bluuebunny/crossref_metadata_2025 huggingface dataset:
P194 Risk factors of axial spondyloarthritis among inflammatory bowel disease patients
Authors: JEMMALI C , Laabidi A , Hafi M , Ben Mustapha N , Serghini M , Fekih M , Boubaker J
Published: January 2020

Background

Spondyloarthritis (SpA) is the most common extraintestinal manifestation (EIM) in inflammatory bowel disease (IBD) patients. However, the delay for the diagnosis of SpA in IBD patients is still unacceptably long, and may be the main cause of impairment due to ankylosing spondylitis. The aim of this study was to identify predictors of axial SpA in IBD patients, in order to prevent complications.

Methods

We conducted a retrospective study between 2001 and 2018 including all IBD patients diagnosed with symptomatic axial Spondyloarthritis (SpA) (Group1) and non-SpA patients among IBD (Group2). Diagnosis of SpA was based on ASAS 2009 criteria and confirmed by rheumatologists. Medical data were collected then uni and multivariate statistical analysis (p significant if ≤0.05) were performed.

Results

Seventy-eight patients with mean age 38 ± 11 years and sex ratio H/F = 1.6 were included. There were 58 (74.4%) Crohn’s disease (CD) patients and twenty patients (25.6%) had ulcerative colitis (UC). The average duration of IBD in all patients was 89.7 ± 69.1 months. SpA group included 26 patients (33.3%), six of whom (23%) had a late-stage disease (ankylosis). Most of the SpA patients (53.8%) had their disease before IBD onset with an average delay of 52.5 ± 68 months between SpA diagnosis and IBD symptoms. In univariate analysis, factors associated with SpA in IBD patients were familial history of IBD (p = 0.025) and the type of IBD (39.7% in CD vs. 15% in UC; p = 0.04). Among CD patients’, structuring-type was significantly associated with SpA (p = 0.04). Multivariate analysis showed that familial history of IBD (OR = 0.17; IC95%; 0.03–0.93; p = 0.04) and CD (OR = 3.72; IC 95%; 0.98–14.15; p = 0.05) were independent risk factors of axial SpA during IBD. EIMs other than SpA were more frequent in group 1 than in group 2 such as peripheral arthropathies (19.2% vs. 8.3% respectively; p = 0.02), anterior uveitis (11.5% vs. 0% respectively; p = 0.01) and erythema nodosum (7.7% vs. 0% respectively; p = 0.04).

Conclusion

In conclusion, predictors of symptomatic axial SpA were familial history of IBD and CD with structuring behaviour. Early-stage diagnosis is important to avoid ankylosis, which is a major cause of handicap in younger patients.
P244 Validation of the Red Flags index for early diagnosis of Crohn’s disease: A prospective general practitioner study
Authors: Fiorino G , Gilardi D , Bonovas S , Di Sabatino A , Angeli E , Gaffuri N , Allocca M , Furfaro F , Roda G , Lenti M , Nicola A , Mengoli C , Peyrin-Biroulet L , Danese S
Published: January 2020

Background

A diagnostic delay >12 months is frequent in Crohn’s disease (CD), and associated with lower therapeutic response rates and worse outcomes. The Red Flags index, a simple tool to help to identify early CD and reduce diagnostic delay, was recently developed. We aimed to assess its accuracy for early diagnosis of CD patients.

Methods

Consecutive adult patients, suffering from intestinal symptoms and having no medical history of any gastrointestinal disease, referring to the General Practitioner (GP) were screened. Patients should have at least one of the following symptoms: chronic abdominal pain, chronic diarrhoea, nocturnal diarrhoea, unexpected weight loss, or perianal lesions. The GPs administered the Red Flags questionnaire to each eligible patient. Then, all patients were referred to the nearest participating Centre to confirm or exclude the diagnosis of CD. IBD specialists were blinded to the results of the questionnaire. The first-line examination systematically included blood cell count, serum C-reactive protein, faecal calprotectin (FC) and abdominal ultrasound, according to routine practice. If required to confirm CD, second-line examinations were planned (i.e. colonoscopy and cross-sectional imaging). Sensitivity (Se), specificity (Sp), positive and negative predictive values (PPV, NPV) of the Red Flags index were estimated. Patients lost to follow-up were included in the analysis by a non-responder imputation assuming they were negative for CD.

Results

From 11/2016 to 11/2019, 64 GPs participated (Bergamo: 52, Pavia: 12, in charge of a population of 93,000 subjects) and 112 patients over a mean number of 53,568 subjects screened were included in the study (median age 35 years, range: 18–69, 37% males). Only 66 subjects (59%) completed the study. The prevalence of CD was 3.6% in the study population (4 of 112 subjects; 3 with B1, and 1 with B2 phenotype). The Red Flags index had Se=0.50 (95% CI: 0.07–0.93), Sp = 0.58 (0.49–0.68), PPV=0.04 (0.01–0.15), and NPV=0.97 (0.89–1.00). A combined diagnostic strategy with faecal calprotectin (in which a subject was considered ‘positive’ if having RFI ≥8 and/or FC >250) resulted in significantly improved diagnostic accuracy: Se=1.00 (0.29–1.00), Sp = 0.72 (0.55–0.85), PPV=0.21 (0.05–0.51), NPV=1.00 (0.88–1.00); however, only 42 subjects (with 3 confirmed cases of CD) were available for this analysis.

Conclusion

The diagnostic accuracy of the Red Flags questionnaire was moderate when applied alone to a primary care setting. However, the combined diagnostic strategy of the Red Flags index and faecal calprotectin has given promising results. Further research is warranted on how to best identify patients with early clinical onset of CD.
P289 Biological therapies and the trajectories of biopsychological factors in inflammatory bowel diseases
Authors: Tavakoli P , Vollmer-Conna U , Vazquez Campos X , Hadzi-Pavlovic D , Grimm M
Published: January 2020

Background

Therapeutic aims in IBDs are to induce remission through rapidly effective treatment. Conventional therapeutic methods including immunosuppression have been available for more than half a century with biological therapies the treatment of choice in patients who fail immunosuppressive drugs. There has been little attempt to longitudinally examine the differences in biopsychological factors and their associations with treatment modalities in IBD patients.

Methods

50 IBD participants (24 UC, 26 CD) in clinical remission were followed for 12 months. Complete longitudinal datasets including demography, disease status (HBI, Mayo score), monthly stool and blood samples for inflammatory biomarkers, monthly validated scores of psychological state, baseline physiological state and autonomic function were collected for analysis of association. Microbiome analysis was performed using V4 16SrRNA for identification of microbial phylogenetic relationships. Patients were grouped on whether or not they were in remission on biological agents.

Results

CD: There was a larger magnitude of change in linear trends of anxiety (p = 0.007) in CD patients on non-biologic treatment. Quality of life (QOL), health-related quality of life (HRQOL) and faecal calprotectin measures were similar regardless of treatment. Longitudinal quadratic trends of CRP were significantly different between the two (p = 0.039) with the larger magnitude of change in non-biologic groups. CD patients had similar microbial profile when compared between two treatment groups. UC: Similar distributions of longitudinal psychological measures were found in two treatment groups, although results suggested significant linear trend (p = 0.019) in QOL scores but not with HRQOL. Faecal calprotectin had significant longitudinal linear trend (p = 0.016) with significant interaction between biologic therapy and this trend (p = 0.023). CRP had significant quadratic trend (p = 0.005) with strong interaction between biologic therapy and this trend (p = 0.009). Microbial α diversity was significantly different between two groups of treatments (Shannon; p = 0.041, evenness; p = 0.045) with biologic group having more diverse and more even microbial community.

Conclusion

Baseline biological and psychological factors were mostly similarly distributed between the two treatment options in remissive IBD patients, however biological therapy significantly influenced longitudinal trends of some psychological, inflammatory and microbiome dynamics, especially in UC. This suggests an underlying interrelationship between mode of treatment and biopsychological trajectories which might overshadow response to the treatment, requiring further assessment.
P299 A prospective randomised trial comparing dye-based chromoendoscopy with electronic virtual chromoendoscopy for detection of colonic neoplastic lesions during IBD surveillance colonoscopy
Authors: González-Bernardo O , Vivas S , de Francisco R , Pérez-Martínez I , Castaño-García A , Jiménez-Beltrán V , Flórez-Díez P , Martínez-González S , Rolle V , Suárez P , Suárez A , Riestra Menéndez S
Published: January 2020

Background

Patients with inflammatory bowel disease (IBD) have an increased risk of colorectal cancer. Dye-based chromoendoscopy (CE) is the currently recommended method for the detection of dysplasia in IBD surveillance colonoscopy; the role of virtual chromoendoscopy (VCE) is not yet well defined. To compare CE with VCE using iSCAN1 digital image enhanced colonoscopy in the detection of colonic neoplastic lesions in IBD patients.

Methods

Randomised, single-centre trial to assess the detection rate of colonic neoplastic lesions in patients with long-standing IBD. Patients were randomised in two arms: dye-spraying CE using indigo carmine and electronic VCE using iSCAN1 digital image. Detection rates of dysplasia or any neoplastic lesion were compared by the two endoscopic techniques.

Results

A total of 129 patients were studied (67 by CE and 62 by VCE). Demographic and clinical characteristics were homogeneous in the two groups; 26 Crohn′s disease and 103 ulcerative colitis, 52% women, mean age 50 years, median duration of IBD 204 months, family history of colorectal cancer in 10 (8%), associated primary sclerosing cholangitis in 8 (6%), personal history of colorectal dysplastic lesions in 12 (9%), and more than 50% colonic involvement in 72 (56%). In total, 27 lesions (9 hyperplastic, 8 adenomatous and 10 low-grade dysplasia) were detected in 23 patients, without differences between CE and VCE arms (15 [22%] and 12 [19%] lesions, respectively; p = 0.98); on the other hand, neoplastic lesion (dysplasia or adenoma) detection rates was similar (12 [18%] in CE and 6 [10%] in VCE arms, p = 0.2). The duration of the withdrawal time of colonoscopy in minutes for patients in the CE group was median 14 min and in the VCE group was median 10 min (p < 0.001).

Conclusion

There is no statistical difference between CE and VCE using iSCAN1 in the detection rate of colonic neoplastic lesions in IBD patients. Surveillance colonoscopy with VCE (iSCAN1) spends less time than conventional CE.
P300 Colectomy and health-related quality life in children with ulcerative colitis
Authors: DIPASQUALE V , Catena M A , Paiano L , Trimarchi G , Romeo C , Navarra G , Mattioli G , Romano C
Published: January 2020

Background

Restorative proctocolectomy and ileal pouch-anal anastomosis (IPAA) is the recommended elective surgery for children with ulcerative colitis (UC). The aim of the present study was to evaluate health outcomes of children with UC and undergone restorative proctocolectomy with IPAA and to compare preoperative and postoperative health-related quality of life (HRQoL).

Methods

We reviewed the hospital records of all paediatric patients who had undergone surgery for UC between January 2009 and December 2016 in the Units of Paediatric Surgery and Gastroenterology of the University Hospitals of Messina and Genoa. Surgical treatment was represented by restorative proctocolectomy and laparoscopic IPAA. Patients and parents were interviewed by telephone before and after surgery, and responded to the modified IMPACT III questionnaire about health outcomes and HRQoL. The final version was made up of 15 closed questions of functional outcomes and HRQoL. All of the issues were grouped into 5 domains, such as gastrointestinal functional aspects (7 questions), school functioning (2 questions), social functioning (3 questions), emotional functioning (3 questions). The questionnaire was scored on a five-point scale with higher scores indicating a better HRQoL. The total score ranged from 35 (worst HRQoL) to 175 (best HRQoL).

Results

Data were obtained in 30 patients (16 males), who underwent surgery after a median post-diagnosis period of 3 years (range 1–4.5), at a median age of 12 (range 3–16). The most common indication for colectomy was acute severe colitis (63%, n = 19). Table 1 shows all the functioning total scores before and after IPAA. HRQoL scores showed a statistically signiﬁcant improvement after IPAA. This difference was observed in all dimensions of HRQoL (symptoms, school attendance, social activities, and emotional functioning). Overall, nearly all were completely satisﬁed with the outcome of colectomy. No operation-related mortality was reported. By the end of the follow-up, one patient developed pouchitis 1 month after colectomy, and responded well to antibiotic therapy.

Conclusion

Our data confirmed that HRQoL is low in children with UC referred for possible operation, and showed that surgical treatment may positively affect the overall HRQoL.
P325 A propensity score-weighted comparison of vedolizumab and adalimumab in Crohn’s disease: Real-life data from the Sicilian Network for inflammatory bowel disease (SN-IBD)
Authors: Macaluso F S , Ventimiglia M , Fries W , Viola A , Sitibondo A , Cappello M , Scrivo B , Busacca A , Privitera A C , Camilleri S , Garufi S , Di Mitri R , Mocciaro F , Belluardo N , Giangreco E , Bertolami C , Renna S , Orlando R , Rizzuto G , Cottone M , Orlando A
Published: January 2020

Background

Currently, there are no randomised controlled trials focussing on direct comparisons between biologics in Crohn’s disease (CD), while there is an unmet need to better understand and compare the effectiveness of these drugs. We performed a multicentre, real-life, comparison of the effectiveness of vedolizumab (VDZ) and adalimumab (ADA) in CD.

Methods

Data of consecutive patients with CD treated with VDZ and ADA from January 2016 to April 2019 were extracted from the cohort of the Sicilian Network for Inflammatory Bowel Disease (SN-IBD). A propensity score analysis was performed using the Inverse Probability of Treatment Weighting (IPTW) method. The effectiveness was evaluated at 12 weeks, 52 weeks, and as treatment persistence at the end of follow-up. The clinical endpoints were steroid-free clinical remission (Harvey–Bradshaw Index < 5 without steroid use) and clinical response (reduction of the Harvey–Bradshaw Index ≥ 3 points with a concomitant decrease of steroid dosage compared with baseline). The sum of the two outcomes was defined as a clinical benefit. The achievement of endoscopic response (a reduction of Simple Endoscopic Score for CD ≥ 50% compared with baseline) or mucosal healing (Simple Endoscopic Score for CD ≤ 2) was assessed after at least 6 months of treatment.

Results

A total of 585 treatments (VDZ: n = 277; ADA: n = 308) were included, with a median follow-up of 56.0 weeks (IQR 24.0–104.0). After 12 weeks, a clinical benefit was achieved in 64.3% patients treated with VDZ and in 83.1% patients treated with ADA (p = 0.11 in propensity score analysis), while at 52 weeks a clinical benefit was observed in 54.0% patients treated with VDZ and in 69.1% patients treated with ADA (p = 0.33 in propensity score analysis). The median treatment persistences for VDZ and ADA were 52 weeks and 64 weeks, respectively. Cox survival analysis weighted for IPTW showed no significant difference in the probability of treatment discontinuation between the two drugs (HR for VDZ=1.20; p = 0.34). Post-treatment endoscopic response and mucosal healing rates were similar between the two drugs (endoscopic response: 35.3% for VDZ and 25.5% for ADA, p = 0.15; mucosal healing: 31.8% for VDZ and 33.8% for ADA, p = 0.85).

Conclusion

This is the first real-life study comparing VDZ and ADA in CD patients via propensity score-adjusted analysis. Even if crude rates of all clinical outcomes were higher for ADA compared with VDZ, such differences were not significant when patients’ characteristics at baseline were weighted by propensity score.
P337 Usefulness of drug-level monitoring in therapeutic guidance in patients with ulcerative colitis on anti-TNF-α maintenance therapy
Authors: Oh E H , A-Ran Y , Ye-Jee K , Jeongseok K , Namseok N , Sang Hyoung P , Dong-Hoon Y , Jeong-Sik B , Seung-Jae M , Suk-Kyun Y , Byong Duk Y
Published: January 2020

Background

While treatment optimisation using therapeutic drug monitoring (TDM) of anti-TNF-α agents has become more common in clinical practices, studies comparing its correlation with clinical remission (CR), biochemical remission (BR) and mucosal healing (MH) in patients with ulcerative colitis (UC) are still lacking

Methods

Trough levels of infliximab/adalimumab (TLIs/TLAs) and levels of antibody to infliximab/adalimumab (ATI/ATA levels) were measured using serum samples collected between August 2017 and September 2019 from patients with UC on anti-TNF-α maintenance therapy. CR, BR and MH were defined as partial Mayo score of 0–1, within normal range of both ESR and serum C-reactive protein (CRP) level, and Mayo endoscopic subscore of 0–1, respectively.

Results

This study included 115 patients (72.8%, 91 [76.5%] on infliximab and 24 [61.5%] on adalimumab) in CR and 43 patients (27.2%) in non-CR. ATI/ATA were positive in 31 (26.1%) and 2 (5.1%) patients on infliximab/adalimumab therapy, respectively. TLI showed significant differences according to stats of CR (2.146 [0.273–4.296] vs. 0.405 [0.001–2.962], p = 0.019), BR (2.843 [0.282–4.835] vs. 0.987 [0.022–2.914], p = 0.007) and MH (2.411 [0.282–4.439] vs. 0.240 [0.001–1.674], p = 0.001), however, TLA didn’t (p = 0.783, 0.893 and 0.853, respectively) (Table 1 and Figure 1). In receiver operating characteristics (ROC) curve analysis, TLI of 2.314 μg/ml was identified as cut-off value discriminating MH (area under ROC 0.705, p = 0.001, sensitivity 0.527, specificity 0.885, negative predictive value [NPV] 0.343, positive predictive value [PPV] 0.942). After excluding 36 patients with MH even though their TLI < 1ug/ml, AUROC increased to 0.931 (p < 0.001, sensitivity 0.860, specificity 0.885, NPV 0.742, PPV 0.942) while cut-off TLI remained same. In incremental graph by ranges of TLI, MH rates showed plateau over 4 μg/ml of TLI. In multivariate logistic regression analysis, extensive colitis (hazard ratio [HR] 0.289, 95% confidence interval [CI] 0.079–1.060, p = 0.061) and TLI (HR 1.282, 95% CI 0.974–1.687, p = 0.076) were marginally associated with MH (Table 2).

Conclusion

In this study, TLIs correlated with CR, BR and MH, while TLAs did not. TLI should be targeted to be above 2.3 μg/ml.
P367 Real-life long-term effectiveness and treatment persistence of vedolizumab in a single tertiary care cohort of Crohn’s disease patients
Authors: Calandrini L , Salice M , Privitera Hrustemovic H , Peruzzi G , Rizzello F , Calabrese C , Scaioli E , Belluzzi A , Gionchetti P
Published: January 2020

Background

Long-term effectiveness of vedolizumab (VDZ) in real-life clinical practice is unknown. We aimed to evaluate clinical efficacy and treatment persistence of VDZ in a real-world cohort of patients with Crohn’s disease (CD).

Methods

CD patients from a single tertiary IBD referral centre receiving VDZ treatment outside clinical trials between September 2016 and August 2019 were included. Data were collected prospectively at baseline, weeks 22, 54, and 108. Disease activity was assessed using the Harvey Bradshaw index (HBI). The primary endpoint was steroid-free clinical remission, defined as HBI of 4 or lower without the need of corticosteroids. Secondary endpoints were treatment persistence and durability of VDZ response.

Results

Up to August 2019 114 patients had received at least one VDZ infusion, 79% had prior anti-TNFα drug exposure. Of the 90 patients who reached 54 weeks of follow-up, 68 patients (75,5%) were still under VDZ therapy. 38 of them (55,9%) were in steroid-free clinical remission. We compared the initial response to VDZ at week 22 and at week 54. Among the 29 patients in steroid-free clinical remission at week 22, 25 (86.2%) were still in steroid-free clinical remission at week 54. Three out of 29 patients discontinued VDZ therapy before week 54, for insufficient response and adverse events in two cases and for pregnancy in one. Of the 34 patients who reached 108 weeks of follow-up, 17 (50%) were still under VDZ therapy. 11 of them (64.7%) were in steroid-free clinical remission. We compared the initial response to VDZ at week 22 and at week 108. Among the 11 patients in steroid-free clinical remission at week 22, 6 (54.5%) were still in steroid-free clinical remission at week 108. Two out of 11 patients discontinued VDZ therapy before week 108 for worsening of perianal disease.

Conclusion

After 1 year, 75.5% of patients were still on treatment, of whom more than 55% achieved remission. 86% of patients maintained a response after the first year of treatment. After 2 years the rate of patients who presented with steroid-free clinical remission and who maintained response tended to decrease, consistent with previously published data. However, half of the patients persisted with VDZ treatment. These data support the long-term effectiveness and favourable safety profile of VDZ.
P399 Endoscopic and histologic outcome in tofacitinib treated refractory moderate-to-severe ulcerative colitis: A prospective real-life cohort
Authors: Verstockt B , Outtier A , Lefrère J , Sabino J , Vermeire S , De Hertogh G , Ferrante M
Published: January 2020

Background

The pan-Janus kinase inhibitor tofacitinib (TFC) has recently been approved for treatment moderate-to-severe ulcerative colitis (UC). Real-life data are limited, especially on endoscopic and histologic outcome. We report the efficacy and safety of TFC in refractory UC patients, and assessed potential clinical predictors of response.

Methods

Thirty-five UC patients, all refractory to anti-TNF and vedolizumab, were prospectively included (Table 1). All received TFC 10mg BID till week 8, and were endoscopically assessed at baseline (Mayo endoscopic sub-score ≥2) and week 8. Biological response was defined as a 50% decrease in faecal calprotectin (fCal) or fCal <250 mg/g, and biological remission as a fCal <250 mg/g at week 8. The endoscopic response was defined as Mayo endoscopic sub-score of ≤1, endoscopic remission as a sub-score of 0. Histologic remission was defined as a numeric Geboes score ≤6 (similar to ≤2A.0). A non-response imputation and last observation carried forward analysis was applied.

Results

The Mayo endoscopic sub-score decreased significantly by week 8 (p = 0.004), resulting in an endoscopic response and remission rate of 22.9% and 17.2% respectively. Histological remission was seen in 14.8% of patients. Faecal calprotectin decreased from 1386 mg/g down to 568 mg/g by week 4 (p = 0.03) (Table 2), but not further down by week 8 (703 mg/g, p = 0.5) with a biological response and remission rate of 52.9% and 38.2%. Half of the patients with a PNR to one anti-TNF (10 out of 20) did discontinue TFC because of PNR. However, PNR to two anti-TNF agents almost exclusively (4 out of 5) resulted in PNR to TFC. In contrast, only 3 out of 8 vedolizumab PNR experienced PNR to TFC. Ultimately, 48.6% of all included patients discontinued TFC therapy after a median of 15.9 [12.4–26.6] weeks, all but one due to PNR, of whom 9/17 (52.9%) required colectomy. In multivariate analysis, a higher baseline albumin and a lower Mayo endoscopic sub-score were independent predictors of endoscopic (OR 1.06, p = 0.02; OR 0.59, p = 0.003) and biological remission (OR 1.06, p = 0.03; OR 0.57, p = 0.01). By week 8, creatinine kinase significantly increased (p = 0.001), whereas the lipid profile was not significantly affected. One patient suffered from vaginal herpes infection, and one patient treated with TFC and high dose steroids developed disseminated nocardia, pneumocystic jiroveci, cutaneous zoster and varicella pneumoniae.

Conclusion

TFC can induce biologic, endoscopic and histologic remission in refractory UC, though clinical and predictive molecular markers are required to identify the right patients. In patients with prior PNR to 2 anti-TNF agents, TFC does not seem an alternative treatment strategy.
P401 Sarcopenia in children and young adults with primary sclerosing cholangitis and IBD
Authors: Shteyer E , Cytter-Kuint R , Winberg L
Published: January 2020

Background

Malnutrition is common in children with inflammatory bowel disease (IBD) and in liver diseases. The nutritional status can be assessed by evaluating for sarcopenia, which is described as the loss of muscle mass and/or strength that are reflected by decreased psoas muscle surface area (PMSA). Accumulating data shows association of PSMA with chronic diseases, however, literature regarding sarcopenia in children is still limited. The aim of this study is to assess sarcopenia in children and young adults with sclerosing cholangitis (PSC) with or without IBD.

Methods

Retrospective analysis of patients below 25 years of age diagnosed with PSC between the years 2010–2018 was done. Patients who performed magnetic resonance imaging (MRI) were included in the study. Detailed clinical, anthropometric, laboratory and imaging findings were recorded. The control group was comprised of children who underwent MRI due to suspected scoliosis or kidney structural anomalies and had normal study. PMSA was determined at intervertebral disc L3.

Results

Sixty-five patients were included in the study. Twenty with PSC with a mean age of 15.2 ± 5 years, 12 were female and 9 had IBD. The control group comprised of 45 healthy subjects with no significant difference in age, gender and BMI from the study group. There was no significant difference in PMSA between groups. However, PMSA significantly correlated with aspartate transaminase (AST) and Platelet Ratio Index (APRI) score (marker for hepatic fibrosis, r = −0.49, p = 0.02). Additionally, PMSA was significantly higher in patients who had both PSC and IBD (475.61 ± 136 vs. 789 ± 328, p = 0.01).

Conclusion

Children and young adults with concomitant PSC and IBD were in a better nutritional status in comparison to patients with PSC alone, as evidenced by a lesser degree of sarcopenia. Additionally, sarcopenia correlates to the degree of liver fibrosis assessed by APRI score. Further larger studies are warranted in order to corroborate the importance of sarcopenia in patients with PSC.
P410 Could the disease become ‘a friend’? The mediating role of illness acceptance on self-efficacy and quality of life of gastroenterological patients
Authors: Rudnik A , Piotrowicz G , Rydzewska G , Bidzan M , Ozgo E
Published: January 2020

Background

Irritable bowel syndrome (IBS) and inflammatory bowel diseases (IBD), such as ulcerative colitis (UC) and Crohn’s disease (CD) are chronic conditions characterised by severe intestinal symptoms and other general symptoms, which impede daily functioning and affect the quality of life of patients. Understanding the significance of psychological factors in the disease development and therapy can improve the satisfaction with life of gastroenterological patients. The aim of the study was to analyse the impact of accepting the disease on the relation between an important personal resource, which is one’s self-efficacy and both satisfaction with life and components of the quality of life.

Methods

The study group consisted of 104 patients (N = 104), 58 women and 46 men suffering from IBS (35), UC (33) or CD (36). The average age equalled 32.56 years (SD = 11.04). The average duration of the disease was 8.5 years (SD = 6.9). The following research methods were used: the Generalised Self Efficacy Scale GSES (Schwarzer, Jerusalem, Juczynski), the Acceptance of Illness Scale AIS (Felton, Revenson, Hinrichsen, Polish adapt. by Juczynski), the Quality of Life SF-36v2 Questionnaire—the Polish version, the Satisfaction with Life Scale SWLS (Diener, Emmons, Larson, Griffin, Polish adapt. by Juczynski) and the author’s own questionnaire to collect the demographic data.

Results

The data were analysed using the independent sample t-test, chi-square test, Pearson correlation, regression analysis and mediation analysis. The study did not prove that the disease diagnosis (IBS, UC or CD) differed the level of satisfaction with life or the level of quality of life. Participants with IBS demonstrated a higher level of illness acceptance in comparison to IBD patients (p = 0.028). A strong positive correlation (p < 0.01) was observed between generalised self-efficacy and satisfaction with life—SWL (r = 0.37) and components of quality of life: lower perceived bodily pain—BP (r = 0.20), social role functioning—SF (r = 0.29) and mental health—MH (r = 0.35). Results pointed out that acceptance of illness mediated the relationship between generalised self-efficacy and SWL, BP, SF, and MH (β = 0.38 95% CI: 0.16–0.59; β = 0.25 95% CI: 0.004–0.73; β = 1.23 95% CI: 0.20–2.25; β = 1.18 95% CI: 0.46–1.90).

Conclusion

Psychological factor as acceptance of illness can be considered to be a resource which helps to cope with challenges posed by gastrointestinal disorders. Therefore, it is so significant to increase its level by applying psychotherapeutic methods tailored to the age and the needs of a patient.
P471 What is the appropriate cut-off value of CRP to predict endoscopic remission in ulcerative colitis patients with clinical remission?
Authors: Shin J , Seong G , Song J H , Kong S M , Kim T J , Kim E R , Hong S N , Chang D K , Kim Y H
Published: January 2020

Background

A noninvasive and reliable markers for predicting endoscopic remission (ER) in ulcerative colitis (UC) patients with clinical remission (CR) provide important information in predicting disease progression and in determining treatment. Faecal calprotectin test is known to be the most accurate to predict ER, but patients are reluctant to handle faecal materials. C-reactive protein (CRP) is one of the surrogate markers for assessing disease activity, but it is known to have low sensitivity and specificity of normal CRP value (<0.3 mg/dl). The sensitivity of the CRP test has been improved, and even fine values within the normal range can be measured. The aim of this study was to determine appropriate CRP cut-off values for the prediction of ER in UC patients with CR even though within normal CRP range.

Methods

A total of 132 UC patients who underwent endoscopic evaluation in CR were retrospectively reviewed. Serum biomarkers including haemoglobin, leukocytes, platelets, erythrocyte sedimentation rate, and CRP were evaluated within 1 week period from endoscopic evaluation. The clinical and endoscopic activity was measured by simple clinical colitis activity index and endoscopic Mayo subscore.

Results

In UC patient with CR, CRP level was significantly lower in ER (median 0.05, 0.03–2.57) vs. non-ER (median 0.11 0.03-2.81). (p < 0.005) The proportion of males in non-ER was slightly higher than in ER (24, 72.7% vs. 52, 52.5 %; p = 0.042), and only gender and CRP showed statistical differences in baseline clinical characteristics. CRP had predictive value of ER [Area under the curve (AUC = 0.760)] and the sensitivity was 71.4%, specificity was 71.7 % at cut-off value of 0.09mg/dl. In contrast, the sensitivity and specificity of normal CRP (0.3mg/dl) were low. (sensitivity 27.3%, specificity 90.9%).

Conclusion

Norma CRP cut-off values are not sufficient to reflect ER. It may be helpful to change the CRP cut-off value that predicts ER in CR to value other than 0.3 mg/dl.
P517 A randomised, placebo-controlled pilot trial of faecal microbiota transplantation for paediatric Crohn’s disease
Authors: Hill L , Popov J , Hartung E , Moshkovich M , Figueiredo M , Pai N
Published: January 2020

Background

The role of faecal microbiota transplant (FMT) in Crohn’s disease (CD) remains unclear. Small, open-label case series have shown high rates of clinical remission but protocols have varied across studies, and no randomised controlled trials (RCT) have been performed. We present a protocol for the first pilot RCT of FMT in paediatric CD patients, using a novel colonoscopic + oral capsular intervention that uses fresh-frozen and prepared, lyophilised donor stool. We will measure improvements in clinical disease activity, inflammatory biomarkers, endoscopic markers of mucosal inflammation, as well as, assess key aspects of trial feasibility.

Methods

Patients 3–17 years with active CD, on stable medication doses for 4 weeks are eligible. Patients will have an initial colonoscopy during which they will receive an infusion into the terminal ileum of normal saline (placebo) or prepared healthy donor stool (RBX2660; Rebiotix, USA) (active). This will be followed by 6-weeks of bi-weekly oral capsular therapy, containing methylcellulose (placebo) or lyophilised healthy adult donor stool (RBX7455; Rebiotix, USA). Randomisation is 2:1 to active and placebo arms (n = 45). Patients will be followed over 24 weeks. (Figure 1)

Results

Study feasibility will be assessed by: rate of recruitment, completion of sample collections, and frequency and type of adverse events. Clinical outcomes will be measured serially using: Paediatric Crohn’s Disease Activity Index (PCDAI), faecal calprotectin, blood inflammatory markers, and Simple Endoscopic Score for Crohn’s Disease (SES-CD) at baseline and end-of-study. Stool 16s rRNA, metagenomics, and urine metabolomics profiles will be performed on collected stool and urine samples. Patients who complete the placebo arm will be eligible to enter an open-label extension study.

Results will be measured through ITT and PP analyses. Proportions and percentages will be reported on feasibility outcomes; odds ratios, mean differences and 95% confidence intervals will be reported on clinical outcomes as preliminary estimates of efficacy.

Conclusion

This is the first pilot RCT of FMT in the treatment of CD. Recruitment commenced April 2019 and 13 patients have met screening criteria, with 5 enrolled thus far. This study is novel for its focus on paediatric CD patients, and its use of a combined oral + colonoscopic FMT delivery method. The results of this trial will offer preliminary estimates of efficacy for FMT-based therapies in CD, and may support expansion to a future larger multicenter paediatric RCT using our validated study protocol.
P543 UC remission mucosa displays upregulated inflammatory mediators
Authors: Arkteg C , Goll R , Dixon Gundersen M , Anderssen E , Fenton C G , Florholmen J
Published: January 2020

Background

Ulcerative colitis (UC) is a chronic inflammatory bowel disease. In UC, a wide range of criteria is used for disease remission, with few studies investigating the differences between disease remission and normal control groups. This paper compares known inflammatory and healing mediators in the mucosa of UC in clinical remission and normal controls, in order to better describe the remission state and the fundamental pathology

Methods

Mucosal biopsies from 72 study participants (44 UC and 24 normal controls) were included from the Advanced Study of inflammatory bowel disease (ASIB Study), Arctic University of Norway, Norway. Clinical remission was defined as Mayo clinical score ≤ 2, with endoscopic subscores of ≤ 1. Targeted gene transcription analyses were performed by quantitative polymerase chain reaction (qPCR) and using hydrolysis probes and SYBR-green.

Results

Among the mucosal transcripts examined, 10 genes were regulated in remission vs. normal controls, 8 upregulated pro-inflammatory transcripts (IL1B, IL33, TNF, TRAF1, CLDN2, STAT1, STAT3 and IL13Ra2) and 2 downregulated (pro-inflammatory TBX21 and anti-inflammatory TGFB1). Between the active and normal group, 5 additional genes were differently regulated CASP8, ADAM17, DFB1 and TFF3 were up-regulated while CHUK was down-regulated. Several master transcription factors for T-cell development (TBX21, GATA3, FOXP3, RORC and SPI1) and important inflammatory mediators (IL33, IL6, TGFB, IL10 and TLR4) were upregulated in patients with Mayo endoscopic score of 1 in comparison to 0.

Conclusion

The mucosa of UC in clinical and endoscopic remission differs from normal mucosa, suggesting a remaining dysregulation of inflammatory and wound healing mechanisms. In addition, there is a significant expression difference between mayo endoscopic score of 1 and 0. This difference indicates that t-cell differentiation is still ongoing in the Mayo endoscopic subscore (MES) of 1. Interestingly, TNF did not differ between MES 0 and 1 suggesting an alternative inflammatory pathway in low-grade UC inflammation.
P642 Serum adalimumab levels measured between days 9 and 13 from drug injection can be interpreted clinically in a similar way to trough levels in patients with inflammatory bowel disease
Authors: Guardiola Capón J , Serra K , Rodríguez-Alonso L , Santacana E , Padullés N , Ruiz-Cerulla A , Arajol C , Camps B , Surís G , Sanchez E , Rodríguez-Moranta F
Published: January 2020

Background

AntiTNF therapeutic drug monitoring is currently performed at trough, immediately before drug administration. However, in clinical practice when subcutaneous medications are used, blood extractions often do not coincide with that moment. The aim of this study was to know if adalimumab levels measured between injections are sufficiently similar to trough levels to be used in clinical practice in a similar way.

Methods

295 adalimumab level determinations performed at different time points of 99 injection cycles in 55 patients with inflammatory bowel disease (IBD) were included in the study. 51 patients received 40mg every 2 weeks and 4 patients received 80mg every 2 weeks.

Results

Median adalimumab levels (IQR) at trough, between days 1–4, 5–8 and 9–13 were 10.6 (6–12), 12.3 (7–18), 13 (7–19) and 10.8 (8–12), respectively. The median differences between trough level and days 1–4, 5–8 and 9–13 were 1.7 (IC 95% 1–2.3) (p < 0.001), 2.3 (IC 95% 1.5–3.1) (p < 0.001), 0.6 (IC 95% –0.2–1.3) (p = 0.13), respectively.

Conclusion

Adalimumab levels between days 9 and 13 from drug injection are very similar to trough level and could be interpreted clinically at the same way. Adalimumab levels between days 1 and 8 are significantly higher, although, differences are small.
P692 Exploring relationships between microbiome, faecal calprotectin and healthy eating index in patients with ulcerative colitis: Interim analyses of a randomised controlled trial
Authors: Raman M , Taylor L , Schick A , Ohland C , McCoy K , Kaur S , Panaccione R , Reimer R
Published: January 2020

Background

This study explored relationships between gut microbiome, faecal calprotectin (FCP) and an adapted Canadian healthy eating index (CHEI) in ulcerative colitis (UC) patients enrolled in a randomised controlled dietary intervention trial.

Methods

Patients with both active and quiescent disease were recruited from the Foothills Medical Center in Calgary, Alberta, Canada and randomised to either an 8-week reduced sulfur anti-inflammatory diet intervention (INT; n = 14) or conventional management control group (CM; n = 10). Each INT patient met with a registered dietitian for diet teaching, in person at baseline, over the phone at 2 weeks, and in person at 4 weeks. Stool samples and 24-h dietary recalls were collected at baseline and 8 weeks. DNA from stool samples was extracted and the V4 region of the 16S gene was sequenced. FCP was extracted and analyzed using the EK-CAL ELISA. An adapted CHEI was generated from diet recalls using previously validated scoring guidelines. Relationships between variables were analyzed using analysis of variance and chi-squared.

Results

Mean age of the sample was 36.3 (SD=8.7) and 58% were male. Baseline medications included aminosalicylates (71%), steroids (50%), biologics (33%), immunosuppressants (25%) and 21% of patients had taken antibiotics within the last 3 months. Α-diversity, or within-community diversity, significantly increased in the CM group and remained stable in the INT group over time (p = 0.005). Β-diversity, or between-community diversity appeared to increase in the intervention group over time (p < 0.01); however, this may have been influenced by antibiotic use in five patients. Significant differential features between the CM and INT groups (p < 0.01) at the genus level were identified in the phyla Firmicutes and Proteobacteria, specifically Catenibacterium, Parvimonas, Coprococcus_2 and Desulfovibrio. FCP appeared to be different between the groups (p = 0.05) with a greater percentage of INT patients moving from high FCP (>250 mg/g) to low FCP (<250 mg/g); 50% of INT patients and 20% of CM patients normalised FCP levels. As CHEI increased in the whole sample, indicating higher diet quality, FCP decreased significantly (p = 0.04).

Conclusion

In an interim analysis, a dietary intervention shows efficacy in manipulating the microbiome. Higher diet scores representing a healthier diet were also related to lower faecal calprotectin levels.
P695 Vedolizumab induction and maintenance though levels and long-term clinical and biochemical status in inflammatory bowel disease
Authors: Gutiérrez Casbas A , Sempere Robles L , Muñoz Pérez R , Rodríguez Angulo A , Climent S , Cameo Lorenzo J I , Díaz M , Boada P , Más-Serrano P
Published: January 2020

Background

Therapeutic drug monitoring (TDM) postinduction of vedolizumab (VDZ) could have relationship with long-term outcome of inflammatory bowel disease (IBD) patients. However, clinical utility of TDM during maintenance VDZ therapy remains unclear. To examine the association of induction and maintenance vedolizumab though levels (VTL) with clinical and biochemical long-term outcome in IBD patients.

Methods

We performed a retrospective cohort study, including all consecutive IBD patients of our centre on VDZ treatment who had VTL and anti-vedolizumab antibodies (AVA) measured during induction and maintenance therapy. All patients had received a minimum of 6 weeks therapy following standard induction (0, 2, 6 ± 10 week dosing. Clinical response and remission were defined by Partial Mayo Score (PMS, UC) or Harvey Bradshaw Index (HBI, CD) and were assessed at week 52.Biochemical remission was defined as CRP < 0.5 g/dl and faecal biomarker remission as faecal calprotectin (FC) < 250 µg/g. Measurement of VTL and AVA was performed by ELISA assays(Vedolizumab-TheraDiag(R) with a detection limit for VTL of 2 μg/ml and measurement range of 2–60 μg/ml.

Results

In total, 34 patients were included (55.9% UC; 44.1% CD, 50% women). Median age was 52.76(17–83) and mean disease duration was 8 ± 7.2 years. Median baseline HBI was 6(0–12) and PMS was 5(3–7). FC and CRP measured before first dose of VDZ were 1425 ± 1189 μg/g and 2.1 ± 2.4 mg/dl. A total of 14 patients (41.2%) were naïve for biologic therapy. Only three patients (8.8%) were receiving a concomitant immunomodulator. Clinical response to induction phase was reported in 76%. Clinical remission, clinical response, biochemical remission and faecal biomarker remission were present in 30% (9/29), 41.4% (12/29), 40.9% (9/22) and 35% (7/20), respectively, at week 52. Thirteen patients (13/26, 50%) needed dose escalation at week 52. Twenty-six patients (78.8%) were persistent in VDZ therapy at the end of the study. The median level of VDZ at weeks 6 and 24 were 16.13 ± 7.06 μg/ml and 9.6 ± 6.7 μg/ml. Comparing patients with and without clinical response or remission to VDZ at week 52 no significant difference in VTL was found at Week 6 (16.27 vs. 15.46 μg/ml, p = 0.8) and week 24 (7.6 vs. 12.7 μg/ml, p = 0.1). No difference was observed in VTL in patients in biochemical remission (week 6: 23.6 vs. 15.7 μg/ml, p = 0.2; week 24: 10.3 vs. 10.2 μg/ml, p = 0.9) or with faecal biomarker remission (week 6: week 6: 25.5 vs. 16.2 μg/ml, p = 0.1; week 24: 10.7 vs. 8.2 μg/ml, p = 0.6) at week 52. No patient developed antibodies.

Conclusion

In this real-world study of IBD patients receiving VDZ, early induction or maintenance VTL are not associated with long-term outcome.
P733 The influence of concomitant familial Mediterranean fewer on Crohn’s disease course: Data from an FMF endemic area
Authors: Yuksel I , Kilincalp S , Coskun Y , Akinci H , Hamamci M
Published: January 2020

Background

Crohn’s disease (CD) and Familial Mediterranean fever (FMF) are both inflammatory disorders characterised by recurrent abdominal pain and fever attacks. Mutations of Mediterranean (MEFV) gene appear to be associated with stricturing behaviour and extraintestinal manifestations of CD. Further clinical studies regarding progression of CD in coexistence with FMF is still required. The aim of this study was to evaluate the influence of concomitant FMF in CD patients on the course of the CD in FMF endemic area.

Methods

Total 210 adult patients who had diagnosed with CD with or without FMF between November 2006 and April 2019 were respectively examined. FMF diagnoses were based on Tel-Hashomer criteria. The Montreal classification was used to define location and behaviour of CD. CD patients were divided into two groups FMF positive and FMF negative. Severity of CD was assessed by the need for hospitalisation related to CD, whether biological therapy was received and/or whether surgery was undergone due to CD. All demographic features, MEFV mutations, location/behaviour of disease, and extraintestinal manifestations were analysed retrospectively.

Results

In the present study, 8 (3.8%) of the total 210 CD patients have concomitant FMF. Mean follow-up time in CD-FMF was 59.55 months and CD-non-FMF was 60.98 months. CD patients with or without FMF showed similar demographic features including age, sex, smoking behaviour, disease location, behaviour, and treatment regimen in maintenance of the remission. Regarding extraintestinal manifestations, only peripheral arthritis was found significantly higher in CD-FMF patients (n = 3, 37.5%) compared CD-non-FMF patients (n = 21, 10.4%). In the CD-FMF patients, a result of MEFV mutation gene analysis was found in medical records 6 patients. Of those, 2 had homozygote MEFV mutation, 2 had heterozygote MEFV mutation and 2 without any MEFV mutations. In CD-FMF group, percentage of patients on biological therapy (n = 4, 50%) was significantly higher than CD-non FMF group (n = 24, 11.9%) (p = 0.012). Steroid dependence and hospitalisation in CD-FMF (n = 3, 37.5% and n = 5, 62.5%) group were relatively higher than CD-non-FMF (n = 83, 41.1%) group, but not statistically significant. The percentage of CD-FMF patients who underwent intestinal surgery (n = 1, 12.5%) was similar to that of CD-non-FMF (n = 33, 16.3%).

Conclusion

In the current study, the prevalence of FMF in CD patients was detected 3.8% in FMF endemic area. The group of patients on biological therapy in CD-FMF patients was significantly higher than CD-non-FMF patients. Frequency of hospitalisation in CD-FMF patients was relatively higher than CD-non-FMF patients. Our findings indicate that concomitant FMF in CD patients may have a negative effect on the course of CD.