bluuebunny/crossref_metadata_2025 huggingface dataset:
P108 The importance of developing consensus-driven clinical data standards for Crohn’s disease to amplify data
Authors: Owen J , Baker R
Published: January 2020

Background

When CDISC standards are applied, data is collected, organised and analysed in a clear and consistent manner so that all researchers can leverage and share information from individuals and studies around the world. Required by the USA Food and Drug Administration (FDA) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) and adopted by the world’s leading research organisations, CDISC standards enable the accessibility, interoperability, and reusability of data. Adopting CDISC standards is an invaluable investment that leads to more meaningful, more efficient research for your organisation and the entire global research community.

Methods

With support from The Leona M. and Harry B. Helmsley Charitable Trust and following the CDISC consensus-based standards development process, a team of Crohn’s disease and standards development experts was created to develop clinical data standards for Crohn’s disease. The CDISC standards development process consists of five stages:

Results

The project scoping stage completed in July 2019. The scoping team, consisting of Crohn’s disease clinical SMEs, identified the following topics that would most benefit from development of clinical data standards and to move into the concept modelling and standards development phases of the project:

Package 1

Package 2 Endoscopy assessments

The first package of data standards for Crohn’s disease will be available for Public Review in July 2020 and is anticipated to be published in Q1 2021 for use by researchers and industry. The second package of data standards will be available for Public Review in Q3 2020 with publication in Q2 2021.

Conclusion

CDISC’s vision is to encourage the global adoption of standards to leverage and realise the full potential of data and produce faster, more efficient research, paving the way for more breakthroughs in Crohn’s disease treatments, therapies and cures. ECCO attendees and the Crohn’s disease community are encouraged to participate in CDISC’s informational webinars and Public Review stages to foster all-inclusive development, approval and adoption of the data standards.
P120 Prevalence of endoscopic improvement and endoscopic remission according to patient reported outcomes in ulcerative colitis
Authors: Dulai P , Singh S , Jairath V , Ma C , Narula N , Vande Casteele N , Peyrin-Biroulet L , Vermeire S , D’Haens G , Feagan B , Sandborn W
Published: January 2020

Background

We aimed to quantify the prevalence of endoscopic improvement (EI) and remission (ER) amongst ulcerative colitis patients with various permutations of patient reported outcomes (PRO) following treatment with biologic agents or tofacitinib.

Methods

Individual participant data from active intervention and placebo arms of clinical trials of infliximab, golimumab, vedolizumab, and tofacitinib were pooled to estimate the prevalence of EI (Mayo endoscopic sub-score [MES] 0 or 1) and ER (MES 0) scores with various permutations of the rectal bleeding sub-score (RBS) and stool frequency sub-score (SFS) of the Mayo score, following induction (6–8 weeks) and maintenance (30–54 weeks) therapy. Subgroup analyses were performed by year of publication and centrally read endoscopy scoring.

Results

Data from 2586 trial participants were analysed. Using locally scored endoscopy, the prevalence of EI and ER was highest among participants with a RBS 0 + SFS 0 post induction (EI: 81%, [95% CI 78–84]; ER: 29% [26–33]) and during maintenance (EI: 91% [87–93]; ER: 57% [52–62]). Prevalence estimates were lower for more recently performed trials (p < 0.01). In comparison to locally scored endoscopy, when using central endoscopy scoring the prevalence of EI and ER were lower post-induction (EI 57% [50–64], p < 0.001; ER 15% [11–21], p = 0.09) and during maintenance (EI 74% [67–81], p = 0.001; ER 31% [24–38], p = 0.001) for participants achieving a RBS 0 + SFS 0.

Conclusion

Approximately eight out of 10 patients with normalisation of rectal bleeding and stool frequency have improvement in endoscopic disease activity, whereas approximately only half of these patients have endoscopic remission.
P125 Histological activity as a predictor of clinical outcome in ulcerative colitis: a 1-year prospective study
Authors: Neri B , Romeo S , Ruffa A , Calabrese E , Sena G , Grasso E , Zorzi F , Palmieri G , Soldati S , Biancone L
Published: January 2020

Background

The role of histological activity in clinical management of ulcerative colitis (UC) is under investigation. Primary aim was, in a prospective study, to assess the role of histological activity as predictor of clinical relapse in a cohort of UC patients (patients) undergoing colonoscopy and followed-up for 1 year. Secondary aim was to assess the correlation between clinical, endoscopic and histological activity scores.

Methods

From February 2016 to February 2017 consecutive UC patients with clinical indication for colonoscopy were enrolled and clinically followed-up for 1 year. Inclusion criteria: (1) UC diagnosis; (2) Age > 18, ≤ 80 years; (3) regular follow-up; (4) indication for colonoscopy. During colonoscopy ≥2 biopsies was taken from ≥1 macroscopically involved and, possibly, from ≥1 uninvolved area. The day of colonoscopy clinical activity was assessed by the Mayo partial score, endoscopic activity by the Mayo endoscopic score, histological activity by the Geboes Simplified Score (GSS). Scores blindly assessed by three investigators. Statistical analysis: data expressed as mean [range], Spearman’s correlation coefficients, Cox hazards regression model used for univariate and multivariate analyses to identify predictors of clinical relapse at 1 year (HR[95% CI]).

Results

UC cohort included 77 UC patients. Characteristics of these 77 UC patients: 43 (55.8%) males, age 51 [24–80]; UC duration 14.7 [1–48] years. UC extent included n (%): 33 (42.8%) pancolitis, 24 (31.2%) left-sided, 20 (26%) proctitis. The day of colonoscopy, UC was clinically active in 15 (19.4%), inactive in 62 (80.6%) patients. Endoscopic activity was observed in 39 (50.6%) patients, histological activity (GSS≥ 3.1) in 37(48%) patients. Moderate correlations were observed between clinical and endoscopic scores (r = 0.439;p < 0.0001) clinical and histological scores (r = 0.32;p = 0.0045), endoscopic and histological scores (r = 0.653;p < 0.0001). During the clinical follow-up at 1 year, UC clinical relapse occurred in 24 (31%) patients, while 53 (69%) patients maintained clinical remission. At baseline colonoscopy, 11/24 (46%) UC patients were clinically active, 15/24 (63%) showed endoscopic activity and 16/24 (67%) patients histological activity. Univariate analysis identified clinical activity (HR 4.82 [2.15–10.82]; p < 0.001) and histological activity (HR 2.599 [1.11–6.08]; p < 0.027) as significant predictive factors for clinical relapse at 1 year. Multivariate model confirmed histological activity as predictive marker of clinical relapse (HR 2.44 [1.04–5.75]; p < 0.041).

Conclusion

Histological activity provided independent information for clinical relapse in a cohort of UC patients prospectively followed up for 1 year. Histological activity had a significant correlation with the endoscopic and clinical activity scores.
P126 The Urgency Numeric Rating Scale (NRS): a novel patient-reported outcome measure to assess bowel urgency in adult patients with ulcerative colitis
Authors: Dubinsky M C , Naegeli DrPH, MPH A , Dong Y , Lissoos T , Arora V , Irving P
Published: January 2020

Background

Ulcerative colitis (UC) is a chronic disease characterised by inflammation of the rectum and colon. Bowel urgency, the sudden need for a bowel movement, is one of the most bothersome and important symptoms of UC. Treatment goals in UC focus on restoration of normal bowel frequency, control of primary symptoms of bleeding and urgency, and resolution of inflammation. The Urgency Numeric Rating Scale (NRS) is a newly developed patient-reported measure to assess the severity of the urgency to have a bowel movement in adult patients with UC.

Methods

Development of the Urgency NRS was informed through semi-structured concept elicitation and cognitive debriefing interviews. The scale asks patients to report on the immediacy status of their UC symptom over the past 24 h on an 11-point horizontal NRS anchored at 0 (No urgency) and 10 (Worst possible urgency), with higher scores indicating worse urgency severity (i.e. immediacy of need to have a bowel movement). A 2-week daily diary pilot study was conducted to assess floor and ceiling effects, test–retest reliability and construct validity. Weekly average scores were calculated as mean score over each 7-day period. A bootstrapping simulation was used to assess test–retest with intraclass correlation coefficient (ICC) [≥0.70 = substantial agreement] between week 1 and week 2 scores. Content validity was assessed by Pearson and Spearman correlation with stool frequency (SF) and patient global rating of severity (PGR-S) scores using Cohen’s conventions [r ≥ 0.5 = large; 0.3 to ≤0.5 = moderate] using week 1 scores.

Results

Through qualitative interviews, 16 adult UC patients (mean age 37.9 ± 11.6 years; 50% female; 56% White) confirmed relevance, item content and comprehensiveness of the Urgency NRS. Forty-one adult UC patients (mean age 44.2 ± 14.6 years; 51% female; 56% White) completed the 2-week study. Item distributions were uniform, with no ceiling or floor effects for the Urgency NRS (Figure 1). Test–retest reliability was high (ICC = 0.877), with simulated 95% confidence intervals ranging from 0.770 to 0.947. There was a high correlation between average urgency NRS and PGR-S scores, and a moderate correlation was observed between average Urgency NRS and number of stools in the first week (Table 1).

Conclusion

Bowel urgency is an important symptom of UC, distinct from bowel frequency and rectal bleeding. The urgency NRS is a well-defined, content-valid and reliable measurement of bowel urgency that may be used to help characterise disease activity in adult patients with UC.
P130 Faecal calprotectin is a reliable tool to assess endoscopic activity in ulcerative colitis except for short-extent proctitis
Authors: Collin R , Minet-Quinard R , Blayac L , Manlay L , Pereira B , Buisson A
Published: January 2020

Background

Faecal calprotectin (Fcal) is now considered a reliablebiomarker of endoscopic inflammatory activity in patients with ulcerative colitis (UC). However, this biomarker remains imperfect with some false negative in some clinical situations. We aimed to search for endoscopic factors associated with faecal calprotectin level in patients with UC and to identify situations in which this tool might be less efficient.

Methods

From a database collecting consecutively all the patients with IBD with at least one Fcal dosage in our centre between June 2016 and June 2018, we included all patients who had an endoscopic evaluation within the month before or after dosing without intervention therapeutic during this interval. Fcal level was measured by immuno-chemiluminescence in all patients.

Results

One hundred and thirty-four patients were included (E1 in 12 patients (9.0%), E2 in 69 patients (51.5%) and E3 in 53 of them (39.5%)). There was a significant correlation between the UCEIS score and Fcal level (r = 0.55, p > 0.001). Fcal level was significantly associated with endoscopic Mayo score with higher values in severe cases (Mayo 0: 32 [15.5–75.3], Mayo 1: 119 [48.0–634.0], Mayo 2: 773 [150.8–1965.0] and Mayo 3: 1200 [572.0–3717.5] μg/g; p < 0.01 for all comparisons). Using an ROC curve, we have defined the best CF thresholds to define an endoscopic Mayo> 1. The performances are presented in the Table 1.

In the same way, 100 μg/g was the best Fcal threshold to define a remission endoscopic (endoscopic Mayo score = 0): sensitivity = 79.3% [66.6%–86.3%], specificity = 88.9% [65.3%–98.6%], PPV = 97.9% [92.5%–99.7%], VPN = 40% [24.9%–56.7%]. In multivariate analysis, endoscopic factors associated with the values of CF are: the UCEIS sub-score – vascular pattern (p = 0.001), the UCEIS sub-score – ulcerations (p = 0.013) and the extent of the disease (p = 0.009). CF level in patients with endoscopic Mayo 0 or 1 is lower in the case of low proctitis (<5 cm) than in the case of more extensive RCH (45.5 [19.5–90.5] vs. 214.5 [71.5–730], p < 0.001). While the values of CF were significantly correlated with UCEIS score in patients with proctitis >5 cm (ρ = 0.3665, p < 0.001), they were not low rectal (<5 cm) (ρ = 0.1571, p = 0.71).

Conclusion

CF is a reliable tool for indirect and non-invasive assessment of activity endoscopic inflammatory disease in UC. Fcal is mainly influenced by severity and extent of the lesions. Its use should be careful in case of proctitis under 5 cm, a situation in which its performances are more questionable.
P137 Is there an abuse in the histological diagnosis of Crohn’s disease? (retrospective study)
Authors: Abou Rached A , Sanyour J , Karaki J , abi abdalllah N , Ghoussoub S
Published: January 2020

Background

Nine histological lesions are suggestive of the presence of Crohn’s disease: Ulcerations, erosions, granulomas, abscesses, chronic inflammation, lymphoid hyperplasia, fibro-inflammatory dystrophy, atrophy, and acute inflammation. The presence of a granuloma with at least one of the other histological lesions or the presence of at least three of these histological lesions without any granuloma will be in favor of Crohn’s disease diagnosis. The objective of our study is to review the pathology reports of patients in whom Crohn’s disease diagnosis was made and to see if they meet these histological diagnosis criteria.

Methods

It is a retrospective study whose aim is to review all histopathological reports of patients diagnosed with Crohn’s disease over a period of 10 years (2007–2017) in the largest pathology centre in Beirut. Several elements were analysed: the age, the sex, localisation of the endoscopic lesions (esophagus, stomach, duodenum, ileum and colon) as well as the number and the type of histological lesions present.

Results

During this period the number of patients diagnosed with Crohn’s disease was 3336. The mean age was 39.8, women accounted for 45.7%. The most common histological lesions in the colon and stomach were chronic inflammation (73.2% and 60.7%, respectively, acute inflammation in the ileum (79.8%), in the duodenum (80.6%) and in the esophagus in 88.2%, the presence of granuloma was noted in 22.9% of cases. The presence of granuloma with one or more other lesions was noted in 22.6%, whereas the presence of more than 3 histological criteria and more were found only in 29.4% of the biopsies.

Conclusion

This study demonstrates that only 52% of the biopsy specimens had the histological criteria necessary for the diagnosis of Crohn’s disease. A correlation with endoscopy findings and the clinics is needed to confirm the diagnosis of Crohn’s disease in 48% of patients.
P144 Vitamin C deficiency in inflammatory bowel disease: the forgotten micronutrient
Authors: Dunleavy K , Ungaro R , Manning L , Novak J , Gold S , Colombel J F
Published: January 2020

Background

Micronutrient deficiencies are common in patients with inflammatory bowel disease (IBD). To date, the majority of the literature has focused on vitamin D, vitamin B12, and iron deficiencies. We report a case series of patients with IBD and vitamin C deficiency.

Methods

We performed a retrospective chart review of 20 patients with IBD who had vitamin C deficiency (defined as a level ≤0.2 mg/dl) treated in a single tertiary care centre from February 2018 to October 2019. Demographics as well as disease characteristics and laboratory data were collected. In addition, data from routine nutritional assessments, performed by a nutritionist, were also included.

Results

Of these 20 patients, 11 (55%) were female with a median age of 27.5 years. Fifteen (75%) had Crohn’s disease (CD) and 5 (25%) had Ulcerative colitis (UC). Ten (50%) had been diagnosed with IBD within the last 3 years, and 10 (50%) had a duration of disease >5 years. Disease location was L1 ileal in 6 (30%) patients, L2 colonic in 5 (25%) and L3 ileocolonic in 9 (45%); behaviour was B1 non-stricturing, non-penetrating in 10 (50%) patients, B2 stricturing in 7 (35%) and B3 penetrating in 3 (15%). Nine (45%) patients had previous history of surgery. At the time of the study, 13 (87%, N=15) CD patients had a Harvey–Bradshaw Index >5, and 3 (60%, N = 5) UC patients had a Partial Mayo Score 5–7, indicating active disease. Overall, 14 (70%) patients were on biologic therapy. Sixteen (80%) patients had symptoms consistent with clinical scurvy, including 9 (45%) arthralgia, 6 (30%) dry brittle hair with hair loss, 4 (20%) pigmented rash, 3 (15%) gingivitis, 2 (10%) easy bruising and 1 (5%) brittle nails. Six (32%) had 3 or more of these clinical manifestations. Of those who underwent a nutrition evaluation (N = 18), 10 (56%) reported avoidance of all fruits and vegetables and 3 (17%) reported a reduction of fruits and vegetables in their diet.

While all patients experienced vitamin C deficiency, some also had concomitant vitamin D, vitamin B12, iron and ferritin deficiencies (Table 1).

Conclusion

Vitamin C deficiency can occur in IBD patients and is associated with clinical symptoms of scurvy. Prospective studies are needed to evaluate prevalence of vitamin C deficiency in IBD and its ultimate impact on clinical outcomes. Meanwhile this study emphasises the need for appropriate dietary counselling in patients with IBD.
P146 Comparison of three histologic indices in ulcerative colitis: Evaluation from the Phase 2 study of upadacitinib (U-ACHIEVE)
Authors: Jairath V , Lee W J , Zhou W , Heap G , Butler J , Shields A L , Ollis S , Harpaz N
Published: January 2020

Background

Several histologic indices are available for evaluating mucosal inflammation activity in ulcerative colitis (UC), although there is no consensus regarding which is the most appropriate for evaluating disease activity in clinical trials.

Methods

The correlation of three histologic indices, the Geboes Score (GS, range of major grade 0 to 5), Robarts Histopathology Index (RHI, range 0 to 33), and Nancy Index (NI, range grade 0 to grade 4) were evaluated in a Phase 2b, multicenter, randomised, double-blind, placebo-controlled study of upadacitinib in patients with moderately to severely active UC. Biopsy data were collected and centrally read using GS at Baseline and week 8; scores of RHI1 and NI2 were derived based on GS. Descriptive statistics, correlational analyses, and stratified analyses were performed in the pooled study population using as observed data.

Results

Among 250 UC patients enrolled at Baseline, 224, 214, 209 patients with non-missing values of GS, RHI and NI were observed, respectively. At week 8, the GS, RHI, and NI correlated strongly to each other (r = 0.90 to 0.98), and these 3 indices correlated highly with the subgrade of lamina propria neutrophils, erosion or ulceration, neutrophils in the epithelium, and chronic inflammatory infiltrate (Table 1). The Mayo endoscopic subscore (r = 0.62) was found to have higher correlation with GS, RHI and NI, followed by physician global assessment subscore (r = 0.48 to 0.51), rectal bleeding subscore (r = 0.36 to 0.39) and stool frequency subscore (r = 0.31 to 0.33). Faecal calprotectin (r = 0.47 to 0.50) and C-reactive protein (0.36 to 0.39) and total IBDQ score (r = 0.34 to 0.38) were moderately correlated with GS, RHI, and NI. Over 50% of patients with Mayo endoscopic subscore ≤1 were observed among patients scoring GS = 0 (24/41, 59%), GS = 1 (8/15, 53%), GS = 2 (13/26, 50%), RHI≤3 (45/82, 55%), and NI = 0 (40/69, 58%) at week 8.

Conclusion

In a moderately to severely active UC population, GS, RHI and NI correlate strongly with each other. Higher correlations were found between histologic scores and endoscopic activity than symptom-related disease activity. Further studies are warranted to evaluate the relationship between histological inflammation and long-term clinical outcomes.

References

Acknowledgements and Funding statement: Design, study conduct, and financial support for the study were provided by AbbVie; Financial support for the study was provided by AbbVie. AbbVie participated in interpretation of data, review, and approval of the abstract. All authors contributed to development of the abstract and maintained control over final content.
P156 Interobserver variation of visual assessment vs. measuring ulcer size in Crohn’s disease using the RAPID9 Software in PillCam COLON2
Authors: Quah S , Gorelik A , Tsoi E , Chow E , Sivanesan S , Brown G , Anwar S , Taylor A , Macrae F
Published: January 2020

Background

Ulcer size is important when assessing mucosal healing in Crohn’s disease (CD) and commonly assessed with visual estimation. There is a new built-in measurement tool in the RAPID9 reader software used in colon capsule endoscopy (CCE). We aimed to assess the agreement between visually estimating ulcer size vs. using the estimation tool and the interobserver agreement for both methods independently using PillCam Colon studies in patients with Crohn’s disease.

Methods

7 experts of PillCam readers were recruited to assess CCE in this study. 7 CCE recordings were thumbnailed for the presence of ulcers. A total of 43 ulcers were consecutively selected for this study. The readers were provided with an instruction manual which specified that they were to first visually estimate the ulcer and then subsequently measure the ulcer with the size estimation tool in RAPID9 software. Two measurements were taken, A – longest distance of the ulcer end to end, and B – longest distance that is perpendicular to A. Results were analysed using Kendall’s Coefficient of Concordance (Kendall’s W).

Results

When comparing visual assessment of ulcer size vs. using the estimation tool, both measurements A and B demonstrated statistically significant agreement (p of A = 0.000, p of B = 0.000; W of A=0.90, W of B=0.82). For measurement A, our results demonstrated higher interobserver agreement when assessing ulcer size using the estimation tool (W=0.84) as compared with visually assessing ulcer size (W=0.80). This contrasts with measurement B where there was higher interobserver agreement when visually assessing ulcer size (W=0.75) as compared with using the measurement tool (W=0.73). Nevertheless, there was no statistically significant variability amongst measurement A nor B (p = 0.000) in visual assessment and measurement tool.

Conclusion

The conventional visual estimation of ulcer size in CD using CCE was just as accurate as the measurement tool. Furthermore, consistency between readers was demonstrated with the high level of interobserver agreement for the measurement tool and visual estimation. This novel finding is reassuring given the decade of capsule studies done with older software, where a measurement tool was not available. Further study should be conducted to assess and consolidate the validity of the estimation tool in assessing ulceration and mucosal healing in CD with a larger number and variety of lesions studied.
P167 Changes of diagnosis after colectomy: a single-center experience
Authors: Variola A , Di Ruscio M , Vernia F , Resimini S , Lunardi G , Geccherle A
Published: January 2020

Background

Total proctocolectomy (TPC) is relatively common in inflammatory bowel diseases (IBD), occurring more in ulcerative colitis (UC) as compared with Crohn’s disease (CD) (20.3% vs. 10.5% of patients). Among IBD patients undergoing colectomy, a major complication affecting the clinical outcome is the change of diagnosis. In clinical practice, approximately 5% to 20.9% of UC patients develop CD of the pouch or of the neo-small intestine. The incidence of UC diagnosis after colectomy for complicated colonic CD is less clear. Drugs and progression of the disease can dramatically change the histological findings in this patients; endoscopy after baseline can be atypical and doesn’t provide cross-sectional informations about bowel wall. Aim of the study is to assess the rate of diagnosis change after colectomy in our center.

Methods

All the IBD patients who consecutively underwent TPC with ileal pouch–anal anastomosis (IPAA) or permanent ileostomy from January 2015 to December 2018 in our IBD Unit were included in this observational, retrospective study.

Results

Thirty-one patients (22 UC; 22 Males) were included in the study. Among UC patients 14 had pancolitis and 8 a left-sided colitis. Seven were steroid-resistant, 8 were steroid-dependant, 14 experienced failure to medical treatment (one or more biologics) and 8 patients had dysplasia. Mayo endoscopic score was 3 in all patients, but 3. In 5 out of 22 UC patients (22%), diagnosis changed in colonic CD after evaluation of the surgical specime by the pathologist. Four of these patients were referred to our institution by peripheral hospitals with a severe disease, requiring urgent/emergent colectomy and was therefore performed only a proctosigmoidoscopy. Permanent ileostomy was performed in all 5 patients. Among the 8 colonic CD patients 2 were steroid-resistant, 2 were steroid-dependant, 7 failed to one or more biologics, 1 showed mucosal dysplasia and two had bowel stenosis. Two patients (20%) were diagnosed as UC after TPC and IPAA could therefore be performed.

Conclusion

The change of diagnosis leads to a different surgical outcome, resulting in a worsening in former UC patients and in an improvement in former CD patients. An accurate clinical, endoscopic and histological re-evaluation of the patients is therefore mandatory before TPC. Providing an elevated number of specimens to dedicated pathologists is advisable to avoid potential complications especially in UC patients.
P177 Lower vedolizumab trough levels before interval shortening are not predictive of success of the intervention
Authors: Ungar B , Malickova K , Hanžel J , Abu-Arisha M , Paul S , Rocha C , Ben-Shatach Z , Haj-Natour O , Yavzori M , Fudim E , Picard O , Eliakim R , Kopylov U , Lukas M , Drobne D , Chowers Y , Roblin X , Magro F , Ben-Horin S
Published: January 2020

Background

Pharmacokinetics of vedolizumab have been associated with therapy outcome, although real-life data has been contradictory. Thus, we set to examine whether vedolizumab levels before therapy intensification may be associated with clinical, inflammatory and endoscopic outcomes further on.

Methods

In this retrospective cohort study, vedolizumab drug levels were determined in vedolizumab-treated patients with insufficient therapy response from six medical centers in Israel and Europe, before they underwent dose-intensification. The success of dose-increase gauged by clinical scores, inflammatory (C-reactive protein values, calprotectin) indices and endoscopic data was assessed vis-à-vis pre-escalation drug levels.

Results

Overall, 161 IBD patients (74, 46% Crohn’s disease) were included, of whom 32 patients underwent intensification at end-of-induction (week 10) and 129 during maintenance period (weeks 14–44, median week 30). In total, 34%, 60% and 30% of the 161 patients reached clinical, inflammatory and endoscopic remission by 6 months after intensification, respectively.

Among 129 patients intensified during maintenance period, pre-intensification trough levels were not lower among those reaching clinical and inflammatory remission after dose-escalation (median vedolizumab levels 34.4 vs. 24.4 μg/ml, 30.7 vs. 30.5 μg/ml, p = 0.09, 0.25 respectively). Patients who reached mucosal healing also had higher, rather than lower, vedolizumab levels before intensification (median vedolizumab levels 31.3 vs. 17 μg/ml, p = 0.04 for patients with and without mucosal healing, respectively).

Similarly, among 32 patients intensified at week 6 by an extra-dose at week 10, those with higher, while not lower, levels before escalation had higher rates of post-escalation clinical remission (median levels 101 vs. 61.5 μg/ml, p = 0.05). A similar trend was observed in terms of mucosal healing (88.5 vs. 43 μg/ml, p = 0.09) and inflammatory remission (median levels 100 vs. 55 μg/ml p = 0.15).

Conclusion

Lower vedolizumab trough levels before interval shortening were not predictive of success of the intervention. These results argue against a pharmacokinetic basis for insufficient response to vedolizumab and question the need for dose-escalation. A higher pre-escalation drug-level was associated with better later outcomes, possibly indicating a lower inflammatory burden, and may serve to predict patients with low likelihood to respond to therapy continuation.
P179 The acceptability and utility of United Registries for Clinical Assessment and Research (UR-CARE) database to improve clinical care in a single centre setting
Authors: Fenech V A , Kamperidis N , Tyrrell T , Dyall L , Misra R , Barber S , Randall S , Arebi N
Published: January 2020

Background

The United Registries for Clinical Assessment and Research (UR-CARE) is a validated pan-European database developed by the European Crohn’s and Colitis Organisation (ECCO) to support clinical practice for patients with inflammatory bowel disease (IBD). ECCO has published guidelines to reduce variation in care. We examined the value of UR-CARE database to improve care in a cohort of newly-diagnosed IBD patients.

Methods

All patients with a new diagnosis of IBD within 6 months attended a New Diagnosis Clinic (NDC). Prior to registering patients, the purpose of UR-CARE database was explained. Patients who consented to have their clinical data added to the database signed a consent form. Mandatory fields and additional data that reflected quality of care were inputted. Descriptive statistics summarised the findings. The association between consent and disease activity or gender was examined using a chi-square test and for age using a two-sample t-test.

Results

Twenty-five out of 29 newly diagnosed patients consented for data inclusion in UR-CARE (13 males). Median age was 44 (range 18–77). Fourteen had ulcerative colitis (UC), 8 had Crohn’s disease (CD) and 3 had unclassified IBD. 8.3% reported extra-intestinal manifestations within 6 months of diagnosis. 17/25 patients had active disease. The patients that did not consent consisted of 2 males, 3/4 had active disease and mean age was 44.4 (SD 16.1) compared with 36.3 (SD 19.4) consenters.

Through the database we noted that not all mandatory diagnostic tests were requested at the time of hospital visit: 4/14 UC patients did not have a full colonoscopy and 3/8 CD patients lacked a small bowel imaging or capsule endoscopy. Only 4 out of 14 UC patients and 2 out of 8 CD patients were prescribed steroids within 6 months of their diagnosis. The 7 patients with missing investigations were identified and tests subsequently booked in line with guidelines. There was no association between consent and disease activity (p = 0.78), gender (p = 0.94) and age (p = 0.37).

Conclusion

In newly diagnosed IBD cohort, most patients consented to inclusion in UR-CARE database. There were no contributing factors associated with patient consent. The easily accessible visualisation of our data detected incomplete diagnostic tests and initiated actions to improve care early on in the disease course. UR-CARE offers potential to deliver high quality IBD care by aligning practice against ECCO guidelines. Attention to data-sharing legal and administrative barriers offers a promise for large scale studies and foster collaborative research networks.
P189 Use of transabdominal ultrasonography for the evaluation of Crohn’s disease activity
Authors: Yorulmaz E , Yigit B , Erturk M S , Erdem U , Yanc U , Yorulmaz H , Bilik Oyman G , Sezgin O
Published: January 2020

Background

Ileocolonoscopy is accepted as the gold standard method for the diagnosis of Crohn’s disease (CD). However, there are cases where it is inadequate due to being invasive, failure to allow endoscopic exploration of the small intestine, and failure to show the extraintestinal pathologies. In the present study, it is aimed to compare clinical, endoscopic scores and computerised tomography enterography (CTE) findings with transabdominal ultrasonography (TAUS) findings in order to evaluate the activity of CD.

Methods

The study included 79 patients diagnosed with CD. Crohn’s Disease Activity Index (CDAI) and Harvey Bradshaw Index (HBI) were used for the evaluation of the clinical activities of the patients. The patients with CDAI equal to 150 and more and HBI equal to 5 points and more were assessed as clinically active. Colonoscopic disease activity was assessed by The Simple Endoscopic Score for Crohn’ disease (SES-CD), SES-CD score of 3 and higher was defined as endoscopically active. In the evaluation of CTE and TAUS, the measurement of the thickness of the intestinal wall above 3 mm was accepted as pathological. Abscess, mass, fistula and ileus were evaluated as complications. Superior mesenteric artery (SMA) flow velocity was assessed by Color Doppler US. Limberg score was graded from Grades 0 to 4 for Doppler TAUS.

Results

Of the patients, 57 (72.1%) were male and 22 (27.8%) were female. Age average of the patients was 37.5 years (17–64) and the mean duration of disease was 48.6 months (0–240 months). Increase in the wall thickness in CTE and TAUS, detection of inflammation and complication in mesenteric fatty planes were found to be highly significant (p ˂ 0.0001). Wall thickness increase sensitivity level of TAUS according to CTE was 82%, specificity level was 97%, sensitivity level of the inflammation finding in mesenteric fatty planes was measured as 80%, and specificity level as 95%. A significant correlation was found between the wall thickness increase in CTE and TAUS and inflammation in mesenteric fatty planes via CDAI, HBI and SES-CD scoring (p ˂ 0.05). In addition, there was a significant relationship between the presence of lymphadenopathy in CTE in active patients according to HBI (p ˂ 0.05). According to the CDAI and SES-CD scores, Doppler flow velocity of SMA was significantly higher in the active group than the inactive group (p ˂ 0.05). CDAI, HBI and SES-CD results were found highly significant via the Limberg Scoring results (p < 0.0001).

Conclusion

In the current study, it is shown that TAUS is a diagnostic tool as effective as CTE in the evaluation of CD activity. In addition, it is an important finding that the flow velocity of SMA increases as correlated with inflammation via the Doppler feature of TAUS.
P201 Evaluating access to inflammatory bowel disease care across Canada: Proceedings from the 2017 IBD Access Summit
Authors: MacDonald S , Heisler C G , Mathias H , Mirza R , Jones J
Published: January 2020

Background

Inflammatory bowel disease (IBD) is a chronic, immune-mediated disease, with Canada demonstrating the highest incidence and prevalence rates in the world. Patients with IBD often require lifelong treatment and, therefore, lifelong interactions with the healthcare system. Access to care can have a direct impact on patient health-related outcomes. Although acknowledged as a problem, the complexity of accessing IBD speciality care in Canada has not been reviewed. This lack of understanding presents a barrier in evaluating and implementing changes in IBD speciality care. The aim of the project was to identify key barriers and facilitators for and to develop a national working strategy to address limitations in access to IBD speciality care.

Methods

The IBD Summit was held in Toronto, Ontario in November 2017, sponsored by SPOR-CIHR catalyst funding and in partnership with Crohn’s and Colitis Canada. Perceptions and experiences of key stakeholders were gathered during two audio-recorded stakeholder dialogues held during the Summit. The audio recordings were transcribed and coded to compare and contrast between key stakeholders to determine potential differences in access to IBD care. Five final themes are highlighted in this report.

Results

A total of 21 key stakeholders attended, including paediatric and adult gastroenterologists, patients, researchers, and policymakers. Five key themes of importance relating to access to IBD care arose from The IBD Summit:(1) Integrated Models of Care, (2) IT Enhanced Care, (3) Health System Process, (4) Communication and Advocacy, and (5) Community Supports. The IBD Summit identified similar perceptions and experiences, highlighting common barriers and facilitators that transcend provincial borders. Shared perceptions included a need for common medical records and overall improved IT-enhanced care for managing IBD; improved centralised triage systems; increased comprehensive care support for patients and primary care physicians; and increased community supports for patients and providers.

Conclusion

Highlights from the IBD Summit present several clinically relevant and actionable suggestions for improved access to IBD speciality care across Canada. The suggestions provided by key stakeholders highlight the need for a system-level redesign in order to improve access to enhanced models of care. Improvements in access to IBD speciality care can only occur through partnerships between those working within the healthcare system and those within the community. Future research will involve pursuing deeper insight into the experience of patient and provider stakeholders as they navigate the healthcare system in order to access and provide care.
P207 Modelling 1-year surgery risk in Crohn’s disease: A retrospective cohort study
Authors: Yao J , Peng X , Jiang Y , Zhi M
Published: January 2020

Background

Accelerated therapeutic treatment should be considered in patients with progressive Crohn’s disease (CD) to prevent complications as well as surgery. Therefore, screening for risk factors and predicting the need for early surgery is of great importance in clinical practice. We aimed to establish a model to predict CD-related early surgery.

Methods

This was a retrospective study collecting data from CD patients diagnosed in our inflammatory bowel disease (IBD) centre from 1 January 2012 to 31 December 2016. All data were randomly stratified into a training set and a validation set at a ratio of 8:2. Multiple logistic regression analysis was conducted with receiver operating characteristic (ROC) curves constructed and areas under the curve (AUC) calculated. This model was further validated with a nomogram developed.

Results

A total of 1002 eligible patients were enrolled with a mean follow-up period of 53.54 ± 13.10 months. In total, 24.25% of patients received intestinal surgery within 1 year after diagnosis due to complications or disease relapse. Disease behaviour (B2: OR 6.693, p < 0.001; B3: OR 14.405, p < 0.001), smoking (OR 4.135, p < 0.001), BMI (OR 0.873, p < 0.001) and CRP (OR 1.022, p = 0.001) at diagnosis, previous perianal (OR 9.483, p < 0.001) or intestinal surgery (OR 8.887, p < 0.001), maximum bowel wall thickness (OR 1.965, p < 0.001), use of biologics (OR 0.264, p < 0.001), and exclusive enteral nutrition (OR 0.089, p < 0.001) were identified as independent significant factors associated with early intestinal surgery. A prognostic model was established as follows: X1 = maximum BWT [mm]; X2 = smoking [0: no, 1: yes]; X3 = BMI at diagnosis [m/kg2]；X4 = previous perianal surgery [0: no, 1: yes]; X5 = previous intestinal surgery [0: no, 1: es]; X6 = disease type (stricturing or penetrating disease); X7 = use of biologics; X8 = use of EEN; X9 = CRP at diagnosis). ROC curve and calculated AUC (94.7%) confirmed an ideal predictive ability of this model with a sensitivity of 75.92% and specificity of 95.81%. Nomogram was developed to simplify the use of predictive model in clinical daily practice.

Conclusion

This prognostic model can effectively predict 1-year risk of CD-related intestinal surgery, which will assist in screening progressive CD patients and aid in tailoring therapeutic management.
P209 Prospective validation of faecal calprotectin as a predictor of steroid failure in patients with acute severe colitis
Authors: SAHU P , Kumar S , Jain S , Singh Mohil N , Sahni P , Pal S , Ranjan Das N , Nayak B , Sachdev V , Kumar Singh M , Kedia S , Makharia G , Ahuja V
Published: January 2020

Background

Optimal outcomes in acute severe colitis (ASC) are related to time-bound management based upon an early prediction of response to intravenous (IV) corticosteroids. We have demonstrated good diagnostic accuracy of day 3 faecal calprotectin (FCP) in this setting. The present study intended to validate these findings in a different cohort.

Methods

This prospective cohort study included IV steroid naïve (for this episode) patients with ASC, satisfying Truelove and Witts’ criteria, hospitalised from September 2018 to August 2019. Patients were subjected to baseline sigmoidoscopy, day 1 and day 3 faecal calprotectin, baseline hemogram and biochemistry, and day 3 CRP. All patients received IV steroids after hospitalisation, and the primary outcome measure was steroid-failure defined as colectomy and/or rescue therapy with ciclosporin or infliximab during admission.

Results

Of 47 patients with ASC, eight were excluded (four received steroids outside, 2-directly taken for surgery/infliximab therapy, 1-toxic megacolon on day 1, 1-infectious colitis), 39 were finally included [mean age−36.08 ± 12.58 years, male (30.7%)]. Fifteen patients (38.5%) failed IV steroids and required rescue therapy (10 infliximab, 2 cyclosporine, four surgery). On univariate analysis, the factors significantly different between steroid responders and steroid failure included UCEIS >6 at baseline, Day 1 and Day 3 FCP, day 5 stool frequency, day 5 ESR and CRP, and oxford criteria (Figure 1). On multivariate analysis, only D3 FCP, UCEIS at baseline and Oxford criteria were significant predictors of steroid failure. Like the previous study, on ROC curve analysis, the day 3 FCP had similar diagnostic accuracy [AUC-0.86(0.75–0.98), and 1120.61 μg/g as a cut-off could predict steroid failure with 87% sensitivity and 79% specificity. Similarly, a combination of baseline UCEIS>6 and day 3 FCP>1120.61 μg/g had 100% specificity and positive predictive value for steroid failure.

Conclusion

FCP retained its value as an objective predictor of steroid failure in ASC.
P215 The effect of resection margin involvement of Crohn’s disease on the surgical and clinical recurrence after intestinal surgery
Authors: Seo J H , Lee J L
Published: January 2020

Background

Approximately 80% of patients with Crohn’s disease (CD) require major intestinal surgery during their lifetime and a quarter of patients will undergo repeat surgery within 5 years of the index surgery. For this reason, operative treatment of CD has been the bowel-sparing approach for several decades. This study evaluated the effects of the Crohn’s disease involvement of resection margin on clinical and surgical recurrence.

Methods

This retrospective study analysed 803 patient who underwent intestinal surgery for CD between January 2006 and December 2015. The CD involvement of resection margin was defined as microscopic involvement from the pathologic reports and grossly involvement from the operative records. Anastomosis recurrence was reviewed using the operative records and radiologic findings including colonoscopy, computed tomography and magnetic resonance imaging.

Results

In total, 41 patients (5.1%) had an active CD in the bowel resection margin – 31 patients (3.9%) with histologically, 10 patients (1.2%) with grossly. We had 221 (26.8%) reoperation cases, of which 87 (10.6%) patients were an anastomotic recurrence. When patients were stratified by surgical recurrence at anastomosis, the increased risk was not significant in resection margin positive grossly (odds ratio [OR], 3.65; 95% confidence interval [CI], 0.93–14.41) and in microscopic (OR, 1.26; 95% CI, 0.43–3.70) comparing with negative resection margin. Also, resection margin involvement was not related with clinical recurrence grossly (OR, 0.30; 95% confidence interval [CI], 0.07–1.26) and in microscopic (OR, 0.50; 95% CI, 0.21–1.17)

Conclusion

The current practice suggests the CD involvement of resection margin, even grossly or microscopic, do not influence surgical and clinical recurrence.
P218 Linked colour imaging predicts the risk of the clinical relapse in ulcerative colitis
Authors: Kanmura S , Komaki Y , Komaki F , Tanaka A , Sasaki F , Ido A
Published: January 2020

Background

Ulcerative colitis (UC) is a chronic inflammatory bowel disease with unknown aetiology. Recently, mucosal healing (MH) has emerged as an important therapeutic endpoint in UC. Linked colour imaging (LCI) is a novel endoscopic system that enhances the colour differences of the gastrointestinal mucosa. We aimed to evaluate the correlation between the endoscopic observation using LCI and the clinical relapse rate in UC patients.

Methods

We retrospectively analysed UC patients who underwent a total colonoscopy between August 2016 and May 2019 at our facility with Mayo endoscopic score (MES) of 0 or 1. We assessed the most relevant endoscopic findings, including erythema, vascular pattern, and friability using white-light imaging (WLI) and LCI observation. We analysed the correlation of clinical relapse rate, which means requiring additional treatment for UC, during the 2-year follow-up period with endoscopic assessment using WLI and LCI. We also evaluated the utility of LCI-observation method for predicting the prognosis in UC patients with clinical remission.

Results

Forty-seven patients were analysed, and clinical relapse was observed in 10 patients (21%) during the 2-year. Univariate analysis revealed a significant difference in decreased vascular pattern and friability between the clinical relapse and remission groups; multivariate analysis showed decreased vascular pattern observed on LCI as the only variable, which remained significantly associated with clinical relapse (p <0.03). We defined LCI-mucosal score (MS) as LCI-MS 0, distinct vascular pattern and no friability; LCI-MS 1, either indistinct purple/magenta vascular pattern or friability; and LCI-MS 2, both indistinct purple/magenta vascular pattern or friability on LCI observation. The relapse rate in patients with LCI-MS 0 was 10% (3/30), which was significantly lower than in patients with LCI-MS 1 or 2 (36 %; 6/16).

Conclusion

LCI findings have the diagnostic implications in predicting the risk of clinical relapse in UC during the 2-year follow-up period.