bluuebunny/crossref_metadata_2025_split 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

Abstract

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&lt;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

Abstract

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 &lt;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

Abstract

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

Abstract

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

Abstract

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&lt;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&lt;0.001 & p&lt;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&lt;0.001 & p&lt;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&lt;0.001 & p&lt;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&lt;0.001 and p&lt;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&lt;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

Abstract

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 &lt; 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

Abstract

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&lt;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

Abstract

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&lt;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.