bluuebunny/crossref_metadata_2025_split huggingface dataset:
P302 Malignancy surveillance in patients with primary sclerosing cholangitis and Inflammatory Bowel Disease – keeping up with international guidelines? A Norwegian cohort study
Authors: Tønjum T K , Anisdahl K , Folseraas T , Midgard H , Høivik M L 
Published: January 2022

Abstract

Background
Primary sclerosing cholangitis (PSC), especially PSC in inflammatory bowel disease (PSC-IBD), increases risk of developing several types of cancers, including cholangiocarcinoma (CCA), gall bladder cancer and colorectal cancer (CRC) – highlighting the need for frequent and thorough screening employing several diagnostic modalities, in these patients. We aimed to assess whether current international guidelines for malignancy surveillance were followed for the PSC-IBD population at the Department of Gastroenterology (DoG) at Oslo University Hospital (OUH).

Methods
Data from health records of patients at DoG OUH containing the term ‘PSC’ was screened for IBD and PSC diagnoses, disease activity and severity, as well as follow-up of PSC disease progression and surveillance of PSC-associated malignancies. All data was collected in the last quarter of, 2020 and registered in the local IBD registry.

Results
Clinical characteristics [Table 1] and surgical intervention for PSC-IBD [Table 2] are displayed below. In the last year, magnetic resonance cholangiopancreatography (MRCP) was performed in, 16 patients (26%), while, 47 (78%) had an abdominal ultrasound (US). Colonoscopy or other lower endoscopy was performed within the last year in a total of, 42 patients (69%). In those who had not undergone colectomy, 33/40 (83%) underwent colonoscopy in the last year, while, 31/40 (78%) had biopsies taken.

Conclusion
Abdominal US and colonoscopy with biopsies should be performed annually in all PSC-IBD patients1,2, meaning, on average, about one fifth of PSC-IBD patients at OUH may be at risk of unnecessary and preventable affliction. Also, there is a void of guidelines regarding CRC screening in colectomised patients. Evidence for screening for CCA with MRCP remains unclear3, but when performed may indicate severe economic impact on public health systems.
References
1. Chapman MH et al. British Society of Gastroenterology and UK-PSC guidelines for the diagnosis and management of primary sclerosing cholangitis. Gut., 2019;68(8):1356–78.
2. Aabakken L et al. Role of endoscopy in primary sclerosing cholangitis: European Society of Gastrointestinal Endoscopy (ESGE) and European Association for the Study of the Liver (EASL) Clinical Guideline. Endoscopy., 2017;49(6):588–608.
3. Schramm C, Eaton J, Ringe KI, Venkatesh S, Yamamura J. Recommendations on the use of magnetic resonance imaging in PSC - A position statement from the International PSC Study Group. Hepatology., 2017;66(5):1675–88.
P304 Intensified versus conventional infliximab induction in acute severe steroid-refractory Ulcerative Colitis
Authors: Pedro J , Coelho Rodrigues I , Botto I , Fernandes S , Bernardo S , Gonçalves A R , Moura Santos P , Valente A , Correia L , Tato Marinho R 
Published: January 2022

Abstract

Background
Infliximab is effective as salvage therapy in severe steroid-refractory Ulcerate Colitis. However, up to one third of patients do not respond to this treatment and require surgery. There is still insufficient evidence regarding the benefits of intensified infliximab induction regimens in this setting.

Methods
Retrospective study including, 51 patients meeting the Truelove and Witts criteria for severe acute Ulcerative Colitis with refractoriness to intravenous steroids requiring infliximab rescue therapy. We compared patients under conventional infliximab induction therapy (n=29) with patients performing an intensified infliximab induction regimen (n=22), defined as a higher dose/shorter interval of treatment during induction.

Results
There was no difference in respect to median age [IQR] (32.0 [27.0–43.0] vs, 42.0 [29.0–58.0], p=0.116), and male gender (69.0 % vs, 63.6%, p=, 0.458) between patients with conventional or intensified infliximab. Compared to patients with conventional induction, patients under optimized infliximab presented reduced admission to intermediary/intensive care unit (4.5% vs, 31.0%, p=, 0.019), and surgery (13.6% vs, 41.4%, p=, 0.031). There were no differences in deaths (3.4% vs, 9.1%, p=0.396), readmission rates (17.2% vs, 28.6%, p=, 0.270), and median duration [IQR] of hospitalization (19.0 [10.5–31.0] vs, 12.0 [8.0–15.5], p=0.094) between patients with conventional or intensified regimens. In a multivariate analysis, the use of an intensified infliximab induction regimen was associated with a lower risk of surgery (OR, 0.224, 95%CI [0.054–0.929], p=, 0.039).

Conclusion
In this small cohort, there was some suggestions that intensified infliximab induction may improve treatment outcomes in acute severe steroid refractory Ulcerative Colitis.
P308 Quadruple oral antibiotic treatment in refractory Paediatric Inflammatory Bowel Disease – incidence and analysis of responders from a, 10 year cohort
Authors: Meredith J J , Armstrong K , Russell R K , Henderson P , Wilson D C 
Published: January 2022

Abstract

Background
Recent, albeit limited, studies indicate that combination oral antibiotic therapy may be an efficacious, immunosuppressive-free, alternative strategy to achieve remission in a subset of medically refractory IBD patients. We sought to identify incidence data and provide cohort analysis of any refractory IBD patients who subsequently responded to combination oral antibiotic therapy from a large paediatric inflammatory bowel disease [PIBD] centre.

Methods
We identified a regional cohort of prospectively acquired incident cases of paediatric inflammatory bowel disease (CD, UC and IBD-U) diagnosed &lt;16 years of age in South-East Scotland over a, 10-year period (2009–2018) and conducted a retrospective review identifying all cases with treatment refractory disease who subsequently achieved remission with a quadruple oral antibiotic regimen (vancomycin/doxycycline/metronidazole/amoxicillin) as salvage therapy. We characterised demographic data, IBD disease type, classification, severity, duration, as well as prior treatment efficacy and duration. There was a minimum of, 2 years of follow data available.

Results
In total, 4 cases of successful treatment with a quadruple oral antibiotic regimen in refractory patients were identified from our, 10-year PIBD registry that included, 222 new cases of PIBD (cumulative incidence, 1.8%). Treatment was attempted in, 9 refractory patients over the period. All responders were male, median age at diagnosis, 13.1yrs (0.5, 11.3, 14.8, 15.7yrs), median disease duration was, 1.3yrs. All responders had chronically active moderate-severe disease., 3 had ulcerative colitis (Paris classification E4), the remainder had Crohn’s disease (Montreal classification B1, L3/4). All responders had disease refractory to a least, 2 biological therapies that were co-administered with either thiopurines or methotrexate., 3 of the, 4 had failed at least one steroid induction course., 3 of the, 4 maintained clinical remission at the minimum, 2 year follow up on regular oral vancomycin therapy.

Conclusion
A subset of patients with PIBD that is highly refractory to conventional therapeutics, including to steroids and multiple biologics, may achieve remission with a quadruple combination oral antibiotic regimen. Those with active colitic phenotypes at intervention were more likely to respond and longer-term disease remission may be maintained with regular oral vancomycin.
P311 Depression and anxiety are associated with poor clinical outcomes in Inflammatory Bowel Disease: A Nationwide Population-Based Study in South Korea
Authors: Kim S , Seungwoo L , Kyungdo H , Hyun Jung L , Jong Pil I , Joo Sung K 
Published: January 2022

Abstract

Background
The increase in prevalence of depression and anxiety disorder in Inflammatory Bowel Disease (IBD) is demonstrated from previous studies, but it is uncertain whether the patients with depression and anxiety are at higher risk of poor outcomes of IBD. Therefore we aimed to determine the impact of depression and anxiety on clinical outcomes in patients with IBD.

Methods
We conducted a nationwide, population-based retrospective cohort study using the Korean national health insurance claims data between, 2010 and, 2017. Patients with Crohn’s Disease and Ulcerative Colitis were targeted through the registration program for rare/intractable diseases, and patients with depression and anxiety were also identified by the International Classification of Disease, tenth revision (ICD-10) code. The primary outcome of this study is the poor IBD-related outcomes and we defined the poor IBD-related outcomes as IBD-related emergency room visits, hospitalization, and surgery in this study.

Results
A total of, 36,379 IBD patients (10,754 Crohn’s disease (CD) and, 25,625 ulcerative colitis (UC)) were enrolled in this study between, 2010 and, 2017 and among them, 4,335 (11.9%) had depression/anxiety. Multivariate analysis showed that CD patients with depression/anxiety were at an increased risk of ER visits (HR, 1.858, 95% CI, 1.5–2.301) and hospitalization (HR, 1.727, 95% CI, 1.315–2.269). UC patients with depression/anxiety were also at increased risk for ER visits (HR, 1.339, 95% CI, 1.084–1.654) and hospitalization (HR, 1.367, 95% CI, 1.059–1.764). While the risk of surgery in patients with depression/anxiety was not different from those without depression/anxiety in both CD and UC.

Conclusion
Depression and anxiety disorder was associated with a higher risk for poor clinical outcomes in patients with IBD. The results of this study suggest that psychologic co-morbidities such as depression and anxiety might improve the clinical course of IBD
P315 High symptom burden and impact on health-related quality of life in patients with Crohn’s perianal fistulas: results from a global burden of illness study
Authors: Karki C , Sharpe E , Hantsbarger G , Lee K , Perovic M , Raven L , Sajak-Szczerba M , Silber A , Yoon A , Tozer P 
Published: January 2022

Abstract

Background
Perianal fistulas (PAF) are a common complication in Crohn’s disease (CD) and can be associated with an increased burden of illness. A global study was conducted to assess the burden of illness in patients with Crohn’s perianal fistulas (CPF) compared with patients with CD without PAF (non-PAF CD). Here we present patient symptom burden and impact on HRQoL.

Methods
This cross-sectional study was conducted in seven countries (France, Germany, Spain, UK, Canada, Australia and Japan) in patients aged ≥21 and ≤90 years with self-reported physician-diagnosed CD. Patients were classified as having non-PAF CD (cohort, 1) or CPF without PAF-related surgery (cohort, 2) or CPF with PAF-related surgery (cohort, 3). Customised questions and validated general and disease-specific patient-reported outcome data were collected via a, 45-min IRB/EC-approved web-enabled questionnaire. Symptom burden and impact on HRQoL were evaluated using the Short Inflammatory Bowel Disease Questionnaire (SIBDQ, scores, 1–7 [low–optimum] with, 2-week recall period) in all cohorts and Quality of Life in Patients with Anal Fistula (QoLAF, scores, 14–70 [low–high impact]) in cohorts, 2 and, 3. Data were analysed using descriptive statistics.

Results
Of, 929 patients recruited (cohort, 1, n=620; cohort, 2, n=174; cohort, 3, n=135), 58–69% were male and, 55–67% were aged, 21–40 years across all cohorts. Cohorts, 2 and, 3 experienced a significantly higher frequency of CD-related complications than cohort, 1 (mean [standard deviation, SD]:, 9.4 [4.5] and, 11.1 [5.2] vs, 6.0 [4.1], respectively; both p &lt;0.05, Table, 1) and had a higher number of CD-related surgeries (other than PAF-related surgeries) in the past, 12 months (mean [SD]:, 1.8 [1.1], p =0.109 and, 2.2 [1.3], p &lt;0.0001 vs, 1.5 [0.9], respectively). In patients with CPF, a smaller proportion in cohort, 2 had active PAF vs cohort, 3 (136 [78%] vs, 119 [88%], respectively; p =0.022) and a smaller proportion had experience with post-treatment PAF recurrence/persistence in cohort, 2 vs cohort, 3 (84 [48%] vs, 80 [59%], respectively; p =0.055). Overall SIBDQ scores were significantly lower (worse) in cohorts, 2 and, 3 than in cohort, 1 (3.8 and, 3.7 vs, 4.1 respectively; both p &lt;0.001). In patients with CPF, total QoLAF scores were comparable between cohorts, 2 and, 3 (41 and, 42, respectively), although patients in cohort, 3 had a significantly higher (worse) score in the physical impact domain compared with cohort, 2 (21 vs, 19, respectively; p &lt;0.05).

Conclusion
In this large global study, we observed that patients with CPF had incrementally higher symptom burden, owing to both CD and PAF, compared with patients with non-PAF CD. For patients with CPF, there was no difference in HRQoL irrespective of whether they had received PAF-related surgery or not.
P321 Mucosal Healing and Clinical remission after Treatment with Adalimumab in Small Intestinal Crohn’s Disease (SIMCHA study): final results from a prospective, open-label, single-arm study
Authors: Wetwittayakhlang P , Golovics P , Hahn G , Bessissow T , Afif W , Wild G , Bitton A , Lakatos PhD P L 
Published: January 2022

Abstract

Background
Endoscopic mucosal healing is a key treatment target in inflammatory bowel disease (IBD). The aim of this study was to investigate small bowel (SB) mucosal healing using video capsule endoscopy (VCE) in patients with Crohn’s disease (CD) following, 24 weeks of adalimumab therapy.

Methods
In this prospective study, moderate to severe SB involvement CD patients were enrolled, defined by a Lewis score on VCE at diagnosis &gt;, 790 in at least one tertile. All patients were treated with adalimumab monotherapy at the standard dosing for CD for, 24 weeks prior to undertaking the follow-up second VCE. The primary outcome was the endoscopic healing defined as a Lewis score (LS) &lt;, 350, whereas partial response was defined as a &gt;, 50% decrease from baseline in LS. Secondary outcomes included the remission in the clinical symptoms (Harvey Bradshaw Index, HBI &lt;, 4) and biomarkers (fecal calprotectin, FC &lt;, 200 ug/g, and c-reactive protein, CRP &lt;, 5 mg/l).

Results
A total of, 59 CD patients were screened at McGill University Health Centre between November, 2011 and October, 2021;, 15 patients were met the eligibility criteria and were enrolled. The median age at inclusion was, 46 years (IQR, 28–51), 8 patients (53.3%) had ankylosing spondylitis. The most frequent locations of CD on VCE findings were the proximal-mid ileum (93.3%) and jejunum (73.3%). Primary outcome; complete endoscopic healing was observed in, 8 patients (53.3%, p=0.002, OR for remission = 2.14, 95%CI:, 1.25–3.68), and partial response in an additional, 5 patients (33.3%) after, 24 weeks. The median total Lewis score was decreased significantly compared to the baseline (1,912 vs., 337, p=0.0005). Secondary outcomes; the HBI at baseline was elevated (&gt;, 4) in, 11 patients. Post-treatment HBI was consistent with clinical remission in all cases (11/15 vs., 0/15, p &lt;0.0001 OR clinical remission = 0.27,95%CI:0.12–0.62). Nine patients who had baseline CRP elevation had achieved normal CRP after treatment, and the median CRP was significantly decreased from, 7.3 mg/L (1.8 -18.0) to, 1.6 mg/L (IQR, 1.0 –, 3.2), p=0.025. However, there were no significant changes in FC pre-and post-treatment. In addition, baseline VCE demonstrated ulcerated SB strictures in, 3 patients, 2 had non-ulcerated strictures on the second VCE. No capsule retention or other adverse events were observed.

Conclusion
Adalimumab led to significant improvement of small intestinal endoscopic healing in Crohn’s disease, with, 53% achieving complete healing.
P335 Utility of Intestinal Ultrasound in Monitoring Disease Activity in Ulcerative Colitis Patients Treated with Biologics
Authors: Tomašić V , Kralj D , Bišćanin A , Ćaćić P , Ogresta D , Dorosulić Z , Hrabar D 
Published: January 2022

Abstract

Background
Given the invasive nature and high cost of frequent and repeated endoscopies needed to monitor UC, search for non-invasive diagnostic alternative is warranted. Intestinal ultrasound is a cost-effective, well-tolerated, non-invasive and readily available „point-of-care“ tool for the management of patients with Crohn’s disease. The role and widespread use of IUS for UC is still limited. We aimed to evaluate association between UC disease activity assessed by IUS on one hand and standard clinical, biochemical, and endoscopic parameters on the other one.

Methods
A single center, noninterventional retrospective chart review of adult UC patients treated with biologics at a tertiary center was performed. Routine clinical (stool frequency score – SFS, and rectal bleeding score – RBS), biochemical (FC), endoscopic (Mayo Endoscopic Subscore - MES), and IUS parameters (bowel wall thickness - BWT and colonic wall hyperemia assessed by colour Doppler imaging - CDS) were assessed before initiating biologics. Normal distribution was assessed using Shapiro-Wilk tests. Spearman correlation coefficients were calculated and ROC analysis was carried out.

Results
Total of, 44 patients (50% females, mean age, 37.4 ±, 14.05 years) with predominantly extensive UC (75%) were analysed. Positive correlation was observed between combination of BWT and level of CDS with SFS (rs = 0.68, p &lt;, 0.01, N = 33) as well as with RBS (rs = 0.44, p &lt;, 0.01, N = 34). Moreover FC values were in positive correlation with BWT (rs = 0.54, p &lt;, 0.01, N = 36), levels of CDS (rs = 0.66, p &lt;, 0.01, N = 33) and combination of BWT coupled with level of CDS (rs = 0.7, p &lt;, 0.01, N = 33). In case of clinical active UC (SFS, 2/3 + RBS, 2/3 + FC &gt;150 mg/g) correlation coefficient between FC level and BWT coupled with level of CDS rises to rs = 0.72, p &lt;, 0.01, N = 30. Positive correlation of CDS with MES (rs = 0.65, p &lt;, 0.01, N = 16) as well as between combination of BWT + level of CDS with MES (rs = 0.6, p &lt;, 0.02, N = 16) was observed. Interestingly, positive correlation between BWT and MES didn′t reach statistical significance (rs = 0.42, p = 0.1, N = 16). The area under the curve (AUC) for the FC values and disease activity (defined as SFS, 2/3 + RBS, 2/3 + BWT &gt;4 mm + presence of CDS) was, 0.96 (SE:, 0.03;, 95% CI, 0.89–0.99, p&lt;0.01). FC values &gt;134 mg/g were associated with active disease (sensitivity, 89.3%, specificity, 87.5%).

Conclusion
Results of this study show a good correlation between IUS and clinical, biochemical and endoscopic parameters of UC disease severity. IUS as a monitoring tool can be helpful in estimation of UC disease activity and can guide daily management of patients treated with biologics.
P337 Therapeutic drug monitoring: standardization of Promonitor Quick IFX and Promonitor Quick ADL point of care tests with WHO International Standards for the quantification of infliximab and adalimumab in whole blood and serum
Authors: Ametzazurra A , Pascual J , Del Rio L , Urigoitia A , Nagore D , Ruiz-Argüello M B 
Published: January 2022

Abstract

Background
Promonitor Quick IFX and Promonitor Quick ADL are rapid point of care lateral flow tests (LFT) based on a sandwich immunoassay for the quantification of infliximab (IFX) and adalimumab (ADL), respectively, in human whole blood (finger prick or venous) or serum. These tests are to be used as an aid in Therapeutic Drug Monitoring (TDM) of inflammatory bowel disease (IBD) and rheumatic patients under anti-TNFα therapy. The international standards (IS) developed by World Health Organization (WHO) for IFX and ADL allow harmonization and comparability among different assays. The aim of this study, was to show that Promonitor Quick IFX and Promonitor Quick ADL can measure either reference or biosimilar drugs, as well as to evaluate the agreement of Promonitor Quick IFX and Promonitor Quick ADL tests and the WHO IS.

Methods
Clinical and Laboratory Standards Institute EP10-A3 guidelines were followed to estimate the bias of Promonitor Quick assays when used to quantify IFX or ADL in samples containing the reference drugs, biosimilars or the WHO IS. Briefly, whole blood was spiked with four known concentrations of IFX or ADL, including current clinical decision levels. Ten replicates were measured of each level along two days.
Promonitor Quick IFX was evaluated using the reference drug, SB2 and CT-P13 biosimilars, and the WHO IS (NIBSC, 16/170).
Promonitor Quick ADL was evaluated using the reference drug, ABP501 and SB5 biosimilars, and the WHO IS (NIBSC, 17/236).
Results were obtained in combination with the automated portable reader PQreader.

Results
Bias was estimated by comparing the observed concentration of drug spiked whole blood samples. Each biosimilar was compared to the reference at the different drug levels tested. Results showed that Promonitor Quick IFX (Table, 1) and Promonitor Quick ADL (Table, 2) are able to measure equivalently any molecule.
The accuracy or closeness of the agreement between the result provided by Promonitor Quick IFX and Promonitor Quick ADL and the true value of the measurand was assessed by measuring the IS developed by the WHO (Tables, 1 & 2).

Similar results were obtained when serum matrix was used.

Conclusion
Promonitor Quick IFX and Promonitor Quick ADL allow monitoring of patients treated with IFX and ADL, respectively, with just a finger prick sample. Both tests can quantify reference and biosimilar drugs with equivalent results. Moreover, comparable results were obtained with the WHO IS, and thus, demonstrate that Promonitor Quick tests are suited to accurately determine drug levels at the clinical decision points in both whole blood and serum, proving to be an effective and valuable tool in TDM and immediate decision making in the doctor office or hospitals.