bluuebunny/crossref_metadata_2025_split huggingface dataset:
DOP86 Corticosteroid-sparing effects of ustekinumab therapy for Ulcerative Colitis through 3 years: UNIFI long-term extension
Authors: Scherl E J , Rowbotham D S , Danese S , Sandborn W J , Miao Y , Zhang H , Abreu M T , Panaccione R , Afif W , Hisamatsu T , Leong R W , Arasaradnam R P , Sands B E , Marano C 
Published: May 2021

Abstract

Background
Ustekinumab (UST) is an IL12/23 blocker approved for use in Crohn’s disease and ulcerative colitis (UC). In the UNIFI maintenance study of patients (pts) with moderate-severe UC, &gt;90% of the pts who achieved clinical response or remission at week (wk) 44 were able to eliminate corticosteroids, an important goal of therapy. In this analysis, we describe the corticosteroid-sparing effects of UST treatment through 3 years among pts who were treated in the UNIFI long-term extension (LTE).

Methods
523 intravenous UST induction responders were randomized to SC maintenance therapy (SC placebo [PBO], n=175; UST 90mg every 12 wks [q12w], n=172; or UST 90mg q8w, n=176). 284 UST pts who completed wk44 entered the LTE. PBO pts were discontinued after wk44 unblinding. Based on the investigator’s clinical judgement of their UC disease activity, pts in the LTE were eligible to receive dose adjustment starting at wk56: PBO to q8w, q12w to q8w, and q8w to q8w (sham adjustment). Pts in PBO or q8w groups were only eligible for dose adjustment or sham dose adjustment before unblinding. Efficacy was evaluated in randomized pts using symptomatic remission (Mayo stool frequency subscore of 0 or 1 and a rectal bleeding subscore of 0).
During the maintenance study, all pts receiving corticosteroids at maintenance baseline were required to initiate tapering. Through wk152 of the LTE, symptomatic remission endpoints were calculated with treatment failure and missing data nonresponder imputation, and dose adjustment was not considered to be a treatment failure. Missing corticosteroid dose data was managed using last observation carried forward.

Results
Of the 284 pts in the randomized population who were treated with UST in the LTE, 139 were receiving corticosteroids at maintenance baseline. Of these, 91.4% (n=127) were no longer receiving corticosteroids at wk152. The average prednisone-equivalent corticosteroid dose among pts receiving corticosteroids at maintenance baseline in the q8w group was 15.4 mg/day at maintenance baseline and 1.7 mg/day at wks44 & 152. In the q12w group, average prednisone-equivalent doses were 15.4, 1.0, and 4.6 mg/day, respectively (Table 1). Corticosteroid-free symptomatic remission rates through wk152 are summarized in Table 2. Results were similar for the q8w and q12w maintenance doses. Of the UST-treated pts who were in symptomatic remission at wk152, 94.6% (88/93) in the q12w group and 98.0% (97/99) in the q8w group were corticosteroid-free.

Conclusion
UST maintenance therapy, with both q8w and q12w dosing regimens, was effective in reducing and eliminating the use of corticosteroids in pts with UC through 3 years. Through 3 years of treatment with UST, the majority of pts in symptomatic remission were corticosteroid free.
P134 Ultrasonographic scores for Crohn’s disease activity assessment – still lag behind CEUS
Authors: Freitas M , Macedo Silva V , Arieira C , Cúrdia Gonçalves T , Dias de Castro F , Leite S , Moreira M J , Cotter J 
Published: May 2021

Abstract

Background
Intestinal ultrasound (IUS) is an increasingly used non-invasive tool to monitor Crohn‘s disease (CD) activity. Currently, there is no widely accepted, reproducible IUS activity index to evaluate inflammatory activity. In 2020, two new scores emerged: the Simple Ultrasound Activity Score for CD (SUS-CD) and International Bowel Ultrasound Segmental Activity Score (IBUS-SAS). We aimed to compare the accuracy of SUS-CD, IBUS-SAS and contrast ultrasound (CEUS) in predicting inflammatory activity in the terminal ileum in ileocolonoscopy.

Methods
Retrospective study including all IBD patients submitted to conventional IUS and CEUS with contrast SonoVue® directed to the terminal ileum performed by a single operator between April 2016 and March 2020. Examinations were performed using an ultrasound Hitachi HI VISION Avius®. Qualitative and quantitative parameters from the conventional IUS analysis including wall thickness, stratification, colour Doppler and inflammatory fat were evaluated, and segmental SUS-CD and IBUS-SAS were calculated. A quantitative measurement of contrast bowel wall enhancement, peak intensity, was evaluated using CEUS. The CD activity was assessed with ileocolonoscopy by Simple Endoscopic Score for CD (SES-CD). Disease activity was graded as inactive (SES-CD&lt;7) or active (SES-CD≥7).

Results
Fifty patients were included, 54.0% female, with mean age of 33±12years. Patients had a mean SUS-CD of 3.4±1.0, IBUS-SAS of 58.9±25.9 and CEUS peak intensity of 12.6±12.2. SUS-CD and IBUS-SAS were not different between patients with active or inactive disease (p=0.15; 0.57, respectively) with a poor capability to predict endoscopic activity (AUC 0.62, 95% CI 0.45–0.78; 0.55, 95% CI 0.38–0.72, respectively). Peak intensity in CEUS was significantly different in patients with active or inactive disease (p=0.004) with a good capability to predict endoscopic activity (AUC 0.80; 95% CI 0.64–0.92). A peak intensity optimal cut-off to predict active disease was 8.2 with a sensitivity of 71.4% and a specificity of 78.9%.

Conclusion
SUS-CD and IBUS-SAS were not able to predict with good accuracy endoscopic activity in terminal ileum in CD. On the other hand, CEUS with peak intensity assessment showed a good diagnostic accuracy for active inflammation in CD. Therefore, CEUS is a non-invasive emerging method, that should be routinely integrated in the ultrasonographic evaluation in CD.
P184 Disease activity in Inflammatory Bowel Disease patients is associated with increased liver fat content during follow-up
Authors: Van Lingen E , Tushuizen M , Steenhuis M , van Deynen T , Martens J , Diaz-Infante Morales D , van der Meulen-de Jong A , Molendijk I , van der Marel S , Maljaars J 
Published: May 2021

Abstract

Background
Increased liver steatosis is a frequently reported condition in patients with Inflammatory Bowel Disease (IBD). Different factors, both metabolic and IBD-associated, are believed to be contribute to the pathogenesis. The aim of our study was to calculate the prevalence of liver steatosis (LS) and fibrosis (LF) in IBD patients and evaluate which factors influence changes in steatosis and fibrosis during follow-up.

Methods
From June 2017 to February 2018, consecutive adult IBD patients were enrolled. Demographic and bio-chemical data were collected at baseline and after 6 to 12 months. The degree of LS and LF was assessed by transient elastography (Fibroscan). LS was defined as a Controlled Attenuation Parameter (CAP) ≥248, LF as a liver stiffness value (Emed) ≥7.3 kPa and IBD disease activity as C-reactive protein (CRP) ≥10 mg/l and/or fecal calprotectin (FCP) ≥150 μg/g. Changes in LS and LF were studied using ∆CAP and ∆Emed (follow-up minus baseline). An independent sample T-test was used to analyze the mean change in ∆CAP and ∆Emed. Univariate and multivariate linear regression analyses were performed, a P-value of ≤0.05 was considered significant.

Results
A total of 117 IBD patients were enrolled, of which 86 patients were also seen for follow-up. Of these 86 patients, 57% were male with a mean age of 43 (16.1) years. 48% of the patients suffered from Crohn’s disease. The mean Body Mass Index (BMI) was 25.0 (4.7) kg/m2 and 28 patients (33%) had an active episode of IBD at enrollment. The prevalence of LS at baseline was 39%, the prevalence of LF at baseline 13%. The mean change in ∆CAP was 22.44 (75.7) in patients with active disease at baseline and -34.1 (67.5) in patients in remission at baseline (p=0.001). The mean change in ∆Emed was 0.40 (1.9) in patients with active disease at baseline and -0.53 (2.7) in patients in remission at baseline (p=0.075).). Using a multivariate analysis, disease activity at baseline (B=37, 95%CI 6.38–67.61,P=0.018) and LS at baseline (B=-0.4, 95%CI -0.64 – -0.23,P=0.000) were associated with an increase in LS during follow-up. In univariate analyses, no factors associated with LF during follow-up were found.

Conclusion
Our study reveals a high prevalence of liver steatosis and liver fibrosis in IBD patients. Active IBD at baseline was associated with an increase in liver steatosis during follow up, but not with an increase in liver fibrosis.
P186 Inflammatory Bowel Disease Care in the Covid-19 pandemic era: Experience from a Tunisian gastroenterology department
Authors: Dahmani W , Sahar N , Aya H , Nour E , Wafa B A , Aida B S , Ahlem B , Mehdi K , Hanene J , Ali J 
Published: May 2021

Abstract

Background
The coronavarius disease (COVID-19) pandemic has brought forth a multitude of challenges for both patients having inflammatory bowel disease (IBD) and clinicians involved in their care. The national-wide lockdown in Tunisia, from Mars to Mai 2020 had substantially decreased healthcare accessibility and drugs availability. In addition, the uncertainty caused by the COVID-19 pandemic was likely to lead to anxiety and negative emotional and behavioral reactions which are thought to be predictors of active IBD and relapses.
We aimed to assess the hospital admission and complication rates in patients with IBD during the first wave of COIVD-19 infection in Tunisia and to compare them to those observed during the same period one year earlier.

Methods
We retrospectively analyzed the clinical features of patients with IBD admitted to our department during the period of time following the national lock-down in Tunisia ( from Mai, the 4th to August, the 31th). We compared the total global admission rate, IBD related complications, surgery rates and postoperative complications between the study period (P1) and the corresponding period of the previous year (P2 : from Mai, the 4th to August, the 31th, 2019). The Chi square test and Fisher exact test were used for analysis of categorical data.

Results
Eighty patients with IBD were included in this study (44 patients in P1 and 36 patients in P2), 73.7% of which (n=59) had Crohn disease. The sex ratio was 1.16 and the mean age was33.8 years ± 11.9. The mean follow-up period was 5 years. In 17.5% of cases (n=14), the IBD was diagnosed during the admission. None of the P1 patients had tested positive for SARS-CoV-2. The incidence of hospitalizations during P1 was 2.6 per week. It was greater than that of P2 but without the difference being statistically significant (2.1 admissions per week; incidence rate ratio: 0.34; 95% CI: 0.67-1.2; p = 0, 54). A total of 31 complications were noted (19 in P1 vs 12 in P2; p=0,489). The complications were as follows: 19 cases of acute severe colitis (12 in P1 vs 7 in P2 ; p= 0,234), 8 cases of intra-abdominal abscesses (6 in P1 vs 2 in P2 ; p=0,234), 4 cases of acute intestinal obstruction (1 in P1 vs 3 in P2 ; p=0,322). Among patients who had presented an acute severe colitis, 6 had undergone subtotal colectomy (6 in P1 vs 0 in P2, p=0,006).

Conclusion
Our study showed that during the pandemic period, there was an increase in the incidence of hospitalizations of patients with IBD as well as a significant increase in the need for surgery in severe acute colitis. These results should be taken into account so that IBD management strategies can be adjusted accordingly, if the COVID-19 pandemic persists or recurs, or in case of future outbreaks.
P232 Assessing effectiveness and patient perceptions of a novel electronic medical record for the management of inflammatory bowel disease
Authors: Kaazan P , Li T , Seow W , Bednarz J , Pipicella J , Ng W , Wiiliams A J , Connor S , Andrews J 
Published: May 2021

Abstract

Background
There is an increasing prevalence of chronic disease worldwide, resulting in multiple management challenges. Inflammatory bowel disease (IBD) is an exemplar chronic disease requiring optimal longitudinal coordinated care. We propose that Crohn’s Colitis Care (CCCare), a novel IBD-specific electronic medical record intended to improve IBD care is effective and acceptable to patients. We aimed to assess both the effectiveness of CCCare for data capture and patients’ acceptability of CCCare.

Methods
Methods:
The study was conducted at two tertiary Australian hospitals with dedicated IBD services: Royal Adelaide Hospital and Liverpool Hospital.
The effectiveness of CCCare was examined by comparing IBD-specific data completeness between pre-existing medical records and CCCare.
Acceptability was assessed with quantitative and qualitative feedback through the CCCare patient portal and with standardized paper-based questionnaires administered to a convenience sample of IBD clinic patients in two unmatched pre-CCCare and post-CCCare exposure cohorts. Descriptive statistics and multivariable regression models were applied to specifically examine overall ratings of CCCare acceptability using a 10-point numeric scale; factors associated with acceptability before exposure to the system and whether exposure or security concerns influenced its acceptability.

Results
In all 73 cases reviewed, there was data gain when using structured CCCare fields compared to IBD documentation in usual medical records.
Acceptability assessment through the patient portal feedback of 287 patients showed that the majority were very likely to recommend it to others (score, 8.56 ± 2.2 on a scale of 0–10). Common themes of concern among the 22 respondents with qualitative feedback were related to the novelty and limited experience of CCCare.
Study questionnaires indicated that the overall acceptability in the combined cohort (n=310) was very high (8.4 ± 2.1; scale of zero to ten) with more than three-quarters of patients rating acceptability as at least 8 out of 10. Self-reported information technology (IT) literacy was positively associated with acceptability. Exposure had a small positive affect on acceptability while the level security concerns had little impact on acceptability.

Conclusion
The IBD-specific electronic medical record CCCare is effective in facilitating enhanced completeness of IBD-specific data capture in comparison to pre-existing medical records. It is highly acceptable to patients, especially those with reasonable IT literacy. Patient concerns about privacy and security of EMRs did not significantly influence acceptability.
P321 Cessation of Anti-Tumour Necrosis Factor Therapy in Patients with Perianal Fistulizing Crohn’s Disease: Individual Patient Data Meta-Analysis of 323 patients from 12 studies
Authors: Ten Bokkel Huinink S , van der Woude J , Casanova M J , Bouguen G , Mak J W Y , Molnar T , Seidelin J , Aurelien A , D’Haens G , Riviere P , Guidi L , Renata B , Lin W C , de Vries A 
Published: May 2021

Abstract

Background
The risk of relapse after anti-tumour necrosis factor [TNF] therapy cessation in Crohn’s disease [CD] patients with perianal fistulas is unclear. We aimed to assess the risk of relapse after anti-TNF cessation in a large cohort and to identify risk factors.

Methods
A systemic literature search was conducted to identify cohort studies reporting on the incidence of relapse after cessation of anti-TNF therapy in CD patients. Individual patient data [IPD] were requested from the original study cohorts. Inclusion criteria for IPD-meta-analysis (IPD-MA) included age ³ 18 years, perianal fistulizing CD as indication for start of anti-TNF therapy, minimal treatment duration ³3 doses, and remission of luminal and perianal CD at cessation of anti-TNF therapy. Primary outcome was CD relapse [either perianal or luminal]. Perianal fistula relapse was defined as recurrence of draining perianal fistula related to previous or new fistula tracks, or abscess. Luminal relapse was defined as a clinical, biochemical, endoscopic, or radiological relapse requiring treatment or dose optimization of IBD medication or surgery. In a secondary analysis, risk factors associated with relapse were assessed using multivariate logistic regression analysis.

Results
A total of 307 patients from 12 studies in 9 countries were included in this IPD-MA. The median duration of anti-TNF treatment prior to therapy cessation was 14 months [IQR 6.1 – 29.9]. In 272/307 patients [89%] anti-TNF therapy was started for active perianal fistula and in 34 [11%] for both active perianal fistula and luminal CD. 169 patients [55%] developed a relapse [either perianal or luminal] after a median follow-up after cessation of 25 months [IQR 12 – 54]. Overall cumulative incidence of relapse was 31% and 43% at 1 and 2 years after anti-TNF cessation. Risk factor for CD relapse include upper GI involvement (L4) [HR 1.9], whereas older age [A3 vs A1, HR 0.48] and continuation of concomitant immunomodulators [HR 0.62] were protective factors. For a subgroup of patients with active perianal fistula and in luminal remission at start of anti-TNF, the cumulative incidence relapse rates were 25% and 43% at 1 and 2 years. No considerable differences in risk factors were found within this subgroup regarding risk of recurrence. Of the 179 patients who relapsed, 104 were retreated with anti-TNF with a response rate of 85%.

Conclusion
According to this IPD-MA, approximately two-thirds of CD patients with perianal fistula remain in remission with regard to fistulizing and luminal disease during 2 years after cessation of anti-TNF therapy. Further risk stratification based on perianal fistula characteristics is required.
P370 Concomitant azathioprine prevents new-onset arthralgia after initiation of vedolizumab: A retrospective cohort study
Authors: Kokkotis G , Zampeli E , Tzouvala M , Giotis I , Orfanos P , Benetou V , Stoupaki M , Gizis M , Kioulos N , Kitsou V , Leontidis N , Leonidakis G , Chatzinikolaou M L , Perlepe N , Koutsounas I , Lagiou P , Michopoulos S , Bamias G 
Published: May 2021

Abstract

Background
Vedolizumab is a monoclonal antibody against the gut-homing integrin α4β7 that is being used for the treatment of moderate to severe Ulcerative Colitis (UC) and Crohn’s Disease (CD). An increasing number of studies have reported new onset or reactivation of extra-intestinal manifestations (EIMs), among which arthralgia is the most prominent.

Methods
We aimed to study the incidence, characteristics and possible predictors of arthralgia development in patients under treatment with Vedolizumab, in a retrospective cohort study in 3 IBD centers in Athens, Greece. UC and CD patients treated with Vedolizumab (n=115, men=50.4%, UC=70.4%, median duration of follow-up=9 months) or Infliximab (n=93, men=69.9%, UC=29%, median duration of follow-up=29.1 months) were recruited. For each participant the entry point for the study was the first day of drug administration while the endpoint was either the day of arthralgia occurrence, the day of drug discontinuation or the day of the last interview if the patient was still receiving the drug. The SPSS-23 statistical program was used for analysis.

Results
Patients under Vedolizumab were at higher risk for new-onset (HR=4.76, P=0.001) and recurrent (HR=5.41, P=0.003) arthralgia compared to patients under Infliximab. New-onset arthralgia occurred in 20.9% while recurrent in 37.8% of 45 patients with a history of articular EIM. New-onset and recurrent arthralgias differed in certain characteristics. New-onset arthralgia involved peripheral joints in 91.7%, was milder, occurred shortly after Vedolizumab initiation (median drug exposure= 3 months, IQR=5 months) in patients in remission and remitted in 50% of cases. In multivariate Cox’s proportional-hazards model new-onset arthralgia was significantly associated with extensive colitis (HR=2.91, 95%CI=1.04-8.12). Of 15 patients with concomitant treatment of azathioprine no one manifested new-onset arthralgia (X2 P= 0.03, Fisher’s exact test P=0.038). Similarly, no patient with a history of appendectomy manifested new-onset arthralgia (n=12, X2 P= 0.067, Fisher’s exact test P=0.12). No predictors were identified for recurrent arthralgia. No patients discontinued vedolizumab due to arthralgia.

Conclusion
Vedolizumab treatment may be associated with the temporal manifestation of arthralgias. Patients under Vedolizumab with extensive ulcerative colitis have a higher risk of developing new-onset arthralgia, whereas, concomitant treatment with azathioprine and a history of appendectomy appears to have a prophylactic effect. This effect could be indicative of a distinct pathophysiological lymphocyte-mediated mechanism.
P378 Oxidative status and antioxidant capacity in children and adults with IBD: preliminary results of the OxIBDiet trial
Authors: Gatti S , Cianfruglia L , Galeazzi T , Palpacelli A , Quattrini S , Quatraccioni C , Catassi G , Monachesi C , Di Sario A , Armeni T , Catassi C 
Published: May 2021

Abstract

Background
Redox imbalance is involved in several aspects of inflammatory bowel disease (IBD). The OxIBDiet (NCT04513015) is a multicentre, 2-phases project involving IBD children and adults with the following aims: 1. To evaluate oxidative status of IBD subjects. 2. To estimate the effects of an antioxidant diet in IBD patients. Preliminary results are shown in this abstract.

Methods
The total antioxidant capacity, lipid peroxidation and the degree of protein oxidation were measured respectively through the ferric reducing ability of plasma (FRAP, µmol/equivalent FeSO4), serum levels of the thiobarbituric acid reactive substances (TBARs, µmol MDA) and advanced Oxidation Protein Products (AOPP, µmol/g protein). Reactive oxygen species (ROS, Arbitrary Units) and activities (nmol/min/mg of protein) of the main antioxidant enzymes, superoxide dismutase (SOD), glutathione peroxidase (GPX), glutathione reductase (GR), glutathione S-Transferase (GST) and catalases (CAT) were evaluated in PMNs cells. Oxidative stress markers were correlated with demographic variables and clinical parameters.

Results
Fifteen adults (mean age: 36.2 ±11.4 years, 47% female, 67% in remission) and thirty five children (mean age: 14.13 ±2.2 years, 60% female, 65% in remission) with IBD have been enrolled so far. FRAP was significantly reduced in IBD children compared to healthy controls (median values: 212.1 vs. 248.3, p=0.0001) and to IBD adults (median value: 281, p&lt;0.001), while no difference was observed between adults with IBD and the control group (p= 0.1). ROS levels did not differ in IBD children compared to adults and controls. The activity of GPX and CAT enzymes was increased in children with IBD in comparison to controls (p:0.02 and 0.001, respectively) while the activity of the other enzymes (GST, GR and SOD) and levels of lipid peroxidation and protein oxidation was not different between the 2 groups. Overall in the IBD group (children plus adults) FRAP was positively correlated with age (r=0.40, p=0.006), male gender (r=0.33, p=0.03) and use of biologics (r=0.47, p=0.001) and inversely correlated to disease activity based on clinical scores (r= -0.38, p=0.009). No correlation was found between FRAP and serum C-reactive protein or calprotectin levels.

Conclusion
The total antioxidant capacity (FRAP) is significantly impaired in IBD children respect to IBD adults and to healthy controls, thus suggesting an early involvement of oxidative stress in IBD pathogenesis. Moreover, the activity of the main antioxidant enzymes (GPx and CAT) in IBD children is increased, as a possible compensation for redox imbalance. Final results will clarify the involvement of antioxidant cascade in IBD pathogenesis and in therapeutic approach.