bluuebunny/crossref_metadata_2025_split huggingface dataset:
737 Economic Burden of Biologic Treatment in Patients With Inflammatory Bowel Disease in the U.S.
Authors: Bornheimer Rebecca , Hass Steve , Nag Arpita , Oster Gerry 
Published: October 2019

INTRODUCTION:
Inflammatory bowel disease (IBD), including Crohn's disease (CD) and ulcerative colitis (UC), is a chronic relapsing condition. IBD treatment has shifted from symptom management with corticosteroids to biologics aimed at achieving clinical remission. Patients refractory to first-line biologics are candidates for second and third-line agents. In this study, we explore the economic burden of IBD in the USA among patients initiating treatment with a biologic, and we examine whether this differs in relation to receipt of additional biologics during follow-up.

METHODS:
Using the IQVIATM Real-World Data Adjudicated Claims Database – US, we identified adults (≥18 years) with CD or UC and evidence of receipt of ≥1 IBD-related biologic from January 1, 2011 through December 31, 2017. Date of therapy initiation was designated the index date. Persons with <12 months of continuous data prior to index date or previous receipt of a biologic were excluded. Biologic use was examined from index date to date of IBD-related surgery, receipt of another biologic or end of study period, whichever came first. Total healthcare, outpatient and inpatient costs, prior to index date and during follow-up, were examined using Kaplan–Meier Sample Average methods and least-squares means.

RESULTS:
A total of 8071 patients with CD and 4832 with UC were identified. Of the patients with CD, 1028 received ≥1 additional biologic during follow-up (Multiple Biologic Cohort), while 7043 did not (Single Biologic Cohort). Corresponding counts for patients with UC were 843 and 3989, respectively. While total healthcare costs were similar for Multiple and Single Biologic Cohorts in the 12 months preceding the index date, mean (SD) total quarterly healthcare costs over 20 quarters post index date were significantly higher for the former group (CD: US$13,262 [15,463] vs US$10,902 [12,798]; P < 0.001; UC: US$14,313 [16,967] vs US$11,433 [13,387]; P < 0.001; Multiple and Single Biologic Cohorts respectively; Figures 1 and 2). Mean total quarterly inpatient and outpatient costs for patients with CD and UC post index date were also significantly higher in the Multiple compared with the Single Biologic Cohort.

CONCLUSION:
The level of healthcare utilization and costs post index date were significantly higher for patients with IBD who received more than one biologic during follow-up compared to those who did not.
758 The Hidden Burden of Faecal Incontinence in Active and Quiescent Ulcerative Colitis: An Underestimated Problem?
Authors: Nigam Gaurav B. , Limdi Jimmy K. , Hamdy Shaheen , Vasant Dipesh H. 
Published: October 2019

INTRODUCTION:
Despite advances in Ulcerative Colitis (UC) therapies, many patients suffer refractory defecatory symptoms in the absence of active inflammation. For this group, treatment is challenging, with a paucity of research and limited therapeutic options. In this prospective, ongoing study, we aim to determine the prevalence of faecal incontinence (FI) in patients with quiescent UC.

METHODS:
In a cross-sectional study, consecutive patients with UC attending Inflammatory Bowel Disease (IBD) clinics completed a series of validated questionnaires; including an IBD-specific FI questionnaire (ICIQ-IBD questionnaire), Hospital Anxiety and Depression Scale (HADS), the Rome IV diagnostic questionnaire, and the IBD-control questionnaire. Participants were requested to return a Faecal Calprotectin (FCP) within 2 weeks of completing questionnaires. Quiescent UC was defined as IBD-control 8 score ≥13 and IBD-control-VAS ≥85, and/or FCP levels ≤250 (where available, FCP data were used in preference to IBD-control to classify UC activity). Data were compared between active and quiescent groups using chi-square and non-parametric tests.

RESULTS:
Overall, n = 97 UC patients (n = 50 males, mean age 48 (range 18-82) participated. ICIQ-IBD data revealed that most patients experience FI (84/97 (87%) during 'relapses'. Interestingly, 58/97 (60%) reported FI when in 'remission', and this group had higher median HADS depression (P = 0.0002), poorer QoL scores (P < 0.0001), and trend towards higher HADS anxiety (P = 0.09) scores, compared to those without FI. Disease activity data (IBD-control and/or FCP) were available for all patients, and based on these 61/97 (63%) had quiescent UC. The prevalence of FI based on ICIQ-IBD did not differ between those with active (22/36, 61%) and quiescent UC (36/61, 59%), P = NS. In those with FI on ICIQ-IBD, median IBD-FI symptom scores, IBD-FI QoL scores and HADS (anxiety: P = 0.47, depression: P = 0.18) id not differ between disease activity groups. However, within the quiescent group, patients that met the more stringent Rome IV criteria for FI (n = 13) had higher median IBD-FI symptom scores (P = 0.007) and HADS-depression scores (P = 0.05), a trend to worse IBD-FI QoL (P = 0.07), but similar HADS-anxiety (P = 0.68).

CONCLUSION:
This is one of the first studies to identify that FI affects most patients with UC, regardless of disease activity, with a detrimental impact on patients' psychological wellbeing and QoL. FI be screened for in IBD clinics. There is an urgent need for further research in this area.
759 A UK National Survey of Therapeutic Drug Monitoring With Anti-TNF Medications in IBD
Authors: Nayeemuddin Shadab , Nigam Gaurav B. , Kontopantelis Evangelos , Hayee Bu , Limdi Jimmy K. 
Published: October 2019

INTRODUCTION:
A growing body of evidence supports use of therapeutic drug monitoring (TDM) in improving efficacy and cost-effectiveness of anti-TNF therapy in patients with inflammatory bowel disease (IBD). Existing and evolving knowledge of TDM in clinical practice is less well understood. Our objective was to assess attitudes and barriers to TDM use with anti-TNF's in the UK.

METHODS:
A 17-question survey was distributed to members of the British Society of Gastroenterology. Information on clinician characteristics, demographics, use and barriers towards implementing TDM with anti-TNF's was collected. Logistic regression was used to predict factors influencing TDM use.

RESULTS:
243 respondents participated (51.6% male) of which 237 respondents met inclusion criteria; treating >5 IBD patients and at least 1 with an anti-TNF per month. Of the total respondents, 45% were Consultant Gastroenterologists (GI), 40% IBD Nurse Specialists (CNS) and 15% GI Specialist Registrars (SPR). Of these 237 respondents, TDM was used by 95.7% for secondary loss of response; 71.4% for primary non-response and 53.6% used TDM proactively. Barriers for TDM use were time lag in receiving results (27.1%), lack of awareness of guidelines (15.6%), and cost (11.9%). Clinicians working at a teaching hospital were more likely to use TDM compared to a district hospital (OR 2.6, 95% CI 0.71-9.8). IBD CNS and GI SPR used TDM more often, when compared to Consultant GI (OR 2.6, 95% CI 0.69-10 & OR 1.5, 95% CI 0.3-7.2 respectively). Clinicians practising for >20 years were more likely to check TDM than less experienced clinicians (OR 4.1, 95% CI 0.4-41.8). Clinicians with large volume IBD practice (>50% IBD patients per month) were more likely to check TDM than those seeing fewer IBD patients (OR 45.6, 95% CI 7.5-275). Proactive TDM was more likely to be used by clinicians working in a tertiary care setting (OR 2.25, 95% CI 0.84-6.05), IBD CNS (OR 1.2, 95% CI 0.6-2.1), clinicians managing large volume IBD practice (OR 10.8, 95% CI 1.2-90) and clinicians with 5-9 years of experience in practice (OR 2.6 & CI 1.04-6.42).

CONCLUSION:
Significant barriers to TDM implementation in the UK are time lag from test to result, lack of awareness of current guidelines and evolving knowledge, cost and less experience. Validation of point of care testing, lower cost assays, and wider dissemination of current evolving paradigms with updated recommendations may further optimise treatment with anti-TNF therapies.
760 Disease Location Is Associated With Non-Alcoholic Fatty Liver Disease in Patients With Crohn's Disease
Authors: Ritaccio Gabrielle , Abutaleb Ameer , George Lauren A. , Salas Samuel , Cross Raymond K. , Sakiani Sasan , Shetty Kirti , Wong Uni 
Published: October 2019

INTRODUCTION:
Non-alcoholic fatty liver disease (NAFLD) is the most common liver disorder in western countries and an increasing cause of end stage liver disease and hepatocellular carcinoma (HCC). While patients with inflammatory bowel disease (IBD) are traditionally viewed as underweight and malnourished, increasingly effective therapies have led to similar rates of obesity in these patients when compared to the average population. The aims of this study were to 1) characterize rates of NAFLD in a large cohort of patients with IBD and 2) identify IBD-related predictors of NAFLD.

METHODS:
We conducted a single-center retrospective chart review of patients referred to our IBD program from 2007-2017. NAFLD was defined as imaging or biopsy findings of hepatic steatosis without coexisting liver disease or significant alcohol use. Relevant patient demographic and clinical data was collected within one year of NAFLD diagnosis. Comparisons between NAFLD rates in various groups were made using chi squared tests and one-way ANOVA tests.

RESULTS:
1673 unique patients presented to our IBD program between the years 2007-2017. While patients were receiving care at our program, 237 (14%) had imaging or biopsy findings of hepatic steatosis. Of those 237 patients, 28 were excluded from analysis due to concurrent diagnosis of hepatitis C (n = 7) or B virus infection (n = 1), HIV infection (n = 2), significant alcohol use (n = 10), methotrexate-related liver injury (n = 2), sarcoidosis of the liver (n = 1), or primary sclerosing cholangitis (n = 5). As expected, increasing BMI was associated with higher NAFLD rates (P = 0.05). NAFLD rates were also significantly different between different types of IBD (P = 0.02). 63% of NAFLD patients had Crohn's disease (n = 132/209) and 19% had ulcerative colitis (n = 39/209). In patients with Crohn's, disease location in the proximal colon and rectum was positively associated with NAFLD (P = 0.02 and 0.02 respectively). NAFLD rates were not significantly different between types of Crohn's disease phenotypes including inflammatory, obstructing, and perforating (P = 0.77).

CONCLUSION:
NAFLD rates among patients with Crohn's disease are high. Disease location in the proximal colon and rectum was associated with NAFLD while disease behavior was not. Further research is needed to determine mechanisms driving development NAFLD in patients with Crohn's disease.
768 Association Between Hepatocellular Carcinoma and Inflammatory Bowel Disease: 5-Year Nationwide Analysis in the Unites States
Authors: Shah Hardikkumar , Botros Youssef , Baddoura Walid 
Published: October 2019

INTRODUCTION:
Hepatocellular Carcinoma (HCC) commonly occurs in patients with Cirrhosis and Hepatitis B. Inflammatory Bowel Disease (IBD) is well known to be associated with intestinal malignancy like colon cancer and extra intestinal malignancy such as Cholangiocarcinoma. There are few case reports showing increased risk of HCC among patients with IBD, but larger studies are lacking so we aim to study association between HCC and IBD in a nationwide database.

METHODS:
We performed data analysis on Nationwide readmissions Database (NRD) from year 2010 through 2014. We compared hospitalized adult patients with IBD and HCC with patients with IBD alone. Patients with liver disease and primary sclerosing cholangitis were excluded from analysis. Univariate analysis was done for categorical data using chi-square or fisher's exact test while continuous data were analyzed using t-test. Multivariate logistic regression analysis was performed to look for factors associated with HCC in patients with IBD and factors associated with mortality.

RESULTS:
There were total of 939224 weighted admissions with IBD and 350(180 Ulcerative Colitis, 170 Crohn's Disease) admissions with both IBD + HCC. In Univariate Analysis, male gender, age more than 50, higher CCI (Charlson's Comorbidity Index) were significantly more in IBD+HCC group. Mean total Charges (58177 USD vs 44201 USD, P < 0.001) and in hospital mortality (3.2% vs 1.4%, P < 0.0001) were significantly higher in IBD + HCC group (Table 1). Multivariate analysis showed that significantly more patients with IBD + HCC group were male (Odds Ratio (OR) 2.9, P < 0.0001) but significantly less patients in IBD + HCC group were having diabetes (OR 0.51, P 0.0002). Among IBD patients, male gender (OR 1.15, P 0.001), age more than 50 (OR 11, P 0.0001), renal failure (OR 3.3, P 0.001) and higher CCI (OR 3.1, P 0.0001) were associated with higher in hospital mortality in multivariate analysis.

CONCLUSION:
HCC does co-exist in about 0.04% patients with IBD. There is no clear pathophysiology of developing HCC among patients with IBD. One theory is development of HCC due to IBD itself altering gut microbiome and causing passage of harmful bacteria to portal circulation which causes abnormal expression of cell adhesion molecules in liver causing immune mediated damage to liver. Another mechanism is development of HCC due to immunomodulating effect of medications like Azathioprine in treatment of IBD. There is need of more research to find factors associated HCC development among IBD patients.
771 No Increase in Odds for Infection or Malignancy When Treating to Disease Severity in Elderly IBD Patients
Authors: Nadhem Omar , Spataro Joseph , Gaidos Jill 
Published: October 2019

INTRODUCTION:
The prevalence of inflammatory bowel disease (IBD) in the elderly population is increasing. Current studies suggest that the use of immunosuppressive therapies in this population leads to a higher risk of complications, particularly an increase in infections. However, many studies show prolonged steroid use and ongoing active inflammation in elderly patients, suggesting undertreatment of their IBD. The aims of this study were to assess for an increase in infections or malignancy among an elderly Veteran population of IBD patients with treatment based on disease severity and disease activity.

METHODS:
After obtaining IRB approval, we performed a retrospective chart review of all VA IBD patients seen in the outpatient Gastroenterology Clinics at the Hunter Holmes McGuire VA Medical Center from January 1, 1999 through March 27, 2019. Data collected included demographic data, details of the IBD history, medication use, and any history of infection or malignancy after IBD diagnosis. Breslow-Day test was used to determine the Odds Ratios between elderly (diagnosed at 60 years or older) and non-elderly cohorts for each outcome based on medication use.

RESULTS:
153 Veterans with IBD were included: 126 (82.4%) male, 80 (52.3%) had UC, and 132 (86.3%) diagnosed <60 years of age (Table 1). At enrollment, most non-elderly subjects were treated with 5-ASAs (49%) then biologics (44%) compared to 62% of elderly subjects on 5-ASA and 38% on biologics. At one year of follow-up, there was no difference in the odds of developing infection or malignancy for elderly compared to non-elderly IBD patients with any IBD therapy (Table 2).

CONCLUSION:
In this single-center retrospective study, we found no increase in infections or malignancy in elderly IBD patients regardless of IBD therapy. Our elderly cohort is small, so our study may have been underpowered, however data collection is ongoing.
773 The Natural Course of Inflammatory Bowel Disease After Bariatric Surgery
Authors: Singh Amandeep , Aminian Ali , Nan Lan , Shen Bo , Schauer Philip , Regueiro Miguel 
Published: October 2019

INTRODUCTION:
Approximately 32–52% of inflammatory bowel disease (Crohn's disease [CD] and ulcerative colitis [UC]) patients have obesity or are overweight. Bariatric surgery (BS) is a recommended and widely used approach to address severe obesity and its related comorbidities. However, data on the effect of BS on IBD are equivocal. We aimed to assess the course of IBD after BS.

METHODS:
Using ICD-9 codes all IBD patients who underwent BS (Roux-en-Y gastric bypass [RYGB], sleeve gastrectomy [SG] or gastric band/balloon [GB]) at a major referral center between January 2000-June 2018 were identified. Data on baseline demographics, co-morbidities and concomitant medications was collected. Laboratory data, endoscopic data (Mayo score for UC and Simple Endoscopy score [SES] for CD), patient reported outcomes (PROs) and medications at baseline and 6-12 months after BS were collected. We also assessed exacerbation of IBD, hospitalization and adverse events after BS.

RESULTS:
A total of 58 IBD patients (46.6% CD and 53.4% UC) underwent BS (79.3% GS, 15.5% RYGB and 5.2% GB) during the study period. Our cohort consisted of 74% females and 81% were Caucasians. At the time of BS, mean age was 47.8 ± 12.2 years, mean BMI was 43.5 ± 7, and 36.2% were active smokers. Compared to baseline, 6 months after BS, a decrease in WBC (8.6 ± 3 vs. 7.2 ± 2), CRP (0.7 vs. 0.6), aspartate aminotransferase (34.1 ± 28 vs. 23.5 ± 10) and alanine aminotransferase (34.4 ± 28 vs. 20.2 ± 11) and an increase in vitamin D (25.5 ± 15 vs. 20.2 ± 11) (P < 0.05 for all) was noted. Beside the significant decrease in BMI (43.5 ± 7 vs. 36.3 ± 7) and HbA1C (5.6 vs. 5.2), extraintestinal manifestation of IBD also improved (50% vs. 5.2%) (P < 0.05 for all). There was no differences in PROs, IBD therapy, and endoscopy scores (Table 1). Five patients (8.6%) had IBD exacerbation (all after GS) of which two had active disease at the time of BS, only two required hospitalization and intravenous steroids, but none of the patients required any further surgery or intervention.

CONCLUSION:
To date, our study is the largest on the natural course of IBD after bariatric surgery. A significant improvement in BMI, HbA1c, liver enzymes and IBD-related extraintestinal manifestations were noted after bariatric procedures. Longer follow-up is required, but based on these results; bariatric surgery for obesity appears to be safe in IBD patients.
776 Accelerated Infliximab Infusion Protocol for Inflammatory Bowel Disease: A Safety and Cost-Effectiveness Study in an Asian Tertiary Center
Authors: Lim Chong Teik , Ong Wan Chee , Shim Hang Hock , Chan Elaine , Lim Teong Guan , Loy Kia Lan , Chan Webber 
Published: October 2019

INTRODUCTION:
The recommended infusion time for infliximab for inflammatory bowel disease (IBD) is 2 hours or more. Time spent on receiving infliximab infusions in the hospital disrupts school and work activities. Significant nursing time is also spent which increases healthcare costs. Shortening infliximab infusion to over 1 hour has been shown to be safe and has the potential to decrease time spent in hospital. This study aims to determine the safety and effectiveness of this accelerated infliximab infusion protocol in patients with IBD in Southeast Asia.

METHODS:
We conducted a retrospective study on patients with Crohn's disease (CD) and ulcerative colitis (UC), who received infliximab from September 2018 to May 2019 at Singapore General Hospital. Patients on stable maintenance infliximab were offered the accelerated protocol if they had tolerated ≥4 infliximab infusions without reactions. The need for pre-medications was determined by the prescribing physician. Primary endpoint was infusion-related reaction rate and secondary endpoints were cost and time saved per infusion.

RESULTS:
A total of 187 infusions were administered to 57 patients (53 CD, 4 UC). The mean age was 52.0 ± 17.0 years and 61.4% of the subjects were male. Out of the 57 patients, 22 of them received the accelerated infusion protocol with a total of 86 1-h infusions. Three reactions (1 immediate, 2 delayed) were observed during the 1-h infusions and were reverted back to the standard 2-h infusion subsequently. However, this was not found to be statistically significant after adjustment for age, sex, administration of pre-medications or types of disease. The median time spent per infusion in the hospital for the accelerated infusion protocol was significantly reduced compared to for the standard infusion (138 ± 26 minutes vs. 216 ± 26 minutes; P < 0.05). This improvement amounts to an estimate of 65 minutes returned to the patient for normal activities outside of the hospital per infusion. There was also a reduction in nursing time and cost (S$ 42.9 per infusion and 46.4% relative cost reduction) to the hospital.

CONCLUSION:
The accelerated infliximab infusion protocol is safe in our cohort of IBD patients. It also results in a decrease in in-hospital time for patients and improves the efficiency of healthcare delivery.
781 Dietary Practices and Beliefs of Patients With Inactive Ulcerative Colitis: A Prospective Study From the United Kingdom
Authors: Crooks Benjamin J. , McLaughlin John , Limdi Jimmy K. 
Published: October 2019

INTRODUCTION:
An epidemiological association implicating diet in inflammatory bowel disease (IBD) risk or protection is widely accepted and patients often make links to diet. Recent studies have explored dietary habits in the general IBD population but few studies have specifically addressed this in active or inactive disease.
1
We aim to describe the dietary practices of patients with inactive ulcerative colitis (UC) and the information resources which guide these beliefs.

METHODS:
We developed a questionnaire assessing demographics, dietary beliefs and habits in patients with inactive UC (defined as a PRO2 score ≤ 1 (rectal bleeding sub score = 0)). This is being prospectively administered to 200 consecutive patients with UC. We report an interim analysis of our findings.

RESULTS:
Data from 47 patients; mean age 53.7 years, 60% male and 89% Caucasian, are available so far. Mean disease duration was 10.6 years. Disease extent was 17% E1, 49% E2 and 30% E3. Mean CRP was 3.5. 68% of patients reported no relapse in the last year. 40% considered diet to be an initiating factor for their UC and this was based on their own experience (95%), a gastroenterologist's advice (26%) and the internet (26%). 49% of patients felt that diet had triggered a relapse of their disease, the most commonly reported triggers being spicy foods (57%), alcohol (39%), fatty foods (30%) and coffee (30%). 64% of patients avoided certain foods to prevent relapse. Spicy and fatty foods were most frequently avoided (70%) followed by alcohol (50%), carbonated drinks (47%), coffee (43%), milk products (37%) and sweet foods (37%). 21% of patients consumed specific foods or nutritional supplements to prevent UC relapse, most commonly turmeric in 40% of these patients. 57% reported being able to find specific dietary advice for UC, most commonly on the internet.

CONCLUSION:
A significant proportion of patients with inactive UC have strong beliefs pertaining to diet and specific dietary triggers. A high prevalence of dietary restriction may put these patients at risk of nutritional deficiency and impact upon quality of life. More data and mechanistic explanations are needed to understand the complicated relationship between dietary components and gut inflammation. A larger dataset will be presented at conference proceedings.