bluuebunny/crossref_metadata_2025_split huggingface dataset:
P221 Thromboembolic events in hospitalised patients with inflammatory bowel disease – a large tertiary hospital experience
Authors: Levartovsky A , Barash Y , Ben-Horin S , Ungar B , Klang E , Soffer S , Kopylov U 
Published: January 2020

Abstract

Background
Patients with inflammatory bowel disease (IBD) have a greater risk of venous thromboembolism (VTE) events compared with the general population especially during flares, in both hospitalised and ambulatory patients. Although VTE prophylaxis (thromboprophylaxis) is recommended in hospitalised IBD patients, the implementation is not universal, especially for non-IBD-related hospitalisations. In this study, we aimed to present the rates of VTEs and thromboprophylaxis among hospitalised IBD patients.

Methods
We created an electronic data repository of all IBD patients who visited the emergency department (ED) of our tertiary medical centre between 2012 and 2018. Data included tabular demographic and clinical variables (reason for referral, VTEs, clinical characteristics, hospitalisation, lab results, treatment and outcome) as well as free-text physician records. For this study, we searched the data repository for VTE cases, using ICD10 coding.

Results
Overall, there were 7009 ED visits of 2405 patients with IBD, 1556 (64.7%) Crohn's disease and 849 (35.3%) Ulcerative colitis patients. Thromboprophylaxis was administered in 463 hospitalisations (12.4% of IBD-related and 10.9% of non-IBD-related hospitalisations). 1.5% of patients (36/2405) who visited the ED had a new VTE. Thirty patients were diagnosed with a deep vein thrombosis (DVT), two patients with a pulmonary embolism (PE) and six additional patients were diagnosed with both a DVT and PE in the same hospitalisation. Eleven patients had a VTE during a non-IBD-related hospitalisation and six patients during an IBD-related hospitalisation (0.6% vs. 0.3%, respectively, pv = 0.12). Five patients (29.4%) developed VTEs after receiving thromboprophylaxis during hospitalisation. The majority (72.7%) of VTEs diagnosed during a non-IBD-related hospitalisation did not have additional thrombosis-related risk factors. One patient died during hospitalisation and two more patients died in the upcoming 30 days (unrelated to VTEs).

Conclusion
The rate of thromboprophylaxis in hospitalised IBD patients is low, despite posing life-threatening implications. Thromboprophylaxis should be implemented in IBD patients hospitalised for all indications.
P223 Oesophagal involvement is a predictor of anti-TNF treatment failure in patients with Crohn’s disease
Authors: Sakata Y , Tsuruoka N , Esaki M 
Published: January 2020

Abstract

Background
Oesophageal Crohn’s disease (CD) is rare and not well known. We aimed to determine the clinical features of CD patients with oesophagal lesions seen at our institution.

Methods
Upper gastrointestinal (GI) endoscopy was performed as a routine procedure for the diagnosis of upper GI involvements in CD patients from 2012 to 2018 at Saga University Hospital. CD patients with oesophagal lesions were evaluated for demographics, CD characteristics, endoscopic findings, and treatments.

Results
A total of 68 CD patients underwent upper gastrointestinal endoscopy and 8 patients with oesophagal involvement were identified. The detecting rate of CD specific lesion in the oesophagus by endoscopy was 11.8%. 7 out of 8 patients were male and average age is 27 years (range, 18–61 years). Extraesophageal lesions included three types of CD (3 patients with ileitis, 3 patients with colitis, and 2 patients with ileocolitis) were found. 6 patients (75%) had oral ulcers at the time of oesophageal CD symptom onset. Four patients (50%) complained of retrosternal pain as an oesophageal-specific symptom and other patients complained of loss of appetite. Endoscopic findings showed small, round, superficial ulcerations in 4, and deep longitudinal ulcerations in 4. Superficial ulcerations were found throughout the entire oesophagus. No patients were found to have oesophageal strictures and fistulizing disease. 5 out of 8 patients (62.5%) developed loss of response (LOR) to anti-TNF treatment. Incidence of LOR in CD patients with oesophageal involvement was significantly higher compared with patients without oesophageal involvement (odds ratio 6.67, 95% CI 1.23–36.06, p = 0.031).

Conclusion
Although oesophageal lesions of CD have been regarded as uncommon in adults, it has become increasingly recognised. The oesophageal CD should be considered in all CD patients complaining of upper gastrointestinal symptoms. Oesophageal involvement in CD patients predicted LOR to anti-TNF treatment.
P228 Cytomegalovirus Infection: is it a cause of flare-up in inflammatory bowel diseases?
Authors: Busacca A , Mascaretti R , Carrozza L , Guida L , De Grazia S , Peralta S , Calvaruso V , Cappello M 
Published: January 2020

Abstract

Background
The presence of CMV in blood is quite common in patients with severe flares of ulcerative colitis (UC) and Crohn’s disease (CD) and seems to predict an adverse outcome. The impact of antiviral treatment on CMV in this setting (indications and drug options) is an unresolved issue. Our aim was to reassess the CMV role in patients with IBD hospitalised for severe exacerbations, analysing the relationship between CMV positivity, clinical characteristics, antiviral therapy and disease outcomes.

Methods
We evaluated a homogeneous cohort of 97 consecutive patients with IBD hospitalised from 2012 to 2018. Data regarding age, gender, smoke, familial predisposition, type of IBD, extent, according to Montreal classification, disease activity (clinical and endoscopic), therapy at the time of relapse were registered in a dedicated database. CMV was tested by PCR in whole blood. The relationship between antiviral therapy and disease outcomes (rate of colectomy, mortality) was analysed.

Results
Among the 97 patients, 51 were females. In the UC group (67 patients, 69.1%), mean age was 48,8, SD ± 17,7 whereas in the CD group (30 patients, 31%), mean age was 39,9 years (SD ± 15,2). Fifteen per cent of patients had a family predisposition for IBD. There were no differences at baseline between UC and CD, except disease duration (longer in UC) and therapy at the time of relapse (high dose steroids more common in UC). Thirty-one patients (32 %) tested positive for CMV on PCR. Smoking habit, shorter disease duration, therapy on admission (high dose steroid and/or immunomodulators) and endoscopic activity assessed by Mayo endoscopic sub-score were the variables significantly related to CMV positivity. Antiviral therapy was adopted in 22% of patients and the decision to treat was based on clinical judgement and viral load. Treated patients had higher endoscopic activity than untreated (Mayo sub-score 3 vs. 2,6, p &lt; 0,004). The mean hospital duration was longer in treated patients 22.3 ( ± 11.1) days, vs. 14,8(+/−8,6) days. 3 patients underwent surgery within 90 days, 2 patients died; all of them were positive for CMV DNA. No significant differences were observed on either colectomy or mortality rate in relation to the use of antiviral therapy.

Conclusion
This single-centre study confirms that the CMV reactivation during disease flares of IBD is common and related to disease duration, severe endoscopic lesions, and immunosuppression (high dose steroids and/or immunomodulators).Antiviral drugs do not seem to modify surgical outcomes or mortality but increase the hospitalisation length. However, the retrospective design and the limited sample size of the study do not allow to draw definitive conclusions: the real impact on outcome and the role of antiviral therapy will require adequately powered prospective studies.
P232 In suspected small bowel Crohn’s disease: Clinical impact of using capsule endoscopy to make decisions
Authors: Gonzalez R A , Gómez E J , Pereyra L , Mella J M , Panigadi G N , Fischer C , Roel M , Cimmino D , Pedreira S , Boerr L A 
Published: January 2020

Abstract

Background
Capsule endoscopy (CE) can detect small bowel (SB) lesions compatible of Crohn’s disease (CD) in patients with suggestive symptoms but with inconclusive results for the diagnostic workup. However, the clinical impact of CE in helping physicians to make decisions about patients with suspected CD is not currently well established. The aim of the study was to investigate the clinical impact of CE to confirm diagnosis of CD and also to evaluate whether the results of CE modify therapeutic decisions.

Methods
We conducted a single-centre retrospective cohort study. All consecutive adult’s patients submitted to CE for clinical suspected of CD, on period November 2012 to November 2018, were included. Data on demography, previous research, medications for IBD, CE procedures and follow-up were analysed. Multivariate logistic regression analysis was carried out to identify predictors of CD.

Results
A total of 329 CE protocols in adult’s patients were performed over the study period. Ninety were in IBD patients and were included in the analysis 63 CEs submitted for suspected of CD: Clinical suspected CD 54(86%) and colitis unclassified 9 (14%). The mean age was 41 years (range 17–77 years) and 54% were males. The CE reached the caecum in 58 cases (92%) and retention was observed in 5 (8%) with only one patient (1.6%) requiring surgical removal. Overall, 28 of 63 patients (44%) had CE findings consistent with the diagnosis of CD. The lesions identified by CE included ulcers 24 (86%), erythema and villous oedema 17(61%), aphthas and mucosal erosions 5 (18%), stenosis 2 (7%) and were distributed mainly in the distal part of the SB (third tertile) in 23 (82%), but in 14 (50%) cases the proximal SB (first and second tertiles) was also affected. The mean Lewis Score (LS) was 903 (112–4356). Significant inflammatory activity (LS ≥ 135) was detected in 17 (27%) and was moderate or severe (LS &gt; 790) in 7 (11%). CE visualise normal SB mucosa in 34 (54%) of patient’s, which rules out CD. Therapeutic started in 23 (36%) of patients, initiating a new IBD medication in most cases in the 3 months after the CE. On logistic regression analysis, male (p = 0.02) and findings in ileocolonoscopy (p = 0.004) were independents predictors of CD.

Conclusion
In our cohort, CE in suspected CD confirm diagnosis in 44% of cases. Male gender and findings in ileocolonoscopy appear to be independents predictors of CD. CE is a useful tool in suspected CD, since it adds relevant information for diagnosis and had a great impact on therapeutic decisions.
P233 Evaluating the association between faecal calprotectin and endoscopic outcomes in ulcerative colitis using the HICKORY open-label induction cohort
Authors: Reinisch W , El Azzouzi B , Li R , Lacey S , Daperno M , Mishkin D , Park K T , Hassanali A , Hussain F , Oh Y 
Published: January 2020

Abstract

Background
In clinical practice, faecal calprotectin (FC) is used to monitor disease activity in ulcerative colitis (UC); however, there is no consensus on optimal cut-off values of FC for predicting endoscopic outcomes. FC performance has not been extensively assessed in the context of clinical trials using central endoscopy. This study aimed to evaluate the association between FC and endoscopic disease activity and to propose a meaningful cut-off FC value to predict endoscopic outcomes using data from the open-label induction (OLI) cohort of HICKORY (NCT02100696).

Methods
HICKORY is a Phase 3 study evaluating etrolizumab in anti-tumour necrosis factor α-experienced patients with moderate-to-severe UC. The study included patients who received ≥1 dose of etrolizumab 105 mg subcutaneously every 4 weeks during a 14-week induction period. Percentage change in FC was calculated at week 14. The endoscopic activity was measured by Mayo Clinic score (MCS) endoscopic subscore (ES) using a robust central-reading model. Endoscopic improvement was defined as ES=0/1; clinical remission as MCS ≤2 and no individual subscore &gt;1. FC analysis was performed by Covance® (Bühlman FC ELISA assay). Receiver operator characteristic (ROC) curve analyses were used to calculate cut-off FC values.

Results
A total of 97 patients (mean age [standard deviation], 41.2 ± 13.4 years) were included in the analysis. Median (interquartile range [IQR]) baseline duration of disease was 6.3 (3.2–12.3) years with a median (IQR) MCS of 9 (8–10). Median (IQR) baseline FC and ES were 254 (156–455) µg/g and 3 (3-3). At week 14, median (IQR) FC percentage change was −13 (−57 to 112). A numerical association between changes in FC level and ES was observed (Table). A cut-off FC value of 159 µg/g was observed to predict endoscopic improvement with &gt;70% sensitivity and specificity; ROC area under the curve was 0.78 (Figure). Similar results were observed for clinical remission.

Conclusion
In this exploratory analysis using HICKORY OLI cohort data, changes in FC appear to associate with changes in ES. A cut-off FC value of 159 µg/g predicted endoscopic improvement. In UC, FC may be a useful non-invasive biomarker for ascertaining endoscopic disease activity in clinical trials; however, further clinical studies validating FC cut-offs against centrally read endoscopy are needed.
P235 Serological biomarkers of interstitial matrix and basement membrane remodelling correlate the Modified Mayo Endoscopic Score (mMES) for ulcerative colitis
Authors: Mortensen J , Godskesen L E , Lindholm M , Krag A , Karsdal M A , Manon-Jensen T , Kjeldsen J 
Published: January 2020

Abstract

Background
Endoscopy is a mainstay in ulcerative colitis (UC) for disease activity monitoring. The modified Mayo Endoscopic Score (mMES) for UC takes into account disease extent and hereby additional objectivity can be achieved for endoscopic assessment. However, endoscopic evaluation of the intestinal mucosa is time-consuming and inconvenient for the patients. Therefore, surrogate biomarkers for endoscopic examinations are warranted. The aim of this study was to evaluate serological neo-epitope biomarkers of type IV collagen degradation (C4M) and formation (PRO-C4), type III collagen degradation (C3M), type V collagen formation (PRO-C5) and macrophage activity (VICM) and their association with the mMES for UC.

Methods
Endoscopic disease activity was scored using mMES for UC patients (n = 63). Patients were stratified according to the disease activity severity based on mMES (remission = 0–1, mild = 2–4, moderate = 5–6, severe &gt;6). ELISA was applied for biomarker measurements (C4M, PRO-C4, C3M, PRO-C5 and VICM) in serum. Pearson correlations and one-way-ANOVA with FDR correction were applied for statistical analysis. A multivariate regression model was developed in order to combine the ECM biomarkers as a composite index. This model was correlated with the mMES and compared with FC and C-reactive protein (CRP) levels.

Results
All the biomarkers correlated to mMES (VICM: r = 0.35, p = 0.0063; PRO-C5: r = 0.33, p = 0.009; C3M: r = 0.32, p = 0.011; C4M: r = 0.28, p = 0.0255; PRO-C4: r = 0.25, p = 0.044). Stratification of the patients revealed that VICM, C3M, and C4M serum levels were significantly elevated in UC patients with severe mMES compared with patients in remission (VICM: p = 0.0158, C3M: p = 0.04), mild disease activity (VICM: p = 0.0002, C3M: p = 0.0049, C4M: p = 0.0084) and moderate disease activity (VICM: p = 0.0166). Biomarkers that correlated significantly with the mMES were included in the multivariate regression model as a composite biomarker index. The biomarker model correlated significantly with mMES (r = 0.45, p = 0.0002) (Figure 1A) and the model was also able to discriminate between the different stages of disease activity (p = 0.0007) (Figure 1D). FC correlated with mMES (r = 0.48, p = 0.0001) (Figure 1B and E), however CRP did not correlate with mMES (Figure 1C and F).

Conclusion
The combined tissue-remodelling biomarkers correlated significantly with mMES for UC. The ECM serological biomarkers performed better than CRP, and equally good as FC. Thus, serological biomarkers of ECM remodelling, especially basement membrane degradation, interstitial matrix degradation and macrophage activity biomarkers may be used as surrogate markers for endoscopic disease activity assessment for UC.
P240 CDEIS score of 2 is optimal cut-off associated with lower risk of disease progression in early Crohn’s disease: Data from the CALM study
Authors: Ungaro R , Jordan R , Yzet C , Bossuyt P , Baert F , Vanasek T , D’Haens G R , Wilhelmus Joustra V , Panaccione R , Novacek G , Reinisch W , Armuzzi A , Golovchenko O , Prymak O , Goldis A , Travis S , Hébuterne X , Ferrante M , Rogler G , Fumery M , Danese S , Rydzewska G , Pariente B , Hertervig E , Stanciu C , Serrero M , Diculescu M , Peyrin-Biroulet L , Laharie D , Wright J P , Gomollón F , Irina G , Schreiber S , Motoya S , Hellström P M , Halfvarson J , Colombel J F 
Published: January 2020

Abstract

Background
The optimal endoscopic target in early Crohn’s disease (CD) that limits long-term disease complications is unknown.

Methods
We analysed medical records from patients who had follow-up data since the end of CALM. Patients with Crohn’s disease endoscopic index of severity (CDEIS) scores at the end of CALM were included. The primary outcome was a composite of major adverse outcomes reflecting CD progression: new internal fistula/abscess, stricture, perianal fistula/abscess, CD hospitalisation, or CD surgery since the end of CALM. We compared median CDEIS and per cent improvement from baseline CDEIS. Youden index analysis was used to identify optimal CDEIS cut-off score associated with CD progression. Kaplan–Meier and Cox regression methods were used to compare rates of progression by different CDEIS targets. Multivariable models were adjusted for age, prior surgery, and stricturing behaviour.

Results
110 patients with median age 28 (IQR 22–38) years, disease duration 0.2 (0.1–0.5) years, and median follow up of 3.1 (1.9–4.4) years were included. Eleven per cent had a history of stricture, 5.5% history of surgery, and 52% were originally in the tight control arm of the CALM study. Median CDEIS score at end of CALM was 3 (0–5.4) and 32 (29%) patients had disease progression. Baseline median CDEIS score was similar between those with and without progression [10.9 (7.5–15.5) vs. 11.9 (8–17.5)]. Median CDEIS score at the end of CALM was higher among those with progression [1.3 (0–5.1) vs. 4.9 (3–9.1), p &lt; 0.001)]. Patients within higher quartiles of CDEIS score had higher rates of progression over time (Figure 1). Patients without disease progression had a greater median decrease in CDEIS score from baseline to end of CALM [90% (60–100%) vs. 50% (30–80%), p &lt; 0.001]. The optimal CDEIS score cut-off was 2 with sensitivity 84%, specificity 60% and NPV 90% for progression. Patients with CDEIS ≤ 2 had less progression over time compared with patients with &gt; 50% improvement from baseline CDEIS (not reaching CDEIS ≤ 2) and those not meeting either endpoint (Figure 2). On adjusted analysis, CDEIS score ≤ 2 was associated with a decreased risk of progression (aHR 0.23, 95% CI 0.09–0.56).

Conclusion
In early CD, a CDEIS score ≤ 2 is optimal cut-off associated with a lower risk of disease progression.
P242 Prior pregnancy outcome is an important determinant of subsequent pregnancy outcome in women with inflammatory bowel diseases
Authors: Rottenstreich A , Fridman Lev S , Rotem R , Mishael T , Koslowsky B , Goldin E , Grisaru-Granovsky S , Bar-Gil Shitrit A 
Published: January 2020

Abstract

Background
Inflammatory bowel diseases (IBD) are commonly diagnosed in women of childbearing age. As such, pregnancy is often encountered in this subset of patients. Disease flare throughout gestation are not uncommon and can substantially affect pregnancy outcomes. We aimed at the effect of prior pregnancy outcome on the risk of disease flare at subsequent pregnancy in women with IBD.

Methods
Women with IBD attending a multidisciplinary clinic for the preconception, antenatal and postnatal treatment were prospectively recruited during 2011–2018.

Results
Overall, 476 IBD women were followed during the study period. Of them, 69 (14.5%) had two pregnancies throughout the follow-up period and constituted the study cohort. Among these 69 women, 48 (69.6%) had Crohn’s disease and 21 (30.4%) ulcerative colitis. The median interpregnancy interval was 20 [11–32] months. Overall, 34 (49.3%) women experienced disease flare at the subsequent pregnancy. In multivariate analysis, active disease at conception (odds ratio [95% CI]: 25.65 (3.05, 215.52), p &lt; 0.001) and history of disease flare at the previous pregnancy (odds ratio [95% CI]: 4.21 (1.10, 16.58), p &lt; 0.001) were the only independent predictors of disease relapse in current gestation. Rates of hospitalisation during pregnancy (14.7% vs. 0, p = 0.02) and preterm delivery (32.4% vs. 5.7%, p = 0.006) were higher, and neonatal birth weight was lower (median 3039 vs. 3300 grams, p = 0.03), in those with disease flare as compared with those with maintained remission.

Conclusion
History of disease relapse at previous gestation and periconception disease activity were found as an important predictor of disease flare among IBD women. These data would facilitate adequate counselling and informed management decisions among reproductive-aged IBD women and their treating physicians.