bluuebunny/crossref_metadata_2025_split huggingface dataset:
P251 Antiphospholipid antibodies in Crohn’s disease: Results of a prospective single-center study
Authors: Serghini M , Ben Youssef H , Baccouche H , Hafi M , Labidy A , Ben Mustapha N , Fekih M , Boubaker J 
Published: May 2021

Abstract

Background
Assess the prevalence of antiphospholipid antibodies (APL) and their association with disease phenotype and activity in patients with Crohn disease (CD).

Methods
This is a prospective study involving 30 patients with CD over a period of 2016 to 2020. Family and personal history of thromboembolic disease and fetal loss as well as their delay in relation to the date of the sample were taken from from the interrogation. Disease-related data such as age at the time of diagnosis, location and phenotype of the disease as well as treatment medical received were identified from the medical records. Disease activity was evaluated according to the CDAI (Crohn Disease Activity Index) score calculated time of inclusion. The serum of the patients was tested on anti-β2-glycoprotein-I (anti-β2-GPI Ig M / G), anti-cardiolipin (ACA Ig M / G) by method enzyme immunoassay (ELISA). This test was considered positive if the rate of anti-cardiolipin antibody was&gt; 12U / mL and the level of anti-β2- glycoprotein-1&gt; 8U / mL. The occurrence of thromboembolic events was noted during follow-up.

Results
The average age was 47.3 ± 10.8 years (29 men and 21 women). A family history of thromboembolic disease has been noted in 2 patients. A patient developed a pulmonary embolism 37 months before his inclusion in postoperative context. A history of fetal loss was reported in 7 women (16%) with a delay ranging from 5 to 432 months (in mean 181.6 ± 146) before their inclusion in the study. The average age at time of diagnosis was 37.9 ± 11.7 years. Colonic localization of the disease was noted in 12 patients (41.4%) and the inflammatory phenotype was the more common (62.1%). The disease was active in 13 patients (44.8%) with a mean CDAI score of 149.2 ± 111.7 (23–469). A patient has presented a mesenteric infarction during his follow-up 35 months after his inclusion. Positive anti-β2-glycoprotein-1 antibody levels IgG type with levels negative anti-cardiolipin antibodies were found in 2 patients (6%). No patient had positive anti-cardiolipin antibodies. No difference was found for the prevalence of anti-β2-GPI in patients patients in remission compared to those with active disease (p = 0.22) and in patients with severe acute colitis compared to the rest of the patients (p = 0.2). The frequency of β2-GP1 was not higher in patients with CRP greater than 6 mg / L compared to those with a normal CRP (p = 0.4). Anti-TNF treatment was started in 5 patients and no association was found between anti-TNF treatment and the prevalence of anti-β2-GP1 (p = 0.7). APL status was not associated with phenotype and localization of disease or thrombotic events.

Conclusion
The present study did not demonstrate an association between APL antibodies and disease phenotype or activity.
P258 Rates of admission of acute IBD flares during the COVID-19 pandemic in a tertiary healthcare setting
Authors: Hazel K , Glynn E , Boland K , O’Toole A 
Published: May 2021

Abstract

Background
Environmental tiggers are thought to contribute to Inflammatory Bowel Disease flares. The COVID-19 pandemic and resulting lockdown led to an emphasis on outpatient care, fewer presentations to hospital for non-COVID-19-related illnesses, changes in work practices and a reduction in air pollution. Our aim was to determine the impact of these changes on hospital admissions with acute IBD flares.

Methods
The hospital in-patient enquiry (HIPE) department provided records of all patients admitted with acute IBD flares during the first Irish lockdown from March to May 2020 and for the corresponding period in 2017, 2018 and 2019. Electronic patient records were used to assess patient demographics, biochemical markers, imaging, medication use and outcome.

Results
101 patients were admitted with an acute IBD flare. This was a marked reduction when compared to the corresponding period in the previous three years (p&lt;0.0001). Despite the rates of admission decreasing in this period, rates of colectomy were significantly increased (p&lt;0.0001). (Table 1).

Conclusion
We demonstrated a significant decrease in hospital admissions for acute IBD flares during the first wave of the pandemic. We postulate that changes in environmental triggers of IBD such as working from home and reduced stress levels in addition to reduced air pollution may account for this reduction. The increased rate of colectomy likely reflects a more severe presentation of IBD and patients’ reluctance to attend the hospital at an early stage in their disease flare as well as non-adherence to prescribed IBD therapies due to a perceived COVID-19-related risk.
P295 Comparative Assessment of Infliximab Trough Levels between Point-of-Care Testing and current Standard of Care (enzyme linked immunosorbent assay) in patients with Inflammatory Bowel Disease
Authors: Maniero D , Lorenzon G , Marsilio I , Rigo A , Cardin R , Facchin S , Barberio B , D’Incà R , Zingone F , Bahur B , Bray K R , Savarino E V 
Published: May 2021

Abstract

Background
Infliximab (IFX) is a monoclonal antibody that targets cytokine tumor necrosis factor; it is used for the treatment of patients with active inflammatory bowel disease (IBD), including Crohn’s disease (CD) and ulcerative colitis (UC). IFX induces and maintains remission and mucosal healing in patients with IBD. Measurement of trough levels (TL) of IFX is important to assess if the drug is within its therapeutic concentrationand to explain lack/loss of response. Standard laboratory tests to assess IFX trough levels (enzyme linked immunosorbent assays, ELISA) present some downsides, related to the long turnaround (about 3 hours), and the need of specialized equipment and laboratory personnel. For this reason, point-of care testing (POCT) was developed to provide results within a few minutes from blood collection, leading to a decision-making approach.

Aim
To determine the degree of analytical correlation between a recently developed POCT (ProciseDx) IFX assay which analyze capillary whole blood and the comparative ELISA from serum.

Methods
From October 2020 to January 2021, patients (aged≥18 years) taking IFX were recruited at Gastroenterology Unit, Padua University Hospital. In each patient, IFX levels from capillary whole blood collected by finger stick were performed using the ProciseDx IFX assay with reportable range between 1.7-77.2 µg/mL; at the same time, a serum sample from venous blood was collected to carry out Grifols’ Promonitor ELISA test (range 0.035–14.4 µg/mL). A Deming regression test was used to identify the correlation between the two methods.

Results
Eighty-seven patients were enrolled (63% males; mean age of 44±16), with 52% of them having CD, 45% UC and 3% an undetermined-Inflammatory Bowel Disease. The assessment with ProciseDx POCT was feasible in each patient and only in three cases blood collection from finger prick was repeated. Moreover, from blood collection to results we needed about 3±0.5 minutes, while serum ELISA analysis required the collection of at least 40 samples (around three weeks at our centre) and 3 hours to be performed. 39 patients (59% males; mean age of 44±16) had TL as assessed by ProciseDx IFX assay lower than 1.7 or greater than 14.4 µg/mL, in accordance with ELISA assessment. Among the remaining 48 patients (67% males with mean age of 45±17), The correlation between the two tests was high (the total results showed an R squared of 0.691 (95% CI 0.717-0.902).

Conclusion
The ProciseDx POCT has good accuracy but was more rapid and easy to be performed in providing the results of Therapeutic Drug Monitoring in outpatients taking IFX. This could lead to a more effective optimization of the biological drug, thus avoiding treatment failure.
P346 Decreasing disparities in and use of systemic corticosteroid and disparities in use among paediatric patients with Crohn disease in a multicentre collaborative
Authors: Adler J , Kandavel P , Eder S , Saeed S 
Published: May 2021

Abstract

Background
Systemic corticosteroids (CS) have long been used to treat Crohn disease. However, cumulative CS exposure is associated with adverse effects, particularly among growing children. Steroid sparing therapies are increasingly available. It remains unknown to what extent CS use has decreased among children with Crohn disease.

Methods
This was an observational cohort study using data from ImproveCareNow Network, multi-centre international paediatric inflammatory bowel disease collaboration (2007-2018). Paediatric patients diagnosed with Crohn disease were included. We performed serial cross-sectional analyses of period prevalence for entire population. Patients enrolled &lt;30 days from diagnosis were included in logistic multivariate regression to predict odds of CS use 120-365 days after diagnosis. All families provided consent/assent.

Results
The total population included 17,646 patients (82% white, 59% male). Systemic CS were used by 5,862 (33%), more commonly among black than white patients (37% vs 32%; p&lt;0.001). Those with inflammatory phenotype had more CS use than stricturing or penetrating (34%, 28%, 22% respectively; p&lt;0.001).
Overall, CS use decreased from 28% (2007) to 9% (2018). Excess CS use among blacks compared to whites reduced from mean 17% in first 3 years to 3% in last 3 years (Figure 1). Changes in other medications appear in Figure 2. Multivariate results are in Table 1. CS or 5-aminosalicylate use &lt;120 days after diagnosis predicted later increased odds of CS use. Anti-tumour necrosis factor-α (anti-TNFα) use &lt;120 days after diagnosis was associated with reduced odds of later CS use.

Conclusion
Corticosteroid use among paediatric patients with Crohn disease in the ImproveCareNow Network has decreased over time. Racial disparities in CS use were found, but gradually improved. Early 5-aminosalicylate or CS use predicted later CS use. Early anti-TNFα treatment is associated with reduction in later CS use.
P381 Fatigue is an independent disease manifestation largely independent of chronicity, comorbidity and disease activity in patients with Inflammatory Bowel Disease
Authors: Risager Christensen K , Steenholdt C , Buhl S , Skougaard M , Brynskov J , Ainsworth M A , Schjødt Jørgensen T , Kristensen L E 
Published: May 2021

Abstract

Background
Fatigue is a common reported symptom by patients with inflammatory bowel disease (IBD) and often with profound negative impact on quality of life including daily activities. The aim of this study was to encircle clusters of key components associated with fatigue to explore if fatigue is an independent IBD disease manifestation.

Methods
A cross-sectional study was conducted in patients with IBD receiving biologic therapies at the tertiary IBD Clinic at Herlev Hospital, Denmark, from March to May 2019. Consecutive patients were asked to participate in a questionnaire survey when visiting the clinic. The questionnaire included: FACIT-Fatigue, Harvey-Bradshaw Index/Simple Clinical Colitis Activity Index, short health scale, short IBD Questionnaire, and EQ-5D-5L. Additional disease-related information was retrieved from medical records. Principal component analysis (PCA) was used to identify factors associated with fatigue.

Results
Three hundred patients with IBD (Crohn’s disease n=190 (62%); ulcerative colitis n=110 (38%), mean age 44 years, SD 14) treated with biologics were included. The median FACIT F-score was 39 for the population, and scores ≤39 were considered moderate-to-severe fatigue. A high proportion of patients had moderate-to-severe fatigue (n=152 (51%)), these patients had significantly higher clinical disease activity (moderate-to-severe, n=56 (37%); remission, n=47 (31%)), compared to those with none-to-mild fatigue (n=148 (49%)) (moderate-to-severe, n=10 (7%); remission, n=105 (71%)) (p&lt;0.005). Initial correlation analysis showed high clinical association between moderate-to-severe fatigue and patient reported outcomes, notably quality of life (rs=0.78), general well-being (rs=0.67), and disease worry (rs=0.52). The PCA subsequently reduced co-variables associated with fatigue into 3 main components, explaining 37% of fatigue (Figure). The first major component, explaining 15% of total fatigue, included ‘chronic disease related factors’, such as long disease duration, increasing age, previous use of biologics and corticosteroids, and previous surgery. The second component contributed to 13% of fatigue and comprised ‘comorbidity factors’, e.g., other chronic diseases, high body mass index (BMI), and self-reported disease activity. The third major component, explaining 11% of fatigue, comprised ‘disease activity and nutrition factors’ such as of high c-reactive protein, low iron, and low BMI.

Conclusion
Fatigue in IBD is only to a lesser extent driven by disease activity and nutritional deficits, chronicity, and co-morbidity. This indicates that fatigue is an independent disease manifestation in IBD.
P411 Baseline Hypertrophy of the Submucosa at intestinal ultrasound predicts Failure of Treatment in patients with ulcerative colitis
Authors: de Voogd F , Duijvestein M , Ponsioen C , Löwenberg M , D’Haens G , Gecse K 
Published: May 2021

Abstract

Background
Submucosal fibrosis in ulcerative colitis (UC) has been associated with disease severity in colectomy specimens. As intestinal ultrasound (IUS) visualizes all individual wall layers, we aimed to evaluate baseline IUS features to determine endoscopic response and investigate changes in wall layers during anti-inflammatory treatment in patients with UC

Methods
Moderate-severe UC patients (endoscopic Mayo score (EMS)≥2) extending beyond the rectum starting treatment were included. Simple Clinical Colitis Activity Index (SCCAI), fecal calprotectin (FCP), IUS and endoscopy were performed at baseline and at follow-up between week 8 and 26. BWT, individual wall layer thickness (WT) (mucosa (MC), submucosa (SM) and muscularis propria (MP)) and ratios among layers, Colour Doppler Signal, loss of haustrations, loss of stratification and hyperechogenicity of the submucosa (HoS) (Figure 1) were scored for the sigmoid colon (SC). EMS was assessed for the SC: endoscopic remission (ER) was defined as EMS=0 and endoscopic improvement (EI) as EMS≤1. For statistical analysis a paired t-test and X2-test were used.

Results
49 patients were included of whom 61% failed ≥1 biological. 59% started tofacitinib and 41% started a biological. At follow-up, 30% and 49% reached ER and EI, respectively. BWT decreased significantly when ER (2.32 ± 1.63 mm vs 1.00 ± 1.98 mm, p=0.034) or EI (2.53 ± 1.66 mm vs 0.30 ± 1.58 mm, p&lt;0.0001) was reached. In patients with ER and EI, the SM thickness showed significantly more pronounced decrease compared to the other wall layers (Table 1 and Figure 2). Baseline presence of HoS (29% of patients) predicted failure of treatment (ER: OR: 0.10, 95% CI: 0.01-0.87, p=0.014, EI: OR: 0.16, 95% CI: 0.04-0.65, p=0.008,). Furthermore, when HoS was present, SCCAI (7.33 ± 3.62 vs 9.75 ± 3.23, p=0.023) and FCP (1249 ± 903 µg/g vs 2494 ± 2277 µg/g, p=0.008) were significantly lower at baseline. Also, patients with HoS more frequently failed one (OR: 4.44, 95% CI: 1.08-18.32, p=0.03) or multiple biologicals (OR: 5.63, 95% CI: 1.54-20.52, p=0.009). However, disease duration (p=0.950) or age at onset (p=0.853) did not differ between groups.

Conclusion
This is the first study showing that HoS on IUS is a predictor of endoscopic non-response to biologicals and tofacitinib in patients with UC. Additionally, changes in SM layer thickness is the most important component of the total bowel wall when evaluating mucosal healing on IUS.
P438 Maladaptive decision-making is associated with psychological morbidity in people with Inflammatory Bowel Disease
Authors: Grinsted Tate L , Johnson L , Jones G , Lobo A 
Published: May 2021

Abstract

Background
Inflammatory Bowel Disease (IBD) is a chronic relapsing-remitting inflammatory condition. Due to its long-term, multifaceted nature, patients will need to make many complex decisions during their treatment.
The Melbourne Decision Making Questionnaire (MDMQ) assesses the use of four decision-making styles. Vigilance is the only style considered adaptive, with a thorough, analytical approach. Buck-passing (avoiding responsibility), procrastination and hypervigilance (a hurried, anxious approach) are considered maladaptive.
This study aimed to assess the impact of psychological morbidity, health-related quality of life (HRQoL) and demographic/disease factors on decision-making in IBD.

Methods
People over the age of 16 with IBD completed the MDMQ. Psychological morbidity was assessed by the DASS-21 questionnaire, and HRQoL by the EQ-5D-3L/EQ-5D-Y. Demographic data included age, gender, ethnicity, Index of Multiple Deprivation quintile, educational level and employment status. Diagnosis, disease duration and age at diagnosis were also recorded.
Exploratory analysis of all variables against scores for each of the four decision-making styles was conducted. Significant results were used to perform multivariate analysis. All statistical analysis was performed using IBM SPSS Statistics software (v26).

Results
172 patients were studied (94 CD, 75 UC, 3 IBD-U, 68 (39.5%) male), median age 46.5 (16-83). Median MDMQ scores for vigilance, buck-passing, procrastination and hypervigilance were 10/12, 3/12, 2/10 and 3/10 respectively.
Multivariate analysis showed strong positive associations between psychological morbidity scores and all three maladaptive decision-making styles: buck-passing (F(1, 95)=12.512, p=0.001), procrastination (F(1, 115)=35.009, p&lt;0.001) and hypervigilance (F(1, 114)=34.342, p&lt;0.001). Age and duration of disease were not associated with decision making style.
Current employment and higher HRQoL scores were significantly associated with greater degrees of buck-passing (F(3,95)=5.100, p=0.003; and F(1, 95)=6.351, p=0.013 respectively). A diagnosis of CD was associated with lower vigilance score (F(2, 133)=3.224, p=0.043).

Conclusion
People with IBD are likely to have an adaptive decision-making style, demonstrated by a high median vigilance score. However, psychological morbidity is associated with maladaptive decision-making – an important consideration for clinicians and in shared decision making. Further studies are required to determine whether interventions for psychological morbidity can improve maladaptive decision-making.
P452 Oral ciclosporin is a convenient, effective and safe rescue therapy in steroid refractory Acute Severe Ulcerative Colitis: A single tertiary centre experience
Authors: Jiang C D , Thalagala T , Rosembert D , Parkes M , Lee J , Raine T 
Published: May 2021

Abstract

Background
Parenteral ciclosporin (CsA) is an effective rescue therapy for acute severe ulcerative colitis (ASUC) and has similar efficacy to infliximab (IFX). Although CsA is cheaper and can facilitate bridging to any IBD therapy, including newer biologics, its use is limited by variable pharmacokinetics and possibility of significant systemic toxicity particularly associated with the intravenous preparation. Despite favourable pharmacokinetics and bioavailability, the use of lipid-emulsified oral CsA in steroid-refractory ASUC is undefined.

Methods
All patients who received oral CsA (Neoral®) rescue therapy for ASUC at Addenbrooke’s Hospital, Cambridge, UK from Nov 2014 to May 2020 were identified from electronic healthcare records. Baseline data and outcomes were extracted and compared to patients who received IFX rescue therapy. Statistical significance was assessed using non-parametric tests. Survival estimates were computed using the Kaplan-Meier method.

Results
A total of 37 patients received oral CsA for refractory ASUC. Median time from admission to CsA initiation was 5 days (IQR 4–6 d) and median initial dose was 8 mg/kg/d (IQR 7–8 mg/kg/d). At admission, the median CRP was 26 (IQR 14–95) and Truelove and Witt’s severity criteria met in 21/37 (57%). 70% of patients (26/37) avoided colectomy during the index admission. No parameters were demonstrated to predict need for acute colectomy.
Median follow-up after hospital discharge was 3 years (IQR 2-5years). For those who avoided acute colectomy, median duration of therapy was 4 months (IQR 2.5-5months) with bridging to azathioprine (24/26, 92%), vedolizumab (1/26, 4%), or 5-ASA (1/26, 4%). Estimated colectomy-free survival in responders were 84%, 84% and 78% at 12, 24, and 60 months. No parameters were shown to predict colectomy-free survival. Comparable colectomy-free outcomes were obtained for contemporaneous IFX-treated ASUC patients in our hospital.
9 of 26 patients remained biologic-naïve and colectomy-free after a median of 3 years. Estimated colectomy and biologic-free survival were 51%, 47% and 18% at 12, 24, and 60 months.
15 patients experienced adverse events, which were all mild and self-limiting. There were 3 infective complications. No patients required drug cessation and no serious adverse events associated with parenteral CsA occurred.

Conclusion
In this cohort, oral CsA was a safe, well tolerated and effective rescue therapy for steroid-refractory ASUC. A proportion of patients remain biologic and colectomy-free for up to 5 years. Given the feasibility to bridge to effective maintenance therapies, including newer biologics, oral CsA should be considered as a rescue therapy in ASUC and avoids many of the side effects associated with intravenous CsA.
P457 Long-term follow-up of patients with IBD after switching from original adalimumab to adalimumab biosimilar during COVID 19 pandemic
Authors: Klimova K , Padilla Suarez C 
Published: May 2021

Abstract

Background
Studies have reported good efficacy outcomes for patients with inflammatory bowel disease (IBD) treated with biosimilars. There are limited long term data. We assessed the long-term efficacy data and safety after switching from adalimumab to adalimumab biosimilar Imraldi in patients with IBD.

Methods
A prospective single-centre observational study involving patients with Crohn’s disease or ulcerative colitis switched from adalimumab originator to adalimumab biosimilar and reviewed up to 24months. Efficacy and loss of response were measured using the Harvey–Bradshaw (HB) index and partial Mayo score for patients with Crohn’s disease and ulcerative colitis respectively. Blood tests including C-reactive protein, adalimumab drug levels and antidrug antibodies were monitored. We have recorded side effects and possible serious adverse effects including COVID 19 infection.

Results
113 patients were switched to Adalimumab biosimilar Imraldi from Adalimumab originator between January 2019 to March 2019. After 12 months of treatment, 25 patients interrupted treatment and 89 (78.8%) continued. These were analysed after 24 months of treatment - 57 (52.3%) continued on Imraldi. Of those who discontinued, 9 were switched back to Adalimumab originator due to side effects, and 34 stopped treatment - 16 patients due to loss of response, 11 patients developed antibodies, 5 underwent a surgery, 4 were in remission and 4 did not tolerate side effects. There was no statistical difference in CRP or Adalimumab levels prior to switch, at 12 months and at 24 months between the patients who continued or discontinued treatment.
Overall, 18 of the patients who completed 24 months of treatment reported side effects, most frequently pain after injection (9 patients), followed by skin rash and recurrent infections (in 3 patients each). No patient was diagnosed with COVID 19 during until now.

Conclusion
After 24 months of follow up, 52.3% patients continued on adalimumab biosimilar and no serious side effects were reported. In particular, none of our patients acquired COVID 19 infection.