bluuebunny/crossref_metadata_2025_split huggingface dataset:
P402 Is co-trimoxazole prophylaxis necessary for Inflammatory Bowel Disease patients receiving triple immunosuppression?
Authors: Phillips G , Moore-Gillan C , Mohamed Z , Mikin P , Peake S , Hicks L 
Published: May 2021

Abstract

Background
ECCO Guidelines (1) advocate Co-trimoxazole (TMP/SMX) prophylaxis against Pneumocystis jirovecii for patients with inflammatory bowel disease (IBD) on triple immunosuppression, although the evidence level is low and based on non-IBD patient data (2). We assessed adherence to this guidance and frequency of infection events among IBD patients at Imperial College Healthcare NHS Trust, London, UK.

Methods
Eligible patients were defined as those on a combination of 2 immunosuppressants (with one of those being a biologic) between December 2017 to December 2020, who received a course of high dose steroids (≥20mg prednisolone). Patient demographics, IBD treatment, TMP/SMX prophylaxis and infections (including hospitalisation) developed within 30-days of starting high dose steroids were recorded retrospectively using the hospital electronic patient records.

Results
In the cohort of 247 patients on concomitant biologic and immunosuppression dual therapy 176/247 (71%) were ≤ 49 years old and 136/247 (55%) were male. Over the three year observation period, 333 individual thiopurine-biologic combinations were prescribed; Of the biologics 157/333 (47%) were infliximab, 91/333 (27%) adalimumab, 50/333 (15%) vedolizumab, 27/333 (8%) ustekinumab and 8/333 tofacitinib (3%). All received azathioprine or 6MP concurrently.
Steroids were prescribed on 75 occasions for 50 (20%) patients. Of 28/75 (37%) prescriptions where TMP/SMX was co-prescribed 4/28 (14%) developed infections with 1/28 (4%) requiring hospitalisation. There were no respiratory infections in this group. Of the 47/75 (63%) where TMP/SMX was not prescribed 7/47 (15%) developed infections (4/47 respiratory, 2/47 skin or bone, 2/47 [MZ1] gastrointestinal infections). One patient had 2 infections. The hospitalisation rate was 2/47 (4%). There were no confirmed cases of Pneumocystis jirovecii in either group.

Conclusion
Existing evidence for TMP/SMX prophylaxis in this setting is limited and is reflected in the varied clinical practice observed. However, no difference in clinically significant infection rates among individuals with and without TMP/SMX prophylaxis was observed in our setting. Further data are required to validate the utility of antibiotic prophylaxis in severely immunosuppressed IBD cohorts to better guide its use.

References
P430 Prognostic significance of neuropeptide expression in ileal neural plexuses in Crohn’s disease. A retrospective study
Authors: Gklavas A , Tiniakos D , Karandrea D , Karamanolis G , Bamias G , Papaconstantinou I 
Published: May 2021

Abstract

Background
Intestinal resection in Crohn’s disease (CD) is not curative and the risk for postoperative recurrence (POR) remains high. Highlighting risk factors for POR is crucial for the postoperative management of CD patients. Myenteric plexitis is a well-established risk factors for POR. The primary purpose of this study was to evaluate the correlation of neuropeptide P (NPY)-, vasoactive intestinal peptide (VIP)- and substance P (SP)-ergic nerve density with the presence and severity of plexitis in myenteric and submucosal plexuses in the proximal resection margin. Secondary aims were to assess the value of abovementioned neuropeptides’ expression in predicting POR and to recognize additional risk factors.

Methods
We conducted a retrospective, single-center study on CD patients who underwent ileocolonic resection (ICR) between January 2010 and December 2016. Exclusion criteria were age &lt;16 years, patients with missing or invalid data precluding analysis, the presence of a diverting ileostomy on enrollment and specimens inappropriate for the evaluation of histologic features of interest in the proximal resection margin. Demographic and clinical data were retrieved, and the incidence or endoscopic, clinical and surgical POR was recorded. The presence and severity of plexitis was evaluated by hematoxylin and eosin staining. Giemsa staining was used for the recognition of mast cells. Immunohistochemistry was used was used for the detection of T-lymphocytes and NPY-, VIP- and SP-ergic neurons. The expression of the above peptides was quantified using image analysis.

Results
Seventy-nine patients (44 males) with a median age of 35 years were included. The median follow-up was 71 months. Myenteric and submucosal plexitis were present in 83.5% and 73.4% of patients, respectively. No association was detected between the density of NPY, VIP and SP expression and the presence or severity of plexitis. Similarly, the number of the involved T-lymphocytes or mast cells was not correlated with the expression of these peptides. Univariate and multivariate Cox proportional regression analysis was performed for the detection of risk factors for POR. Smoking and moderate/severe myenteric plexitis were independent risk factors for endoscopic and clinical POR, whereas an involved ileal margin was recognized as a risk factor for clinical POR.

Conclusion
This study did not document a correlation between plexitis in proximal resection margin and the expression of specific neuropeptides. According to our findings, smoking, myenteric plexitis, and involved ileal margin are independent risk factors for POR.
P498 Diagnosing and differentiating iron deficiency in inflammatory disorders: still an unsolved mystery?
Authors: Aksan A , Aksan S , Farrag K , Schröder O , Stein J M 
Published: May 2021

Abstract

Background
It is well established that inflammation can mimic some aspects of iron deficiency (ID) by impairing the utilisation of existing iron stores for red cell production and inducing an iron-sequestration syndrome and hypoferraemia. Diagnosis of ID is therefore complex and there is currently no standard clinical test capable of clearly distinguishing ID when inflammation is present. Often, a combination of parameters is necessary. The aim of this study was to investigate which sole parameter or combination of parameters can best predict ID in patients with IBD.

Methods
A cross-sectional study was conducted using routine blood samples from patients with IBD. Blood samples were analysed for standard blood count, iron status (serum ferritin; SF, transferrin saturation; TSAT), inflammation parameters (high sensitivity C-reactive protein; hsCRP) and soluble transferrin receptor (sTfR) using standard methodology. A multiparameter index test (MCV, TSAT, SF) was performed to define patients with iron restricted erythropoiesis (IRE) (IRE group) when at least 2 of the 3 parameters indicated IRE. Cut-off values for TSAT (&lt;20%) and SF (&lt;30/μL) were defined according to ECCO guidelines and for MCV (80 fL) according to the literature. Criteria taken to indicate absolute ID (AID) were hsCRP &lt;5 mg/L, SF 30 μg/L and TSAT &lt; 20%, while functional ID (FID) was denoted by hsCRP ≥ 5 mg/L, SF &lt; 100 μg/L and TSAT &lt; 20%.

Results
168 IBD patients (88f; 85CD/83UC;43.4±14.9y) were enrolled. Of these, 107/168 had inflammation. 100/168 patients had IRE, of whom 70/100 had FID and 30/100 had AID. ROC analysis was performed to compare different parameters as detectors of IRE and to summarise the performance of each respective parameter (Table 1). When inflammation was absent, the best combination was SF and TSAT, whereas in the presence of inflammation, the best combination was found to be TSAT and sTfR. The addition of MCV, which showed high specificity regardless of inflammation, was found to add additional value to the diagnosis in the context of inflammation (p &lt;0.001).

Conclusion
Of those parameters studied, none was suitable to diagnose IRE when taken alone. In the absence of inflammation, ID in IBD can be adequately determined by combining SF and TSAT. When inflammation is present, however, the combination of TSAT with sTfR measurement was found to be more accurate, while the additional inclusion of MCV added additional value to the diagnosis.
P513 Assessment of quality indicators in The Swedish Inflammatory Bowel Disease Registry (SWIBREG) for Crohn’s Disease treated with biological therapies
Authors: Xu C , Byman V , Hossain J , Storlåhls A , Hedin C 
Published: May 2021

Abstract

Background
The development and clinical application of quality indicators (QI) for IBD are objectives of The Swedish inflammatory bowel disease registry (SWIBREG)(1). These include objective and subjective parameters aiming to standardise IBD care in Sweden(2).We aimed to evaluate QI target attainment at Karolinska University Hospital, and to identify specific patient or disease parameters associated with failure to reach QI targets.

Methods
QI targets as defined by SWIBREG were analysed in patients with Crohn′s disease undergoing treatment with biologics. A retrospective register-based study included 292 patients who received biological treatment between 2018-08-01 and 2020-01-31. Pediatric Crohn’s patients and patients with a treatment duration &lt;6 months were excluded.

Results
Faecal Calprotectin (FC) and Haemoglobin (Hb) values were registered for 80% and 86%, respectively. Anaemia prevalence was 30%. Significantly lower monitoring frequencies were observed in patients undergoing treatment with Adalimumab and patients with biological treatment duration &gt;1 year. FC was &lt;250 μg/g in 77% of patients. The QI target for the frequency of Short Health Scale (SHS) registration was met whereas that of Physician Global Assessment (PGA) was not. The QI target for the most recent value of both SHS and PGA were met. Only 70% of smokers, 72% of patients with biological treatment duration &gt;1 year and 52% of adalimumab patients had a registered SHS evaluation.

Conclusion
Adalimumab treatment, treatment duration and smoking are associated with decreased frequency of registration of QIs. Efforts are needed to ensure quality of care for these groups. A lower rate of PGA monitoring may reflect a lack of capacity for physician assessments and could be complemented with “professional global assessments” by specialist IBD nurses.

References
1. Ludvigsson JF, Andersson M, Bengtsson J, Eberhardson M, Fagerberg UL, Grip O, et al. Swedish Inflammatory Bowel Disease Register (SWIBREG) - a nationwide quality register. Scand J Gastroenterol. 2019;54(9):1089–101.
2. Berry SK, Melmed GY. Quality indicators in inflammatory bowel disease. Intest Res. 2018;16(1):43–7.
P518 Compliance with Faecal calprotectin home testing as standard during COVID-19 pandemic compared to laboratory based testing pre-COVID
Authors: Edwards D , Ibrahim M , Cooney R , Boulton R 
Published: May 2021

Abstract

Background
Faecal calprotectin (FC) testing has become a standard non-invasive tool to monitor disease control in Inflammatory Bowel Disease (IBD)(1). Reported patient compliance with submitting samples for hospital testing has been as low as 35% (2). We aimed to evaluate patient compliance with rapid home faecal calprotectin testing kits compared to hospital based testing in our university teaching hospital.

Methods
100 patients with a diagnosis of IBD for at least 1 year and attended IBD clinic between January 2019 and August 2020 were selected. Our laboratory ceased performing FC testing in late March and we introduced home testing (BÜHLMANN IBD doc). 50 patients who were, pre-pandemic, requested to bring a stool sample to the laboratory for hospital-based ELISA testing were randomly selected. We compared these to 50 random patients who had a home-based FC testing. Patients who were supplied with home testing kits received training from IBD nurses as well as on-line training materials. Data was collated retrospectively. Compliance was recorded if result was documented within 6 weeks of request.

Results
Prior to the introduction of home testing, only 52% of the patients’ sampled complied with hospital-based testing. This compared to a 70% compliance rate, when home testing was requested (Figure 1).
Figure 1. Comparison of percentage of compliance between hospital and home faecal calprotectin test request.

Conclusion
The improvement in FC testing compliance with rapid home testing kit compared to laboratory based testing illustrates the benefit of adapting home testing as the standard in future. The considerable increase in compliance by home testing may be due less disruption to patient’s personal life i.e., ability to undergo testing at home, symptoms such as faecal incontinence preventing patients delivering samples to hospital and COVID pandemic compelling patients to stay at home. Adopting rapid FC home testing as standard provides patients with increased locus of control regarding their care, providing health care professionals with rapid results, thus, will improve management of IBD. The ability for patients to perform home test has obvious advantages during the COVID pandemic.

References
P546 The safety and efficacy of the new-generation budesonide-MMX in the aspect of the cytochrome P-450 enzyme genotype
Authors: Resál T , Farkas K , Molnár T 
Published: May 2021

Abstract

Background
Unlike previous forms of budesonide absorbing from the ileal and ascending colon region, the new-generation budesonide-MMX contains a formula, that allows absorption throughout the whole colon. Budesonide is degraded in the liver by cytochrome P450 3A enzyme, but so far, there is no study examining the relationship between the budesonide’s effect and the enzyme activity. CYP3A5 is absent in 90% of the European/caucasian population due to a functional loss mutation (CYP3A5*3), whereas patients with the wild-type CYP3A5*1 allele may be expected to have increased metabolism. The most common genetic polymorphisms in CYP3A4 (CYP3A4*1B and CYP3A4*22) result in increased and decreased expression, respectively.

Methods
We enrolled 33 patients with UC in this prospective study until January of 2021. Patients received 9 mg oral budesonide-MMX once daily until 8 weeks. Laboratory parameters (cholesterol, triglyceride, CRP) and serum hormone levels (parathormone, dehydroepiandrosterone and cortisol) were monitored before and after the 8-week therapy to follow metabolic and hormonal changes. During these visits, body composition analysis was also performed with InBody 770 machine to observe the adverse effects of budesonide-MMX in respect of body fat mass, body mass index, protein content of the body and bone mineral content. We examined the CYP450 3A (CYP3A5 and CYP3A4) enzyme genotype of the patients, to see, whether the different alleles of this drug-degrading enzyme affect the efficacy and safety.

Results
33 patients had received the 2-month therapy. By the end of follow-up, based on partial Mayo score, 26 (78.8%) patients experienced remission and 6 patients (18.2%) were primary non-responders. Mean pMayo score decreased from 4.18 to 1.63 (p&lt;0.001). No significant changes were observable regarding body composition. Serum cholesterol level showed significant increase (p&lt;0.001), while triglyceride and CRP did not show significant changes. Serum cortisol levels were decreased (p&lt;0.001), while PTH and DHEA showed no significant decrease. Only two patients experienced side effects: one of them hypertonia, headache and acnes, while the other mild diarrhoea. 3 patients have CYP3A5*1/*3 genotype, and 16 have CYP3A5*3/*3. There was no significant difference between the two groups, regarding safety and efficacy. Only 1 patient have CYP3A4*1B genotype, while the rest have CYP3A4*1, hence, no statistics could be performed.

Conclusion
In our study, budesonide-MMX proved to be safe and effective in the therapy of UC, however, cholesterol was elevated in the serum. Based on our cohort, different genotypes of CYP3A don’t have an impact on the effect of the drug, however, CYP3A allele variants are rare, therefore, further examinations should be performed.
P557 Long-term outcomes following laparoscopic ileocecal resection without any residual lesion for Crohn’s disease: a single-center observational study
Authors: Ge X , Zhou W 
Published: May 2021

Abstract

Background
To describe the characteristic of Crohn’s disease (CD) patients undergoing ileocecal resection, and to analyze the long-term outcomes following surgery.

Methods
A retrospective study on patients undergoing ileocecal resection without any from residual disease in the remnant intestine from July 2011 to March 2020 was conducted. The clinical data and the following outcomes were evaluated.

Results
Among 86 CD patients, the mean disease duration was 33.4 months, 40 patients had perianal fistula. 53 patients underwent surgery due to stricture, 26 was perforation, and 7 was failure of medical therapy. 27 (31.4%) patients suffered postoperative complications. Mean follow-up was 44.4 months, 47 (54.7%) patients had an endoscopic recurrence with 9 were non-anastomotic recurrence, 20 were anastomotic recurrence, and 18 were both anastomotic and non-anastomotic recurrence, and 4 patients had a surgical recurrence. Furthermore, 41 (47.7%) had postoperative prophylaxis with 22 (25.6%) azathioprine and 17 (19.8%) infliximab. 45 (52.3%) patients were without postoperative prophylaxis, 19 (42.2%) had an endoscopic recurrence, and 26 (57.8%) had none endoscopic recurrence. The penetrating disease and lower skeletal muscle index were independent risk factors for endoscopic recurrence.

Conclusion
CD patients with penetrating disease or lower skeletal muscle index were suggested to have earlier postoperative prophylaxis after ileocecal resection without any from residual disease in the remnant intestine.
P574 Exploring treatment of Crohn’s disease and ulcerative colitis in the Middle East and Northern Africa: An analysis of the HARIR observational cohort study
Authors: Hamed W , Salem O E , Alharbi O , Sharaf M , Taylor C , Sherief A , Besar A 
Published: May 2021

Abstract

Background
This analysis of the HARIR study explored disease characteristics, treatment and outcomes of patients (pts) with diseases including Crohn’s disease (CD) or ulcerative colitis (UC) treated with biologics in clinical practice where data are limited: North Africa, the Middle East and Western Asia.

Methods
HARIR was a prospective, observational, multicentre, cohort, phase 4 study (NCT03006198). This analysis included adult pts with CD or UC who were starting infliximab, golimumab or ustekinumab (study period: March 2016–December 2018; terminated early). Pts needed to be previously untreated with study drugs or received ≤2 biologics prior to enrolment. Treatment was at physician’s discretion. Pts were followed for 1 year or until study withdrawal (amended from 2 years); pts who stopped the study due to study termination were considered to have completed the study. For CD, the main efficacy outcomes were Crohn’s Disease Activity Index (CDAI) treatment response, remission and change from baseline of inflammatory Bowel Disease Questionnaire (IBDQ). Adverse events (AEs) and serious AEs (SAEs) were recorded.

Results
A total of 86 pts with CD or UD from Algeria, Egypt, Kuwait, Qatar and Saudi Arabia were enrolled; 56 pts completed the study. Target enrolment was achieved for CD but was 1 pt short for UC. Mean (SD) age was 32.7 (11.5) years for CD and 29.6 (9.4) years for UC. Most pts with CD and UC had not previously received biologics (CD: 95.2%, 59/62; UC: 66.7%, 16/24). All pts with CD and UC received infliximab. Investigators noted lack of access to study drug and concomitant treatments as limiting factors for enrolment. Immunosuppressant use was low; methotrexate was used by 1 pt with UC prior to study treatment and azathioprine or mycophenolate mofetil were used by 19.4% (12/62) of pts with CD and 24.0% (6/25) of pts with UC during the study. At Month 3, 29.2% (14/48) of pts with CD had a positive treatment response (CDAI score ≥70 to ≥25% versus baseline; Figure). The percentage of pts with CD in clinical remission was 53.8% (28/52) at baseline and 70.8% (34/48) at Month 3 (Figure). Mean (SD) IBDQ score increased by 11.3 (39.6%) points from baseline to Month 3 (Figure). Overall, pt numbers were too low to analyse outcomes for CD after Month 3 and over the study duration for UC. In CD and UC, respectively, AEs were reported by 25.8% (16/62) and 37.5% (9/24) of pts and SAEs were reported by 12.9% (8/62) and 16.7% (4/24) of pts.

Conclusion
Infliximab treatment was well tolerated, and a moderate clinical response was observed for this Middle Eastern and Northern African population. Limited accessibility to biologics and concomitant treatments in these countries restricted conduct of the study.
P599 Perspectives on disease- and treatment-related issues encountered by patients with Inflammatory Bowel Disease: a qualitative concept mapping study
Authors: Risager Christensen K , Steenholdt C , Skougaard M , Ainsworth M A , Brynskov J , Buhl S , Kristensen L E , Schjødt Jørgensen T 
Published: May 2021

Abstract

Background
Therapeutic options for inflammatory bowel diseases (IBD) have documented effect on hard endpoints such as clinical and endoscopic remission. However, little is still known about issues that are of concern and importance to patients. This study aimed to explore, and rate, the importance of treatment- and disease-related issues and concerns experienced by patients with Crohn’s disease (CD) and ulcerative colitis (UC) by a state-of-the art qualitative approach.

Methods
Concept Mapping (CM) is a validated qualitative method, widely used to identify and organize disease- and treatment-related issues. In 8 CM workshops each with 3–4 participating patients, patients’ statements were elicited through a nominal group technique and organized using themes. The statements were visualized by multidimensional scaling, and cluster analysis was used to retrieve clusters organized by themes. The result was validated by patients, and further rated in terms of clinical importance. Then, thematic analyses were performed to generate a conceptual model of disease-related issues and concerns.

Results
In all, 13 CD and 13 UC patients participated of whom 7 (53%) and 3 (23%) were in clinical remission. There were 8 (62%) and 9 (69%) females, median disease duration of 17 years (IQR 12–20) and 11 years (5–15) respectively. In each disease group, 12 (92%) received biologics and 1 (8%) thiopurine, median age was 42 years (38–50). In the CD and UC workshops, 335 and 408 statements were generated, respectively, resulting in 10 CD and 11 UC clusters. The 5 highest rated clusters from each disease group along with generic clusters are shown in the Figure 1ab. Three clusters were rated to be “very important” (mean ≥ 4) for CD (Positive attitude, Acceptance and recognition, and Personal experiences living with CD), and 1 cluster for UC (Take responsibility and control over your own life). In the above-mentioned clusters, statements rated as of great importance (median= 5) were scattered as follows for CD 6/15 (40%), 10/35 (29%) and 12/30 (40%), respectively; and for UC 27/62 (44%)). In addition, UC patients also rated statements about efficacy of medication, and concerns and consequences high. CD patients created 26 (8%) (median=4) and UC 10 (2.5%) (median=4.5) symptoms specific statements scattered in different clusters.

Conclusion
The majority of the core concepts found in this study originated from patients’ perspectives focused on personomics, rather than from conventional patient reported outcomes such as bowel symptoms. Some core concepts differed across diseases, but most were independent of disease type. These data offer new knowledge to guide selection of clinically relevant and value-based treatment outcomes for IBD patients.