bluuebunny/crossref_metadata_2025 huggingface dataset:
P1062 Effectiveness and safety outcomes beyond five years of IBD patients treated with vedolizumab. The LONG-LIVE IG-IBD study
Authors: Privitera G , Pugliese D , Armuzzi A
Published: January 2024

Background

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

Methods

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

Results

782 (70%) pts were enrolled in the LTE (394 CD, 388 UC), 316 (40%) of whom had already definitively discontinued VDZ; 43% were female, mean age was 53±16 years, mean disease duration was 17±9 years, 76% of patients were bioexposed to anti-TNFα therapy. Among the 466 still receiving VDZ, 204 (44%) subsequently suspended VDZ permanently and 9(2%) temporarily: mean VDZ therapy duration was 113±92 and 311±60 weeks among those who suspended and those who continued VDZ, respectively. Mean therapy persistence was 195±5 weeks (no differences between CD and UC); longer mean persistence was observed in bionaive vs bioexposed CD pts (214±16 vs 178±8 weeks, p<0.05), while no such difference was observed in UC pts. Among pts who continued VDZ throughout the entire LTE, 74% and 50% were in clinical and endoscopic remission, at the last fup. During the LTE, 153(20%) pts (83 CD, 70 UC) received IBD-related surgery after a mean time of 136±87 weeks from VDZ start; 85 (11%, 54 CD, 31 UC) pts underwent IBD-related hospitalization for nonsurgical reasons. New or recurrent cancers were reported in 17 pts, 3 of which localized in the gastrointestinal tract: mean interval between first VDZ administration and cancer diagnosis was 214 (±95) weeks; 20 non-oncological SAEs were recorded in pts receiving VDZ, the most common being infections (n=7), mostly pneumonia. Finally, 15 deaths were reported: 5 due to infections and 5 due to cardiovascular diseases.

Conclusion

About one-third of pts were still receiving VDZ after a fup of more than 6 years, with the majority of them being in clinical remission and more than 50% also having quiescent endoscopic activity at the last observation; bionaive CD patients had longer persistence compared to bioexposed ones. Most IBD-related hospitalizations were due to the necessity of surgery. SAEs were observed in a minority of patients and predominantly consisted of infections; the rates of cancer diagnosis are seemingly in line with those of the general population. Our study strengthens the notion that VDZ is associated with long-term real-life durability in terms of effectiveness and safety.
P1063 Comparison of all paediatric patients and young adults with Crohn’s Disease treated with ustekinumab in the REALITI Real-World Evidence Effectiveness Study
Authors: Shehzad S , Steiner S , Adler J , Colletti R B , Strauss R , Heile J , Adedokun O , Sheahan A , Zhang R , Lo K H , Kim L , Xiao Y , Volger S
Published: January 2024

Background

Treatment of paediatric patients (pts) with Crohn’s disease (CD) can offer some challenges to providers. There is an urgent need to inform prescribers about paediatric efficacy, safety, and dosing. REALITI evaluated the effectiveness and safety of ustekinumab (UST) routine clinical care in paediatric pts (age 2 to <18) regardless of disease severity or baseline corticosteroid use. Reference data are shown for young adults (age 18 to 25) with CD, for whom UST is approved. Data were obtained from the ImproveCareNow (ICN) Registry.

Methods

Data from pts from ICN with CD initiating treatment with UST between 10 January 2010 and 29 February 2020 were evaluated. A supplemental, retrospective chart review collected data not in ICN. The primary endpoint was clinical remission (Short Paediatric CD Activity Index [sPCDAI] score ≤10) at Week (Wk) 52. Data were summarized descriptively, and the proportion of pts achieving clinical remission and associated 2-sided 95% confidence intervals (CI) were calculated along with rates of inflammatory bowel disease (IBD)-related hospitalization and surgeries and serious/opportunistic infections.

Results

Overall, 479 pts in ICN with CD were treated with UST. We report an analysis of paediatric pts (n=348) compared to young adults (n=131). Most paediatric pts (98.9%) and young adults (95.4%) had received prior biologic therapy, with approximately half (47.1% and 50.4%, respectively) receiving corticosteroids at baseline. Slightly higher proportions of pts had moderate to severe disease (sPCDAI ≥30) among paediatric pts (49.7%) vs young adults (44.8%). Clinical remission at Wk52 was achieved in 30.2% of paediatric pts (105/348; 95% CI: [25.6%, 35.2%]) vs 28.2% of young adults (37/131; 95% CI: [21.2%, 36.5%]) (Figure 1A). Clinical remission rates decreased slightly over time from Wk 20-52 (Figure 1B); discontinuation rates through WK 52 remained low and were similar between groups (21.0%, 22.9%, respectively).

Overall, 31.9% of paediatric pts and 19.8% of young adults had IBD-related hospitalizations; IBD-related surgery was reported in 16.1% and 9.2% of pts, respectively. Serious infections occurred in 7.5% of paediatric pts and 3.8% of young adults. Rates of opportunistic infections were low (1.4%, 0%, respectively).

No events of tuberculosis, malignancy, or anaphylaxis requiring UST discontinuation occurred. One death, deemed by investigators as unrelated to IBD or UST treatment, was reported among paediatric pts; no deaths were reported among young adults.

Conclusion

Using real-world data from the ICN Registry, the remission rates for using UST to treat CD were found to be generally comparable between paediatric pts and young adults. No new safety signals were identified.
P1114 Integral care of the non-Spanish speaking migrant population in inflammatory bowel disease units
Authors: Berdugo-Hurtado F , Benito-Palma S , Martínez-Tirado M P , Del Mar Martin Rodríguez M , Zúñiga-De Mora-Figueroa B
Published: January 2024

Background

In recent years, given the change in the paradigm of management of Inflammatory Bowel Disease (IBD), the different societies have been working to ensure continuous, homogeneous, multidisciplinary social and health care with the patients and their autonomy as the central axis; promoting the creation of Integrated Care Units for IBD patients (ICU-IBD).

In the latest analyses of our ICU, attention was drawn to the progressive increase in the demand for care from non-Spanish-speaking migrant patients. This prompted us to carry out this study, with the aim of finding out how this population uses our unit and how it responds to their needs.

Methods

A retrospective longitudinal descriptive observational study with analysis of demographic, clinical and care variables of all non-Spanish-speaking migrant patients followed in the ICU-IBD of our centre until 30 June 2023.

Results

Thirty patients of 14 different nationalities were included, with Moroccan being the most frequent (43.3%); only one of them (3.3%) was fluent in Spanish. Other clinical and demographic characteristics of note were: mean age at follow-up of 43.2 years, predominantly female (66.6%) and predominantly Crohn's disease (63.3%) (Table 1).

A total of 86.7% of the patients were referred to our ICU-IBD from the Emergency Department, which they attended due to symptoms related to flare-ups of their intestinal disease.

After the initial assessments, we observed that 73.3% did not attend for check-ups, 83.3% of the patients attended the emergency department in the event of a clinical flare-up, and 93.3% showed irregular adherence to treatment. In the subsequent follow-up, we observed a significant change, 76.7% regularly attended consultations, 76.7% consulted the unit in the event of an outbreak and 60% followed treatment regularly (Figure 1). These changes coincide with a socio-health intervention carried out by the specialised nurse; in which patients and their environment were provided with information regarding their disease, treatment and use of the UAI-EII; as well as addressing socio-health problems in order to facilitate their wellbeing and integration into the community.

Conclusion

In view of our results and the data published in other studies, we suggest that the language barrier, the social and healthcare culture of the country of origin, the socioeconomic situation and integration into the new social environment are factors to be taken into account in order to achieve adequate comprehensive care for this migrant population.

The role of the IBD nurse is fundamental in the daily work of offering individualised, continuous and comprehensive care to both the patient and their environment; even more so in this population with marked socio-cultural barriers.
P1126 Navigating the Future: Minimally Invasive Surgery Trends in Ulcerative Colitis
Authors: Ferrari D , Violante T , Novelli M , Larson D
Published: January 2024

Background

Minimally invasive surgery (MIS) has been associated with lower rates of postoperative complications in ulcerative colitis (UC), both in the elective and emergency setting, compared to the traditional open approach. Despite these findings, some clinical guidelines state that minimally invasive surgery is not superior to open surgery in UC and emphasize an individual approach based on the surgeon’s judgment. This study analyzed the trends in open and minimally invasive approaches in total colectomies for UC.

Methods

A retrospective analysis was conducted on the ACS-NSQIP database encompassing all patients undergoing total colectomy for UC from 2012 to 2021. The primary endpoint involved analyzing open, laparoscopic, hand-assisted, and robotic surgery trends. A time series analysis was performed to forecast the future direction of these surgical techniques. Quarter (Q) and admission year were reported for time trend analysis. Dynamic relationships between various time series representing different surgical techniques were modeled using Vector Autoregressive (VAR) models. These models were employed to predict future trends in operative approaches until Q2 of 2025, along with 95% confidence intervals.

Results

A total of 7099 patients (44.5% female) were included, with a mean age of 45.1 (±17.8) years and mean BMI of 25.5 (±7.7) kg/m². Smoking was reported in only 8.7% of patients, with 49.1% classified as ASA 3 and 41.4% as ASA 2. Most patients (71.5%) were on steroids or immunosuppressants at the time of intervention.

At the beginning of the study period, nearly half of the interventions were performed with an open approach (45.2%), followed by laparoscopy (35.7%) and hand-assisted laparoscopy (19%). Trends indicated a decline in open surgery to 17.7% by Q2 of 2021, with an increase in laparoscopic (45%), hand-assisted (25%), and a consistent growth of robotic surgery to 12.3%. Forecasting shown in Figure 1 suggested a continuous decrease in open surgery until Q2 of 2025 (8.7%, 95% CI 0-32.5%), with laparoscopic (51.2%, 95% CI 26.4-75.9%), hand-assisted (29.1%, 95% CI 11.9-46.3%), and robotic (11.0%, 95% CI 7.5-14.6%) approaches on the rise.

Conclusion

Minimally invasive surgical techniques have steadily grown over the past decade in the treatment of ulcerative colitis. Predictions indicate continued growth, displacing traditional open approach, which may persist as a rescue procedure.
P1129 Fistulising Crohn's Disease in a large Australasian cohort - Crohn's Colitis Cure (CCC) Data Insights Program
Authors: Mcnamara J , Wilson W , Pipicella J L , Ghaly S , Gearry R , Begun J , Ng W , Lynch K , Lawrance I , Schultz M , Walker G , Radford-Smith G , Andrews J M , Connor S J
Published: January 2024

Background

Fistulising Crohn’s disease (fCD) affects up to 40% of people with Crohn’s disease (CD) over their lifetime, leading to perianal pain, faecal incontinence and sepsis. Despite its high prevalence, the burden of disease, treatment and “natural history” in the current biologic therapy era are poorly described. This study explored demographics, disease and treatment factors in a real-world cohort

Methods

The clinical quality registry (CQR) is created from deidentified data flowing into a registry during documentation in routine care. The CQR was interrogated in December 2022. People with CD with a care encounter in the last 14 months at one of 20 treating centres were included (n=3039). People with a current fistula were defined as those with an actively draining fistula on most recent clinical assessment, radiologic or endoscopic investigation. Previous fCD was defined as the prior presence of a fistula with most recent documentation showing resolution

Results

There were 3039 people with CD with a mean age of 43.1 years (SD +/- 16.23). 49% of the total CD cohort were female with a mean disease duration of 13.7 years (SD +/- 10.1). 532 (17.5%) people with CD had fCD documented in the CQR, with 220 current and 312 previous fCD. People with current or previous fCD were younger than those with no prior fistulising disease (40.5 & 39.6 vs 44.1, p=0.005 & p<0.001). Male gender was more commonly seen in those with current (58% p=0.022) or previous fCD (58% p=0.007) compared to those with no prior fCD (50% n=1270)

People with current and previous fCD had higher rates of current biologic use compared to those with no prior fCD recorded (75.5% & 68.3% vs 48.9%, p<0.001 & p<0.001, respectively). Of those on biologic therapy, people with current or previous fistula were more likely to be on anti-TNF therapy (Adalimumab or Infliximab) compared to those with no history of fCD (85.5% & 82.2% vs 68.1%; p<0.001 & p<0.001 respectively). People with active or previous fCD were less likely to have ever been on steroid therapy compared to those without a history of fistulising disease (23.6%, 24.4% & 32.3%, p<0.001 & p<0.001)

People with current or previous fCD had higher rates of CD-related hospital admissions compared to those without a history of fCD (5% & 6% vs 1.9%, p<0.001 and p<0.001 respectively). People with previous fistulising disease had higher rates of surgery within the last 12 months compared to people with no prior fCD (21.2% vs 13.3%, p<0.001)

Conclusion

People with current and previous fCD continue to experience higher hospitalisation rates for disease related complications and more frequently require surgical procedures. This highlights the importance of proactive management of fCD to reduce morbidity and avoidable healthcare utilisation
P1134 Incidence of invasive fungal diseases in inflammatory bowel disease patients: a nationwide study in South Korea
Authors: Jung S H , Kim T O , Kang S B , Na J E , Kim J S
Published: January 2024

Background

Limited reports exist regarding invasive fungal diseases (IFDs) in inflammatory bowel disease (IBD) patients. This study aims to investigate the incidence and risk factors of IFDs, specifically invasive candidiasis, aspergillosis, and pneumocystosis, in IBD patients in South Korea using nationwide data.

Methods

A population-based retrospective cohort of 42,913 IBD patients between January 2010 and December 2018 was evaluated using the Health Insurance Review and Assessment database. The primary outcome was the incidence of IFDs, including invasive candidiasis, aspergillosis, and pneumocystosis, while the secondary outcome involved analyzing the risk factors associated with each specific infection.

Results

The study included a total of 42,913 IBD patients, with 29,909 (69.7%) diagnosed with ulcerative colitis (UC) and 13,004 (30.3%) diagnosed with Crohn's disease (CD). IFDs occurred in 166 IBD patients (0.4%), with 93 cases in UC patients and 73 cases in CD patients. The incidence rates of invasive candidiasis, aspergillosis, and pneumocystosis in IBD patients were 0.71 per 1,000 person-years (PYs), 0.15 per 1,000 PYs, and 0.12 per 1,000 PYs, respectively. The cumulative incidence of invasive candidiasis (adjusted p-value < 0.001) and pneumocystosis (adjusted p-value = 0.012) was found to be higher in CD patients than in UC patients. Each IFD had different risk factors, including IBD subtypes, age at diagnosis, anti-tumor necrotic factor agents, or the Charlson comorbidity index.

Conclusion

Based on nationwide data in South Korea, this study shows that IFDs occur consistently in patients with IBD, albeit with a low frequency.
P1140 Complementary and alterantive medicicne in patients with Inflammatory Bowel Disease in Poland
Authors: Maciejewska K , Lodyga M , Tulewicz-Marti E , Karlowicz K , Rydzewska G
Published: January 2024

Background

There is an increasing interest in complementary and alternative medicine (CAM) in patients with chronic diseases, including inflammatory bowel disease (IBD). We decided to investigate this problem because there is still not much data on this interesting and underestimated topic.

Methods

This single-center, cross-sectional study was conducted between October 2021 and June 2022 among patients of the Department of Gastroenterology of the National Institute of Medicine of the Ministry of Internal Affairs and Administration, both hospitalized and outpatients. Patients with IBD were asked to complete an anonymous survey that included questions about the use of CAM, their type and reason for use. The questionnaire also included data on the course of the disease, treatment and socio-demographic information.

The results of qualitative variables were expressed as frequencies and percentages. We used the chi-square and Mann-Whitney U tests.

Results

435 patients were included in the study: 203 women (46.9%) and 230 men (53.1%). In this group, there were 250 (58.5%) with Crohn's disease (CD) and 177 (41.5%) with ulcerative colitis (UC). The average duration of the disease is 10.9 years. A little more than a half of patients received immunosuppressive and biological treatment. Among respondents, 66.9% (291) had ever used CAM. CAM was statistically more frequently used by people treated with immunosuppressive 60.26% (p=0.002) and biological drugs 72.51% (p=0.004), as well as people with higher education 71.75% (p=0.006) and secondary education 58.97 % (p=0.009), living in large cities 73.63% (p=0.006) and earning the highest income 85.51% (p<0.001). Age, gender, disease duration, use of other drugs (5-ASA, steroids) and disease diagnosis (UC vs. CD) did not influence the use of CAM. As many as 74.1% of CAM users use various types of dietary supplements. 61.5% of respondents follow special diets, 56.9% take probiotics, and 53.4% take herbs. Patients most often gain knowledge about CAM from other patients, family members (76.3%) and from the Internet (76.3%). The treatment is carried out independently, without medical supervision, and only 62.1% of patients inform the gastroenterologist about the use of CAM.

Conclusion

Our research shows that CAM is very often used by IBD patients in Poland, especially among patients with severe disease treated with immunosuppressive and biological therapy. This is particularly important for patient safety, taking into account the possible risk of interactions with conventional drugs and the usually lack of medical supervision.
P1147 Symptoms of irritable bowel syndrome are common in patients in remission from Inflammatory Bowel Disease: Results from an observational population-based cohort study in Norway
Authors: Olsen B , Opheim R , Kristensen V A , Høivik M L , Lund C , Aabrekk T B , Johansen I , Aass Holten K I , Strande V , Frivold Glad I , Bengtson M B , Ricanek P , Detlie T E , Medhus A W , Boyar Cetinkaya R , Torp R , Vatn S , Frigstad S O , Bernklev T , Jelsness-Jørgensen L P , Huppertz-Hauss G
Published: January 2024

Background

The present study aimed to estimate the prevalence of irritable bowel syndrome [IBS] symptoms and associated variables in a prospective cohort of patients with inflammatory bowel disease [IBD] in remission one year after diagnosis.

Methods

Adult patients [≥18 years old] with ulcerative colitis [UC] and Crohn’s disease [CD] were recruited from the Inflammatory Bowel Disease in South-Eastern Norway [IBSEN] III study, a population-based inception cohort. The prevalence of IBS-like symptoms was assessed using the Rome IV criteria for patients in remission one year after their IBD diagnosis was made. Three different definitions of remission were applied to evaluate IBS prevalence. Remission was defined as either endoscopic [Mayo endoscopic score 0 for UC, no visible ileal or colonic inflammation for CD] or biochemical [calprotectin ≤150 µg/g or ≤250 µg/g]. Results were compared to IBS prevalence in the general Norwegian population, as represented by data from the Trøndelag Health Study [HUNT4 study] 1. Demographic, psychosocial and disease-related factors associated with IBS-like symptoms were evaluated with uni- and multivariate logistic regression. Substantial fatigue was defined as a score of ≥4 on the Fatigue Questionnaire [FQ].

Results

Of 1320 patients with UC or CD who met for one-year follow-up, 635 patients completed the Rome IV questionnaire [response rate 48.1%; 52.1% female; mean age 44 years]. For 151 patients in endoscopic remission, 16.6% [95% CI: 11.0-23.5] reported IBS-like symptoms compared to 19.7% [95% CI: 14.9-25.2] of 244 patients with calprotectin ≤ 150 µg/g, and 21.8% [95% CI: 17.2-27.1] of 284 patients with calprotectin ≤ 250 µg/g. All three definitions of remission resulted in significantly higher prevalence of IBS-like symptoms compared to the Norwegian population [HUNT4 study; 9.5%; 95% CI: 9.2-9.8; p<0.005]. In multivariate analysis, IBS-like symptoms were independently associated with substantial fatigue [odds ratio (OR) 3.05, 95% CI: 1.48-6.27, p=0.002] and female sex [OR 2.67, 95% CI: 1.34-5.32, p =0.005].

Conclusion

Patients in IBD-remission one year after diagnosis reported a prevalence of IBS-like symptoms between 17% and 22%, depending on the definition of remission. This prevalence was significantly higher than that reported in the general Norwegian population. IBS-like symptoms were independently associated with substantial fatigue and female sex.

Reference

1. Johansen SG, Ness-Jensen E. The changes in prevalence and risk of irritable bowel syndrome over time in a population-based cohort, the HUNT study, Norway. Scand J Gastroenterol 2022:1-7.
P1151 Incidence and risk factors of thromboembolic events in Pediatric-Onset Inflammatory Bowel Disease: a population-based study
Authors: Richard N , Leroyer A , Ley D , Dupont C , Bertrand V , Wils P , Gower-Rousseau C , Turck D , Guillon N , Sarter H , Savoye G , Fumery M
Published: January 2024

Background

Patients with inflammatory bowel disease (IBD) are known to be more susceptible to thromboembolic events. However, limited data on the incidence and risk factors for both venous (VTE) and arterial thromboembolic events (ATE) have been documented at the population level, especially in pediatric-onset IBD.

Methods

All patients diagnosed with Crohn’s disease (CD) or ulcerative colitis (UC) before the age of 17 years from 1988 to 2011 in a prospective population-based registry were retrospectively followed until 2013. Every VTE and ATE occurring during the follow-up period were included. Cox proportional hazard models with hazard ratio (HR) were performed using time dependent variable except for patient’s characteristics at diagnosis.

Results

A total of 1,344 patients diagnosed with IBD between 1988 and 2011, including 1,007 (75%) patients with CD and 337 (25%) with UC, with a median age at diagnosis of 14.3, IQR [11.7-16.0] years were included. After a median follow-up of 8.3, IQR [4.3–13.9] years, 15 (1.1%) VTE and 2 (0.15%) ATE occurred at a median age of 20.4, IQR [16.6-24.5] years (younger age: 14.8 years). The global incidence rate for both VTE and ATE was 1.32 per 1000 person-years, 95%CI [0.77 - 2.11]. In CD patients, the incidence of VTE was 1.41 per 1000 person-years, 95%CI [0.77 - 2.37], whereas it stood at 0.33 per 1000 person-years, 95%CI [0.01 - 1.85] in UC patients. The risk of VTE and ATE did not change over the study period. Periods of active disease (HR 8.4 [2.3-30.5], p=0.0002), the 3-months postoperative period (HR 16.4 [5.2-52.3], p=0.0002) and hospitalization (HR 21.7 [7.5-62.9], p<0.0001) were found to be associated with an increased risk of VTE.

Conclusion

The risk of both arterial and venous thromboembolism was low in this pediatric-onset IBD population-based cohort. VTE were strongly associated with active disease, surgery and hospitalization among IBD patients.
P1152 Health-related quality of life among Irish Inflammatory Bowel Disease patients: a cross-sectional survey using the EQ-5D-5L
Authors: Mallon K , Doherty G , Burns R
Published: January 2024

Background

Inflammatory Bowel Disease (IBD), which includes Crohn’s disease (CD) and ulcerative colitis (UC) is a chronic, lifelong illness that has multiple impacts on patients’ physical and mental health. Approximately 40,000 individuals in Ireland have IBD and the burden on quality of life is expected to be substantial. Health-related quality of life (HRQoL) utilises quality weights (utilities), measured on a ‘0’ to ‘1’ scale where ‘0’ is defined as a health state equivalent to being dead and ‘1’ is full health, and is often used as a measure of population health status to inform public health and health care policy. Previous evidence has shown that a reduced HRQoL in patients with IBD is associated with higher disease activity, increased medication use, increased sick leave, decreased work participation, smoking, rheumatic symptoms, female gender, and having CD. Despite this evidence, there is a paucity of data on the impact of IBD on the HRQoL of IBD patients in Ireland.

Methods

A cross-sectional, online study was developed aimed at IBD Patients in Ireland and patients were recruited through study invites advertised on The Crohn's and Colitis Ireland social media channels and among patient representatives of INITIative IBD. Information on quality of life was collected using the EuroQol EQ-5D-5L questionnaire. Descriptive statistics describe sociodemographic and clinical characteristics. Categorical variables are summarized as frequencies and percentages. Utility scores are presented as the mean and standard deviation (SD). To evaluate factors correlating with HRQoL in IBD patients, a univariate regression model was applied. Significant variables (p<0.05) were further included in a multivariable ordinal least squares regression model.

Results

A total of 161 IBD patients were recruited. The average EQ-5D-5L utility score was 0.76. Average utility scores were similar for UC (0.76) and CD (0.75) patients, with IBDU patients scoring slightly higher (0.80). Average utility scores were highest for those aged 50-59 years (0.93), with an average utility score for those aged 30-39 of 0.71. Average utility scores were higher in males (0.78). Utility scores ranged from .133 to 1. When compared with those in remission, patients with severe disease severity had significantly lower utility scores (β=-.261; p=0.000).

Conclusion

Findings suggest that HRQoL in IBD patients in Ireland varies according to disease severity. These findings may indicate that follow-up care should include generic HRQoL measurements along with disease-specific as an objective tool for monitoring IBD disease course. This research offers important information for policy-makers for developing better strategies for IBD patients, as well as clinicians, academics and IBD patients.
P1179 Long-term impact of COVID-19 on the disease course of IBD: a meta-analysis
Authors: Vitus E S , Mann S , Lees C , Jess T , Elmahdi R
Published: January 2024

Background

Viral infections have been implicated in the exacerbation of immune-mediated inflammatory diseases like inflammatory bowel disease (IBD). The COVID-19 pandemic, therefore, sparked interest in whether infection with the virus has an adverse effect on the course of IBD. Since the existing evidence is conflicting and limited by a small sample size, we performed the very first meta-analysis to study the long-term impact of SARS-CoV-2 infection on the disease course of IBD.

Methods

We performed a systematic literature search in MEDLINE and EMBASE for studies that explored the risk of adverse IBD outcomes following a SARS-CoV-2 infection. We used the random effects model meta-analysis to calculate the pooled hazard ratio for the risk of IBD flares following the acute phase of COVID-19. Subgroup meta-analysis was carried out for the risk of the outcomes by IBD subtype. Meta-regression was carried out for sex and duration of follow-up. The ROBINS-E tool for observational studies was used to assess the quality of the studies.

Results

A total of 5 studies were included in the meta-analysis. The studies were based on cohorts from Denmark, Italy, the US, and a cohort from a consortium of the EU comprising a total of 34977 SARS-CoV-2 positive IBD patients and 53270 IBD patients without the infection as controls. Two of the studies had a high risk of bias according to the quality assessment tool. The meta-analysis did not show an increased risk of IBD-related outcomes in IBD patients who contracted a SARS-CoV-2 infection compared to those who did not (HR: 1.0514, CI: 0.7547- 1.4646, p= 0.7671). There was substantial heterogeneity between the included studies (91%, p<0.01). There was no significant difference between CD and UC patients in terms of disease flare (CD- HR: 0.9134, CI: 0.8163-1.0220; UC- HR: 0.8257, CI: 0.7549-0.9032). Neither sex nor the duration of follow-up was a predictor of the overall effect size.

Conclusion

In this group of patients, SARS-CoV-2 infection does not increase the risk of adverse outcomes related to IBD. High-quality studies with longer follow-up duration are required to understand the long-term impact of SARS-CoV-2 infection on IBD prognosis.
P1185 IBD Has No Age: Preliminary results of an international survey among older patients with Inflammatory Bowel Disease (IBD)
Authors: Fons A , Girardi P , Savini C , Maljaars J , Haaf I , Avedano L , Asscher V
Published: January 2024

Background

Future research and health policy can benefit from a better understanding of the characteristics of a globally growing, but often underrepresented, older population with Inflammatory Bowel Disease (IBD). The aim is to evaluate the characteristics of this population, including frailty, comorbidity, and reported therapy goals through a survey.

Methods

An international, anonymous online survey was conducted among older patients (aged ≥ 60 years) with Crohn’s disease (CD), ulcerative colitis (UC) and IBD-unclassified (IBD-U). The survey was developed by the European Federation of Crohn’s and Ulcerative Colitis Associations (EFCCA), translated in 21 languages and distributed in 46 countries through national IBD associations affiliated with the EFCCA. The survey contained questions about demographic- and IBD characteristics, IBD-therapy and symptoms. Clinical disease activity was assessed by the Harvey-Bradshaw Index (HBI) (≥ 4) for CD, and 6-point Mayo score (≥ 1.5) for UC and IBD-U. Self-reported versions of the Geriatric-8 (G8) questionnaire and Charlson Comorbidity Index were included to assess frailty (G8 ≤ 14) and comorbidity, respectively. Respondents were asked to choose three out of the following 12 therapy goals they considered most important: to experience less abdominal pain, decrease inflammation, prevent/postpone IBD surgery, not feel fatigued, stop using corticosteroids, decrease diarrhea/incontinence, maintain or get to their preferred weight, be comfortable with their body image, or to preserve/restore their mobility, social life, good mood or sexual activity. Descriptive analyses were performed using R, version 4.3.

Results

Out of 2191 respondents, 1785 (81.4%) completed the survey for the variables of interest and were retained for analyses. Respondents were mainly from the Netherlands (47.2%), Norway (9.1%) and Italy (8.4%). Mean age was 67.3 years (Standard Deviation (SD) 5.9), 61% was female, and 58.1% was retired. The most common type of IBD was CD (50.9%). Clinical disease activity was found in 33% of respondents. Therapy with aminosalicylates was most common among patients with UC (58%), biological therapy among patients with CD (44%). Frailty was reported by 39% of respondents and 64% of respondents reported to have one or more comorbidities. Three therapy goals that were most frequently reported were: to not feel fatigued (56.1%), to be of good mood (42.2%) and decrease in diarrhea/incontinence (31.1%).

Conclusion

Preliminary results from the "IBD Has No Age" survey suggest that it will contribute a wealth of knowledge to the IBD landscape, providing insight in a range of IBD characteristics, frailty, comorbidity and therapy goals in an older population with IBD.
P1203 Fecal transplantation for Ulcerative Colitis from diet conditioned donors followed by dietary intervention results in favorable gut microbial profile and decreased gut inflammation compared to fecal transplantation alone
Authors: Leibovitzh H , Sarbagili Shabat C , Hirsch A , Zittan E , Mentella M C , Petito V , Cohen N A , Ron Y , Fliss Isakov N , Pfeffer J , Yaakov M , Fanali C , Turchini L , Masucci L , Quaranta G , Kolonimos N , Godneva A , Weinberger A , Scaldaferri F , Maharshak N
Published: January 2024

Background

Several fecal microbial transplantation (FMT) approaches for ulcerative colitis (UC) have been investigated with conflicting results. We have recently published the clinical outcomes from the CRAFT UC Trial using FMT with the UC Exclusion Diet (UCED), a novel diet for active UC, compared with FMT alone. Here we aimed to compare the two FMT strategies in terms of microbial profile and functional outcomes.

Methods

Subjects recruited to the CRAFT UC study with available pre- and post-intervention fecal samples were included. Seven donors received diet conditioning for 14 days in line with the UCED principles. Group 1 received single donor standard FMT by colonoscopy on Day 1 and rectal enemas on Days 2 and 14 without dietary conditioning of the donor (N=11). Group 2 received FMT as above but with dietary pre-conditioning of the donor and UCED for the patients (N=10). Pre- and post-intervention fecal samples were assessed by DNA shotgun metagenomic sequencing to obtain microbial compositional and functional data. Data was analyzed using a multivariable linear regression mixed effects model and spearman correlation. Benjamini-Hochberg correction was used for multiple testing with p-values<0.05 and q-values<0.2 considered significant.

Results

Following diet conditioning, donors had significant depletion in microbial metabolic pathways involved in the biosynthesis of sulfur-containing amino acids. Only patients in Group 2 receiving FMT from diet conditioned donors followed by the UCED showed significant shifts towards the donors’ microbial composition (ADONIS: R2=0.15, p=0.008). Eubacterium sp AF228LB was significantly increased post-intervention in Group 2 (β-coefficient 2.66, 95% CI 2.1 to 3.3) and was also inversely correlated with fecal calprotectin levels (rho=-0.52, p=0.035). Moreover, microbial metabolic pathways involved in gut inflammation and barrier function including ribonucleotides biosynthesis (β-coefficient 0.29, 95% CI 0.07 to 0.51) and branched chain amino acids (β-coefficient 0.44, 95% CI 0.16 to 0.72) were enriched post intervention only in Group 2 and were significantly correlated with decrease in fecal calprotectin (rho=-0.78, p=0.01 and rho=-0.58, p=0.09, respectively).

Conclusion

FMT from diet conditioned donors followed by the UCED diet led to microbial alterations associated with favorable microbial compositional and functional profile related to sulfur metabolic pathways, which translated to decreased gut inflammation. Our findings support further exploration of additive benefit of dietary intervention for both donors and patients undergoing FMT as a potential treatment of active UC.
P1209 Baseline gut microbiota composition and function reflect response to 5-ASA treatment in Ulcerative Colitis
Authors: Radhakrishnan S T , Alexander J L , Mullish B H , Danckert N P , Valdivia-Garcia M A , Serrano-Contreras J I , Balarajah S , Perry R , Gallagher K I , Hicks L C , Powell N , Li J V , Marchesi J R , Williams H R T
Published: January 2024

Background

Mesalazine (5-ASA) is a key initial treatment of ulcerative colitis (UC); recent studies have highlighted the role of the gut microbiota in 5-ASA metabolism. There is no established means of predicting treatment outcome. We sought to investigate changes in the gut microbiota and metabolome with 5-ASA treatment, and whether such changes may reflect clinical outcomes.

Methods

Longitudinal faeces, serum and urine samples were collected from patients with newly diagnosed UC before and after 5-ASA treatment. We documented longitudinal microbiota and metabolome changes with 5-ASA treatment and compared baseline gut microbiota and metabolome in responders (simple clinical colitis activity index (SCCAI) of <4 and faecal calprotectin (FC) of <100 µg/g) and non-responders to 5-ASA. Stool bacterial profiling was performed via 16S rRNA gene sequencing of the V1/V2 hypervariable regions. Host and microbial metabolites in stool, serum and urine were detected and semi-quantitated using liquid chromatography mass spectroscopy (LC-MS) and nuclear magnetic resonance spectroscopy (1H-NMR). Kruskal-Wallis tests and paired analyses using a Wilcoxon rank test were used and p values were adjusted using Benjamini-Hochberg false discovery rate (FDR) correction.

Results

37 patients newly diagnosed with UC were recruited. Samples were collected at baseline and a median of 83 days (IQR 22.5 days) later; there were 27 responders and 10 non-responders. Comparing pre- and post- 5-ASA treatment samples demonstrated a reduction in gut microbial α diversity (P=0.01) (Fig 1). Faecal methionine increased with 5-ASA (P=0.04) in all patients, and isovalerate reduced with 5-ASA (P<0.01). Similar reductions after 5-ASA were noted in serum glycoprotein B (GlycB) (P=0.02).

At baseline, responders tended to have increased α diversity compared to non-responders, but not statistically significantly (P=0.09). Similarly, there were β diversity differences, although these did not reach significance (P=0.06). At baseline non-responders had a higher relative stool abundance of Bacteroidetes and Firmicutes (P<0.01) compared to responders. Agathobacter, Coprococcus and Blautia genera were enriched in non-responders (P=0.05). At baseline, urinary hippurate was higher in patients going on to respond to 5-ASA compared to non-responders (P=0.04); faecal lysine (P<0.01) and putrescine (P=0.01) levels were also higher in non-responders at baseline. 5-ASA responders had reductions in faecal 2-methylbutyrate and isobutyrate (P=0.02) longitudinally.

Conclusion

We have shown that baseline relative abundance of certain taxa (such as Blautia), urinary Hippurate and faecal lysine reflect response to 5-ASA. Alterations in the gut microbiome and metabolome are associated with 5-ASA treatment.
P1229 The Role and Niche-Specific Adaptation of Malassezia in patients with Ulcerative colitis
Authors: Shin Shin S , Cho Y J , Yang J , Kim H K , Rintarhat P , Park M , Lagree K , Underhill D M , Yang C S , Moon J M , Seo J , Kim K , Jung W H , Choi C H
Published: January 2024

Background

Accumulating evidence has underscored the role of gut fungal microbiota (mycobiota) in the development of inflammatory bowel disease. We aimed to isolate a Malassezia strain directly from the human intestine mucosal surface from the patients with ulcerative colitis (UC) and investigated its genome and virulence in comparison with the same fungal species isolated from the human skin.

Methods

Mucosal lavage samples were collected separately from colonic areas with and without inflammation in patients with UC. Samples from healthy individuals (HT) were obtained in the same manner as from patients with UC at sigmoid or descending colon. Skin samples were taken from HT in our previous work. DNA was extracted from these lavage samples, and fungal isolation was conducted using PCR amplification with ITS4 and ITS5 primers. Comprehensive analysis and comparison of the genomes, transcriptomes, and virulence between M. globosa gut isolates and those of M. globosa strains isolated from the skin were performed. To determine the contribution of M. globosa gut isolates to exacerbating inflammation, 1107 fungal cells were orally gavaged to DSS-induced colitis mouse model for three days.

Results

Total 56 and 11 intestinal water-lavage samples from 29 UC patients and 11 HT were obtained respectively. The α- and b-diversities of mycobiota showed no significant differences between the groups, patients with UC vs. HT or the sites with inflammation vs. non-inflammation of the patient with UC. Malassezia was the fifth most frequently found fungal genus throughout the samples, and live fungal strains belong to 28 and 7 different species were isolated from the patients with UC and HT, respectively. The patients with UC tend to have higher frequency of M. globosa and M. restricta than HT in their gut mucosal surface with inflammation. Whole genome sequencing showed no specific genomic characteristics between gut-isolated M. globosa and skin-isolated M. globosa. However, gut-isolated M. globosa were suffered more from the higher oxygen levels than the skin isolates in different oxygen concentrations. In a mouse model, gut-isolated M. globosa exhibited a more pronounced exacerbation of DSS-induced colitis and elevated production of inflammatory cytokines, including TNF-a, IL-6, IL-12p40, IL-1b, and IL-18, while the skin isolates showed no difference compared to the negative control (Figure).

Conclusion

Our data shed new light on the pivotal role of M. globosa in the pathogenesis of UC, highlighting the potential influence of niche-specific adaptations on the virulence of this fungus. These findings provide critical insights into the complex interplay between the member of the gut mycobiota and host health.
P1238 Exploring the Role of Klebsiella variicola and Klebsiella pneumoniae in Pediatric Ulcerative Colitis Pathogenesis
Authors: Arjomand Fard N , Bording-Jorgensen M , Cheng C , Kerr K , Aujla H , Mansour S , Elhenawy W , Perry T , Wine E
Published: January 2024

Background

Recent studies indicated that Klebsiella (K) pneumoniae (isolated from the stool of IBD patients) and K. variicola (isolated from the mesenteric tissue of Crohn disease patients) have the potential to induce inflammation in epithelial and preadipocyte cells, exacerbating colitis in murine models. We isolated these strains from pediatric ulcerative colitis (UC) patients' appendix (relevant to UC pathogenesis given the protective effects of appendectomy) and other non-inflamed colon sections. We hypothesized that these isolates are invasive and induce inflammation in UC. These strains have not been previously studied in UC.

Methods

K. variicola and K. pneumoniae were isolated from two pediatric UC patients' appendices and other non-inflamed colon sections and identified using 16S DNA Sanger sequencing. Virulence of the two strains was determined by infecting Caco2 cell lines and performing adhesion and invasion assays, quantifying biofilm formation, and assessing barrier functions using transepithelial electrical resistance (TEER) measurement. Importantly, we monitored the production of pro-inflammatory (e.g., IL-8, TNF-α) and anti-inflammatory (IL-10) cytokines using reverse transcriptase quantitative polymerase chain reaction (RT-qPCR).

Results

K. variicola and K. pneumoniae exhibited high levels of biofilm formation compared to adherent-invasive Escherichia coli (AIEC), which are commonly isolated from IBD patients. Furthermore, the Klebsiella strains adhered to epithelial cells within 2-3 hours post infection. TEER experiments showed compromised barrier integrity after 6 hours and overnight infection. Except for K. pneumoniae isolated from the ascending colon, the tested strains exhibited a significant increase in IL-8 expression. Similarly, K. variicola from the peri-appendicular region demonstrated elevated TNF-α gene expression.

Conclusion

K. variicola and K. pneumoniae isolated from UC patients have the potential to form biofilms, disrupt barrier integrity, and trigger inflammatory responses. These findings unravel a potential role for pathogenic Klebsiella strains in driving UC pathogenesis. Importantly, these data shed light on the role of appendix-associated bacteria in the development of UC. Future work includes using comparative genomics to map the virulence determinants of these bacteria.
P1239 Characterization of Clostridioides strains and antibiotic resistance profile in Inflammatory Bowel Disease patients with Clostridioides infection
Authors: Oliveira R , Tavares de Sousa H , Roseira J
Published: January 2024

Background

There is an increasing incidence of community-acquired Clostridioides difficile infection (CDI), particularly in IBD. Due to a suspected community outbreak in mid-2023, we aimed to investigate the microbiological and antibiotic resistance profile of CDI in an IBD cohort, employing blind central reading, in order to better understand its epidemiology.

Methods

This was a prospective study of a University Tertiary Hospital in collaboration with the Infection Control Unit and a central laboratory at the forefront of Infectious Diseases investigation in Portugal (Instituto Ricardo Jorge [IRJ]). Faecal samples from all IBD-related CDI from Apr to Oct 2023, were analysed at IRJ, including isolation and identification of C. difficile strains and testing for antimicrobial susceptibility. Infectious diseases investigators were blinded to patients’ data.

Results

Eleven patients with IBD (median 42 years, 60.0% female) had at least one episode of CDI, comprising 15 IBD-related CDI cases, which represents 26.3% of all CDI cases in this 6-month period. Moreover, this compares to only 14 cases of IBD-related CDI in the previous four years combined. All patients had UC (66.7% extensive), with a median diagnosis of 11 years. All cases were community-acquired, diagnosed in the context of acute worsening of UC symptoms; 40% required hospitalization. Remarkably, only 2 patients had recent antibiotic therapy, while 3 had a recent visit to the emergency department. No predominant ribotype (RT) was recognised: RT 002/2, RT 017, RT 039, RT 078, RT 106 and RT 839 were identified in similar proportions. There were two new RTs detected, which are under characterization. All isolates were susceptible to vancomycin and metronidazole, but 46.7% were resistant to moxifloxacin, which is higher than ever reported in Portugal. Most cases (n=12) were prescribed vancomycin and followed a taper-and-pulse dosing (n=9). None of the three patients who had a recurrence had received taper-and-pulse dosing. Optimization of UC therapy was performed in all cases, including concomitant immunosuppressive therapy escalation when needed, as recommended. Interestingly, one case, despite having tested positive for C. difficile, had a Clostridioides hathewayi isolated in the culture instead. To our knowledge, this is the first case of C. hathewayi associated diarrhoea resolving upon treatment with vancomycin.

Conclusion

The absence of a predominant ribotype, excluding a community outbreak, demands heightened CDI vigilance in IBD even in absence of traditional risk factors. Alarming moxifloxacin resistance underscores evolving dynamics. A novel C. hathewayi-associated diarrhoea case and the emergence of two new ribotypes adds complexity.