European Crohn's And Colitis Organisation Research Articles

Preventing Recurrence of Crohn's Disease Post-Ileocaecal Surgery in Paediatric Patients: A Therapy Guide Based on Systematic Review of the Evidence.

Ileocaecal resection (ICR) is frequent in paediatric patients with Crohn's disease (pCD). Despite rates of reoperation being low, the risk of clinical or endoscopic post-operative recurrence (POR) is high; effective medical strategies to prevent POR are thus needed. The aim of this systematic review(SR) was to identify and evaluate the published literature on post-operative medical prevention of POR in pCD to draft a possible therapy guide for pCD patients undergoing ICR. We performed an SR according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) standards and registered it in the PROSPERO database (ID: CRD42024533855). The population, intervention, control, outcome (PICO) model was focussed on post-surgical medical prevention of POR in pCD with clearly expressed definition of recurrence (endoscopically using a standardized scoring system (e.g. Rutgeerts score) or by laboratory markers, for example, faecal calprotectin (F-CPT), C-reactive protein (CRP) or by histological findings or by clinical activity indexes [e.g. weighted paediatric Crohn's disease activity index - (w)PCDAI]. From inception until 29 February 2024, the following databases were searched: PubMed/MEDLINE, Scopus/Embase, Web of Sciences, Evidence-Based Medicine Reviews (including Cochrane), Cochrane Central Registrar of controlled Trials (CENTRAL), ClinicalTrials.gov and EudraCT. Retrieved articles were evaluated for eligibility and finally selected publications for risk of bias using ROBINS-I tool. Out of 811 publications identified by the search, only 5 fulfilled inclusion criteria of the SR. None of the studies fully answered our PICO question. The studies were overall of poor quality and the heterogeneity of the data did not allow us to perform meta-analysis, detailed statistical analysis or formal synthesis of data. Adverse events of post-operative medication were not described in any of the included studies. Existing guidelines of European Society for Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN), North American Society for Paediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN), European Crohn's and Colitis Organisation (ECCO) and American Gastroenterological Association (AGA) were reviewed and paediatric therapy guide for pCD undergoing ICR was drafted with respect to recent SRs and meta-analyses in adult population and including scarce paediatric data identified by our SR. As pCD patientsundergoing ICR are a high-risk population, they should not be left untreated post-operatively. Anti-tumour necrosis factor (anti-TNF) drugs should be considered as first-line therapy in the majority of patients. Non-anti-TNF biologics should be considered in case of anti-TNF failure. Regular endoscopic monitoring starting at 6 months after the surgery and supported by regular F-CPT evaluation should be used to identify early endoscopic recurrence and to escalate the treatment. Our SR revealed that there is wide variability in treatment strategies in children, and high-quality data are generally lacking. At the moment, paediatric prophylaxis of POR should be guided by available adult evidence with respect to the high-risk nature of pCD. Extensive research in pCD should be encouraged.

Prevalencia de manifestaciones extraintestinales y otras condiciones asociadas en una cohorte de pacientes con enfermedad inflamatoria intestinal de un centro avanzado en Bogotá, Colombia

Introduction and aimsThe prevalence and incidence of inflammatory bowel disease (IBD) has increased significantly in Latin America. Extraintestinal manifestations (EIMs) have elevated morbidity and are poorly characterized in the region. Our aim was to describe the characteristics of EIMs in patients with IBD at the Hospital Universitario Fundación Santa Fe de Bogotá, utilizing the EIM classification proposed by the European Crohn's and Colitis Organisation (ECCO). Materials and methodsA cross-sectional study was conducted based on an institutional database of patients with IBD and the EIM definition used by the ECCO. Prevalence and prevalence ratios (PRs) of the EIMs were calculated. ResultsThe study included 168 patients, 66 of whom were diagnosed with Crohn's disease (CD) and 102 with ulcerative colitis (UC). A total of 30.4% patients had at least one EIM, and the most frequent were oral ulcers (13.7%), arthritis (10.1%), and uveitis/episcleritis (6.5%). There was a greater prevalence of EIMs in CD (31.8% vs 29.40% in UC) and women (32.47% vs 28.57% in men). There was a significant PR between uveitis/episcleritis and arthritis, erythema nodosum and arthritis, and erythema nodosum and other eye diseases. ConclusionsOur study shows a high prevalence of EIMs, surpassing that of previous Colombian studies, with a predominance of CD. Oral manifestations stand out as the most common. Prevalence studies on EIMs in Colombia are needed to establish multidisciplinary specialized centers, improving the quality of life of patients with IBD.

Is the European Crohn’s and Colitis organisation (ECCO) e-guide an acceptable and feasible tool for increasing gastroenterologists’ guideline adherence? A mixed methods evaluation

Background and aimsManagement of inflammatory bowel disease is constantly evolving, increasing the importance for gastroenterologists to keep up to date with guidelines. Traditional implementation strategies have had only small positive impacts on clinical practice. eHealth strategies such as the European Crohn’s and Colitis Organisation e-guide may be beneficial for clinician decision making in keeping with guidelines. The aim of this study was to evaluate the feasibility and acceptability of the e-guide.MethodsA mixed methods approach was used to evaluate feasibility and acceptability. Cognitive (think-aloud) interviews were conducted with Australian gastroenterologists while using the e-guide. Two clinical scenarios were developed to allow evaluation of various aspects of the e-guide. Content analysis was applied to the qualitative interview data and descriptive analysis to the quantitative and observational data.ResultsSeventeen participants completed the study. Data saturation were reached. The ECCO e-guide was largely feasible and acceptable, as demonstrated by most clinical questions answered correctly, 87% reaching the answer within 3 min, and most feeling it was useful, would be beneficial to their practice and would use it again. Issues raised included difficulties with website navigation, layout of the e-guide and difficulties with access (network firewalls, paid subscription required).ConclusionsThe ECCO e-guide is largely acceptable and feasible for gastroenterologists to use. Aspects of the e-guide could be modified to improve user experience. This study highlights the importance of engaging end-users in the development and evaluation of clinician educational tools.

Comparative evaluation of a language model and human specialists in the application of European guidelines for the management of inflammatory bowel diseases and malignancies.

Society guidelines on colorectal dysplasia screening, surveillance, and endoscopic management in inflammatory bowel disease (IBD) are complex, and physician adherence to them is suboptimal. We aimed to evaluate the use of ChatGPT, a large language model, in generating accurate guideline-based recommendations for colorectal dysplasia screening, surveillance, and endoscopic management in IBD in line with European Crohn's and Colitis Organization (ECCO) guidelines. 30 clinical scenarios in the form of free text were prepared and presented to three separate sessions of ChatGPT and to eight gastroenterologists (four IBD specialists and four non-IBD gastroenterologists). Two additional IBD specialists subsequently assessed all responses provided by ChatGPT and the eight gastroenterologists, judging their accuracy according to ECCO guidelines. ChatGPT had a mean correct response rate of 87.8%. Among the eight gastroenterologists, the mean correct response rates were 85.8% for IBD experts and 89.2% for non-IBD experts. No statistically significant differences in accuracy were observed between ChatGPT and all gastroenterologists (P=0.95), or between ChatGPT and the IBD experts and non-IBD expert gastroenterologists, respectively (P=0.82). This study highlights the potential of language models in enhancing guideline adherence regarding colorectal dysplasia in IBD. Further investigation of additional resources and prospective evaluation in real-world settings are warranted.

DOP03 Gaps between ECCO quality standards of care and the real world: the E-QUALITY survey on processes and outcomes

Abstract Background The European Crohn’s and Colitis Organisation (ECCO) Position Paper on Quality-of-Care (QoC) proposed essential standards on process and outcomes for units that manage patients with inflammatory bowel disease (IBD). The E-QUALITY taskforce investigated whether gaps between these standards and real-world practice exist. Methods A 74-question web survey accessible to all institutions affiliated with ECCO was developed. One delegate per institution was requested to respond. A descriptive analysis was done. Results From March to October 2023, 166 centres from 28 different countries replied to the survey (Fig.1). At diagnosis, disease extent is assessed by colonoscopy in 96% and completed by small bowel (SB) evaluation in 43%. At least 2 biopsies from each segment are obtained in 55%. SB investigation for Crohn’s disease (CD) takes place in 60%. 54% of centres provide access to endoscopy with deep sedation for the majority of patients. To assess treatment response, faecal calprotectin is used in 65%, endoscopy in 54%, cross-sectional imaging for CD in 36%. In the case of primary failure of any drug, therapeutic decisions are based on objective measures of inflammation in 98%. A scheduled monitoring protocol for asymptomatic patients is followed in 42%. Patients with prolonged use of corticosteroids are being switched to a steroid-sparing treatment in 84%, but there is no protocol to track or act upon high steroid exposure in 43% of centres. 72% centres monitor metabolic bone health. Only 51% of units screen IBD patients for colorectal cancer, but screening is done with high-definition endoscopy in 92%. Chromoendoscopy with targeted biopsies is performed in only 47% units. Patients with perianal fistula are managed by combined medical and surgical approach in 67%, and reassessment by clinical and endoscopy and/or pelvic MRI is done in 62%. Laparoscopic approach for intra-abdominal surgery is used in 76%, and preoperative nutritional assessment in 62%. Patients receive therapies to prevent post-operative recurrence based on risk factors in 70%, standard endoscopy within 6-12 months after surgery is done only in 52% of centres. Although only 8% of centres lack a defined protocol to manage acute severe ulcerative colitis flares, 13% lack a standard algorithm, and 36% do not involve the surgeon in this setting from day 1. 38% of centres have a paediatric to adult transition clinic. The main reason for not adhering to ECCO standards are difficulty of providing tests in a timely fashion in up to 83% of centres. Conclusion Our survey has revealed significant gaps between ECCO standards and real-world practice. These results will help ECCO improve initiatives to help institutions to provide standard QoC. 1) Fiorino et al. JCC 2020;14:1037-48

DOP01 Definitions of histological abnormalities in inflammatory bowel disease: an ECCO position paper

Abstract Background High quality histological examination of ileocolonic biopsies in inflammatory bowel disease (IBD) plays a critical role in optimising clinical management, investigative studies, and clinical trials. The correct assessment of histological features can confirm the diagnosis of IBD, assist with its subclassification (as ulcerative colitis or Crohn’s disease), facilitate the estimation of disease activity and disease extent, and aid the detection of mimics and complication. However, there are surprisingly few universal definitions of each histological abnormalities and the existing definitions are often inconsistent. The main practical concern is that histological scoring schemes, or guidelines on histological diagnosis, include detailed features, and many of these features have, paradoxically, no, or vague definitions. Furthermore, interobserver variability for many histological features in IBD is significantly high, possibly reflecting lack of precision. The aim of this paper is to review and assess any existing histologcal definitions and criteria, selecting the most appropriate where possible, and modifying them or writing new definitions where necessary. Methods The European Crohn's and Colitis Organisation (ECCO) and the project leaders formed a panel of experts in the IBD field, composed of pathologists and gastroenterologists to explore inconsistencies in the definitions of histological abnormalities using the best resources and evidence available. The panel examined existing definitions, peer reviews publications, scoring schemes, guidelines and textbooks. An important contribution was also given by their professional experience and knowledge. Results The literature review process confirmed that most current existing definitions often have no evidence base and vary between sources. The panel of experts developed 40 statements on histological definitions in IBD with accompanying supporting text for each statement. Conclusion The statements represent expert consensus with the support of evidence where available. Further possible development of this process will include attempts to grade histological changes, aiming to improve the consistency of pathological diagnosis, a reduction in currently high rates of interobserver variability, more precision in clinical trial work and research, and to facilitate development of new guidelines and scoring schemes for IBD.

P309 Impact of EBV Status on decision making for advanced therapies in IBD Patients

Abstract Background The CESAME study suggested that Thiopurines confer increased risk of lymphomas in IBD patients who are naïve to Epstein - Barr virus (EBV) particularly in young males. European Crohn’s and Colitis Organisation (ECCO) guidelines recommend considering EBV screening in individuals prior to initiating immunomodulator therapy. The impact of EBV serology status on decision-making processes regarding advanced therapies in IBD patients is not studied before. Methods Consecutive patients initiated on advanced therapies (biologics or small molecules). EBV nuclear and vca IgG status were recorded. The first advanced therapy of the positive and negative patients were compared. Proportion of the negative patients who seroconverted and the time to seroconversion were analysed. Results We included 491 patients (M: F 1:14). Median age of patients who had EBV serology done prior to initiating on advanced therapies was 31.5 years (range 5-84 years) .In 41 (8.35%) patients, neither nuclear nor vca IgG antibody were detected at initial screening. The median age of EBV negative patients was 26 years (range 13-51 years).30 of the EBV negative patients were males. Azathioprine/6MP was not initiated in 37 (90.24%) of the EBV negative patients. Re-testing of EBV negative patients were done at a median interval of 28 months (range 3-90 months). 5 of these retested patients (12.2%), seroconverted and in three of this patients Azathioprine was used following seroconversion. Conclusion A significant minority of IBD patients are EBV negative when tested as part of pre biologic screening, including in male patients above the age of 25. Thiopurine therapy was avoided in these patients. Only a fraction of EBV negative patient seroconverted on re-testing. The impact of EBV testing in treatment decision, as well as the attributable costs needs to be evaluated further.

P815 Infliximab drug monitoring: proactive or reactive: a North West England NHS 3 trust retrospective study

Abstract Background Therapeutic drug monitoring (TDM) plays a vital role in the management of patients on Infliximab. (1) The British Society of Gastroenterology (BSG) recommends TDM assessment ideally takes place 2-4 weeks after the initial loading doses, however the European Crohns and Colitis Organisation (ECCO) do not make particular proactive or reactive recommendations for TDM. (1,2,3) Methods Three North West England NHS trusts retrospectively collected data on 75 patients who had Infliximab trough and antibody levels done within a 12 month time frame. The aim was to establish if collectively TDM was done proactively or reactively and the overall outcomes from the monitoring. Results The demographic profile gave us 37 females and 38 males with the disease distribution predominantly Crohns disease ( N=53). There were more participants in the 18-50 age range (N=53) with 22 patients being 31-40 years of age, less participants in the 51-70+ age range ( N=22). Dual therapy with either Mercaptopurine or Azathioprine accounted for 49 out of the 75 participants with a majority favouring Azathioprine. Clinical management and routine use of TDM was seen in 40.5% ( N= 54) of patients indicating proactive use of monitoring in this study. TDM was undertaken after induction and annually in 48 patients whilst the remaining 27 patients received monitoring as ‘maintenance’, this is similar to the BSG recommendations and in a study by Sagar et al in 2021 ( 4). Conclusion Although the three participating trusts may use differing assays for the TDM, the outcomes show that it is used proactively for the majority of patients after induction and annually in keeping with BSG recommendations (3). From the data collected a further examination of results regarding subcutaneous versus intravenous TDM outcomes is proposed as the trusts move towards providing patients with both modes of administration of Infliximab.

P646 Clinical decision support in the prevention of adverse effects associated with immunosuppressive drugs in patients with Inflammatory Bowel Disease

Abstract Background With the goal of effective and early prevention and detection of medication-related adverse effects, an explosion of technological advances is taking place. However, none of these systems are currently intelligent enough to ensure safe prescribing of treatments on their own. Purpose To design and integrate clinical decision rules (CDR) to increase the safety of immunosuppressive treatments in patients with inflammatory bowel disease (IBD) into an electronic prescribing assistance software (HIGEA). Methods This is a descriptive study conducted in a tertiary university hospital in Madrid (Spain). 1. We reviewed the technical product information sheet of the immunomodulatory drugs used in the treatment of patients with IBD and the current recommendations and clinical practice guidelines on the management of IBD. 2. The CDR were developed within a multidisciplinary team of physicians and pharmacists by integrating data from pharmacogenetics, microbiology, biochemistry, immunology and haematology laboratories, the electronic medical record and the electronic prescribing programme. 3. Integration was performed using a standard language (HL7). Results The technical product information sheet of 33 immunomodulatory drugs (19 biological therapies, 6 small molecules and 8 traditional disease-modifying drugs) and the clinical practice guidelines for the treatment of IBD of the European Crohn's and Colitis organisation (ECCO) and the Spanish working group on Crohn's disease and ulcerative colitis (GETECCU) were reviewed. A total of 169 CDR were developed: 2 related to pharmacogenetics laboratory values, 26 to microbiology, 38 to biochemistry, 24 to immunology, 42 to haematology, 28 to clinical history and 9 related to concomitant use of other drugs. Of the 169 CDR, 50 (29.58 %) were related to screening prior to initiation of immunosuppressive treatment, 10 (5.92%) to drug interactions and 109 (64.5%) related to clinical conditions requiring adjustment or discontinuation of immunosuppressive treatment. Conclusion The incorporation of personalised clinical rules into the medical prescription and pharmaceutical validation process will allow the selection of patients in whom there could be a safety problem with immunosuppressive treatment, increasing the percentage of early detected and avoided adverse events. Future steps will be to evaluate the impact of the implementation of the CDR tool on increasing safety, reducing healthcare costs and improving patient health outcomes.

P1075 Outcomes in patients stopping biologic during the first trimester of pregnancy : a retrospective monocentric study

Abstract Background Both the American Gastroenterological Association (AGA) and the European Crohn's and Colitis Organisation (ECCO) recommend to continue biologic during the whole pregnancy and until the third trimester, respectively. However, these positions are associated with a baby's exposure to the drug and from our clinical practice are not necessarily in line with patients' wishes and fears. In patients in full clinical and biologic remission, stopping biologic before it is actively transported through the placenta (around the week 20) would be a possible approach to get around these drawbacks. We aimed to assess the outcome of disease activity and pregnancies in patients stopping biologic before the week 20. Methods We performed a retrospective monocentric study. All patients who gave birth between 2010 and 2023 were included. The following parameters were collected: clinical and demographic characteristics, biomarkers (CRP and faecal calprotectin before pregnancy and during the 3 trimesters), IBD treatment at time of pregnancy, whether it was stopped during pregnancy, when and in what circumstance (patient versus medical agreement). We also looked at the disease course, whether a relapse occurred (defined as the need to take corticosteroids, a biologic, or surgical resection), and the pregnancy outcome. Results A total of 185 pregnancies were reported in 143 patients (73.4% Crohn disease and 26.6% ulcerative colitis). Patient's characteristics are shown in Table 1. Among these women, 106 (74.1%), 32 (22.4%) and 5 (3.5%) reported one, two or 3 or more pregnancies, respectively. Figure 1 summarises the treatments during these reported pregnancies, disease activity outcomes and pregnancy outcomes. The biologic was stopped before conception for 9 pregnancies and 90 pregnancies started under biologics (anti-TNF, vedolizumab or ustekinumab). Of these, biologic was continued until delivery in 10 (11.1%) patients, whereas it was stopped before the week 20 for the others (88.9%). Among patients who stopped biologics before conception, before the week 20, and those who continued biologics through delivery: 3/9 (33.3%), 13/80 (16.3%; including 10/66 or 15.2% among those stopping on medical agreement) and 4/10 (40%) relapsed, respectively. Among the 10 relapses in patients who stopped in first trimester on medical agreement, 6 had normal biomarkers before cessation (unknown for the others). Conclusion Biologic discontinuation before week 20 on medical agreement was associated with relapse in 15.2% of cases. Fate of disease activity and pregnancies in patients stopping biologic before week 20 should be studied prospectively in a dedicated study.

56 Audit of assessment, prevalence, and treatment of osteoporosis for patients attending the inflammatory bowel disease Service in Mullingar Regional Hospital

Abstract Background Courses of steroids are common in patients with Inflammatory Bowel Disease (IBD) and are a risk factor for developing osteoporosis. Osteoporosis is a clinically silent entity and osteoporosis-related fractures are associated with chronic pain, disability, and impact quality of life. Screening of high-risk populations is the mainstay of fracture prevention. In this audit, we aimed to assess adherence to international guidelines for osteoporosis risk assessment and bone protection. Methods A retrospective audit was performed with a random sampling of 10% of the patients attending between October 2021 to October 2022 the IBD outpatient clinic in Mullingar Regional Hospital. Data included demographics, IBD diagnosis, FRAX tool components, FRAX score, bone health screening, DEXA results, and use of bone mineral protection. Clinical practice was compared against European Crohn’s and Colitis Organisation (ECCO) recommendations on bone protection in IBD. Results Of 150 charts reviewed, 39 charts were missing essential data and 8 had a diagnosis other than IBD. All 103 patients included in the analysis had received >3 months of systemic steroid use, of which 50 had a diagnosis of Crohn’s disease and 63 with ulcerative colitis. Two (2%) patients had a FRAX risk assessment for osteoporosis, and 22 (21%) had a DEXA ordered, of which 7 (7%) were by the IBD clinic. Two (2%) patients had a previous fragility fracture and 3 (3%) had been diagnosed with osteoporosis. Bone protection was used in 21 (20%) patients receiving steroids, including calcium and vitamin D supplementation (n = 19), and bisphosphonate (n = 2). Conclusion There are low rates of osteoporosis screening for IBD patients attending this service. There was inadequate data in the charts to calculate FRAX scores to assess osteoporosis prevalence. An intervention tool is currently being designed and the audit cycle will be completed with a repeat audit after implementation.

Adherence to ECCO Guidelines for Management of Iron Deficiency and Anemia in Inflammatory Bowel Diseases Among Israeli Adult and Pediatric Gastroenterologists.

The consensus guidelines of the European Crohn's and Colitis Organization (ECCO) for the diagnosis and treatment of iron deficiency anemia (IDA) were published in 2015. We examined the management practices of both adult gastroenterologists (AGs) and pediatric gastroenterologists (PGs) in Israel in treating ID among patients with inflammatory bowel disease (IBD). An 18-question multiple-choice anonymous questionnaire was electronically delivered to AGs and PGs. Questions explored 3 areas of interest: physician demographics, adherence to ECCO guidelines, and management practices of IDA in patients with IBD. Completed questionnaires were returned by 72 AGs and 89 PGs. Practice setting and years of practice were similar. A large majority of AGs and PGs (89% and 92%, respectively) measure complete blood count (CBC) and serum ferritin (S-Fr) at least every 3 months in outpatients with active IBD, as recommended by the ECCO guidelines. In contrast, in IBD patients in remission, only 53% and 26% of AGs and PGs, respectively ( P < 0.001), reported adherence to ECCO guidelines, measuring CBC and S-Fr every 6 months. The ECCO treatment guidelines recommend that intravenous (IV) iron should be considered the first-line treatment in patients with clinically active IBD, with previous oral iron intolerance and those with a hemoglobin level <10 g/dL. Study results indicate that only 43% of AGs recommend IV iron for these indications, compared to 54% of PGs ( P > 0.1). In this study we have demonstrated a relatively low level of adherence to ECCO guideline recommendations among both AGs and PGs, regarding the management of IDA in patients with IBD.

An Overview of Emerging Trends and Technologies in Ulcerative Colitis

&#x0D; This report provides an overview of the evolving therapeutic landscape for moderate to severe ulcerative colitis (UC), including recent changes to clinical practice guidelines, key trends in therapeutic strategies, and new or emerging treatment options, with a focus on biologics and small-molecule therapies.&#x0D; Recent guidelines on the medical management of patients with UC include those of the American Gastroenterological Association (AGA), American College of Gastroenterology (ACG), and European Crohn’s and Colitis Organisation (ECCO), which were published in 2019, 2020, and 2022, respectively. These guidelines provide an accurate reflection of how clinical practice has changed to incorporate newer therapies that have entered the market and newer evidence that has been published since the release of the Canadian guidelines in 2015. The ACG, AGA, and ECCO guidelines all recommend use of a tumour necrosis factor (TNF) antagonist, vedolizumab, or tofacitinib for induction of remission in patients with moderate to severe UC; the AGA and ECCO guidelines also recommend ustekinumab as an option and recommend vedolizumab over adalimumab, whereas the AGA guidelines recommend early use of biologic drugs over a step-up approach after failure of 5-aminosalicylates.&#x0D; Two important trends in therapeutic strategies for UC include changes in the use and definition of treatment targets and recommendations regarding therapeutic drug monitoring (TDM).&#x0D; &#x0D; The 2021 Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE-II) guidelines provide contemporary consensus recommendations for using new and updated targets throughout an individualized treatment timeline in patients with inflammatory bowel disease (IBD). Although histologic remission is not considered a formal UC treatment target in STRIDE-II, it is acknowledged as an adjunctive measure to endoscopic remission to represent a deeper level of healing and is the focus of many current studies.&#x0D; The use of TDM emerged from challenges associated with the use of older biologics (primarily TNF antagonists), which posed difficulties related to immunogenicity and dosing. The relevance of TDM for newer biologics with different mechanisms of action, reduced immunogenicity, and fixed dosing (e.g., vedolizumab and ustekinumab) is a topic of ongoing debate. Although AGA guidelines on TDM in IBD and expert consensus statements support the use of reactive TDM for patients with UC who lose response to a TNF antagonist, evidence gaps remain regarding appropriate use of proactive TDM, utility of TDM for small molecules and biologics outside of the TNF antagonist class, and consistent target concentration thresholds to guide dose changes.&#x0D; &#x0D; &#x0D; There is a substantial pipeline of new and emerging drugs for the treatment of adults with moderate to severe UC, with many in phase IIb or III of clinical development; several notable trends of emerging pharmacotherapies exist, including an increasing number of Janus kinase inhibitors, several therapies with biologic targets that are new in UC (e.g., interleukin-23 antibodies, TNF-like ligand 1A inhibitors), an increasing number of oral therapies, and the first combination of 2 biologic therapies in UC.&#x0D; The Canadian health care system should be prepared to adapt to the rapidly evolving treatment landscape and potential clinical practice changes in moderate to severe UC. Drugs with new mechanisms of action in the treatment area and the new paradigm of combination therapy with multiple biologics of different classes may lead to improved patient outcomes but can also further complicate the treatment decision-making process. Therefore, it is important for health care providers to stay up to date on new and upcoming treatment options, which may require educational initiatives for both providers and patients as well as updates to the Canadian treatment guidelines. Overall, potential changes on the horizon may have substantial implications for the health care system given the prevalence of UC in Canada, the costs of advanced therapies, and the increasing number of available treatment options.&#x0D;

OP19 Gaps between ECCO quality standards of care and the real world: the E-QUALITY survey

Abstract Background Recently, the European Crohn’s and Colitis Organisation (ECCO) Consensus on Quality-of-Care (QoC) Standards proposed essential criteria on the structure of units who manage patients with inflammatory bowel disease (IBD)1. The E-QUALITY taskforce investigated whether there is a gap between the given recommendations and the real-world structure of IBD units across ECCO-affiliated countries. Methods The E-QUALITY task force developed a web survey accessible to all institutions affiliated to ECCO across Europe. Each institution was invited by email to participate. Only one delegate per institution was requested to respond to the 48 questions listed in the web questionnaire. A descriptive analysis was done. Results Data were collected from September 2022 to December 2022. One-hundred nineteen institutions from 24 countries responded (Figure 1). Characteristics of the institutions are shown in Figure 2. Overall, 80 (67%) institutions identified their hospital as an IBD Unit, 75 (63%) had identified IBD sub-specialists (4 on average per hospital), 66 (55%) had a dedicated IBD nurse, 69 (58%) had an IBD surgeon, and 92 (77%) had a referral pathway for complex IBD surgery. In 81 (68%) institutions there was a regular MDT discussion of IBD cases. The multidisciplinary team (MDT) included at least one pathologist in 80 (67%) institutions, a radiologist in 86 (72%), a dietitian in 69 (58%), and a stoma specialist in 79 (66%). In 107 (90%) institutions, timely access to another sub-specialist (i.e., dermatologist, rheumatologist) was provided. Paediatric-to-adult transition clinics were available in 66 (55%) institutions. In 77 (64%) institutions, departmental IBD management guidelines were reported however, only 56 (47%) developed and applied quality indicators. Almost all institutions (113, 95%) provide direct contact to patients, mainly by telephone and email, and 105 (88%) provide remote follow-up to their IBD patients. In 111 (93%) institutions, there were facilities to administer intravenous therapies, 103 (86%) had an integrated hospital emergency department, 107 (90%) had inpatient admission rights, and 86 (82%) defined a pathway for early recognition of flares. Collaboration with patients’ associations was present in 99 (83%) of institutions, and a patient database was available in 88 (74%). Lack of dedicated funds, protected time and shortage of personnel were regarded as the three main challenges to achieving and maintaining QoC. Conclusion Our survey has revealed that the structure of IBD units across Europe seems to be consistent with the ECCO standards, although some gaps still exist. ECCO will improve programs and initiatives to help institutions provide standard QoC across countries.

DOP82 Biological Treatment Cycles in Crohn’s Disease

Abstract Background There are now a growing number of licensed biological therapies for patients with Crohn’s disease (CD) but given the costs of long-term maintenance treatment, as well as some concerns about potential side effects, there has been increasing interest in elective biological treatment discontinuation in selected patients, after a period of sustained remission. Following discontinuation, in cases of relapse, limited but reassuring evidence has suggested that remission may often be regained by retreatment with the same biological agent. Therefore, a concept has emerged where cycles of biological therapy might be used. If this treatment strategy were applied in a subgroup of patients at low-risk of relapse, cycling might allow lower, overall drug exposure but still enable appropriate disease control. However, currently, there remains uncertainty about the benefit-risk balance for using cycles of biological treatment in patients with CD. Methods An expert panel was convened by the European Crohn’s and Colitis Organisation (ECCO) to review the published literature and agree a series of consensus practice positions (CPPs) on the topic of biological treatment cycles (biocycling). An open-call was announced to all ECCO members, following which 15 individuals were selected based on their expertise, and three subgroups were formed. The panel aimed to provide evidence-based guidance to support shared decision-making. Results A total of 14 CPP consensus statements were developed following comprehensive review of the literature. The statements evaluated multiple different aspects of biological treatment discontinuation and cycling, including the risk of relapse after elective treatment discontinuation, predictors of likely relapse or remission, safety, patient preferences and pharmacoeconomic aspects. Discussion and a preliminary voting round took place, with subsequent revision of CPP statements and supporting text, followed by a further meeting with voting to agree on final statements. Conclusion With increasing focus on patient preferences, long-term safety and costs, elective biological treatment discontinuation may be considered for some patients with CD in remission. In cases of relapse, there have been reassuring findings on subsequent retreatment with the same biological agent. However, there is a need for more data to support routine elective treatment discontinuation and cycling in CD, especially for newer biological agents. In particular, randomised, controlled trials comparing biological cycling to current maintenance therapy strategies would be highly informative. Currently, discussions about biological treatment discontinuation and cycling should be individualised, to enable shared decision-making by patients with their clinicians.

Biological markers of disease activity in inflammatory bowel diseases.

Inflammatory bowel diseases (IBD) are chronic intestinal conditions of multifactorial aetiology including genetic susceptibility, immunological impairment, dysbiosis, and environmental factors. The diagnosis is based on both clinical and endoscopic features, wherein histopathological evaluation remains a gold diagnostic standard. However, fast, reliable, and non-invasive biological markers have been used for years for diagnosis as well as for disease activity monitoring. Currently, commonly used faecal calprotectin is the only biomarker approved and recommended by the European Crohn's and Colitis Organization (ECCO). Nonetheless, other biological markers discriminating between functional and organic bowel conditions have been widely studied. Therefore, the aim of this manuscript was to review new potential biomarkers of inflammation in IBD. The aim of this study was to review currently available biomarkers of intestinal inflammation and increased gut permeability in IBD.

Anemia and Iron Deficiency in Outpatients with Inflammatory Bowel Disease: Ubiquitous Yet Suboptimally Managed.

Iron deficiency (ID) and anemia in patients with Inflammatory Bowel Disease (IBD) are associated with a reduced quality of life. We assessed the prevalence of ID and anemia in Dutch outpatients with IBD and compared routine ID(A) management among medical professionals to the European Crohn's and Colitis Organisation (ECCO) treatment guidelines. Between January and November 2021, consecutive adult outpatients with IBD were included in this study across 16 Dutch hospitals. Clinical and biochemical data were extracted from medical records. Additionally, medical professionals filled out questionnaires regarding routine ID(A) management. In total, 2197 patients (1271 Crohn's Disease, 849 Ulcerative Colitis, and 77 IBD-unclassified) were included. Iron parameters were available in 59.3% of cases. The overall prevalence of anemia, ID, and IDA was: 18.0%, 43.4%, and 12.2%, respectively. The prevalence of all three conditions did not differ between IBD subtypes. ID(A) was observed more frequently in patients with biochemically active IBD than in quiescent IBD (ID: 70.8% versus 23.9%; p &lt; 0.001). Contrary to the guidelines, most respondents prescribed standard doses of intravenous or oral iron regardless of biochemical parameters or inflammation. Lastly, 25% of respondents reported not treating non-anemic ID. One in five patients with IBD suffers from anemia that-despite inconsistently measured iron parameters-is primarily caused by ID. Most medical professionals treat IDA with oral iron or standard doses of intravenous iron regardless of biochemical inflammation; however, non-anemic ID is often overlooked. Raising awareness about the management of ID(A) is needed to optimize and personalize routine care.

What Is the Role of the Environment (Exposome) in Inflammatory Bowel Disease?

OPENING Day 2 of the 17th Congress of European Crohn’s and Colitis Organisation (ECCO), James Lindsay, Professor of Inflammatory Bowel Disease, Barts Health NHS Trust, London, UK, and The London School of Medicine, Queen Mary University of London, UK, discussed the influence of the environment on the risk of developing inflammatory bowel disease (IBD). The presentation discussed the pathways that mediate environmental impact on IBD as well as the limitations of presently available research, giving a valuable insight into what future studies could be conducted to ultimately determine the role of environmental factors in IBD. The present understanding of IBD, an inflammatory disease, which includes Crohn’s disease (CD) and ulcerative colitis (UC), is that the condition arises from an immune response to micro-organisms of the intestinal flora in genetically susceptible individuals. In addition to disease pathogenesis, other important aspects such as progression, extraintestinal manifestations, and immunogenicity to therapies, are yet to be well understood. While the genetics base is clear, it does not account for the discordance of disease in monozygotic twins, the increased incidence in second generation immigrants, or the rapid increase in IBD cases in the last 50 years. In light of these observations, Lindsay expressed the importance of examining the role of the environment, which, he stressed, does not comprise a single factor, but a multitude of factors that are likely to impact disease onset and natural history.

P119 Hereditary Colorectal Cancer Syndromes and Inflammatory Bowel Diseases: an ECCO CONFER Multicenter Case Series

Abstract Background Hereditary colorectal cancer syndromes (HCCS) are rare polyposis or nonpolyposis syndromes with a higher risk of developing colorectal cancer (CRC). Coexisting inflammatory bowel disease (IBD), including ulcerative colitis (UC) and Crohn’s disease (CD), with HCCS is exceedingly rare and presumably increases the risk of early-onset colorectal cancer. Methods This was a multicenter case series performed as a part of the European Crohn’s and Colitis Organisation (ECCO) Collaborative Network of Exceptionally Rare case reports (CONFER) project. Results This report includes 26 patients with IBD (10 UC, 15 CD, and one with IBD unclassified (IBD-U)) and concomitant HCCS. Among these 26 patients (median age 33 years, IQR 20–44), 15 (57.7%) were males, 24 (92.3%) Caucasians and 2 (7.7%) of Arab origin. Among patients with UC, 4 (40%) had proctitis, 3 (30%) left-sided colitis and 3 (30%) an extensive disease; while, among patients with CD, 8 (53.3%) had ileal, 5 (33.3%) ileocolonic, 2 (13.3%) colonic disease. One of these patients had ileocolonic disease associated with upper disease location and six (40%) had an associated perianal disease. Many of patients with CD had a non-stricturing non-penetrating phenotype (53.3%, n=8), while 20.0% (n=3) and 26.7% (n=4) had a stricturing or penetrating phenotype, respectively. HCCS was diagnosed before the IBD diagnosis in 11 patients (42.3%), after diagnosis of IBD in 11 patients (42.3%) and concurrently in 4 patients (15.4%). Sixteen patients had Lynch syndrome, 7 had FAP, 2 had AFAP and one had MAP. The most frequent genetic mutations were those of APC (n=7) and MLH1 (n= 7). Thirteen patients were treated with immunomodulatory (IMM) therapy. During IMM therapy, only 5 patients developed drug-induced side-effects which did not require drug interruption. One patient treated with vedolizumab developed CRC, despite yearly colonoscopy surveillance, after 4 years of treatment. Overall, CRC developed in 38.5% of patients (n=10): in 5 patients (50%) after IBD diagnosis, in 4 (40%) patients before IBD diagnosis, and in 1 patient the 2 conditions were diagnosed simultaneously. Eighteen (69.2%) patients underwent colectomy or abdominal surgery: 9 patients due to CRC diagnosis, 7 patients preventively due to the underlying HCCS and 2 patients because of active IBD disease. On follow-up, one patient died due to CRC. Conclusion This case series describes the largest series to date of patients with IBD patients and HCCS, with special emphasis on the use of IMM in this population. The most frequent diagnosis of HCCS associated with IBD was Lynch syndrome. These data demonstrate the high malignancy rate and surgical intervention rate in this IBD cohort. The optimal medical approach still needs to be addressed.

Assessing aCCess to Investigations in Inflammatory Bowel Disease (ACCID): results from an international survey.

Multiple investigations are available to aid the diagnosis and monitoring of disease activity in inflammatory bowel disease (IBD). Fecal calprotectin (FC) is an established surrogate for intestinal inflammatory activity. Therapeutic drug monitoring (TDM) including thiopurine metabolites, anti-tumor necrosis factor (TNF) levels and antidrug antibody measurements are a step toward personalized medicine in IBD, but face access barriers. We aimed to assess test availability and barriers for these investigations in European practice. Five-hundred questionnaires were distributed to workshop participants at the 11th Congress of the European Crohn's and Colitis Organisation (ECCO). Access to FC, TDM for thiopurines and anti-tumor necrosis factor agents, as well as factors associated with usage and barriers to access were recorded. Responses were obtained from 195 attendees from 38 countries across a range of practices, healthcare settings and levels of experience. FC was available to 92.3% while access to anti-TNF (78.9%, P = 0.02 vs. thiopurine TDM, P = 0.0002 vs. FC) and thiopurine TDM (67.7%, P = 0.0001) were less widespread. Cost was a frequently cited barrier to test access or usage, with access having a significant West-East and North-South divide across all three investigations. The strongest independent predictor of access to all tests was healthcare spending per capita (P = 0.005 for FC; P < 0.0001 for both TDM). FC, anti-TNF and thiopurine TDM are increasingly incorporated as part of routine practice in IBD care across Europe and have the potential to impact positively on patient care. However, access barriers remain of which we found test cost the most significant with the investment required to reduce these barriers.