bluuebunny/crossref_metadata_2025_split huggingface dataset:
P170 Correlation between health-related quality of life and smartphone-based self-assessment of activity index in patients with ulcerative colitis
Authors: Park J J , Jung Y , Na S Y , Lee Y J , Kim J W , Kim N H 
Published: May 2021

Abstract

Background
E-health platform can facilitate remote monitoring of ulcerative colitis (UC) patients. A recent study shows that patient-administered simple clinical colitis activity index (SCCAI) via online correlated well with physician-assessed SCCAI. We evaluated the correlation between the self-administered SCCAI through smartphone and health-related quality-of-life assessment.

Methods
Clinical disease activity was assessed by the SCCAI and health-related quality of life by the disease-specific, self-administered Inflammatory Bowel Disease Questionnaire (IBDQ). Patients were followed-up over six months. At months 3 and 6, patients completed SCCAI through access to the web-based system (PROscore system) via link sent by text message to the smartphone at the outside of the hospital; within 48 h, patients subsequently completed the questionnaire of IBDQ in the clinic and attending gastroenterologist (blinded to patients’ scores) assessed the in-clinic SCCAI (reference). SCCAI scores were categorized into remission or active disease.

Results
A total of 157 patients (median age: 41 years; 62% male) contributed with 310 pairs of questionnaires. SCCAI scores by patients inversely correlated well with IBDQ (Pearson’s ρ =0.39). Moreover, linear regression revealed that this correlation persists irrespective of patient age, gender, disease extent, and education status. Correlation of SCCAI scores by patients and physicians was good (Spearman’s ρ =0.36), with 66% agreement for remission or active disease. The negative predictive value for the active disease was 84.3%; the positive predictive value was 41.2.0%.

Conclusion
In patients with UC, self-administered SCCAI via smartphone showed a good correlation with physician assessed disease activity and the patient’s quality of life. This validated e-health platform may be useful in remote monitoring of UC patients.
P192 Frequency of hereditary and acquired thromboembolic complications in patients with inflammatory bowel diseases in Moscow Clinical Scientific Center named after A.S. Loginov
Authors: Knyazev O , Lishchinskaia A , Kagramanova A , Zvyaglova M , Noskova K , Kulakov D , Parfenov A 
Published: May 2021

Abstract

Background
Thromboembolic complications (TC), which are one of the characteristic manifestations of inflammatory bowel diseases (IBD).

Objective
to identify the frequency of acquired and inherited hypercoagulation factors that contribute to the development of TC in patients with IBD.

Methods
The clinical status of 1238 IBD patients undergoing treatment in 2019 was evaluated in the Department of IBD. 748 patients with ulcerative colitis (UC) and 490 patients with Crohn’s disease (CD). In 112 patients with IBD (9.0%), clinically significant TC (venous thrombosis of the lower extremities, upper extremities and others) was detected. In patients with clinically significant feasibility studies, DNA isolated from peripheral blood lymphocytes was examined to identify molecular genetic mutations that lead to hypercoagulation.

Results
Of the 112 patients with TC, 76 (67.8%) patients had UC, and 36 (32.2 %) patients had Crohn’s disease. Of 112 IBD patients with clinically significant TC, 45 (40.2 %) had genetic mutations that increase affinity for fibrinogen, increase platelet aggregation, disrupt folic acid metabolism, and reduce the activity of the methylentetrahydrofolate reductase enzyme, which may be manifested by a moderate increase in homocysteine levels. 67 patients with IBD (59.8%) did not have genetic mutations that lead to hypercoagulation. Of the 45 IBD patients with clinically significant feasibility studies due to hereditary factors, 30 (66.6%) patients had UC, 15 (33.7%) patients had CD (RR-1.038, 95% CI 0.746–1.444; x2-0.049; p=0.83921).

Conclusion
Clinically significant feasibility studies were found in 9.0% of IBD patients. More than 40% of patients with clinically significant feasibility studies (n=112) have inherited factors that contribute to the development of feasibility studies. About 60 % of IBD patients with clinically significant feasibility studies do not have hereditary factors that lead to the development of feasibility studies.
P210 Healthcare resources utilisation prior to the diagnosis of ulcerative colitis and Crohn’s disease
Authors: Rodríguez-Lago I , Agirre U , Intxaurza N , Cantero D , Barreiro-de Acosta M , Cabriada J L 
Published: May 2021

Abstract

Background
Ulcerative colitis (UC) and Crohn’s disease (CD) are two chronic conditions of the gastrointestinal tract. Previous data suggest that a subclinical inflammatory process precedes the initial symptoms. Our aim was to determine if patients with UC or CD have an increase in healthcare utilization in the years preceding the disease onset.

Methods
A single-centre retrospective case-control study was performed at Hospital de Galdakao (Spain). We included all consecutive patients with a new diagnosis of UC/CD between 01/01/2018 and 31/12/2019. Cases were matched 1:3 with controls adjusted by sex, age and date, excluding those subjects with any visit to Gastroenterology Department. The main outcomes were the number of outpatient or Emergency visits, hospital admissions, radiological examinations (ultrasound, CT, MRI), sick-leaves, and prescriptions (antibiotics, steroids) in the 5 years before the diagnosis of UC/CD. Descriptive statistics were used, followed by chi-square tests and a multivariable hurdle regression model, adjusted by smoking habits and Charlson index, in order to perform a per year analysis. Additional grouped comparisons of the preceding 3 and 5 years were performed, and also excluding the 12 months prior to diagnosis.

Results
A total of 305 cases were included (160 UC, 168 CD; median 48 years; 53% female) and compared with 915 controls. Baseline characteristics including age, smoking habits, and comorbidities were comparable. Grouped analysis (excluding 12 months prior to UC/CD diagnosis) are summarized in Table 1. Patients had an increase in the number of hospital admissions, visits to the Emergency room or Primary Care physician, sick-leaves, radiological examinations, and prescription of antibiotics or corticosteroids in the previous 3 to 5 years, excluding the 12 months prior to diagnosis of UC/CD.

Conclusion
Patients with UC and CD show an increased use of healthcare resources in the years prior to the diagnosis. Diagnostic tools should focus in early predictors of disease onset as they may prompt an earlier identification of patients with IBD.
P219 An application of artificial intelligence in Inflammatory Bowel Disease detection
Authors: Rasmagina I , Bakulin I , Mariya S 
Published: May 2021

Abstract

Background
Inflammatory bowel disease (IBD) is verified on the basis of complex assessment of clinical, laboratory, endoscopic and morphological data. However, due to the lack of a ‘golden’ standard and similarity of the clinical picture, it usually takes more than 1 year to diagnose ulcerative colitis (UC) and more than 2 years for Crohn`s disease (CD). The aim of the study is to optimize the existing methods in diagnosis of IBD with an application of an artificial neural network (ANN).

Methods
216 patients with verified IBD (163 – UC, 53 – CD of large bowel) and 34 patients without endoscopic findings underwent colonoscopy in the Peter the Great Clinic of Mechnikov North-Western State Medical University (Saint-Petersburg, Russia). During the endoscopic examination 856 images were obtained: 268 images of “normal mucosa”, 194 ones of CD of large bowel and 394 ones of UC. The study included images of mild, moderate and severe activity of IBD. Mayo endoscopic score was used to assess endoscopic activity of UC. For CD the scoring scales were not provided, the activity of the disease was based on the length of the affected segment, presence of erosions, ulcers and complications such as strictures, fistulae and stenosis. All images were captured in high-resolution with the same endoscope (Olympus) and stored in a jpeg format. Poor-quality images resulting from blurs, defocus and poor air insufflation were excluded. We also created the ANN using the Neural Network Toolbox application from the MATLAB application package. The ANN consisted of 2 models: the first one was multilayer perceptron which determined a presence of pathology, the second was convolutional neural network which differentiated the types of IBD (UC or CD).

Results
All the endoscopic images were downloaded to the created ANN. It was trained 3 times due to the decrease of its accuracy. The average accuracy of the developed model in differentiation of pathology was 77%. This result could be associated with an insufficient number of CD images or ANN training on continuous data set of images with UC and CD features without clustering them to particular patient.

Conclusion
We conclude that the developed ANN shows moderate accuracy in recognition of different forms of IBD. This study has a limitation as the images were taken only with endoscope Olympus. Enlarged sample size and inclusion of morphologic images are needed in order to improve the accuracy of ANN.
P249 What’s the role of anti-TNF α in correcting anemia in Crohn’s disease?
Authors: Hassine A , Hammami A , Jaziri H , Elleuch N , Ksiaa M , Ben Slama A , Jmaa A 
Published: May 2021

Abstract

Background
Anemia is the most common extra intestinal complication in Inflamatory Bowel Diseases (IBD) affecting the quality of life of patients. Iron deficiency and inflammation are the two most common mechanisms. It has been suggested that controlling disease activity is sufficient to correct well-tolerated anemia. Anti-TNF α by their powerful anti-inflammatory action and their role in increasing the growth of erythroid progenitors can lead to correction of anemia. The aim of this work was to determine the effect of anti-TNFα on the course of anemia in Crohn’s disease (CD).

Methods
This is a single-center retrospective study including patients followed for CD, between 2011 and 2017, on anti-TNF. Anemia was tested in these patients before the initiation of anti-TNF. After six months of treatment, a correlation between the achievement of therapeutic efficacy and the correction of the anemia was sought. The judgment criteria adopted were: clinical response (CDAI score &lt;150 points), mucosal healing at endoscopy (absence of ulcerations), and normalization of the C-reactive protein (CRP &lt;5mg / l).

Results
120 patients were included, 60% of whom are female. The mean age at diagnosis was 29.8 years [12–56 years]. The mean duration of the disease was 7.42 ± 4.8 years. The disease phenotype was penetrating in 55% of cases and structuring in 45% of patients. Anoperineal manifestations (PAD) were noted in 20% of patients. 50% of patients were on Adalimumab, 50% on Infliximab and 45% of cases were on combination therapy. The indications for Biotherapy were: the presence of anoperineal manifestations (20%), failure of immunosuppressants (25%), postoperative recurrence (20%), intolerance to immunosuppressants (20%), and extradigestive manifestations in particular articular (15%). Pre-therapy, anemia was noted in 84 patients (70%), most of whom had chronic microcytic hypochromic anemia. The presence of anemia was well correlated with disease activity (p = 0.038). During the control, correction of anemia was obtained in 72 patients (60%), with a statistically significant association with the therapeutic efficacy criteria (clinical response: p &lt;10–3, mucosal healing: p = 0.009, normalization of CRP: p &lt;10–3).

Conclusion
Our study showed the effectiveness of anti-TNF alpha agents in correcting anemia in Crohn’s disease. Larger scale studies are needed to confirm our results.
P261 Predictors and outcomes of ustekinumab dose escalation to every 4 or every 6 weeks in ulcerative colitis: a multicenter cohort study in the United States
Authors: Dalal R , Esckilsen S , Barnes E , Pruce J , Marcus J , Allegretti J 
Published: May 2021

Abstract

Background
Patients with ulcerative colitis (UC) on ustekinumab (UST) therapy may have suboptimal response to standard every 8 week (q8w) dosing. Empiric dose escalation to q4w or q6w is common, but the efficacy of these strategies are unknown in UC. We performed a multicenter cohort study to identify predictors and outcomes of UST dose escalation in UC.

Methods
This retrospective cohort study included adults initiating UST for UC (ICD-10-CM 51x) at three academic medical centers in the United States 1/1/2016-11/1/2021. Patients with prior colectomy were excluded. Disease activity was assessed using the 9-point Mayo score or simple clinical colitis activity index (SCCAI) in electronic health records. Independent variables included demographics, UC duration, extraintestinal manifestation, medication/substance use history, endoscopic extent/severity, reason for escalation, intravenous (IV) reinduction, dose interval, albumin, C-reactive protein, and bowel frequency. The primary outcome was steroid-free clinical remission (SCCAI/Mayo &lt;3 points) 12–16 weeks after escalation. Secondary outcomes were clinical response (reduction in SCCAI/Mayo by ≥3 points from baseline) at 12–16 weeks and time to escalation. Additional endpoints included endoscopic response, failure within 16 weeks (treatment discontinuation or colectomy), improvement in fecal calprotectin, UC hospitalisation, and adverse events. Multivariable logistic and cox regression were used to identify factors associated with remission and time to escalation, respectively.

Results
108 UC patients initiated UST: 91.7% had prior anti-TNF exposure and 57.4% were taking oral steroids (Table 1). 39.6% (40/101 with data) achieved remission 12–16 weeks after induction. 42.6% (46/108) were escalated to q4w (n=33) or q6w (n=13) after median of 95 days (IQR 65–208 days) primarily for no/minimal response to induction (22/46) or loss of response (20/46) (Fig 1A). 55.0% (22/40 with data) achieved remission at 12–16 weeks, 67.5% (27/40) had response, 56.3% (9/16 with data) had endoscopic response (Table 2), and 30.0% (12/40) had treatment failure (Fig 1B). 10.0% (4/40) were hospitalised after median of 80 days and 5.0% (2/40) had adverse events (urinary tract infection and C. difficile infection). After multivariable analysis, lack of response to induction was inversely associated with remission after escalation. Bowel frequency and &gt;2 prior biologics were associated with time to escalation (Table 3).

Conclusion
UST dose escalation resulted in clinical remission in &gt;50% of UC patients and was more effective in those with loss of response compared to no/minimal response after induction. Prospective studies are needed to identify UC subpopulations that will benefit from various dosing strategies of UST.
P276 Influence of vedolizumab on extraintestinal manifestations in Inflammatory Bowel Disease: a nationwide multicenter study of the GETECCU Eneida registry
Authors: Pérez Galindo P , Gisbert J P , Carrillo-Palau M , Bertoletti F , González-Vivó M , Ferrer J A , Pajares R , Merino O , Castaño A , Chaparro M , Calvo M , Barreiro-de-Acosta M , Rodríguez A , Lorente R H , Algaba A , Riado D , Vela M , De-la-Maza S , Llaó J , Vega P , Utrilla A , Almela P , Carpio D 
Published: May 2021

Abstract

Background
Evidence regarding vedolizumab (VDZ) influence on extraintestinal manifestations (EIMs) in inflammatory bowel disease patients (IBD) is scarce. Our aim was to analyze the effectiveness of VDZ in pre-existing EIMs and the occurrence of de novo EIMs during VDZ therapy in IBD.

Methods
We performed an observational, multicenter, retrospective cohort study including patients from the Spanish ENEIDA registry promoted by GETECCU. We retrospectively identified 551 patients from 20 centers. The co-primary outcomes were to evaluate the response of EIMs to VDZ and to assess the frequency of de novo EIMs during therapy. Secondary outcomes were to analyze associated factors with EIMs response to VDZ, time from VDZ initiation to occurrence of de novo EIMs and the discontinuation rate of VDZ because of worsening/de novo EIMs. Response and worsening of IBD and EIMs were defined by clinical and laboratory criteria according to the physician’s assessment.

Results
The median age of the cohort was 49.7 years (IQR 38-60), 50.8% were female, 50.8% had Crohn’s disease and 90.4% had prior biologic exposure (more than 1 biologic drug in 57.9%). At baseline 133 patients (24.1%) had pre-existing EIMs of whom 21 showed more than 1 EIM; 76.7% of EIMs were articular and 31% cutaneous. Regarding 77 patients with active EIMs at baseline, response of EIMs to VDZ at 3 months was observed in 23 (29.9%), worsening in 13 (16.9%) and no change in 41 (53.2%). Response rates for active EIMs were 35.4% for peripheral arthritis (PA), 11.8% for axial arthropathy (AA), 35.7% for cutaneous EIMs and 33.3% for ocular EIMs. Response of IBD at 3 months was the only associated factor with response of EIMs to VDZ (OR=3.72; CI 95% [1.08-12.83]). Among 56 patients with inactive EIMs at baseline, worsening of EIMs was observed in 5 patients after 12 months of VDZ therapy (13.5%) (3 cases of PA and 2 of AA). During follow-up 25 patients (4.5%) developed 27 de novo EIMs (17 cases of PA, 4 of AA, 4 of erythema nodosum, 1 of pyoderma gangrenosum and 1 of episcleritis). Median time from VDZ initiation to onset of de novo EIMs was 244 days (IQR 115-693). Presence of more than 1 pre-existing EIM was the only associated factor with de novo EIM onset during first year of VDZ therapy (OR=14.5; 95% CI [3.3-62]). Worsening of pre-existing EIMs or de novo EIMs was the cause of VDZ discontinuation in 15 patients (5.8% of all patients who discontinued VDZ).

Conclusion
VDZ achieved clinical response of active EIMs in nearly a third of patients after 3 months of therapy, being the response of IBD to VDZ the only associated factor. Worsening of inactive EIMs or de novo EIMs during VDZ therapy was infrequent.
P282 High plasma oncostatin-M predicts non-response to tumour necrosis factor-alpha antagonists in inflammatory bowel disease
Authors: Guo A , Ross C , Chande N , Gregor J , Ponich T , Beaton M , Khanna R , Kim R , Wilson A 
Published: May 2021

Abstract

Background
The interleukin-6 family cytokine, oncostatin-M (OSM) has been associated with a lack of remission to tumor necrosis factor-α antagonists (anti-TNFs) in small cohorts of patients with inflammatory bowel disease (IBD). We aimed to further evaluate the association between plasma OSM concentrations and response to anti-TNFs (infliximab and adalimumab) in addition to other clinical outcomes in both ulcerative colitis (UC) and Crohn’s disease (CD).

Methods
A retrospective cohort study was carried out in patients with IBD with a history of anti-TNF exposure. Blood samples, collected prior to anti-TNF exposure, were analyzed by enzyme-linked immunosorbent assay for the presence and quantity of OSM. The primary outcome evaluated was clinical remission at 1-year based on the Harvey Bradshaw Index (HBI, remission, HBI&lt;5) for CD and the Partial Mayo Score for UC (remission, Partial Mayo Score&lt;2). Data pertaining to the occurrence of surgery, hospitalization, corticosteroid use, and adverse drug events during the 1-year follow-up period were also collected. Lastly the threshold OSM plasma concentration associated with anti-TNF non-response was assessed by receiver operator characteristic (ROC) curve analysis.

Results
One hundred and fourteen patients with IBD (CD, n=73; UC, n=40) seen at a tertiary care centre in London, Ontario Canada, were included in the analyses. Patients received one of infliximab (n=61) or adalimumab (n=53). For those with UC achieving clinical remission at 1-year (n=24), the mean OSM concentration was 84.5±119.7pg/ml versus those not achieving clinical remission (n=16) where the mean OSM concentration was 1064.0±958.8pg/ml (p&lt;0.0001). For those with CD, the mean OSM concentration was 116.3 ± 222.3pg/ml in those achieving clinical remission (n=52) versus those did not (n=22) where the mean OSM concentration was 1220.0 ± 1274.0pg/ml (p&lt;0.0001).
A threshold OSM concentration of 168.7pg/ml in CD and 233.6pg/ml in UC separated those who achieved clinical remission at 1-year on an anti-TNF from those who did not (CD: area under the receiver operator characteristic curve, AUROC=0.880, 95%CI=0.79-0.96, p&lt;0.0001; UC: AUROC=0.938, 95%CI=0.87-1.00, p&lt;0.0001).
In CD, participants with a plasma OSM concentration above the threshold concentration of 168.7pg/ml, were more likely to discontinue their anti-TNF at 1-year (p&lt;0.0001), require hospitalization (p=0.0019) and/or corticosteroid rescue therapy (p&lt;0.0001), require a surgical intervention (p=0.0087) or experience a drug-related adverse event (p=0.009).

Conclusion
OSM plasma concentrations were associated with response to anti-TNFs at 1-year in IBD. A threshold OSM concentration of 168.7pg/ml distinguished patients with CD at-risk of poor clinical outcomes.
P306 MORF-057, an oral selective α4β7 integrin inhibitor for Inflammatory Bowel Disease, leads to specific target engagement in a single and multiple ascending dose study in healthy subjects
Authors: Ray A , Cui D , Lee D , Mangada M M , Jones J , Bain G , Traber P G , Vrishabhendra L H , Krzeski P W , Vande Casteele N , Reardon M M , Stern T P , Soo C L , Nguyen H , Rogers B N , Linde P G 
Published: May 2021

Abstract

Background
MORF-057 is an orally administered small molecule designed to inhibit the α 4β 7 receptor, addressing an unmet medical need in inflammatory bowel disease (IBD) patients, and avoiding the need for periodic therapeutic infusions and the risk for infusion-related reactions. This study evaluated single (SAD) and multiple ascending doses (MAD) of MORF-057 in healthy volunteers.

Methods
This was a randomized, double-blind, placebo-controlled, single and multiple doses, phase 1 study of the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of MORF-057 conducted in a Phase I Unit in the USA. Subjects were randomized 3:1 to MORF-057 or placebo capsules once daily in the SAD cohorts: 25, 50, 100, 150, and 400 mg; or twice daily (BID) in the MAD cohorts: 100 and 200 mg total daily doses (dosed as 50 and 100 mg BID, respectively). In the MAD cohorts, trough PK samples were obtained premorning or pre-evening dose following administration of 50 or 100 mg BID, respectively. Blood samples to assess receptor occupancy (RO) of α 4β 7 and α 4β 1 integrins were obtained prior to the first dose and 12 hours after treatment.

Results
To date, 51 healthy subjects were dosed; 1 subject withdrew consent on Day 2 for personal reasons. Eleven non-serious adverse events (AEs) were reported; AEs were mild and did not result in discontinuation. Two reversible mild AEs in the 200 mg MAD cohort were possibly related to MORF-057 (macular / maculopapular rash). No safety signals were identified to date. Following dosing, MORF-057 was rapidly absorbed and systemic exposure increased approximately dose-proportionally (Fig.1). Mean α 4β 7 RO was found to be greater than 95% after each of the three highest single doses (Fig.2). In multiple dosing, mean α 4β 7 RO was greater than 90% at the lower dose, while the highest dose tested resulted in α 4β 7 RO saturation at steady state. α 4β 1 RO was below the limit of quantitation with mean trough values estimated to be &lt;10% at any of the dose levels.

Conclusion
Current results demonstrated that single and multiple ascending doses of MORF-057 were well tolerated, with only mild, non-serious AEs reported that did not result in study drug discontinuation. MORF-057 demonstrated a favorable PK profile where target engagement was confirmed and resulted in α4β7 receptor saturation in many subjects receiving higher doses. These results support further investigation of MORF-057 and provide a basis for dose selection phase 2 studies in patients with IBD. (NCT04580745)