bluuebunny/crossref_metadata_2025_split huggingface dataset:
P380 Comparison of mucosal healing through segments of ileocolonic Crohn’s disease treated with biologics
Authors: Temido M J , Portela F , Lopes S , Mendes S , Ferreira M , Ferreira M , Figueiredo P 
Published: May 2021

Abstract

Background
Although major advances in Inflammatory bowel disease’s treatment have been observed, the response to the pharmacologic therapies is still unpredictable and highly variable. Mucosal healing (MH) is an important endpoint in Crohn’s disease patients undergoing biologic therapies as it improves outcomes. Nevertheless, endoscopic response is usually evaluated as a whole entity and not by intestinal segments. Moreover, to the best of our knowledge, it has never been assessed whether different plasmatic drug levels (PDL) of biologics result in different response rates by segments of disease. Taking all these considerations into account, this work aimed at assessing putative differences in MH between ileal and colonic disease.

Methods
Retrospective, single centre, cohort study of 131 consecutive patients undergoing biological therapies for Crohn’s disease. Patients included had at least six months of follow-up and an endoscopic evaluation before and after the initiation of biologic therapy. Clinical and endoscopic data were obtained at baseline and at the time of assessment of response. Potential prognostic factors included were: age at diagnosis, time from diagnosis at beginning of biologic agents, location and behaviour of disease, biologic agent taken, PDL and smoking. MH was defined as absence of ulcers in the previously affected segment.

Results
Mean age at diagnosis was 28±12.9 years (range 10-67years). 26.7% of patients had ileal disease and 34.5% only had colonic lesions. 61.83% of patients initiated infliximab and 29.8% started treatment with adalimumab. MH was present in 48.85% of patients. Rates of response were significantly different between ileal (48.9%) and colonic lesions (69.8%) both in the whole cohort and in patients with ileocolonic disease (54.9% and 74.5% respectively) (p&lt;0.05). PDL were higher in the patients achieving response comparing subgroups of patients (responders versus non-responders) with ileal and colonic lesions (p&lt;0.05). There were no significant differences in the PDL between ileal and colonic lesions achieving response. In the multivariate analysis, factors independently associated with higher rates of MH were PDL, location (ileum versus colon) of the affected areas and type of disease (ileal versus colonic versus ileocolonic) (p&lt;0.05).

Conclusion
Rates of MH of ileal lesions are significantly different from colonic segments in Crohn’s Disease. This discrepancy appears not to be related to higher plasmatic concentrations of biologic agents.
P386 Two year follow up of children with Inflammatory Bowel Disease (IBD) treated with vedolizumab and ustekinumab
Authors: Mardare R , Burgess N , Studart D , Deb P , Gasparetto M , Croft N , Naik S , Kadir A 
Published: May 2021

Abstract

Background
In 2018, our Trust approved the use of vedolizumab in children with Ulcerative Colitis (UC) and ustekinumab in children with Crohn’s Disease (CD). At the time, access to these drugs for children was only possible through research studies.
Our aim was to assess the efficacy and safety of these novel treatments in our cohort.

Methods
We conducted an observational single centre cohort study. Data was obtained from our electronic system, Cerner Millennium, and Infoflex database. Analysis was performed using SPSS.

Results
27 children were treated with vedolizumab or ustekinumab with 1 receiving both. All patients had failed anti-TNF medication, except 1 research patient who commenced on vedolizumab at diagnosis.

Conclusion
In children with refractory IBD failing anti-TNF treatment, vedolizumab and ustekinumab are effective and safe alternatives for inducing and maintaining remission, avoiding major invasive surgery.
P392 A mobile application to monitor Inflammatory Bowel Disease patients during intravenous biologic treatment: Results of a feasibility study
Authors: Van Erp L W , Groenen M J M , Heida W , Wisse J , Roosenboom B , Wahab P J 
Published: May 2021

Abstract

Background
Active monitoring of IBD patients during intravenous (iv) biologic treatment is recommended but time-consuming and inconvenient for both patients and nurses. We developed a mobile application to promote self-management and monitor IBD patients cost-effectively during iv biologic treatment. We aimed to study the feasibility of the mobile application.

Methods
A prospective cohort study was performed in a secondary care centre with adult IBD patients treated with infliximab (iv) or vedolizumab (iv) for at least three months. The mobile application was used during four rounds of iv biologic treatment (figure 1). The application includes information modules and a personal interactive timeline with messages one week prior to iv biologic treatment (figure 1). Patients are asked to fill in a health check prior to each treatment to screen for contra-indications, such as respiratory infections or severe side-effects. Patients can also note any particularities or request contact with the IBD nurse. Blood tests are performed before every other infusion. Previously, patients were contacted by telephone prior to each biologic treatment by the IBD nurse. Using the application, patients are only personally contacted in case of abnormalities or upon request.

Results
Of 55 included patients, 52 patients completed the study. Mean age was 42 years (min 19 – max 68), 71% had Crohn’s disease, 76% had clinically quiescent disease, 85% used infliximab and 15% vedolizumab. Most patients used internet for over three years (98%) and their smartphone or tablet every day (98%). Compliance to health checks and blood tests was 67% during the 1st round of biologic treatment and 70%, 87% and 80% during the 2nd, 3rd and 4th round respectively. Patients used the application between median 6 (IQR 5 – 9) and 8 (IQR 5 – 11) times per round of biologic treatment. Patient satisfaction with the application was median 8 (VAS score, IQR 7 – 9). Prior to the 1st round of biologic treatment, all patients (100%) were contacted by telephone as in previous standard care. Using the application the number of patients requiring telephone contact decreased to 47%, 35% and 49% before the 2nd, 3rd and 4th round respectively. Patients remained equally satisfied with IBD care: median VAS score 8 (IQR 8 – 9) before and after implementation of the mobile application. The majority of patients (92%) wanted to continue using the application after the study ended.
Figure 1: Study procedures

Conclusion
Monitoring of IBD patients treated with biologics using a mobile application is feasible. We saw a high compliance and satisfaction of patients, and reduction of health-care utilization. Almost all patients preferred using the application over previous standard care.
P405 Development and validation of a rapid immunoassay for monitoring of ustekinumab concentrations in Inflammatory Bowel Disease patients
Authors: Thomas D , Compernolle G , Guedelha Sabino J P , Ferrante M , Vermeire S , Declerck P 
Published: May 2021

Abstract

Background
Several studies have reported an association between ustekinumab serum concentrations and clinical outcomes, suggesting a potential role of therapeutic drug monitoring (TDM) for guiding clinical decision-making and treatment optimisation in ustekinumab-treated patients with inflammatory bowel diseases. Usually, ustekinumab concentrations are measured with an enzyme-linked immunosorbent assay (ELISA). Disadvantages of using ELISA for TDM are the rather long time-to-result and the necessity of collecting multiple samples in order to reduce the price per determination. The performance of TDM could be further enhanced by using a rapid point-of-care assay, which would allow immediate and individualised dose optimisation based on real-time pharmacokinetic information instead of awaiting dose adjustments at the subsequent administration.

Methods
A fiber-optic surface plasmon resonance (FO-SPR) assay was developed on a White FOx 1.0 device (FOx Biosystems), using a monoclonal antibody (MA)/MA sandwich approach. MA-UST56A2D11 was covalently immobilised to a gold-sputtered fiber surface to capture ustekinumab. After incubation with the serum sample, biotinylated MA-UST56C1H12 was used for detection of bound ustekinumab, and the signal was amplified using a polyclonal anti-biotin antibody conjugated to gold nanoparticles. A calibration curve was constructed by spiking ustekinumab in 1/1000 diluted human serum. Recovery and imprecision were assessed, and the performance of the FO-SPR assay was compared with that of our previously developed in-house ELISA using twelve serum samples of ustekinumab-treated patients.

Results
A dose-response curve ranging from 1.25 – 40 ng/mL was obtained, allowing quantification of ustekinumab concentrations from 0.31 µg/mL (using a 1/250 dilution) up to 80 µg/mL (using a 1/2000 dilution) in serum samples. Measurement of ustekinumab-spiked samples (1 – 25 µg/mL) showed an average intra-assay recovery of 111% (range: 95-124%) and imprecision of 10% (range: 8-15%), and an average inter-assay recovery of 109% (range: 100-122%) and imprecision of 5% (range: 1-8%). Comparison of measurements between FO-SPR and ELISA revealed a very good correlation (Pearson r coefficient of 0.980, 95% CI 0.928-0.995, p&lt;0.001; Figure 1). Using a pre-functionalised fiber, the FO-SPR assay requires 55 min for measuring a single ustekinumab serum sample.

Conclusion
A rapid FO-SPR assay for quantification of ustekinumab concentrations in serum samples was established and showed a very good correlation with ELISA. The reduced assay time and the possibility of measuring a single sample are advantages compared to ELISA, and may allow implementation of FO-SPR as a point-of-care diagnostic tool.
P471 Predictors of bowel damage in long term progression of Crohn’s disease
Authors: Fernandez Clotet A , Panes J , Ricart E , Castro Poceiro J , Masamunt M C , Rodríguez S , Caballol B , Ordas I , Rimola J 
Published: May 2021

Abstract

Background
Crohn’s disease is a chronic inflammatory bowel disorder that progresses to bowel damage over time. An image-based index, the Lémann Index, has been developed to measure the cumulative bowel damage.

AIMS
To characterize the long-term progression of bowel damage in Crohn’s disease based on changes in the Lémann Index and to determine risk factors for long term progression.

Methods
This was a single-center longitudinal cohort study. Patients who had participated in prospective studies on the accuracy of magnetic resonance imaging using endoscopy as gold standard and had a follow-up of at least 5 years were reevaluated after 5–12 years.

Results
Seventy-two patients were included. Lémann Index increased in 38 patients (52.8%), remained unchanged in 9 patients (12.5%) and decreased in 25 patients (34.7%). Small bowel score and surgery subscale significantly increased (p=0.002 and p=0.0001), whereas fistulizing subscale significantly decreased (p=0.001). Baseline parameters associated with bowel damage progression were ileum location (p=0.026), phenotype (stricturing, fistulizing or both with p=0.007, p=0.006 and p=0.035), disease duration &gt;10 years (p=0.019) and baseline Lémann Index stricturing score (p=0.049). No correlation was observed between bowel damage progression and baseline clinical activity, biological markers or endoscopic lesions. Need of surgery during follow-up was a major determinant of bowel damage progression (p=0.0001). Baseline stricturing Lémann Index score was associated with the risk of future surgery (p=0.02).

Conclusion
Bowel damage, assessed by the Lémann Index, progresses in half of the patients with Crohn’s disease over a period of 5–12 years. The main determinants of bowel damage progression are ileum location, stricturing/fistulizing phenotype and disease duration.
P483 Infliximab but not adalimumab drug levels predict faecal calprotectin response in Inflammatory Bowel Disease patients on dose-intensified anti-TNF therapy
Authors: Noack S , Little R , Vaz K , Ward M , Sparrow M 
Published: May 2021

Abstract

Background
Secondary loss of response (SLOR) to infliximab (IFX) and adalimumab (ADA) is common and dose intensification is effective in a proportion of patients. Drug level targets associated with response as measured by faecal calprotectin (FCP) after anti-TNF intensification have not been well established.

Methods
Retrospective observational study of consecutive adult patients with Crohn’s disease (CD) or ulcerative colitis (UC) with SLOR commenced on dose-intensified IFX (5mg/kg 6 weekly) or ADA (40mg weekly) between May 2013-August 2020. Patients were managed via a protocolised virtual clinic. Trough anti-TNF drug levels and FCP were measured at baseline, and at 6 and 12 months post dose intensification. FCP response was defined as ≤150μg/g. Inter-group and longitudinal comparisons used Mann-Whitney U and Wilcoxon signed-rank tests, respectively. ROC curves evaluated anti-TNF drug levels predictive of FCP response.

Results
Of 78 patients (56% male, median age 40 years), 60 had CD (58% on IFX) and 18 had UC (100% on IFX). There were no significant differences in patient or disease demographics between FCP responders and non-responders at 6 or 12 months. At 6 months, median IFX level and increment in level from baseline were higher in FCP responders than non-responders in both CD and UC (Table 1). At 6 months, achieving an IFX level ≥5.7μg/mL in CD (AUC 0.82, sensitivity 88%, specificity 65%, p=0.012; Figure 1A) and an IFX level ≥5.2μg/mL in UC (AUC 0.89, sensitivity 100%, specificity 73%, p=0.015; Figure 1B) best predicted FCP response. ADA levels at 6 months and both IFX and ADA levels at 12 months were not predictive of FCP response in any cohort.

Conclusion
After dose-intensified IFX, CD and UC patients achieving FCP response had greater absolute and increment in drug levels than those with elevated FCP. IFX levels ≥5.7μg/mL and ≥5.2μg/mL at 6 months are predictive of FCP response in CD and UC, respectively. ADA levels were not predictive of FCP response.
P488 The COVID19 pandemic impact on Inflammatory Bowel Disease Patients Management in a Romanian Tertiary Gastroenterology Centre
Authors: Costache R , Iacob R , Vadan R , Stroie T , Gheorghe L , Diculescu M , Gheorghe C 
Published: May 2021

Abstract

Background
The IBD patients management has been challenging during the ongoing COVID-19 pandemic, due to lockdowns, limitation of access to medical facilities and new recommendations regarding patient management. The implications of the COVID-19 pandemic on IBD patient’s management were assessed in our Tertiary Gastroenterology Centre in Bucharest, Romania.

Methods
Using the hospital’s medical system, records of IBD patients admitted between 15th of March and 15th of August 2020 have been retrospectively reviewed and compared to a control cohort of consecutive IBD patients admitted to our unit during the corresponding period of 2019, registering the epidemiological features, patient management and the incidence of COVID-19 infection.

Results
410 individual IBD cases were managed in our unit in 2020 compared to 532 in 2019, with a significant shift towards one-day hospitalization: 1059 admissions (9% ward hospitalizations, 91% one-day hospitalizations) compared to 1327 cases in the corresponding period of 2019 (17.8% ward hospitalizations, 82.2% one day hospitalizations). There was no statistically significant difference between the distribution of patient’s gender, IBD phenotype or newly diagnosed IBD cases between the two periods. A significantly lower proportion of admitted patients received 5-aminosalicylic acid (29% vs. 41.2%, p=0.0001), whereas a substantially higher number pf patients were prescribed biological therapy in 2020 in comparison to the corresponding 2019-time frame (79.5% vs 57.9%, p&lt;0.0001). The distribution of the biological agent used was significantly different, mainly due to the increase of vedolizumab prescription in 2020 (p&lt;0.0001). Among the newly diagnosed cases 50.0% had a severe disease requiring a biological agent (vs 30.2% in 2019, p&gt;0.05). Moreover, from our previously diagnosed patients, 7.1% needed the initiation of biological therapy due to disease flare-up (vs. 4.3% in 2019, p=0.003). During the study period in 2020, seven IBD patients (1.7%) were diagnosed with severe acute respiratory syndrome coronavirus 2 (SARS-Cov2) infection, all of them with mild symptoms without impact on the IBD course.

Conclusion
The COVID-19 pandemic led to reorganizing medical care, restricting the hospital admissions in favour of severe IBD cases, favouring telemedicine for mild disease and optimization of treatment for moderate to severe IBD with an increased use of biologicals aimed to maximize the risk/benefit ratio. Incidence of SARS-Cov2 infection during the first wave of COVID-19 infection in our study group was 1.7% and did not adversely impact the IBD disease course.
P643 Patient perspectives and expectations in inflammatory bowel disease: a systematic review
Authors: Balram B , Al Khoury A , Bessissow T , Afif W , Gonczi L , Abreu M , Lakatos P L 
Published: May 2021

Abstract

Background
In this systematic review, our objective was to assess inflammatory bowel disease (IBD) patient preferences and perspectives relating to their disease diagnosis, treatment, knowledge needs and telemedicine.

Methods
This study was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines (PRISMA). Four databases and conference proceedings were searched between January 1, 1980, and May 1, 2020. The methodological quality of the included studies was assessed using the Standards for reporting qualitative research checklist.

Results
Our search identified 240 citations and 52 studies met the inclusion criteria. The major expectations of the patients are symptomatic and pain control, quality of life and normal endoscopy. Patients’ main concerns are access to information and healthcare, and shared decision making. At the time of diagnosis, patients expressed a greater need for knowledge about their IBD, preferentially by their treating gastroenterologist. The main treatment expectations in active disease are efficacy, safety and convenience. Patients are willing to accept relatively high risks of complications from medical therapy to avoid a permanent ostomy and to achieve durable remission. Patients are more interested in disease monitoring, research and development during the time of remission. Telemedicine and self-management with supervised e-health tools are feasible and acceptable amongst IBD patients.

Conclusion
This systematic review demonstrates that IBD patients expect more information about their disease process, shared decision making and symptom control. Further research is needed to help align patient and physician expectations in order to improve the quality of care provided to IBD patients.
P646 The Loss of Productivity in Employment and Education Associated to Inflammatory Bowel Diseases: A Pilot Study of the Patient’s Perception
Authors: Nieves-Jimenez H , Solis-Pomales C , Ortiz-Domenech S , Marrero-Concepcion F , Marrero-Irizarry J , Torres E A 
Published: May 2021

Abstract

Background
Inflammatory Bowel Diseases (IBD) impact vocational, educational, and psychosocial aspects of a patient’s life and may cause patients to miss work or school or underperform. This study describes loss of productivity in Hispanics with IBD in the workplace and educational settings, along with the patient’s perception.

Methods
Patients with IBD attending a tertiary care clinic were given a self-administered survey related to loss of productivity in employment and education. The questionnaire acquired qualitative and quantitative data about the patients’ past and present work and educational settings. Productivity was determined by the number of absences or early leaves from school or work due to disease manifestations. The patient’s perception regarding psychological aspects of their condition was assessed. Descriptive statistics were used for sociodemographic data, perceptions regarding their condition, and clinical history as captured by the questionnaire. This study is approved by the MSC IRB.

Results
100 patients (M/F: 50/50, CD/UC: 72/28, age range: 18–61, mean age: 29.78 ± 9.81) participated. 45 participants were working, 16 were studying, and 25 were working and studying. 89% of those working had to leave early or miss work due to disease manifestations and, among those, 51% had more than two absences in a given month. During their school years, 100% had absences or had to leave class early because of the disease. 61% said that their condition has a negative effect in their daily lives. Furthermore, 61% perceived their disease affects moderately to severely their daily life. However, 61% expressed that their disease has minimal or no effect on their self-esteem, 75% denoted that their disease does not impact their familial relationships and 74% indicated that they manage their disease with a positive mindset. There was no significant association between sex (p=0.71) or diagnosis (p=0.31) and perception of disease severity.

Conclusion
Work and study absences due to IBD manifestations were frequently reported in the study, translating into decreased productivity. Perception of disease severity was independent of diagnosis and sex. A majority perceived that IBD affected daily life moderately to severely. Strategies to improve work and study conditions may result in improved productivity.
P666 Frequency and outcome of SARS-CoV2 infection in patients with inflammatory bowel disease on different biological therapy
Authors: Resál T , Farkas K , Molnár T 
Published: May 2021

Abstract

Background
Since almost its 1 year outbreak declared by the World Health Organization on 11th March 2020, COVID-19 pandemic still cannot be controlled successfully. Inflammatory bowel disease potentially elevates the risk of infections, independently from the age, while disease activity and medical treatment(s) can increase the risk as well. Based on international data, in total, 4% receives the infection. Furthermore, 1.8% of the patients on biologic therapy needs intensive therapeutic care and 1% passes away.

Methods
This was an observational, questionnaire based study, carried out in Hungary, between February and March 2021. Our questionnaire consisted of 45 questions, that surveyed the impact of the pandemic among IBD patients, and the severity and outcome of the infection. Participants were on biologic therapy. Our aim was to determine the frequency and outcome of SARS-CoV2 infection in patients with inflammatory bowel disease on different biological therapy.

Results
In total, 387 respondents completed the questionnaire, and 47 participants (12%) developed COVID-19 infection. 66.9% of them were receiving anti-TNF inhibitor, 16.8% vedolizumab, 12.1% ustekinumab, and 4.1% tofacitinib. Based on our cohort, different biologic therapies didn’t elevate the risk of infection (p=0.3486), nor the hospitalization rate (p=0.277). No one was in ICU or ventilator, and nobody passed away. Furthermore, 38.3% suspended the current biologic therapy, but it didn’t decrease the rate of hospitalization (p=0.533), however, it didn’t cause flare-ups either in the primary disease (p=0.415). Based on our cohort, neither vitamin supplementations meant protection against the infection (p=0.117), only regular mask wearing seems to protect patients with IBD (p=0.009).

Conclusion
Based on our cohort, more IBD patients develop the infection in Hungary, compared to international data, however, the outcome of the infection is more favourable. It seems, that the different biological treatments don’t affect the infection rate, and neither elevates the hospitalization rate. In generally, there is no need to suspend the current biologic therapy, however, it should be a matter of individual judgment. After all, we claim that mask-wearing still seems to be the most effective form of prevention.