bluuebunny/crossref_metadata_2025_split huggingface dataset:
P643 Development of quantitative ultrasonographic activity score in ileal Crohn’s disease
Authors: Livne Margolin M , Amitai M , Klung E , Ungar B , Eliakim R , Ben-Horin S , Carter D , Kopylov U 
Published: January 2020

Abstract

Background
Intestinal ultrasound (IUS) is as an accurate bedside tool for monitoring Crohn’s disease (CD). However, there is no validated quantitative ultrasonographic score for evaluation of the activity of intestinal inflammation in CD. Such a score may facilitate the use of IUS-based monitoring in clinical practice and in clinical trials in CD. For magnetic resonance enterography (MRE), the magnetic resonance index of activity (MaRIA) is most commonly used. Thus, the aim of our study was to correlate IUS data for the terminal ileum with segmental MARIA score for the terminal ileum in order to devise a quantitative inflammatory index for IUS.

Methods
In this retrospective cohort study, the data of CD patients who were followed in the Gastroenterology Department at Sheba medical centre between January 2016 and December 2018 were extracted. Inclusion criteria were age &gt;18 and an interval&lt;3 months between MRE and IUS. MaRIA score for the terminal ileum was compared with ultrasonographic features of inflammation that included: bowel wall thickness (continuous variable), echogenicity of the bowel wall, pseudostratification of the bowel wall layers, inflammatory mesenteric fat and lymph nodes, hyperemia present on colour Doppler flow and complications (nominal variable). A linear regression model that included the significantly correlated variables was constructed.

Results
Forty-two patients with established Crohn’s disease were included. A stepwise multiple regression model was constructed to predict MaRIA score using US features. Two variables were found to be independently significant in the explanatory model, terminal ileum thickness (r = 0.68, p = 0.001) and US fat proliferation (r = 0.45, p = 0.019). A model was constructed as follows: MaRIA = 7 + 2.5 * TI US thickness (mm) + 7 * US fat proliferation (0 = no, 1 = yes). This model has an R2 of 0.51 for explaining the variability in the results.

Conclusion
Quantitative IUS measurements are significantly correlated with segmental MaRIA score in the terminal ileum; a simple computational model for prediction can be constructed; however,, the accuracy of such model to predict segmental MaRIA was moderate. Additional work to develop quantitative IUS parameters in CD is merited.
P646 Utilisation of indocyanine green fluorescence imaging for Crohn’s disease following intestinal resection
Authors: Duan Y , Li Y 
Published: January 2020

Abstract

Background
Growing evidences have shown that there are important advantages related to the utilisation of indocyanine green fluorescence imaging (ICG-FI) to reduce the risk of postoperative anastomotic leakage (AL) in colorectal surgery. However, the impact of ICG-FI on postoperative AL of Crohn’s disease (CD) following intestinal resection has not been investigated.

Methods
This is a retrospective study of consecutive CD patients who were treated with intestinal resection and anastomosis at a single institution between January 2017 and August 2019. The cohort was divided into 2 groups, those with ICG-FI compared with those without ICG-FI for intestinal resection. ICG was administered intravenously with a bolus of 5 mg, and the intestinal perfusion was evaluated by a SPY Elite system. Their baseline characteristics and perioperative outcomes were further analysed.

Results
No adverse reactions were recorded. Of the 88 CD patients who underwent intestinal resection, 36 patients underwent ICG-FI during intestinal resection, while 52 CD patients who underwent routine intestinal resection were from a prospectively maintained database. The 2 groups were similar in terms of patient demographics, immunosuppressive medication use, and the procedural factors. In patients with ICG-FI, poor perfusion of the bowel judged by ICG-FI led to additional intestinal resection in 25% (9/36). ICG-FI reduces the AL rate from 13.5% (7 leaks) of non-ICF-FI group to 8.3% (3 leaks) in ICG-FI group (p = 0.456). Forty-four (50%) patients had previous intestinal resection. Overall, 10 anastomotic leaks were identified (11.4% leak rate). There were 2 leaks (4.5%) detected in patients with no previous intestinal resection, compared with 8 leaks (18.2%) identified in patients with a history of previous intestinal resection (p = 0.044). The number of previous resections correlated with increasing risk for AL (correlation coefficient = 0.998). In univariate analysis, steroid use, CRP level and preoperative weight loss &gt;10% in 6 months were independently associated with AL.

Conclusion
ICG-FI is applicable to intestinal resection for CD and may play a role in perfusion-related AL. A large prospective randomised trial should be warranted.
P647 Post-marketing evaluation of reported adverse events of a multi-strain probiotic product confirms that change in manufacturing site had no impact on safety profile
Authors: Panetta V , Simonelli I , Bacchieri A , Papetti S , De Stefani E , Colombo S 
Published: January 2020

Abstract

Background
In 2016, the manufacturing site of the multi-strain probiotic product VSL#3 changed. The present work is aimed at verifying if this change had an impact on the safety profile of the product.

Methods
The safety reports from post-marketing surveillance in the USA received by Alfasigma in the years 2014–2015 were compared with those received in the years 2017–2018. 2016 was not considered, because the product on the market during this year could likely come from both manufacturing sites. VSL#3 is sold in the US market as a medical food. Most of the reports were from consumers and were not medically confirmed. However, this happened in both periods, so no bias is introduced in the comparison. Each single safety report contained one or more adverse events (AEs), coded with MedDRA. The comparison between the two periods concerned primarily the number of safety reports in relation to the number of units sold. Given the similarity of trends between the total number of safety reports and sales in the two periods, the frequencies of the AEs and serious AEs were also compared at the System Organ Class (SOC) and Preferred Term (PT) level.

Results
More than 70% of subjects reporting an AE were women in both periods under comparison; mean age was 58; phone was the most frequent means (overall 76%). Table 1 summarises the main results. Sales and number of safety reports were higher in the second than in the first period. However, the ratio between number of reports and sales was higher in the 2014–2015 period compared with the 2017–2018 period: 3.5 vs. 2.9 reports per 10,000 units sold, respectively. Similar results were obtained when stratifying the described ratios by formulation. The percentages of reports with at least one serious AE were respectively 3.2% in the first period and 2.5% in the second. The two periods appeared to be similar even with respect to the percentages of AEs and serious AEs by SOC and PT, being the AEs under the Gastrointestinal SOC the most frequently reported, as expected.

Conclusion
The analyzed data show that the manufacturing site change had no impact on the safety profile of VSL#3.
P649 Dietary habits in patients with inactive Crohn’s disease: Results of a controlled study
Authors: Ben Mustapha N , Ben Youssef H , Labidi A , Hafi M , Fekih M , Serghini M , Boubaker J 
Published: January 2020

Abstract

Background
The purpose of this study was to compare the dietary habits of patients with Crohn’s disease in remission with a control group.

Methods
This is a comparative cross-sectional descriptive study that took place over a period of one month including 45 patients already managed for Crohn’s disease (CD), who had been in stable clinical remission for at least 6 months at the time of the survey and had the same treatment for at least 6 months compared with a group of 40 healthy volunteers adjusted for age, sex and body mass index (BMI) recruited among health personnel. Questionnaires about dietary habits, patients’ attitudes and beliefs about diet and its impact on their illness, and a dietary history-type food survey were asked and completed for all subjects.

Results
Total energy and macronutrient intakes were comparable in both groups and adapted to the guidelines. Fibre and micronutrient intakes were significantly lower in CD group, as was the consumption of dairy products, legumes, vegetables and fruits, oleaginous fruit. There were multiple dietary restrictions among CD patients including milk and its derivatives, fruits, vegetables, and legumes. In fact, 11% of them continued to strictly follow the same residue-free diet prescribed at the time of flares and others had barely expanded their diet. The reasons were mainly represented by the fear of triggering digestive disorders in 77% of cases. Fifty-six per cent of patients believed that fibre and milk negatively affect their disease and could trigger digestive disorders. Forty-four per cent said that the avoided foods gave them digestive disorders. By stratifying patients by age, sex or disease characteristics (location, treatment, history of surgery), we found no predictive factor for these dietary restrictions. Moreover, in 23% of patients, the diet was totally obscured by the doctor during consultations. In addition, and despite the discussion with the doctor about food, 46% turned to other sources such as the entourage, other patients, media and internet to find information on their diet.

Conclusion
Our study shows that patients with Crohn’s disease in remission suffer from several deficiencies due to multiple dietary exclusions. The results suggest that an unbalanced diet should be identified to avoid the micronutrient deficiency observed and highlights the importance of communication about diet between Doctors and patients.
P650 Outcomes of endoscopic balloon dilation for luminal strictures in Crohn’s disease
Authors: Sarraj R , Martinho M , Bravo F , Benz E , Juillerat P 
Published: January 2020

Abstract

Background
Luminal strictures are common complications of Crohn’s disease (CD). Endoscopic balloon dilation (EBD) is an alternative to surgery for CD strictures. (1–3). The aim of this study was to evaluate the EBD success rate and identify predictive factors in CD patients.

Methods
27 consecutive patients with CD in whom EBD was performed at the outpatient clinic of Bern University Hospital were retrospectively included in this study. Clinical, laboratory and endoscopic data were collected from the patient files. Stricture characteristics, short-term procedure success, procedure-related complications, occurrence of surgery and long-term clinical endpoints were documented. Short-term procedure success was defined by the ability to pass an 11.5-mm-wide endoscope through the stricture after dilatation and the absence of any documented complications during a 1-week follow-up.

Results
The study population consisted of 27 patients with Crohn’s disease. A total of 41 dilations were performed. 61.5% of the patients were on biologic therapy. The short-term dilatation success rate was 60%. 48.1% of the patients required stricture related surgery during the follow-up. There were two procedure-related complications 0.08% (bleeding; asymptomatic perforation discovered during surgery). 33.3% were anastomotic strictures. The median increase in dilatation diameter during a single session was 6 mm (range, 3–12mm). 53.8% of the patients required multiple dilatations during the same endoscopic procedure. In the Kaplan–Meier log-rank analysis, anastomotic strictures (secondary) did show a trend toward a longer surgery-free survival after EBD (p = 0.057) (Figure1)

Conclusion
EBD is successful and safe in treating luminal strictures and in prevention of immediate surgery in a high proportion of CD patients, in particular for anastomotic stricture.

References
P651 Does ambient temperature alter faecal calprotectin levels?
Authors: Cauchi S , Schembri J , Muscat M , Ellul P 
Published: January 2020

Abstract

Background
Faecal Calprotectin (FCP) is a marker of intestinal inflammation and its measurement is useful in both the diagnosing and the evaluation of disease activity in patients with inflammatory bowel disease (IBD). Limited and conflicting evidence exists on the reliability of FCP as a stable marker at ambient temperature. While an adult publication suggested that FCP can be delivered to the laboratory at ambient temperature with reliable and consistent results, a recent publication in a paediatric cohort demonstrated that samples stored at 4 ˚C were more reliable than those kept at ambient temperature. The aim of the study was to evaluate if there is any variation in FCP levels depending on ambient temperature in patients in clinical remission.

Methods
Patients with IBD (Crohn`s disease {CD}; ulcerative colitis {UC}) who were in clinical, radiological and/or endoscopic remission in the previous 6 months were recruited. The FCP levels taken in between December 2018 and February 2019 (mean daytime temperature – 15.7ºC; range 4 – 19ºC) and those taken July–September 2019 (mean daytime temperature 29ºC; range 21–39ºC) were analysed. No patients had to have any change in IBD medications or any features of relapse during the study period. All recruited patients had to have two samples of FCP taken—one taken in winter and the other in summer.

Results
109 patients were recruited (males: 57 patients; 56% - CD). The mean patient age was 43.9 years (±3.313 SD; range 19–82 years). The mean FCP during the winter months was 135.6 mg/l (±20.9 SD) while that in summer was 121.9 mg/l (±24.1 SD). No statistically significant difference between the winter and summer months (p = 0.41). The mean winter FCP in CD was 122.2 mg/l (±27.5 SD) while that in UC was 147.0 mg/l (±31.4 SD) (p = 0.19). In the same patients, the mean summer FCP in CD was 128.3 mg/l (±31.8 SD) while in UC it was 114.95mg/l (±39.9 SD) (p = 0.73). While numerically, the levels of the FCP in UC were different, this was not statistically significant (p = 0.32). Further FCP analysis for the variables of age and gender did not reveal any significant differences.

Conclusion
These data demonstrate that FCP is a reliable marker of disease activity in routine clinical practice, when submitted to the laboratory at ambient temperatures. The ability of submitting the stool samples to the laboratory with only a few precautions, will undoubtedly ensure patient compliance in submitting stool samples. However further analysis in FCP variation in UC patients needs to be considered.
P653 Efficacy and safety of an additional 8 weeks of tofacitinib induction therapy: Updated results of the OCTAVE Open study for tofacitinib 8-week induction non-responders
Authors: Rubin D T , Dubinsky M C , Danese S , Saad-Hossne R , Ponce de Leon D , Maller E , Lawendy N , Kwok K , Su C 
Published: January 2020

Abstract

Background
Tofacitinib is an oral, small-molecule JAK inhibitor for the treatment of ulcerative colitis (UC). Efficacy and safety of tofacitinib were demonstrated in three Phase 3, randomised, placebo-controlled trials in patients with moderate to severe UC.1 Patients who received tofacitinib 10 mg twice daily (BID) for 8 weeks (weeks) in OCTAVE Induction 1 and 2 (NCT01465763; NCT01458951) and did not achieve a clinical response (ie induction non-responders [IndNR]) could enter an ongoing, Phase 3, open-label, long-term extension (OLE) study (OCTAVE Open; NCT01470612). We present an update, as of May 2019, of previously published data up to December 2016 from the OLE study for IndNR patients.2

Methods
IndNR patients received tofacitinib 10 mg BID in the OLE study. Patients who were still non-responders after an additional 8 weeks of induction were required to discontinue. Clinical response, remission and mucosal healing were evaluated up to Month (M)36 of the OLE study. Adverse events (AEs) and serious AEs (SAEs) are also presented.

Results
429 IndNR patients enrolled in the OLE study, 295 of which received tofacitinib 10 mg BID during induction trials (Table). The proportions of patients with prior tumour necrosis factor inhibitor and baseline corticosteroid use were slightly higher in non-responders than responders at M2; other baseline characteristics were generally similar in responders and non-responders. At M2, 59.7%, 25.7% and 16.2% of patients achieved clinical response, mucosal healing and remission, respectively (as observed). Corresponding non-responder imputation and last observation carried forward values were 52.2%, 23.1% and 14.2% (Table). The table shows data up to M36. The proportions of patients with AEs, SAEs and discontinuations due to AEs for IndNR patients censored at M2 (52.2%, 3.7% and 2.4%, respectively) were similar to those for all patients in OCTAVE Induction 1 and 2 (tofacitinib: 55.4%, 3.8% and 3.9%; placebo: 56.4%, 6.0% and 4.3%), with no new safety risks identified (table).

Conclusion
The majority of patients who did not achieve clinical response to tofacitinib 10 mg BID for 8 weeks in the induction studies – and subsequently received an additional 8 weeks of tofacitinib 10 mg BID in the OLE study—achieved clinical response, with a considerable number of patients in remission and/or mucosal healing at M36. No new safety risks were observed in the additional 8 weeks of induction. These data support extended induction with an additional 8 weeks of tofacitinib for non-responders to 8-week induction. Current product labelling recommends 5 mg BID for maintenance in responders.3,4

References
P659 The impact of total colectomy on the course of extraintestinal manifestations in Swiss IBD cohort study patients
Authors: Roth R , Vavrick S , Scharl M , Schreiner P , Greuter T , Zeitz J , Safroneeva E , Schoepfer A , Barry M P , Rogler G , Biedermann L 
Published: January 2020

Abstract

Background
Extraintestinal manifestations (EIM) are reported to occur in a highly variable frequency of between 6% and up to 47% of patient with IBD during the course of disease and may substantially contribute to the overall disease burden. Little is known on the impact of colectomy in UC or CD patients on the course of EIM, neither regarding pre-existing vs. de novo EIM occurring after colectomy nor regarding potential differences between EIM typically known to follow a parallel vs. independent course of activity to disease activity of underlying IBD.

Methods
Using data from the Swiss IBD Cohort Study (SIBDCS) we aimed to analyze the course of EIM in UC and CD patients undergoing colectomy during the prospective SIBDCS follow-up.

Results
Amongst a total of 3620 IBD patients (53.6% CD, 42.8% UC, 3.6% IBD unclassified), 115 IBD patients (33 CD and 82 UC) underwent colectomy. One or more EIM had been present at any time antecedent to colectomy in 35.7% of these patients (27.3% and 39% in CD and UC patients, respectively). Within the 115 IBD patients undergoing colectomy any EIM was present only before colectomy in 21 patients (18.3% of all patients undergoing colectomy), i.e. entirely ceased thereafter in 51.2% of patients with any EIM prior to colectomy. After colectomy, overall 30 out of the 115 patients (26.1%) suffered from any EIM after colectomy. Out of these, two thirds (20 patients) already had any EIM prior to colectomy, while in one third (10 patients) occurrence of EIM represented a de-novo event after colectomy. Overall, amongst all patient with no EIM prior to undergoing colectomy 13.5% of patients developed a de-novo EIM after colectomy. The fraction of patients with complete cessation of EIM after colectomy was numerically higher in patients with UC vs. CD with 56.3% vs. 33.3% of patients with EIM prior to colectomy, respectively (51.2% in IBD patients overall). An overview over the frequency of EIM overall and individual EIM is provided in Figure 1.

Conclusion
In IBD patients with undergoing colectomy, any EIM present prior to surgical intervention will persist in about half of patients. Although our results are based on a limited number of patients our findings indicate, that complete cessation of EIM after colectomy may be less common in CD than in UC patients. Absence of EIM prior to colectomy does not equal freedom from any EIM thereafter as up to one in seven IBD patients may develop de-novo EIM after colectomy.
P662 Efficacy and safety of tofacitinib in patients with moderate-to-severe ulcerative colitis: A real-world retrospective study
Authors: Yoshimura N , Okano Soh , Sako Minako , Takazoe Masakazu 
Published: January 2020

Abstract

Background
Tofacitinib is an orally active, small-molecule Janus kinase inhibitor, recently approved for the treatment of moderate to severe ulcerative colitis (UC) refractory to corticosteroid. However, currently, there is inadequate evidence for efficacy of Tofacitinib in UC patients. Therefore, our objective was to evaluate the efficacy and safety of Tofacitinib for inducing and maintaining remission in UC patients.

Methods
In a single-centre retrospective setting, 71 consecutive patients with UC who had failed to respond to corticosteroid or biologics were included. All patients had received 10mg Tofacitinib orally twice daily for at least 8 weeks as remission induction therapy and then, the responders received 5mg twice daily as maintenance therapy for up to 26 weeks. The clinical response and adverse events were evaluated at weeks 8 (induction) and 26 (maintenance). UC activity was assessed by the partial Mayo score. Clinical remission was defined as p-Mayo score ≤1 and the bleeding subscore = 0. Clinical response was defined as p-Mayo score ≤4 and a decrease of ≥3 points relative to baseline. Furthermore, the cumulative remission rates up to 26 weeks were determined by the Kaplan–Meier survival analysis.

Results
At week 8, 24 of 71 patients (33.8%) achieved clinical remission and 20 (28.2%) achieved response level. The mean p-Mayo score fell from 5.8 ± 1.1 at entry to 3.5 ± 2.3 at week 2 (p &lt; 0.01) and 2.3 ± 1.9 at week 8 (P&lt;0.01). The average total cholesterol increased from 180.8 ± 36.0 mg/dl at entry to 206.8±39.3 mg/dl (p &lt; 0.01). In anti-tumour necrosis factor (TNF)-α or vedolizumab (VDZ) naïve subgroup (n = 14), 8 patients (57.1%) achieved response level, while in biologic failure subgroup (n = 57), 36 patients (63.2%) achieved response level. In single biologic failure subgroup (n = 27), 19 patients (70.4%), in double biologics failure subgroup, 14 of 24 patients (58.3%), and in 3 biologics failure subgroup, 3 of 6 patients (50.0%) achieved response level, showing a decrease in the efficacy of Tofacitinib in patients who had failed more than one biologic. Furthermore, of the 25 patients followed for 26 weeks, 23 (92.0%) sustained remission at week 16 and 19 (76.0%) at week 26. Herpes virus infection occurred in 4 patients. The increase in total cholesterol was observed in 68.8% of the patients.

Conclusion
Our retrospective efficacy assessment indicated that Tofacitinib was effective and safe for inducing and maintaining remission in corticosteroid refractory UC patients, regardless of biologic naïve or failure background. The efficacy of 10mg twice daily was rapid and observed within 2 weeks of starting the treatment.