer (6.6%), non-melanotic skin cancer (5.6%). The most common extraintestinal malignancies were non-melanotic skin cancer (14%), 80% of them were treated with biological therapy (immunosuppressive therapy: 20%, biological therapy and immunosuppressive therapy combination: 80%). The most frequently observed IBD-related malignancy was colorectal cancer in our cohort, which mainly involved the distal part of the colon. CRC presented typically in male UC patients with pancolitis or left-sided colitis. The most common extraintestinal malignancies were non-melanotic skin cancer.