bluuebunny/crossref_metadata_2025_split huggingface dataset:
P629 Evolution of disease phenotype, time to biological therapy and medium-, long-term surgery rates in Crohn’s disease patients in Western Hungary – a population-based study between 2007–2018, data from the Veszprem county cohort
Authors: Gonczi L , Lakatos L , Golovics P , Pandur T , David G , Erdelyi Z , Szita I , Lakatos P L 
Published: January 2022

Abstract

Background
The number of prospective population-based studies evaluating the natural disease course and surgical outcomes of Crohn’s disease(CD) are still limited from Eastern Europe. The present study is a continuation of the Veszprem IBD population-based cohort with a follow-up of the incidence and disease course of IBD since 1977. Our aim was to evaluate disease course by examining progression in disease phenotype, time to biological therapy and surgery rates in a prospective population-based database from Veszprem Province, including incident CD patients diagnosed between January1,2007 and December31,2018.

Methods
Data of 421 incident CD patients were analyzed(male/female:237/184; median age at diagnosis:29 years(y)[IQR: 21–42]). Both in-hospital and outpatient records were collected and comprehensively reviewed at diagnosis and during clinical follow-up. The mean length of follow-up was 8.53y(SD: 3.3). Probability of medium-, long-term change in disease course and surgical outcomes were analyzed.

Results
Disease location was ileal(L1), colonic(L2) in and ileo-colonic(L3) in 29.7%/24.5%/45.8% of patients at diagnosis. At the end of follow-up(8.53y), disease location was 27.1%/22.8%/50.1%(L1/L2/L3). The proportion of patients with upper gastrointestinal manifestation remained stable(7.6% and 8.1%), while perianal disease increased from 13.5% to 19% by the end of follow-up. Disease behavior at diagnosis was luminal(B1) in 62.5% of the patients. The probability of disease behavior progression from luminal into stenosing or penetrating phenotype was 11.9%(SE:1.7) at 3 years, 13.2%(SE:1.7) at 5 years and 17.6%(SE:1.7) at 10 years.Figure 1. The Probability of receiving biological therapy after diagnosis was 20.9%(SE:2.0) at 5 years and 28.8%(SE:2.0) at 10 years in this cohort. Overall resective surgery rate was 29.5% in the total population, while perianal surgery rate was 31.3% in patients with perianal disease at the end of follow-up. The probability of resective surgery was 20.7%(SE:2.0) at 1 year, 26.1%(SE:2.2) at 5 years and 30.7%(SE:2.4) at 10 years.Figure 2. For the probability of first perianal surgery among patients with perianal disease see Figure 3.

Conclusion
The probability of progression in disease behavior was lower compared to data from previous decades and similar to results from recent pan-European population-based data.(Burisch 2018, JCC). One-year surgery rates after diagnosis were considerably higher compared to previous data from our cohort or compared to Western and Northern European centers.(Lakatos 2011, IBD). Medium-term(5y) surgery rates were similar(~20%) compared to recent Hungarian and European data, while long-term(10y) rates decreased compared to data from previous decades.(Lakatos 2011,IBD; Lakatos 2012,AJG).
P641 Implementation and short-term adverse events of anti-SARS-CoV-2 vaccines in Inflammatory Bowel Disease patients: an international web-based survey
Authors: Revés J , Abreu B , Chaparro M , Gisbert J P , Mariangela A , Fiorino G , Barberio B , Zingone F , Pisani A , Cassar D , Michalopoulos G , Mantzaris G , Mountaki K , Koutroubakis I , Karmiris K , Katsanos K , Ďuricova D , Burisch J , Madsen G R , Maaser C , Naila A , Orfanoudaki E , Milivojevic V , Buisson A , Avedano L , Leone S , Torres J , Ellul P 
Published: January 2022

Abstract

Background
Pivotal anti-SARS-CoV-2 vaccines clinical trials did not include patients with immune-mediated conditions such as inflammatory bowel disease (IBD). We aimed to describe the implementation of anti-SARS-CoV-2 vaccines among IBD patients, patients’ concerns before vaccination and side-effect profile of the anti-SARS-CoV-2 vaccines using real-world data.

Methods
An anonymous web-based self-completed survey was distributed in 36 European countries between June and July 2021. The results of patients’ characteristics, concerns, vaccination status and side-effect profile were analysed using descriptive statistics and logistic regression.

Results
Among the 3272 IBD patients completing the survey (0.1% of the IBD European population), 79.6% had received at least one dose of the anti-SARS-CoV-2 vaccine, and 71.7% had completed the vaccination process. Most of the patients (70.6%) were vaccinated with the Pfizer-BioNTech (BNT162b2) vaccine. Patients over 60 years old had a significantly higher rate of vaccination (OR 2.98, 95% CI 2.20–4.03, p&lt;0.001). Patients’ main concerns before vaccination were the possibility of having worse vaccine-related adverse events due to their IBD (24.6%), having an IBD flare after vaccination (21.1%) and reduced vaccine efficacy due to IBD or associated immunosuppression (17.6%). After the first dose of the vaccine, 72.4% had local symptoms at the injection site and 51.4% had systemic symptoms (5 patients had non-specified thrombosis). Adverse events were less frequent after the second dose of the vaccine and in older patients. When comparing with previous studies from the general population, the IBD patients answering the survey did not seem to have increased side effects (Table 1). Only a minority of the patients were hospitalized (0.3%), needed a consultation (3.6%) or had to change IBD therapy (13.4%) after anti-SARS-CoV-2 vaccination.

Conclusion
Although IBD patients raised concerns about the safety and efficacy of anti-SARS-CoV-2 vaccines, the implementation of vaccination in those responding to our survey was high and the adverse events were comparable to the general population, with minimal impact on their IBD.
P646 Will the screening of SARS-COV-2 infection in IBD infusion centers be useful?
Authors: Abreu N , Oliveira A , Morna H , Jasmins L 
Published: January 2022

Abstract

Background
The global emergence of SARS-COV-2 virus and the COVID-19 pandemic increased the concerns about the vulnerability of inflammatory bowel disease (IBD) patients. Infusion centers are a crucial part in the management of IBD patients and safety for SARS-COV-2 must be assured. Current recommendations of International Organization for the Study of Inflammatory Bowel Disease suggest that only patients exhibiting symptoms suggestive of COVID-19 should be tested for SARS-COV-2 before the biologic infusion therapy. We evaluated patients admitted at our infusion center, in which all had to be screened before treatment.

Methods
We conducted an observational study, including all adult patients with IBD under biologic therapy infusion between April of 2020 and September of 2021. According to the local institutional protocol all patients were tested for SARS-COV-2 by a polymerase chain reaction (PCR) test in the previous 48–72 hours. Epidemiological, clinical and treatment data were collected.

Results
A total of 105 patients were evaluated, with a mean age of 38,6±12,8 years and a predominance of male gender (61,9%). Crohn’s disease was more prevalent, affecting 81,9% of the patients. The most common biologic infusion therapy was infliximab (93,3%), followed by vedolizumab (4,8%).
A SARS-COV-2 infection were identified in five patients (4,8%), with age between 41 and 66 years, four asymptomatic and without a known risk contact. Four patients developed the infection before vaccination and one patient after the first dose. None of the patients required medical care or hospitalization.
All cases were registered in February of 2021, which temporarily represented one of the most critical phases of the pandemic in our country and region, with one of the highest incidence of cases of SARS-COV-2 infection.
In our cohort, most patients (85,7%) completed the vaccination schedule, with a minority (n=10) without any dose of vaccine.

Conclusion
During this COVID-19 pandemic, health systems have to address unprecedented challenges. Our study support the current recommendation, since the universal screening of SARS-COV-2 infection in IBD patients, before the biological infusion therapy, detected just a few cases of infection. However this recommendation could be adapted locally, maybe when there is raising incidence of SARS-COV-2 in the general population. Our cohort also showed high compliance for the vaccination as general recommendation and even after the infection.
P658 Evolution of disease phenotype, time to biological therapy and medium-, long-term colectomy rates in Ulcerative Colitis patients in Western Hungary – a population-based study between 2007–2018, data from the Veszprem county cohort
Authors: Gonczi L , Lakatos L , Golovics P , Pandur T , David G , Erdelyi Z , Szita I , Lakatos P L 
Published: January 2022

Abstract

Background
The number of prospective population-based studies evaluating the natural disease course and surgical outcomes of ulcerative colitis (UC) are still limited from Eastern Europe. The present study is a continuation of the Veszprem IBD population-based cohort with a follow-up of the incidence and disease course of IBD since 1977. Our aim was to evaluate disease course by examining progression in disease phenotype, time to biological therapy and colectomy rates in a prospective population-based database from Veszprem Province, including incident UC patients diagnosed between January 1, 2007 and December 31, 2018.

Methods
Data of 467 incident UC patients were analyzed (male/female: 236/1231; median age at diagnosis: 36 years(y) [IQR: 25–54]). Both in-hospital and outpatient records were collected and comprehensively reviewed at diagnosis and during clinical follow-up. The mean length of follow-up was 8.34y (SD: 3.5). Disease phenotype was evaluated based on the Montreal classification. Probability of medium-, long-term change in disease course and surgical outcomes were analyzed using Kaplan–Meier survival analysis.

Results
Disease extension was proctitis (E1), left sided colitis (E2), and extensive colitis (E3) in 22.3%/ 43.9%/ 33.8% of patients at diagnosis. The probability of disease progression into more extensive phenotype was 6.9% (SE:1.2) at 3 years, 8.3% (SE:1.3) at 5 years and 11.3% (SE:1.6) at 10 years. Figure 1. The Probability of receiving biological therapy after diagnosis was 9.9% (SE:1.4) at 3 years, 13.9% (SE:1.6) at 5 years and 17.8% (SE:2.0) at 10 years in this cohort. Overall colectomy rate was 4.1% in the total population at the end of follow-up. The probability of colectomy was 1.5% (SE:0.6) at 1 year, 3.6% (SE:0.9) at 5 years and 4.4% (SE:1.0) at 10 years in Kaplan-Meier analysis. Figure 2.

Conclusion
The probability of progression in disease extent was low overall, similar to results from recent pan-European population-based data. (Burisch 2019, JCC). Medium- and long-term colectomy rates were lower compared to Western European centers, but somewhat higher compared to our previous data from the Veszprem cohort (2002–2006). (Lakatos 2011, IBD).
P665 Towards FAIR longitudinal IBD registries: preliminary results of an iterative design process of a reusable and interoperable IBD database model
Authors: Adriaans G M C , Hendrix E M B , Creemers R , Janssen L , Demers K , Rezazadeh Ardabili A , Jonkers D M A E , Pierik M J 
Published: January 2022

Abstract

Background
The Real World Data [RWD] of the Dutch longitudinal IBD registries (population based IBD South Limburg cohort, Parelsnoer IBD, Initiative on Crohn and Colitis drug-registry) have proven to answer knowledge gaps regarding epidemiology, patient stratification, positioning and effectiveness and safety of new drugs. Life-long data-capture in registries for large cohorts is extremely labor intensive and expensive.
Therefore, based on the database models of existing registries, we aim to develop a reusable and interoperable Real World IBD database model that will contribute re-use of every-day care data form hospital information systems and remote monitoring platforms. This project contributes to generation of high quality, multi-dimensional data for (inter)national IBD registries such as the United Registries for Clinical Assessment and Research [UR-CARE] registry and aforementioned registries.

Methods
The design process was iterative and involved the potential end-users of the registries.
For the first iteration the database models of established Dutch IBD cohorts were taken as input, in combination with repeated discussions on the content with three principal IBD investigators.
The second iteration was multifaceted including; 1) Five discussion sessions with 7 IBD researchers (MD medicine of which the majority practiced IBD care and were experienced with the hospital information system) discussing the content, and 2) four discussion sessions with researchers experienced in re-using hospital care data for research that evaluated the model on practical use and difficulties in data interpretation using the output of the first iteration. No data was analyzed, only codebooks describing variables and their values.

Results
The first iteration of the design phase resulted in a database model called IBD common data model [IBDCDM] v1 consisting out of 395 variables, and based on existing codebooks of Dutch IBD registries (figure 1).

The database model, called IBD common data model [IBDCDM] v1 consists out of 27 independent modules on different themes important for the IBD disease course allowing for repeated data recordings (figure 2).

The second iteration of the design phase resulted in pruning the modules’ content, removal of one module, merging and adding of modules.

Conclusion
An iterative design process involving end-users will result in higher data quality by optimizing practical usability and interpretability of the database model. Next step is to encode the model using medical standardized vocabularies (e.g. SNOMED, LOINC), for interoperability.
The database model contributes towards producing reusable IBD datasets that use study hospital care data as a primary source to study the IBD disease course over several decades.
P672 Biologic therapy for Inflammatory Bowel Disease in Poland in 2020: nationwide data
Authors: Kucha P , Zagórowicz E , Walkiewicz D , Perwieniec J , Maluchnik M , Wieszczy P , Reguła J 
Published: January 2022

Abstract

Background
The number of patients in Poland diagnosed with ulcerative colitis (UC) or Crohn’s disease (CD) has been increasing in the last decade, which implies an increase in the number of severe cases, where biologic treatment is required. The aim of this study was to analyse the usage of biologic treatment among patients with both types of inflammatory bowel diseases (IBD) in Poland that was reimbursed by the National Health Fund (NFZ) in 2020.

Methods
The analysis was conducted using administrative data collected since the year 2009 by the National Health Fund (NFZ), the only public payer in Poland. We defined an IBD patient receiving biologic treatment as a patient: (1) who had at least two inpatient/outpatient records in the NFZ registry in the years 2009 – 2020 with ICD10 code K50/K51 assigned; (2) who had filled at least two prescriptions for IBD medications two months apart or who had undergone intestinal surgery prior to the record; (3) and who received biological treatment reimbursed by the NFZ in 2020. We assessed the total percentage of patients with each diagnosis who received biologic treatment as well as the percentage by sex, by age group and by the place of residence (voivodeship).

Results
In 2020, the percentage of patients treated with biologic agents in the population of CD patients was 7.9% (1 863 / 23 574). The percentage of patients treated with biologic agents in the population of UC patients was 1.6% (1 174/73 235). The rate of patients treated with biologics for both CD and UC was significantly lower in women than in men (p&lt;0,001 for both). Among all age groups, the highest percentage of patients receiving biologic treatment for both CD and UC (21,7% and 6,5%, respectively) was observed in those aged 10–19 years and the lowest percentage in patients aged over 70 years (0,8% for CD, 0,2% for UC). The highest proportion of patients treated with biologic drugs among CD patients was found in the Mazovian Voivodeship (13.8%) and the lowest - in the Lubusz Voivodeship (1.2%). In UC, the highest biologic treatment rate was observed in the Świętokrzyskie Voivodeship (3.1%), and the lowest in the Lubusz Voivodeship and the Warmian-Masurian Voivodeship (both 0.2%).

Conclusion
The use of biologic agents in the treatment of both Crohn’s disease and ulcerative colitis in Poland has been presented. Female patients receive biologic treatment for IBD significantly less frequently than male. The highest proportion of patients receiving biologic treatment for both CD and UC was found in the paediatric population. There are voivodeships in Poland where the access to biological treatment is unacceptably low.
P676 Burden of depression and anxiety among inflammatory bowel disease patients in a national cohort in Israel – Data from the EPI-IIRN
Authors: Mekori - Domachevsky E , Ziv - Baran T , Loewenberg Weisband Y , Greenfeld S , Kariv R , Erez M , Friss F , Focht G , Turner D , Ben - Horin S , Kopylov U 
Published: January 2022

Abstract

Background
Depression and anxiety in inflammatory bowel disease (IBD) patients have been receiving much deserved attention in recent years, as consecutive studies demonstrated that these emotional disorders are both common and detrimental for IBD patients. The aim of the current study was to examine the prevalence of depression and anxiety in a national cohort of IBD patients in Israel.

Methods
The epi-IIRN is a validated cohort of all IBD patients in Israel, ensured in four health maintenance organizations (HMOs). In this historical cohort study we included data from three HMOs, encompassing ~85% of Israeli population, between December 1997 [TD1] [UM2] and December 2019. Data included demographic data (age, sex and socioeconomic status), medical data (diagnosis type, time of diagnosis, medical regiments) and mental health status (a diagnosis of depression / anxiety defined by the relevant ICD9 codes or use of antidepressants / anxiolytics for at least two year quarters). For each IBD patient identified, three non-IBD subjects were allocated. Patients younger than 18 years or with a diagnosis of depression / anxiety preceding the diagnosis of IBD were excluded. Using cox regression and Kaplan Meier survival curve, we evaluated the prevalence of comorbid depression / anxiety at 5, 10 and 15 years following the diagnosis of an IBD.

Results
A total of 31340 IBD patients (48.1% females, mean age at diagnosis 38.6±15.9) and 91535 controls (48.7% females, mean age 39.9±16.1) were identified. The risk of depression / anxiety comorbidity was higher in IBD patients in comparison to controls at all evaluated timepoints: At 5 years following a diagnosis of IBD the hazard risk ratio (HR) was 1.48 (95% CI 1.43 – 1.53, p &lt; 0.001, 15.5% vs 10.6%,); at 10 years HR was 1.38 (95% CI 1.34 – 1.42, p &lt; 0.001, 22.9% vs. 17.0%) and at 15 years 1.37 (95% CI 1.33 – 1.40, p &lt; 0.001, 27.5% vs 21.0%). For all analyses, female gender was a risk factor for development of depression/anxiety (HR~1.5, p &lt; 0.001). IBD type (Crohn’s disease / ulcerative colitis) was not significantly associated with the risk of comorbid depression / anxiety.

Conclusion
Our national study highlights the substantial burden of depression and anxiety in IBD patients that is persistent for up to 15 years after diagnosis. Our findings emphasize the need to monitor for potential symptoms of depression and anxiety among our patients, as well as the need for prompt intervention and follow-up by a mental health care provider when such symptoms are identified.
P680 Epidemiology of Inflammatory Bowel Disease in Poland 2009–2020: nationwide data
Authors: Zagórowicz E S , Walkiewicz D , Kucha P , Perwieniec J , Maluchnik M , Wieszczy P , Reguła J 
Published: January 2022

Abstract

Background
The epidemiology of inflammatory bowel disease (IBD) in Poland has only been recognised to a limited extent. We aimed to estimate the prevalence and incidence of the disease by analysing data from the National Health Fund, the sole public health insurer.

Methods
Administrative health claims collected over the 2009–2020 period were used to identify patients with Crohn’s disease (CD) or ulcerative colitis (UC). A definition of a case comprised ≥2 records assigned K50 or K51 codes, plus ≥2 prescriptions for IBD drugs reimbursed, or else intestinal surgery preceding the record. The crude and European age-standardised rates (EASR) and 95% confidence intervals (CI) were calculated for the prevalence and incidence. Time trends were also analysed.

Results
As of 2020 there were 23,574 patients with CD and 73,235 with UC. The CD and UC prevalence was respectively 61.6 [EASR 60.3 (95% CI 59.5–61.0)] and 191.4 [EASR 187.85 (95% CI 186.5–189.2)] per 100,000. The prevalence of CD was higher in men [64.1; EASR 61.3 (95% CI 60.2–62.5)] than in women [59.3; EASR 58.4 (95% CI 57.3-59,5)]. Similarly, the prevalence of UC was higher in men [201.4; EASR 202.7 (95% CI 200.5–204.8)] than in women [182.0; EASR 175.5 (95% CI 173.7–177. 4)]. The incidence of CD was 4.7 per 100 000 [EASR 4.6 (95% CI 4.4–4.8)], while of UC 12.5 [EASR 12.3 (95%CI 12.0–12.7)]. Through the period 2012–2018, the prevalence of both conditions rose, even as downward trends were noted for disease incidence.

Conclusion
The prevalence and incidence of IBD in Poland are presented, with time trends showing substantial increase in the disease burden over the years 2009–2020.
P681 Impact of Crohn’s disease on survival in Korean patients with small bowel adenocarcinoma
Authors: Kim K , Choi K , Hwang S W , Im J P , Ye B D , Kim J S , Yang S K , Koh S J , Park S H 
Published: January 2022

Abstract

Background
In comparison with the general population, patients with Crohn’s disease (CD) are at higher risk of developing small bowel adenocarcinoma (SBA). However, with low prevalence of SBA, data regarding the impact of CD on survival are lacking. We investigated the impact of CD on survival in patients with SBA.

Methods
From January 1998 through July 2021, patients with histologically confirmed SBA were retrospectively collected and classified into binary, namely, sporadic SBA and CD-associated SBA groups. Patients with duodenal SBA were excluded. The overall survival (OS) and factors associated with survival were analysed.

Results
Of 127 patients with SBA, 115 patients were sporadic SBA and 12 were CD-associated SBA (Table 1). Compared to patients with sporadic SBA, poorly differentiated tumour was more common among patients with CD-associated SBA (41.7 vs. 14.8%, p=0.030). Other baseline demographic characteristics including age at the diagnosis of SBA, sex, Charlson morbidity score more than 2 points, smoking history, family history of cancer, location of SBA, initial stage based on American Joint Committee on Cancer (AJCC) staging system, and treatment showed no significant difference. In survival analyses, the 1-year (yr), 2-yr, and 5-yr OS were lower in patients with CD-associated SBA, without statistical significance (1-yr OS; 81.8 vs. 90.5%, 2-yr OS; 61.4 vs. 81.7, 5-yr OS; 61.4 vs. 69.1%, p=0.590) (Fig 1). Factors associated with decreased survival were disease stage (AJCC stage IV) (hazard ratio [HR] 5.485; 95% confidence interval [CI], 2.442–12.279, p&lt;0.001) and palliative treatment (HR 2.447; 95% CI, 1.064–5.624, p=0.035), whereas curative operation plus adjuvant chemotherapy improved survival (HR 0.335; 95% CI, 0.132–0.849, p=0.021) (Table 2). Crohn’s disease was not significantly associated with survival (HR 1.333; 95% CI, 0.472–3.769, p=0.587).

Conclusion
The OS of patients with CD-associated SBA was not significantly lower than that of patients with sporadic SBA. The independent risk factors for survival were the stage of SBA and type of treatment, not Crohn’s disease.