bluuebunny/crossref_metadata_2025 huggingface dataset:
P188 Artificial Intelligence and Colon Capsule Endoscopy: Automatic detection of colonic mucosal lesions and blood using a convolutional neural network
Authors: Afonso J , Mascarenhas M , Ribeiro T , Cardoso H , Ferreira J , Andrade P , Jorge R , Lopes S , Macedo G
Published: May 2021

Background

Conventional colonoscopy is the standard criterion for the diagnosis and staging of colonic disease, including inflammatory bowel disease (IBD). However, it has the risk of complications, including bleeding and perforation. Colon capsule endoscopy (CCE) is a minimally invasive alternative for patients refusing conventional colonoscopy or for whom the latter is contraindicated. However, reading CCE images is a time-consuming task and prone to diagnostic error. Detection of colonic blood is relevant for the diagnosis and assessment of the activity of IBD, particularly ulcerative colitis. An accurate and early diagnosis is essential as it directs subsequent treatment.

Our aim was to develop an Artificial Intelligence (AI) algorithm, based on a multilayer Convolutional Neural Network (CNN), for automatic detection of blood and other significant lesions in the colonic lumen in CCE exams:

Methods

A total of 24 CCE exams (PillCam COLON 2®) from a single centre, performed between 2010–2020, were analysed. From these exams 7640 images (2915 normal mucosa, 3065 blood and 1660 mucosal lesions) were ultimately extracted. Two image datasets were created for CNN training and testing. These images were inserted in a CNN model with transfer of learning. The output provided by the CNN was compared to the classification provided by a consensus of specialists (Figure 1). Performance marks included sensitivity, specificity, positive and negative predictive values (PPV and NPV, respectively), accuracy and area under the receiving operator characteristics curve (AUROC).

Results

Blood was detected with a sensitivity and specificity of 97.2% and 99.9%, respectively. The AUROC for detection of blood was 1.00 (Figure 2). Detection of other findings had a sensitivity and specificity of 83.7% and 96.7%, respectively. The overall accuracy of the CNN was of 95.4%.

Figure 1 - Output obtained from the application of the convolutional neural network. N: normal mucosa; B - blood or hematic residues; ML – mucosal lesions.

Figure 2 – Receiver operating characteristic analyses of the network’s performance in the detection of normal mucosa, blood and colon mucosal lesions. AUROC – are under the receiver operating characteristic curve; N – normal colonic mucosa; B – blood; ML – mucosal lesions.

Conclusion

We developed a pioneer CNN for CCE which demonstrated high levels of efficiency for the automatic detection of blood and lesions with high clinical significance. The development of tools for automatic detection of these lesions may allow for minimization of diagnostic error and the time spent evaluating these exams.
P243 Elevated presepsin levels are a marker of sepsis risk in patients with inflammatory bowel diseases receiving therapy of TNF-α blockers
Authors: Knyazev O , Kagramanova A , Lishchinskaya A , Li I , Noskova K , Fadeeva N , Subbotin V , Demchenko A , Babayan A , Zvyaglova M , Kulakov D
Published: May 2021

Background

Sepsis is a severe disease characterized by a systemic inflammatory response syndrome (SARS) associated with infection. Sepsis is registered in 1–2% of all hospitalized patients. IBD patients receiving immunosuppressive therapy have a high risk of developing sepsis. Diagnosis of sepsis is based on internationally agreed criteria. Predicting the course and outcomes of sepsis is evaluated on the MEDS (Mortality in Emergency Department Sepsis) scale. Clinical studies of a new biomarker called presepsin have shown that it is a promising early and predictive marker of sepsis

Aim

to establish the role of presepsin as a marker of sepsis development in patients with inflammatory bowel diseases (IBD) receiving therapy with genetically of TNF-α blockers.

Methods

The clinical status of 128 IBD patients receiving of TNF-α blockers therapy (without immunosuppressive drugs) was evaluated in the Department of IBD. 68 patients with ulcerative colitis (UC) and 60 patients with Crohn’s disease (CD). Presepsin level (PSP) was determined in all IBD patients (100.0%). To stratify patients, the following criteria were used for baseline PSP levels (pg/ml): < 200 – very low risk of sepsis; - 200 - 300– low risk of sepsis; - 300 - 500– moderate risk of sepsis; - 500 - 1000 – sepsis; - ≥ 1000-severe sepsis, septic shock

Results

The distribution among 128 IBD patients receiving of TNF-α blockers by presepsin level was as follows: < 200 -75 (58,6%); - 200 – 300 – 34 (26,6%); - 300 – 500 – 19 (14,8%); - 500 - 1000 – 0 (0%); ≥ 1000 – 0 (0%).

Of the 75 IBD patients receiving gibp and having a very low risk, none of the patients developed sepsis; of the 34 IBD patients with a low risk, one patient developed septicemia (2.9%). Among 19 patients with IBD with a moderate risk, the development of a septic condition occurred in 4 (21.0%) patients (HR-0.140, 95% CI 0.017 - 1.162; x2-2,800; p= 0.04997).

Conclusion

IBD patients receiving of TNF-α therapy, it is advisable to determine the level of presepsin in order to identify risk groups for the development of sepsis. Patients with IBD who receive of TNF-α therapy and have presepsin values in the range of 300–500 pg/ml have a significantly higher risk of developing sepsis.
P270 Mesenchymal stromal cells contribute to the recovery of secondary loss of response to infliximab in patients with ulcerative colitis
Authors: Knyazev O , Kagramanova A V , Lishchinskaya A , Li I , Shkurko T , Kulakov D , Babayan A , Zvyaglova M , Zhulina E , Parfenov A
Published: May 2021

Background

Long-term experience with infliximab (IFХ) shows that within a year, 20–30% of patients with ulcerative colitis (UC) develop acquired drug resistance (secondary inefficiency).

Aim

To establish the possibility of overcoming the secondary inefficiency of IFX in UC patients using mesenchymal stromal cells (MSC).

Methods

In the IBD treatment Department, the clinical status of 84 UC patients receiving IFX therapy was evaluated. Secondary loss of response was registered in 28 UC patients, which required optimization of IFX therapy. 12 patients (group 1), in order to overcome the secondary loss of response, were administered MSCS three times every 4 weeks, 16 patients with UC (group 2) received standard optimized IFX therapy. The effectiveness of therapy was evaluated after 12 weeks of therapy (reduction of the Mayo score) and normalization of laboratory parameters (ESR, C-reactive protein (CRP), hemoglobin, fecal calprotectin (FCP). The comparative analysis was carried out using the method of four-field tables using nonparametric statistical criteria.

Results

In 10 (83.3%) of 12 patients of group 1, a significant positive dynamics was observed after 12 weeks: a decrease in the Mayo index and normalization of laboratory parameters (ESR, CRP, hemoglobin, FCP). In 4 (25.0%) patients with UC from group 2, against the background of optimized IFX therapy, a significant positive dynamics was also observed with a decrease in the meio index and an improvement in ESR, CRP, hemoglobin and FCP levels. However, 12 patients from group 2 were transferred to therapy with other anti-TNF-α drugs and drugs with a different mechanism of action (RR-0.222, 95% CI 0.061–0.812; x2 - 7.146; p=0.00334).

Conclusion

The use of mesenchymal stromal cells of the bone marrow helps to overcome the secondary loss of response to infliximab in patients with ulcerative colitis.
P283 Decrease in bowel wall thickness at intestinal ultrasound accurately detects early endoscopic remission and improvement in ulcerative colitis patients on tofacitinib: a longitudinal prospective cohort study
Authors: de Voogd F , Van Wassenaer E , Mookhoek A , Bots S , Van Gennep S , Duijvestein M , Ponsioen C , Löwenberg M , D’Haens G , Gecse K
Published: May 2021

Background

To assess disease activity in ulcerative colitis (UC) intestinal ultrasound (IUS) highly correlates with endoscopic outcomes. However, data on treatment response evaluated with IUS is limited. In this study we aim to evaluate bowel wall thickness (BWT) at follow-up to determine treatment effectiveness in moderate-severe UC patients treated with tofacitinib according to central read endoscopy and histology.

Methods

Patients with moderate-severe UC (endoscopic Mayo score (EMS)≥2) starting tofacitinib 10 mg bid were included. Disease activity was evaluated by recorded IUS cine-loops and video-taped endoscopies with biopsies from the sigmoid (SC) and descending colon (DC) at baseline and at 8 weeks. BWT and EMS were assessed per segment (SC and DC). Histology was scored for the SC with the Robarts Histology Index (RHI). BWT, EMS and RHI were centrally read and for IUS there was a second reader. Endoscopic remission (ERem) was defined as EMS=0, endoscopic improvement (EI) as EMS≤1 and endoscopic response (ERes) as a decrease of EMS≥1. For statistical analysis a Wilcoxon signed-rank and Spearman’s test were used. Area under the ROC was used to determine optimal cut-off values. Inter-observer agreement was analyzed by intra-class correlation coefficient (ICC).

Results

29 patients were included and started tofacitinib. 10% reached complete ERem after 8 weeks, respectively. Per-segment analysis for EMS showed 22% and 53% reaching ER and 40% and 60% having EI in the SC and DC, respectively. BWT in SC and DC correlated highly with the EMS (rho=0.68, rho=0.75, both p<0.0001) and moderately with RHI (rho=0.49, p=0.002). Patients with EMS≥2 after 8 weeks had an increased BWT (SC: 4.32 ± 1.57 mm, DC: 4.38 ± 1.58 mm) when compared to ERem (SC: 2.10 ± 0.67 mm, DC: mean: 2.00 ± 1.18 mm, both p<0.0001) and EI (SC: 2.29 ± 0.76 mm, DC: 2.56 ± 1.38 mm, both p<0.0001) in the similar segment (Figure 1 and 2). BWT decreased after 8 weeks when there was ERes (SC: mean: -2.59 ± 1.44 mm, DC: -1.82 ± 1.01 mm, both p=0.007) and did not when there was no ERes (Figure 3). BWT cut-off values for ERem are reported in Figure 4. Furthermore, agreement for BWT in the SC and DC was excellent (ICC: 0.92 and ICC: 0.89), respectively.

Conclusion

BWT reduction showed early endoscopic remission, improvement and response after 8 weeks of tofacitinib treatment and correlated with histology in this central read cohort. Furthermore, accurate and reliable cut-off values for BWT in SC and DC were found for endoscopic remission and improvement. Therefore, IUS should be incorporated in the standard follow-up and close monitoring of UC patients.
P291 Pharmacokinetics, safety, and tolerability of etrasimod (APD334) in subjects with mild, moderate, or severe hepatic impairment: a single-dose, open-label, parallel-group study
Authors: Lee C , Tang Y , Schroeder C , Zhang J , Nguyen-Cleary T , Mullin S , Ma M , Lyon N , Grundy J
Published: May 2021

Background

Etrasimod is an oral, selective sphingosine 1-phosphate receptor modulator in clinical development for immune-mediated inflammatory disorders, including ulcerative colitis, Crohn’s disease, and eosinophilic esophagitis. The objective of this study was to evaluate the effect of hepatic impairment on the pharmacokinetics (PK), safety, and tolerability of etrasimod.

Methods

This single-dose, open-label, parallel-group study included 36 adult subjects (aged 18-80 years; body mass index ≥18 kg/m2) with hepatic impairment, based on Child-Pugh score at screening (mild=5 to 6 [n=8], moderate=7 to 9 [n=8], severe=10 to 14 [n=6]), and their demographically matched control subjects with normal hepatic function (n=14 total). The first subject with severe hepatic impairment was enrolled after ≥2 subjects with mild and ≥2 subjects with moderate hepatic impairment had been enrolled and followed for ≥48 hours after dosing to ensure no observed significant safety signals. On Day 1, subjects received a single oral dose of etrasimod 2 mg after a ≥10 hour fast. PK and safety data were collected over a 21-day follow-up period.

Results

Thirty-six subjects were enrolled and dosed; 35 subjects completed the study. When compared with their respective demographically matched normal control groups, single dose etrasimod peak exposure (Cmax) was comparable for all hepatic impairment groups, whereas etrasimod total exposure (AUC) measures were progressively higher (up to 57.3% higher) in the mild, moderate, and severe hepatic impairment groups (Table 1). Unbound etrasimod Cmax values were progressively lower (up to 42.0% lower) in the mild, moderate, and severe hepatic impairment groups, whereas unbound etrasimod AUC values were typically comparable for all hepatic impairment groups, when compared with their respective demographically matched normal control groups (Table 2). Etrasimod t1/2 only moderately increased as hepatic function decreased, with mean values ranging from 43.9 to 59.5 hours in the demographically matched normal control groups and mean values of 55.7, 69.7, and 76.5 hours in the mild, moderate, and severe hepatic impairment groups, respectively. A single oral dose of etrasimod 2 mg was well tolerated; there were no clinically significant safety findings when administered to subjects with normal hepatic function or subjects with mild, moderate, or severe hepatic impairment.

Conclusion

A single oral dose of etrasimod 2 mg was well tolerated, with relatively modest changes in etrasimod exposure observed in subjects with mild, moderate, or severe hepatic impairment. These results suggest that etrasimod dose adjustment may not be warranted in subjects with hepatic impairment.
P330 Long-term outcomes following a switch from originator adalimumab to the biosimilar SB5 (Imraldi) in IBD
Authors: Derikx L , Dolby H , Plevris N , Lucaciu L , Rees C , Lyons M , Siakavellas S , Constantine-Cooke N , Noble C , O’Hare C , Merchant L , Arnott I , Jones G R , Lees C
Published: May 2021

Background

Multiple adalimumab (ADA) biosimilars, including SB5 (Imraldi) and ABP 501 (Amgevita), are now approved for use in IBD. Data about biosimilar ADA in IBD remain scarce. We therefore aimed to investigate long-term outcomes of the biosimilar SB5 in IBD patients following a switch from the ADA originator (Humira) or after start of SB5 as their first ADA-therapy.

Methods

We performed a retrospective cohort study in a tertiary IBD referral centre. All IBD patients treated with Humira underwent an elective switch to SB5 regardless of IBD phenotype, disease activity and ADA dosing. All patients were reviewed regularly in the virtual biologics clinic with protocol driven collection of clinical disease activity, blood tests, TDM and faecal calprotectin. We identified all patients on SB5 in a biologic prescription database that prospectively registered all ADA by brand name and start and stop dates.

Results

441 patients were treated with SB5, including 234 who switched from Humira to SB5 (CD=209, 89.3%; median IBD duration 10 years, IQR 6-16) and 207 who started on SB5 as their first ADA-therapy (CD=162, 78.3%; median IBD duration 6 years, IQR 1-16.8).

107/234 (45.7%) patients who switched to SB5 used infliximab before ADA. These patients were treated for a median of 32 months (IQR 17-57) with Humira prior to switching. At Humira – SB5 switch, 60.1% (140/234) received 40mg ADA every other week and 39.1% (91/234) once weekly. The median duration of follow up was 13 months (IQR 8-14). At week 26 and week 52, 194/231 (84.1%) and 148/215 (70.3%) patients remained on SB5, respectively (Figure 1). 81/234 patients (35.0%) discontinued SB5, mostly due to adverse events (n=40/81) or secondary loss of response (n=35/81). Pain at the injection site was the most frequently reported adverse event (n=31); all these patients switched to Amgevita. 30/31 patients with a double biosimilar continued Amgevita until the end of follow up (median 30 months), resulting in 172/215 (81.3%) patients that remained on ADA at week 52 (Figure 1).

Proportions of patients in biochemical remission and clinical remission were similar at baseline, week 26 and week 52 following switch (Figure 2). Median ADA trough levels were similar before (10.2 ug/ml, IQR 7.4-13.5) and after switch 10.3 (IQR 7.4-13.1). 17/234 (7.3%) patients developed antibodies during SB5 treatment.

Conclusion

Switching from Humira to SB5 appeared effective and safe in this study with over 12 months of follow up. The most common adverse event was injection site pain; these patients were successfully moved on to Amgevita providing the first data about a double biosimilar switch. Over the 24 months of this biosimilar ADA program substantial cost savings were effected.
P333 Endoscopic severity and CRP predict failure of medical rescue therapy in patients with acute severe ulcerative colitis
Authors: Kakkadasam Ramaswamy P , Subhaharan D , Willmann L , Edwards J , Shukla D , Bhullar M , Moattar H , Dorrington A , Ishaq N , McIvor C , Mohsen W
Published: May 2021

Background

The efficacy of Infliximab and Cyclosporin A as medical rescue therapy in patients with corticosteroid refractory acute severe ulcerative colitis (ASUC) is well established. We aimed to identify predictors of failure of medical rescue therapy and colectomy during the same admission in this population.

Methods

Patients hospitalized with ASUC who received infliximab or cyclosporin A after failing intravenous corticosteroid therapy between 1st January 2013 to 31stJuly, 2020 at two Australian tertiary IBD centres were retrospectively analysed. Patients who underwent colectomy during the same admission after medical rescue therapy were defined as non-responders. Logistic regression analysis was performed to identify predictors of colectomy during same admission.

Results

226 episodes of ASUC [110 (48.7%) female, median disease duration 2 years] were analysed. 104 (46%) episodes required rescue therapy [94 episodes received medical rescue (16 cyclosporine/78 Infliximab) and 10 underwent direct colectomy]. In patients receiving medical rescue therapy, 16 (17%) underwent colectomy during same admission and 28 (29.8%) underwent colectomy by 12 months. On multivariable analysis, UCEIS score at admission [Coef 0.100 (0.02-0.17), p 0.011] and CRP on Day 3 post-rescue therapy [Coef 0.004 (0.0007-0.007), p 0.018] were significant for predicting colectomy during the same admission. A score with 1 point for each variable (UCEIS score ≥ 7 and CRP value of ≥ 22 mg/L on day 3 post medical rescue therapy) was developed. A score of 2 points had sensitivity 57%, specificity 97%, PPV 80%, NPV 91%, accuracy 89% for predicting colectomy during the same admission and sensitivity 33%, specificity 94%, PPV 80%, NPV 67%, accuracy 69% for predicting colectomy at 12 months.

Conclusion

UCEIS and CRP on day 3 after rescue therapy are predictors of non-response to medical rescue therapy and need for colectomy during the admission for the ASUC episode. Combination of UCEIS ≥ 7 and CRP ≥ 22mg/L on day 3 post medical rescue therapy has a PPV of 80% for colectomy during same admission and at 12 months. The score can be used to make decisions about colectomy or further medical rescue therapy.
P374 Safety and drug survival of methotrexate versus tioguanine after failure of conventional thiopurines in patients with Crohn’s disease
Authors: Savelkoul E , Maas M , Bourgonje A , Crouwel F , Russel M , Römkens T , De Boer N , Dijkstra G , Hoentjen F
Published: May 2021

Background

Both methotrexate (MTX) and tioguanine (TG) can be considered as viable treatment options before initiating biological therapy following failure of conventional thiopurines for Crohn’s disease. It is unclear how safety and effectiveness compare for both therapies. This study aimed to compare tolerability and drug survival of MTX and TG therapy after failure of conventional thiopurines in patients with Crohn′s disease.

Methods

We conducted a retrospective, multi-centre study in five Dutch hospitals, including patients initiating MTX or TG for Crohn’s disease after failure (all causes) of conventional thiopurines. Patients with prior MTX or TG use, MTX or TG not primarily prescribed for Crohn’s disease, or patients receiving concomitant biological treatment at baseline were excluded. Follow-up duration from starting treatment was 104 weeks or until treatment discontinuation. Primary outcome was therapy discontinuation rate due to adverse events (AE). Secondary outcome was ongoing treatment without initiation of biological treatment.

Results

In total, 221 patients with failure of conventional thiopurines and subsequent therapy with either MTX (n=106) or TG (n=115) were included. Median follow-up was 89 weeks (IQR 28-104). Previous biological failure was present in 28 (26%) MTX and 17 (15%) TG treated patients (p=0.044). Sixty-four (29%) patients (MTX 41.5%, TG 17.4%, p<0.001) discontinued their treatment due to AE during follow-up (Figure 1). Median time until discontinuation due to AE was 16.5 weeks (IQR 8.0–39.0) for MTX and 17.5 weeks (IQR 1.3–69.8) for TG (p=0.925). MTX use was associated with a significantly higher risk of treatment failure due to AE (OR 3.37 [95% CI 1.82–6.25] p<0.001). Previous biological failure was not predictive for MTX or TG failure due to AE (OR 1.086, p=0.828). The most frequent discontinuation reasons were nausea for MTX (n=11) and abdominal pain for TG (n=4). In both groups, 8 (MTX 8%, TG 7%) serious adverse events (SAE) occurred. Infections comprised the majority of all SAE, 4 (50%) for MTX and 7 (88%) for TG. Discontinuation because of elevated liver enzymes occurred in 5 (11%) MTX and 4 (20%) TG treated patients. There were no cases of histological nodular regenerative hyperplasia, liver fibrosis, or cirrhosis. Initiation of concomitant biological therapy was not significantly different (MTX: n=26, TG: n=30, p=0.877). Total monotherapy drug survival after 104 weeks was 46% for TG and 25% for MTX (p<0.001).

Conclusion

Forty-two percent of MTX, compared to 17% of TG treated patients, discontinued therapy due to AE in patients with Crohn’s disease with prior failure of conventional thiopurines. These data may aid in the selection of subsequent therapy after failure of conventional thiopurine therapy.
P482 Safety and efficacy of ustekinumab for Crohn’s disease in the elderly population
Authors: Fiske J , Liu E , Limdi J , Conley T E , Townsend T , Davies M , Brockwell R , Baig D , Abdelbadiee S , Uney A , Liaros A , Gaba W , Smith P J , Subramanian S
Published: May 2021

Background

The rising incidence of inflammatory bowel disease (IBD) worldwide and an ageing population has led to a marked increase in elderly IBD patients. Anti-tumour necrosis factor (TNF) agents are associated with an increased risk of serious infections and treatment discontinuation among elderly IBD patients but little is known about non anti-TNF biologics in this cohort. We aimed to examine safety and efficacy of ustekinumab in elderly Crohn’s disease (CD) patients.

Methods

Patients ≥60 years old commencing ustekinumab for CD were included in this retrospective multi-centre cohort study. We gathered data on adverse events, Harvey Bradshaw Index (HBI) and concomitant steroid therapy. The primary outcome was serious infections, defined as requiring hospitalisation. Efficacy was assessed by serial HBI measurement and treatment persistence.

Results

70 patients were included, with a median age of 68 years (range 60–87), a male:female ratio of 9:5 and a median Charlson co-morbidity index of 4 (range 2–9). 44 (62.9%) had prior anti-TNF exposure and 15 (21.4%) previous vedolizumab. Median treatment duration was 12 months (range 2–48), with a total of 84 patient years. 31 patients (41.3%) had steroids at initiation, and 33 (47.1%) required a course of steroids at a later date.

Seven patients (10%) had a combined 9 serious infections, of which 1 was life threatening requiring organ support. Incidence of serious infections was 0.107 per patient year. A further 18 patients had a combined 22 non-severe infections (Table 1). The overall infection rate was 0.417 per patient year. Charlson co-morbidity index was numerically higher among those who developed severe infections (median 5, range 3–7 vs. median 4, range 2–9, P=NS). 3 patients developed a malignancy; non-Hodgkin’s lymphoma, melanoma and prostate cancer.

Mean HBI improved from 8.13 at baseline to 4.64 at 6 months and 4.10 at last follow up (both P<0.0001). Treatment persistence rate was 61.4% (N=43) and 36 (51.4%) were steroid-free. Reasons for discontinuation were primary non-response (42%), adverse event (32%), secondary loss of response (10%), malignancy (10%) and lack of funding (5%).

Conclusion

Ustekinumab was safe and effective in a cohort of elderly CD patients. Infections were mostly mild, not resulting in therapy discontinuation. The risk of serious infection was low at 0.107 per patient year of treatment.
P511 Disease-specific risk factors for malnutrition development in IBD
Authors: Einav L , Hirsch A , Ron Y , Aviv Cohen N , Anbar R , Lahav S , Maharshak N , Fliss Isakov N
Published: May 2021

Background

Patients with inflammatory bowel diseases (IBD) are at risk of malnutrition, which is associated with considerable disease related complications. Most available screening tools for malnutrition risk such as the malnutrition universal screening tool (MUST), do not incorporate malnutrition-promoting characteristics of IBDs. Therefore, we aimed to detect disease-specific risk factors for malnutrition development in IBD, which may be incorporated in future malnutrition screening tools.

Methods

A retrospective case-control study, in which detailed information regarding IBD patients treated at the IBD clinic of the Tel-Aviv Medical Center between 2010–2020 was collected.

Cases were patients who developed malnutrition between clinic visits (defined as BMI≤18.5/ weight loss ≥5% of body weight during 3 months/≥10% of body weight during 6 months) and controls were those who maintained a normal nutritional status. Cases and controls were matched by age, gender, disease and disease duration. Data was collected from medical files included reported medical history, clinical manifestations of disease, disease activity, and nutritional status including MUST evaluation during clinic visits. The association between the clinical data and malnutrition development was evaluated using a logistic regression model, with adjustment for MUST components: weight loss of ≥5% of body weight and multiple (≥2) reasons for inadequate nutritional intake.

Results

We collected data from 118 IBD patient (cases, n=59 and controls n= 59, Crohn’s disease n=76, ulcerative colitis n=28, pouchitis patients n=14). All patients were at normal nutritional status at baseline. Patients were followed for a period of 6.2±3.0 months during which, cases lost 5.3±2.3 kg (10.4±4.8 % body weight) and controls gained 0.2±2.3 kg )0.2±3.5 % body weight) (p<0.001). MUST screening misclassified 34% of cases as low risk for malnutrition. Development of malnutrition was positively associated with baseline endoscopic disease activity [Odds ratio (OR)=6.06, 95% Confidence interval (CI) 1.91–19.18], repeated physician/nurse clinic visits ≥4/year (OR=5.26, 1.20–22.98), and negatively associated with advanced therapy (biologics and small molecules) (OR=0.151, 0.03–0.70), and BMI at baseline (OR=0.24, 0.13–0.44). The fit of this model was evaluated by an area under the curve of AUC=0.961 CI 0.93–0.99, p<0.001.

Conclusion

Current tools for prediction of malnutrition among IBD patients are not sensitive enough. Parameters, such as increased disease activity should prompt nutritional assessment among patients to prevent mal-nutrition. The importance of these findings should be evaluated in prospective studies.
P531 SARS-CoV-2 infection in Elderly patients with Inflammatory Bowel Disease with or without immunosuppressants during the first year of the pandemic. An observational, descriptive, cohort study
Authors: Calafat Sard M , González-Muñoza C , Fortuny M , Roig C , Calm A , Mombiela A , Teller-Martin M , Cañete F , Bertoletti F , González-González L , Gordillo J , Mañosa M , Garcia-Planella E , Domènech E
Published: May 2021

Background

Older age has been confirmed as a risk factor for severe clinical presentation of SARS-CoV-2 disease (COVID-19). The prevalence of confirmed SARS-CoV-2 infection in Catalonia among people over 60 years is 6.6%. Biological agents have not been associated with a higher incidence nor a worse prognosis of COVID-19. However, the role of immunosuppressants (IMS) on this issue is still to be elucidated. Moreover, there are scarce data related about COVID-19 in inflammatory bowel disease (IBD) patients under IMS, and none focusing in elderly IBD. Our aim was to describe and to compare the incidence and severity of COVID-19 in patients over 65 years of age with IBD, particularly in relation to the use of IMS.

Methods

We performed a retrospective cohort study including IBD patients over 65 years since January 2020, from two referral centres in the Barcelona metropolitan area (Catalonia, Spain). Patients were grouped in two cohorts regarding the use or not of IMS (thiopurines or methotrexate). Patients on biological treatment were excluded. We identified those cases with confirmed infection with SARS-CoV-2 (positive PCR) during the period from 1st of March 2020 (the beginning of the pandemic in Catalonia) to 1st March 2021 (the beginning of vaccination in the elderly). Demographic data, IBD comorbidities, concomitant non-IBD related treatments, and SARS-CoV-2 infection outcomes were recorded.

Results

Four-hundred and eighteen elderly IBD patients were included. The median age was 74 years (IQR 69–78), 52% were male; 70% had ulcerative colitis, 28% Crohn’s disease and 2% IBD unclassified, 62% had arterial hypertension, 22% diabetes mellitus, 22% cardiovascular disease, 15% chronic obstructive pulmonary disease, 10% chronic renal disease, 5% were active smokers. There were no differences regarding comorbidities and non-IBD treatments between the two study groups. From the whole cohort, 89 (21.3%) patients were on IMS (86 with thiopurines, 3 with methotrexate). The median time on IMS was 121 months (IQR 60–162). During the study period, 32 patients (7.7%) had confirmed SARS-CoV-2 infection (7 of whom were on IST; 7.6% not on IMS vs. 7.9% on IMS, P=0.933). Seventeen (53%) patients required hospital admittance (4% not IMS vs. 4.5% on IMS; P=0.818); 4 of them developed COVID-19 related complications (3 patients not on IMS vs. 1 on IMS), and 7 (22%) patients died (6 not on IMS vs. 1 patient on IMS).

Conclusion

The rate of SARS-CoV-2 infection among elderly IBD patients is quite similar to that reported in the elderly background population. In elderly IBD patients, SARS-CoV-2 infection was associated with a high admission rate and mortality, regardless of the use of IMS.
P541 Efficacy, efficiency and aceptability of telemedicine for inflammatory bowel disease patients follow-up care during the COVID-19 pandemic lockdown
Authors: Ramos Lopez L , Reygosa C , Carrillo-Palau M , Alonso-Abreu I , González Y , de la Barreda R , Amaral C , Hernández A , Benítez-Zafra F , Hernández-Guerra M
Published: May 2021

Background

During COVID-19 pandemic, numerous initiatives have been established to reduce disease transmission but ensure care for patients with inflammatory bowel disease (IBD). Ambulatory clinic visits were replaced by the implementation of telehealth modalities in most of IBD units during the pandemic lockdown. However, the efficacy, efficiency, and patient′s acceptability of using telemedicine by telephone consultation has not been evaluated.

Methods

A prospective cohort study was performed in IBD patients who underwent telephone consultation during lockdown due to COVID-19 pandemic between 16th march and 13th April 2020. To assess the efficacy of this telephone consultation (COVID-visit), change in disease′s activity and treatment, non-scheduled visits, emergency consultation, hospital admission and non-elective surgery from COVID-visit to the next scheduled consultation (postCOVID-visit) were checked. To evaluate efficiency, the time period between COVID-visit and postCOVID-visit were compared with previous consultation (preCOVID-visit). Only patients with a confirmed diagnosis of IBD, regular follow-up in our IBD unit and with full available requested test results were included. A telephone survey was designed (5 questions) and conducted in all patients to rate satisfaction for using telemedicine.

Results

Out of a total of 274 patients, 220 patients (52.2% male; mean age 49±16 years; crohn′s disease n=126/ ulcerative colitis n=83/ indeterminate colitis n=11) were included. During the COVID-visit 41% patients were using biologic agents, 15% had active disease and 6.8% changed treatment (40% initiated corticosteroids; 30% started immunomodulators or biologic agents; 30% upgraded usual treatment). Only 1 patient consulted at the emergency department, 11 patients needed to rearrange the visit and none patient underwent surgery before the scheduled post-COVID visit. The interval to post- COVID visit compared to pre-COVID visit was reduced in 28.6%, remained equal in 33.6% and increased in 37.7% of patients. The satisfaction survey (n=185) revealed that 81.1% patients rated care as excellent, 94.6% perceived it was effective and solved doubts in 96.2% of patients. However, 44.4% of patients rather prefer on-site consultation for follow-up and only 52% considered that incorporating video would improve care.

Conclusion

Telemedicine care during the lockdown and despite been abruptly and rapidly implemented in IBD units, shows to be effective and efficient to care IBD patients. In addition, telephone consultation is well accepted by patients for short follow-up periods. Further follow-up studies should be carried out to determine the patient profile that will benefit most from this monitoring.
P571 Optimal biologic management of endoscopic postoperative recurrence following ileocecal resection in Crohn’s disease
Authors: Bachour S , Shah R , Lyu R , Rieder F , Cohen B , Qazi T , Lashner B , Achkar J P , Philpott J , Lightner A , Holubar S , Regueiro M , Click B
Published: May 2021

Background

Endoscopic postoperative recurrence (POR) of Crohn’s Disease (CD) following ileocolonic resection (ICR) is common; however, optimal treatment strategies of identified POR are unknown. We assessed the role of biologic therapy to treat endoscopic POR in a real-world cohort.

Methods

Retrospective cohort study of adult CD patients who underwent ICR from 2009–2020 at a tertiary center. Patients with endoscopic POR detected on postoperative colonoscopy and a subsequent follow-up colonoscopy were included. Patients were categorized by biologic therapy at time of POR and further sub-grouped by therapy modification after POR detection (no change, therapy optimization, or change in biologic class). Therapy optimization included: starting or modifying immunomodulator therapy, corticosteroids, or budesonide. POR was defined by Rutgeerts’ ≥ i2b.

Results

203 CD patients (49.8% female, 15.4% > 1 prior ICR, 49.0% pre-operative biologic exposure) were included. Of these, 137 (67%) patients were not on biologic therapy at POR detection: 43% subsequently started a biologic, 23% optimized therapy, and 34% had no change. 66 (33%) patients were on anti-TNF at POR identification: 24% subsequently changed biologic class, 48% optimized anti-TNF, and 27% had no change (Figure 1). There was no difference in median time from ICR to POR detection (483 days, p=0.08) or inter-colonoscopy interval (483 days, p=0.25) between groups. In patients not on biologics at POR detection, those who started a biologic saw a 21% increase in subsequent endoscopic remission compared to those who optimized therapy (49.2% vs 28.1%, p=0.09) and a 12% increase compared to those who received no change (49.2% vs 37%). In patients not on biologics with severe POR (i3/i4, n=62), there was significantly higher remission rate by starting biologic therapy compared to optimizing existing therapy (53.3% vs 16.7%) or no change (53.3% vs 35.7%), p=0.04. In individuals receiving anti-TNF at time of POR, there was a 25% increase in endoscopic remission in patients who switched biologic class compared to those who optimized therapy (56.2% vs 31.2%) and a 34% increase compared to those with no change (56.2% vs 22.2%), p=0.1. Furthermore, significantly higher rates of improved Rutgeerts’ score were observed in switching biologic class compared to therapy optimization (68.8% vs 43.8%) or no change (68.8% vs 27.8%), p=0.04.

Conclusion

After endoscopic POR detection following ICR, initiating biologic therapy in individuals not previously receiving it, and changing mechanism of action in those already receiving anti-TNF, may improve clinical outcomes compared to alternative management strategies. If confirmed, these findings may inform optimal management strategies for endoscopic POR.
P630 Inflammatory bowel disease in immigrants to Spain: results of the EIIMIGRA study from GETECCU (ENEIDA registry)
Authors: Gutiérrez Casbas A , Zapater P , Ricart E , González-Vivó M , Gordillo J , Olivares D , Vera-Mendoza I , Mañosa M , Gisbert J P , Aguas M , Sánchez-Rodríguez E , Boscá M , Laredo V , Camps B , Marín-Jíménez I , Zabana Y , Martín-Arranz M D , Muñoz R , Navarro-Llavat M , Sierra E , Madero L , Vela M , Pérez-Calle J , Sainz E , Calvet X , Sicilia B , Morales V , Bermejo F , Fernández-Salazar L , Van Domselaar M , De Castro L , Rodríguez C , Muñoz-Villafranca C , Lorente R , Rivero M , Iglesias E , Herreros B , Barreiro-de-Acosta M , Domènech E , Francés R
Published: May 2021

Background

Previous studies comparing inflammatory bowel disease(IBD) features between migrant and native patients have shown clinical phenotype differences. To date, no study has focused on IBD immigrants(MP) in Spain. The aim of this study was to explore the features of MP in Spain and to compare age of disease onset, IBD phenotype and therapeutic requirements with native-born IBD patients(NP).

Methods

This was an observational, multicentric and case-control study of the nationwide ENEIDA registry. We selected all IBD patients who were born outside of Spain and compared with a control cohort of NP. All included patients were diagnosed with IBD before 2015.

Results

A total of 13,524 patients were included(1864 MP and 11660 NP).The most prevalent ethnic migrant group was Caucasian(771, 41%), followed by Latin American(572, 31%) and Arabian(341,18%), whereas Asian represented only 6%. Table 1 summarizes the demographic and phenotypic features. 71% of MP were diagnosed with IBD in Spain. There was not a gender predisposition to IBD in the overall migrant group, however more female UC MP were detected compared to UC NP(52 % vs 45%, p<0.001). MP were younger at the onset of the disease and had a shorter disease duration compared to NP, in both UC and CD patients. Significantly more CD patients were diagnosed under 16 years(A1) among MP, and more patients over 40 years(A3) among NB. More NB patients had CD stricturing phenotype(24% vs 19%, p=0,002) compared to MP. Disease extension in CD and UC did not differ between groups. The overall proportion of abdominal or perianal surgery was similar in both groups but the use of biologic therapy was more common in MP(36% vs 30%, p=0,001).

Conclusion

In the largest cohort of migrant IBD patients in Spain, immigrants were younger, had a shorter disease duration and required a higher use of biologics than natives, pointing phenotypic differences in this population and a universal access to the healthcare system all over the country.
P641 Impact of lockdown period due to COVID-19 pandemic in patients with Inflammatory Bowel Disease
Authors: García Mateo S , Refaie E , Martínez-Domínguez S J , Gargallo-Puyuelo C J , Lario Quilez L , Carrera-Lasfuentes P , Arroyo Villarino M T , Aso Gonzalvo M C , Gomollón García F
Published: May 2021

Background

The lockdown period due to the coronavirus disease 2019 (COVID-19) in Spain was established from 16th March to 21th June 2020. Therefore, the authorities controlled personal movements and private and public non-essential activities were cancelled. It has probably had an important emotional impact on chronic patients and hence in those who are suffering from Inflammatory Bowel Disease (IBD) due to their high risk of emotional disorders.

The aim of this study is to know how COVID 19 influenced to the patients suffering from IBD during the quarantine period, focusing heavily on the psychological distress through the Perceived Stress Scale-10 (PSS-10), and also the impact of the pandemic on therapeutic adherence using Visual Analogue Scale (VAS).

Methods

This is an unicentric and analytical observational study carried out in IBD unit of a large public teaching Hospital (University Hospital “Lozano Blesa”) during August 2020. Patients were contacted and interviewed by phone by two trained researchers not involved in the patient′s medical care. Inclusion criteria were age ≥ 18 years old and confirmed diagnosis of Crohn′s Disease (CD), Ulcerative Colitis (UC) or Indeterminate Colitis. A descriptive analysis was carried out and, subsequently, the factors associated with the loss of therapeutic adherence and higher-moderate levels of stress were analyzed through Logistic regression multivariate analyses.

Results

Of the 426 patients included, 217 (50.9%) were women, 249 (58.4%) had UC and 177 (41.6%) had EC. During the Spanish lockdown period, most of patients did not have symptoms related to their IBD (302; 72.1%). Among those who had symptoms, the most frequent was diarrhea and abdominal pain (11.5%). Most of subjects were not diagnosed of SARS-CoV2 infection (93%), whereas 2.1% suffered confirmed infection and 4.9% had compatible symptoms without test confirmation. Regarding economic situation of patients, most of them did not have economic difficulties (87.6%). Moreover, 74.4% of participants referred a very good physician-patient relationship and 21.8% a good relationship.

People who participated in the study had a median PSS-10 score of 12 (10–16). A higher level of stress was reported between those who were not married, women, and those who experimented an increase of IBD related symptoms. Adherence to treatment was not associated with stress level based on PSS-10 questionnaire.

Conclusion

Although the lockdown period due to COVID-19 pandemic has probably had an important emotional impact on Spanish population, IBD patients had in general lower PSS-10 scores. It could be due to a good patient-physician relationship, which contributed to maintaining a good adherence to medications in those patients.
Integrative Analysis of Colonic Biopsies from Inflammatory Bowel Disease Patients Identifies an Interaction Between Microbial Bile Acid-inducible Gene Abundance and Human Angiopoietin-like 4 Gene Expression
Authors: Hernández-Rocha Cristian , Borowski Krzysztof , Turpin Williams , Filice Melissa , Nayeri Shadi , Raygoza Garay Juan Antonio , Stempak Joanne M , Silverberg Mark S
Published: May 2021

Background and Aims

Microbial-derived bile acids can modulate host gene expression, and their faecal abundance is decreased in active inflammatory bowel disease [IBD]. We analysed the impact of endoscopic inflammation on microbial genes involved in bile acid biotransformation, and their interaction with host transcriptome in the intestinal mucosa of IBD patients.

Methods

Endoscopic mucosal biopsies were collected from non-inflamed and inflamed terminal ileum, ascending and sigmoid colon of IBD patients. Prediction of imputed metagenome functional content from 16S rRNA profile and real-time quantitative polymerase chain reaction [qPCR] were utsed to assess microbial bile acid biotransformation gene abundance, and RNA-seq was used for host transcriptome analysis. Linear regression and partial Spearman correlation accounting for age, sex, and IBD type were used to assess the association between microbial genes, inflammation, and host transcriptomics in each biopsy location. A Bayesian network [BN] analysis was fitted to infer the direction of interactions between IBD traits and microbial and host genes.

Results

The inferred microbial gene pathway involved in secondary bile acid biosynthesis [ko00121 pathway] was depleted in inflamed terminal ileum of IBD patients compared with non-inflamed tissue. In non-inflamed sigmoid colon, the relative abundance of bile acid-inducible [baiCD] microbial genes was positively correlated with the host Angiopoietin-like 4 [Angptl4] gene expression. The BN analysis suggests that the microbial baiCD gene abundance could affect Angptl4 expression, and this interaction appears to be lost in the presence of inflammation.

Conclusions

Endoscopic inflammation affects the abundance of crucial microbial bile acid-metabolising genes and their interaction with Angptl4 in intestinal mucosa of IBD patients.
Evaluating mobile health technologies: does the traditional randomized controlled trial serve our needs?
Authors: Gallagher Robyn , Zhang Ling
Published: May 2021

Mobile health technologies are increasingly used by cardiovascular nurses and allied health clinicians to support behaviour change and self-care in patients. Randomized controlled trials provide rigorous methodology for evaluation but progress slowly, so the technology is often outdated by completion. A helpful modification to the trial design includes identification of the behaviour intervention principles involved and concurrently track in-app usage data, allowing updates to be made. These data collected alongside user experiences enables analysis of effects on outcomes and determination of the relative influence of component parts. Cardiovascular and mental health mHealth strategies are used to exemplify these recommendations.
Establishment of spruce plantations in native birch forests reduces soil fungal diversity
Authors: Danielsen Jørgen Skyrud , Morgado Luis , Mundra Sunil , Nybakken Line , Davey Marie , Kauserud Håvard
Published: May 2021

Plantations of Norway spruce have been established well beyond its natural range in many parts of the world, potentially impacting native microbial ecosystems and the processes they mediate. In this study, we investigate how the establishment of spruce plantations in a landscape dominated by native birch forests in western Norway impacts soil properties and belowground fungal communities. Soil cores were collected from neighboring stands of planted spruce and native birch forests. We used DNA metabarcoding of the rDNA internal transcribed spacer 2 region and ergosterol measurements to survey the fungal community composition and its biomass, respectively. In the two investigated soil layers (litter and humus), fungal community composition, diversity and biomass were strongly affected by the tree species shift. Native birch stands hosted markedly richer fungal communities, including numerous fungi not present in planted spruce stands. In contrast, the spruce stands included higher relative abundance of ectomycorrhizal fungi as well as higher fungal biomass. Hence, establishing plantations of Norway spruce in native birch forests leads to significant losses in diversity, but increase in biomass of ectomycorrhizal fungi, which could potentially impact carbon sequestration processes and ecosystem functioning.