Abstract Background The A.U.R.O.R.A. database is an Italian multicenter retrospective cohort of patients with ulcerative colitis (UC) treated with the first biological drugs (infliximab biosimilar- IFX-B, adalimumab-ADA, golimumab-GOL, vedolizumab-VDZ) approved in Italy after patent expire of IFX-originator. In a previous published study,1 we showed similar efficacy among all drugs according to the rigorous outcome of 1-year “continuous clinical remission” (CCR). In this study, we focused only on steroid-dependent UC, by comparing all drugs to each other and to patients treated with steroids followed by azatioprine (AZA) monotherapy. Methods All consecutive patients with steroid-dependent UC, treated with IFX-B, ADA, GOL or VDZ after their approval in 2014-2019, were followed-up for 1 year or until drug discontinuation for relapse or adverse events. All drugs were compared to each other and to steroid-dependent patients treated with steroids + AZA in 2006-2014. A propensity score analysis was performed to balance differences at baseline. The primary endpoint was the 1-year CCR, defined as steroid-free clinical remission with Mayo partial score ≤2 (with no bleeding), without any clinical relapse or treatment optimization after the first remission was achieved, and without drug withdrawal due to adverse events. Treatment optimization was defined as the addition of systemic/topical steroids, oral/topical mesalazine or any dose escalation of biologics Results 370 patients (IFX-B=62, ADA=68, GOL=56, VDZ=100, AZA 84) with steroid-dependent UC were included. No significant differences were found among each biological drug according to the 1-year CCR primary end-point (34%, 29%, 30%, 39%, respectively). In patients naive to immunesuppressors and biologics (n= 17, 25, 24 10, 79, respectively), AZA showed significantly higher rate of CCR (68%) than each biological drug (35%, 44%, 33%, 60%; p=0.000 for each comparison) or all biologics as a whole (41%; p=0.012). Adverse events occurred significantly less frequently with ADA (8%) than IFX (29%), GOL (20%) and AZA (26%) in the overall population, but were similar across all drugs in the naive population. Discontinuation for adverse events occurred more frequently (p<0.05) with both IFX-B (16%) and AZA (14%) than ADA (3%), GOL (4%), and VDZ (1%) in the overall population, but not in the naive population (18%, 15%, 4%, 4%, 0%, respectively). Conclusion In steroid-dependent UC, anti-TNF-alpha agents and VDZ were equally effective at 1 year according to the concept of CCR. AZA still appears an effective first-line strategy in the biological era. 1Cassinotti A. et al. Eur J Gastroenterol Hepatol. 2022;34:1238-46. Guided Poster Session

During the recent outbreak of COV-SARS 2 infection, most hospitals in Italy as well as in almost every country of the world have been forced to reallocate their resources to cope with the huge flow of patients in need of hospitalization and even intensive care for respiratory symptoms. In this context, gastroenterology departments and endoscopy centers have significantly reduced their activity. In a recent survey Repici et al. [1Repici A, Pace F, Gabbiadini R. et al. Endoscopy units and the COVID-19 outbreak: a multi-center experience from Italy. Gastroenterology 2020 PMID: 32283102(e-pub).Google Scholar] documented that, following the COVID-19 epidemic, 39 out of 41 endoscopy units (EUs) in northern Italy (95.1%) continued to perform urgent procedures, while the same proportion warranted examinations to hospitalized patients, 28 EUs (68.3%) kept scheduling colorectal cancer screening colonoscopies (FIT+), 9 EUs (22.0%) ensured endoscopic therapeutic procedures, and 7 (17.1%) maintained all kind of endoscopic activities. In quantitative terms, this corresponded to a 75–99% reduction in activity in 28% of endoscopic units, and to a 50–75% reduction in 9% of units, with only a single unit maintaining its workload unchanged. Finally, most EUs limited their activity to urgent cases, including patients at high-risk of cancer, such as FIT+. As a result, a formerly planned endoscopic procedure has been postponed or canceled for a large number of patients; the burden of this unmet demand will affect the booking lists as soon as hospitals resume their usual activities. Elective endoscopy activity must be restored for many reasons: first of all, with the mitigation measures that many countries have adopted, the duration of the pandemic is expected to increase by at least six months, leveling the incidence curve and making the prolonged deferral of elective procedures unsustainable [2Gupta S. Shahidi N. Gilroy N. Rex D.K. Burgess N.G. Bourke M.J. A proposal for the return to routine endoscopy during the COVID-19 pandemic.Gastrointest Endosc. 2020; https://doi.org/10.1016/j.gie.2020.04.050Abstract Full Text Full Text PDF Scopus (32) Google Scholar]; in addition, routine endoscopy has a huge economic and health impact. In the United States alone, a hypothetical suspension of elective endoscopy for 6 months is expected to lead to the delayed diagnosis of over 2800 colorectal cancers and 22,000 high-grade adenomatous polyps with malignant potential [3Peery A.F. Crockett S.D. Murphy C.C. et al.Burden and cost of gastrointestinal, liver, and pancreatic diseases in the United States: update 2018.Gastroenterology. 2019; 156 (e11): 254-272Abstract Full Text Full Text PDF PubMed Scopus (944) Google Scholar]. The 6-month mortality rate for those who would eventually be diagnosed with colorectal cancer would increase by 6.5% [4Pita-Fernández S. González-Sáez L. López-Calviño B. et al.Effect of diagnostic delay on survival in patients with colorectal cancer: a retrospective cohort study.BMC Cancer. 2016; 16: 664Crossref PubMed Scopus (48) Google Scholar]. The problem is how to restart elective endoscopy and how to reschedule the examinations that have been postponed. Inherently, as the COVID-19 epidemic is likely to persist, we should possibly reconsider the current indications for endoscopy, as only a revision of the indications could allow for a workload that must necessarily be significantly reduced, due to social distancing and other restrictive measures to be continued in the near future. We would like to report a survey among 10 endoscopy centers in Northern Italy that had already participated in another study [5Armellini E. Repici A. Alvisi C. et al.Analysis of patients attitude to undergo urgent endoscopic procedures during COVID_19 outbreak in Italy.Digest Liver Disease. 2020; https://doi.org/10.1016/j.dld.2020.05.015Abstract Full Text Full Text PDF PubMed Scopus (29) Google Scholar], related to patients' decision to undergo or cancel endoscopic procedures planned during the coronavirus epidemic, even if prescribed as relatively urgent by their General Practitioners. The purpose of the present survey was to ascertain whether endoscopic examinations, previously booked for the period of interruption of endoscopic activity, would simply be canceled or postponed and, if so, on what policy (i.e. based on a clinical decision, with a medical review of indications and priorities, or simply on an administrative one). To gather information, we prepared a simple questionnaire which asked three simple questions relating to the interval between March 9 and April 30:1)number of upper and lower endoscopies planned but not performed, due to the interruption of the activity connected to the global reorganizations of COVID-19 hospitals, precluding the performance of routine endoscopy;2)policy adopted to "recover" these patients, if any;3)percentage of rescheduled patients who agreed to undergo the procedure. We collected data from 3079 patients regarding 1417 upper endoscopies and 1662 colonoscopies. In most centers, no reprogramming policy was adopted, and endoscopy units were given indications that all previously booked procedures should simply be re-booked by patients. In 6 EUs only, patients were contacted directly by the medical staff and asked if they wanted to reschedule the procedure or, conversely, if they wanted it canceled. Rescheduling was chosen by 27.5% to 85% of patients, cancelation by 10% to 57.5% of cases, the figures highlighting impressive differences among the participating EUs. Patients who agreed to reassign the procedure were informed that the date could be adjusted according to a priority based on the indications and severity of the potential condition. In the remaining 5 EUs, patients were contacted by administrative staff and informed that the procedure would be automatically rescheduled, without any triage. We do not know what corresponding percentage of patients contacted by administrative staff accepted or refused to undergo the endoscopic examination. Globally, the burden of searching for a new appointment has been left to the citizen despite the fact that the choice not to provide endoscopic examinations during the COVID-19 peak was made by hospitals and health authorities in the two Italian regions, and not by the citizens. The ongoing COVID-19 epidemic has been the cause not only of deaths, serious illnesses of previously healthy people and severe stress for hospitals and doctors, but it will likely have long-lasting negative consequences for people's health. In order to safe reopening of EU, the AGA therefore suggested implementing a triage system, and all procedures to be reallocated should be reviewed by qualified medical personnel and classified as time sensitive or non-time sensitive by adopting a suggested framework [6Sultan S. Lim J.K. Altayar O. Davitkov P. Feuerstein J.D. Siddique S.M. FalckYtter Y. El-Serag H.B. on behalf of the AGA, AGA institute rapid recommendations for gastrointestinal procedures during the COVID-19 pandemic.Gastroenterology. 2020; https://doi.org/10.1053/j.gastro.2020.03.072Abstract Full Text Full Text PDF Scopus (237) Google Scholar]. However, we should understand that the COVID-19 epidemic is not close to extinguish but will remain with us for the foreseeable future (at least six months). We must therefore resume routine (i.e. elective) outpatient endoscopy and we must recognize that the volume of endoscopic outpatient procedures will decrease compared to the past, due to persistent limitations (social distance and other practical measures that limit contact between people, to prevent spread of SARS-CoV2 infection). It means that we must actually make a significant selection of deferrable or non-deferrable endoscopic procedures, and this can only be done by experienced gastroenterologists. Here we appeal to our health authorities to understand that COVID-19 does represent a great challenge, but it also offers an opportunity to try to reduce inadequacy in endoscopy, which has so far been a major global concern: for example, it is estimated that 56% of upper gastrointestinal endoscopy diagnostic procedures are considered inappropriate, i.e. not according to guidelines [7Hassan C. Bersani G. Buri L. et al.Appropriateness of upper-GI endoscopy: an Italian survey on behalf of the Italian society of digestive endoscopy.Gastrointest Endosc. 2007; 65: 767-774Abstract Full Text Full Text PDF PubMed Scopus (49) Google Scholar, 8Manes G. Balzano A. Marone P. et al.Appropriateness and diagnostic yield of upper gastrointestinal endoscopy in an open-access endoscopy system: a prospective observational study based on the Maastricht guidelines.Aliment Pharmacol Ther. 2002; 16: 105-110Crossref PubMed Scopus (35) Google Scholar, 9O'Sullivan J.W. Albasri A. Nicholson B.D. Perera R. Aronson J.K. Roberts N. Heneghan C Overtesting and undertesting in primary care: a systematic review and meta-analysis.BMJ Open. 2018; 8e018557PubMed Google Scholar, 10de Jong J.J. Lantinga M.A. Drenth J.P.H Prevention of overuse: a view on upper gastrointestinal endoscopy.World J Gastroenterol. 2019; 25: 178-189Crossref PubMed Scopus (34) Google Scholar]. None.

The COVID-19 pandemic has rapidly affected every country and overwhelmed many healthcare systems. Intensive care treatment may be needed for extended durations. Patients experience consequences of respiratory illness and post-intensive care illness (1,2).

Disease 53S3 (2021) S87-S219 S207 stenting was achieved in 54/56 (96.4%).Clinical success of biliary drainage was obtained in 51/56 (91.1%) and clinical success of duodenal stenting in 49/56 (87.5%).We observed 12/56 (21.4%) complications: 7 intra-procedural (4 self-limiting bleedings, 2 LAMS maldeployments, 1 iatrogenic duodenal perforation), 5 early (pancreatitis) and 13 late "stent-related" (10 cholangitis due to biliary stent ingrowth/plugs, 2 stent migration and 1 outlet obstruction due to duodenal stent ingrowth). Conclusions:In a referral center for bilio-pancreatic diseases, the impact of concomitant malignant GOO and MBO is significant.Combined stenting of bilio-duodenal malignant strictures is an effective, minimally invasive and alternative to surgery procedure, with low complication rate, thus becoming the standard of palliative care in this setting.AF.

We conducted a survey to investigate to what extent the fear of COVID-19 has influenced the patients decision to undergo or to cancel endoscopic procedures. We collected data from 847 patients from 13 centres. The main indication for endoscopy was anemia, followed by pain and unexplained weight loss. The percentage of not presenters progressively increased throughout the three weeks of study, from 15.1% at the beginning to 48.2% at the end. 37 (34.2%) upper GI endoscopies and 112 (56.3 %) colonoscopies showed an organic cause explaining the symptoms presented by the patients, respectively; 5 cases of gastric cancer (4.6%) and 16 cases of colorectal cancer (CRC) (6.0%), respectively, were detected; during the second week the percentage of organic diseases found at upper endoscopy was 19 (33.3%) with 5 cancer (8.7%), and 61 (49.1% ) at colonoscopy, with 2 CRC (1.6%); finally, during the third week the corresponding figures were 19 (48.7%) for upper GI examinations, with 3 gastric cancers (7.7%), and 43 (60.5%) with 4 (6.5%) CRC cases found.We conclude that patients weighted the fear of having a clinically relevant disease with the fear of becoming infected by coronavirus, and a relevant percentage of them (29.4%) decided not to attend the endoscopy suites at the scheduled date.

Abstract Background Recently, comparative trials among biologics in ulcerative colitis (UC) provided conflicting results on their reciprocal superiority or equivalence. Therefore, in patients naive to biologics, the first-choice biological drug is uncertain. Methods In a retrospective, real-life, multicentre inception cohort study involving 11 Italian IBD tertiary centres, all consecutive patients, naive to biologics, treated with adalimumab (ADA), infliximab biosimilar (CTP-13), golimumab (GOL) or vedolizumab (VDZ) after their postmarketing approval (2014–2018) for moderate–severe active UC, were followed up for 1 year or until relapse. All drugs were compared with each other and to naive patients treated with IFX-originator (IFX-O, Remicade) in 2013–2014 as a reference group. A propensity score analysis was performed. The primary endpoint was the 1 year relapse-free, optimisation-free, steroid-free remission, defined as Mayo score ≤2, with bleeding subscore = 0, no relapse after first clinical remission and no optimisation with dose intensification or steroids courses. Multiple further secondary endpoints were analysed (Table 1). Results Two hundred ninety-six naive patients (ADA = 56, CTP-13 = 73, GOL = 60, VDZ = 34, IFX-O = 73) were included. The primary end-point was achieved in similar percentages in all groups, irrespective of optimisation. IFX-O and ADA had similar rates of clinical remission achieved once during the follow-up but higher rates than GOL and VDZ. The 1-year relapse rate, however, was lower with VDZ than ADA, GOL and IFX-O. Treatment failure for primary/secondary no response was higher with GOL than IFX-O and ADA. Treatment failures for intolerance were similar among all drugs. CTP-13 performed differently than the originator for some secondary end-points. Conclusion Based on a strict definition of clinical remission, all biologics appear equally effective at 1 year in patients naive to these drugs. IFX originator and ADA appear more effective in the induction phase, while patients responders to VDZ had more prolonged clinical remission. Some differences on secondary questionable outcomes between IFX biosimilar and originator have been observed.

Abstract Background Until 2014, infliximab originator (Remicade, IFX-O) was the only biological treatment approved in Italy for ulcerative colitis (UC), followed by the sequential approval of adalimumab (ADA), infliximab biosimilar (CTP-13), golimumab (GOL) and vedolizumab (VDZ). Recently, comparative trials among these drugs provided conflicting results on their reciprocal superiority or equivalence. Methods In a retrospective, real-life, multicenter inception cohort study involving 11 Italian IBD tertiary centres, all consecutive patients with moderate-to-severe active UC, treated with ADA, CTP-13, GOL or VDZ after their post-marketing approval (2014–2018) were followed-up for 1 year or until relapse. All drugs were compared with each other and to patients treated with Remicade in 2013–2014 (reference group). The 80% power calculation of the study required at least 75 patients in each arm. A propensity score analysis was performed. The primary endpoint was the 1 year relapse-free, optimisation-free, steroid-free remission, defined as Mayo partial score ≤2, with bleeding subscore = 0, no relapse after first clinical remission and no optimisation with dose intensification or steroids courses. Multiple further secondary endpoints were analysed (Table 1). Results 492 patients (ADA=90, CTP-13=105, GOL=79, VDZ=142, IFX-O=76) were included. Overall, 65% achieved clinical remission once during the follow-up, with IFX-O performing better than GOL and VDZ. The relapse rate was 24%, with the lowest rates with VDZ. The primary end-point was achieved in similar percentages in all groups, except for lower rates with GOL than IFX-O. IFX-O performed better than each other drug for other clinical outcomes (Table 1). Discontinuation for intolerance was similar among the drugs, but CTP-13 had more frequent adverse events (mainly infusion reactions) than ADA, VDZ and IFX-O. Conclusion Based on a strict definition of clinical remission, all biologics appear equally effective at 1 year, except for GOL vs. IFX originator. IFX-O appears more effective in multiple questionable clinical outcomes. IFX biosimilar had more adverse events than the other drugs. IFX originator should be used as the reference drug in head to head, controlled, comparison trials for current and future biologics in UC.

BACKGROUND:Several studies have shown that patients with non-erosive reflux disease (NERD) are less responsive to proton pump inhibitors (PPIs) than those with erosive disease as they belong to different subgroups, in whom factors other than acid can trigger symptoms.AIM:To evaluate whether combined therapy (mucosal protection plus acid suppression) would improve symptom relief compared to PPI treatment alone.METHODS:In a multicenter, randomised, double-blind trial, 154 patients with NERD were randomised to receive Esoxx (Alfa Wassermann, Bologna, Italy), a hyaluronic acid-chondroitin sulphate based bioadhesive formulation, or placebo, in addition to acid suppression with standard dose PPIs for 2 weeks. Symptoms (heartburn, acid regurgitation, retrosternal pain and acid taste in the mouth) and health-related quality of life (HRQL) were evaluated before and after treatment. The primary endpoint was the proportion of patients with at least a 3-point reduction in the total symptom score.RESULTS:At the end of treatment, the primary endpoint was reached by 52.6% of patients taking Esoxx compared to 32.1% of those given placebo (P < 0.01). The same was true also for HRQL, evaluated by means of the Short Form-36 questionnaire, which improved with both treatments, but some items were significantly better after Esoxx plus PPI therapy.CONCLUSION:The synergistic effect of Essox with PPI treatment suggests that mucosal protection added to acid suppression could improve symptoms and HRQL in NERD patients.

Objective Although split regimen is associated with higher adenoma detection and is recommended for elective colonoscopy, its adoption remains suboptimal. The identification of patient-related barriers may improve its implementation. Our aim was to assess patients' attitude towards split regimen and patient-related factors associated with its uptake. Design In a multicentre, prospective study, outpatients undergoing colonoscopy from 8:00 to 14:00 were given written instructions for 4 L polyethylene glycol bowel preparation, offering the choice between split-dose and day-before regimens and emphasising the superiority of split regimen on colonoscopy outcomes. Uptake of split regimen and association with patient-related factors were explored by a 20-item questionnaire. Results Of the 1447 patients (mean age 59.2±13.5 years, men 54.3%), 61.7% and 38.3% chose a split-dose and day-before regimens, respectively. A linear correlation was observed between time of colonoscopy appointments and split-dose uptake, from 27.3% in 8:00 patients to 96% in 14:00 patients (p<0.001, χ2 for linear trend). At multivariate analysis, colonoscopy appointment before 10:00 (OR 0.14, 95% CI 0.11 to 0.18), travel time to endoscopy service >1 h (OR 0.55, 95% CI 0.38 to 0.79), low education level (OR 0.72, 95% CI 0.54 to 0.96) and female gender (OR 0.74, 95% CI 0.58 to 0.95) were inversely correlated with the uptake of split-dose. Overall, the risk of travel interruption and faecal incontinence was slightly increased in split regimen patients (3.0% vs 1.4% and 1.5% vs 0.9%, respectively; p=NS). Split regimen was an independent predictor of adequate colon cleansing (OR 3.34, 95% CI 2.40 to 4.63) and polyp detection (OR 1.46, 95% CI 1.11 to 1.92). Conclusion Patient attitude towards split regimen is suboptimal, especially for early morning examinations. Interventions to improve patient compliance (ie, policies to reorganise colonoscopy timetable, educational initiatives for patient and healthcare providers) should be considered. Trial registration number NCT02287051; pre-result.