bluuebunny/crossref_metadata_2025 huggingface dataset:
790 Does Inflammatory Bowel Disease Predispose Patients to an Increased Risk of Heparin-Induced Thrombocytopenia?
Authors: Aijazi Muaz , Ahuja Ashish , Williams George W.
Published: October 2019

INTRODUCTION:

Heparin-induced thrombocytopenia (HIT) is a rare, but life-threatening, complication seen in approximately 5% of those exposure to heparin for more than 4 days. It is currently believed that the female sex, surgical patients, and those greater than age 40 are at increased risk for developing HIT.
1
Here, we explore the possibility of increased risk of HIT in patients who are known to have inflammatory bowel disease.

METHODS:

We used the National Inpatient Sample (NIS) from 2010 to 2012 to identify 14,121 patients with an ICD-9CM code for HIT. Patients with diagnosis codes for Crohn's disease or ulcerative colitis were classified as having IBD. Outcomes in patients with IBD were compared to those without immune mediated conditions using chi-square and student's t-test where appropriate.

RESULTS:

Of the 14,121 HIT patients identified, 103 had a pre-existing diagnosis of Crohn's disease and 56 had pre-existing ulcerative colitis. Having a prior diagnosis of Crohn's disease corresponded to an OR of 1.17 (P-value 0.115, 95% CI 0.96, 1.42) for subsequently developing HIT. Ulcerative colitis conferred an OR of 1.12 for developing HIT (P = 0.4, CI 0.86, 1.46). A statistically significant change was not demonstrated for either disease.

CONCLUSION:

Our study shows that having a diagnosis of IBD does not significantly increase risk of developing HIT. This is interesting considering IBD is considered as gastrointestinal immune disorders. Also of note, while they themselves are technically not considered autoimmune – it has been demonstrated in the literature that immune mediated diseases were significantly more frequent in patients with IBD.
2
Prospective research will be required to further elucidate a relationship between IBD and HIT.
791 Morbidity and Mortality of Influenza Virus in Inflammatory Bowel Disease
Authors: Maddika Srikanth , Then Eric O. , Aloreidi Khalil , John Febin , Are Vijay S. , Gayam Vijay , Culliford Andrea , Gaduputi Vinaya
Published: October 2019

INTRODUCTION:

Inflammatory bowel disease (IBD) is thought to occur secondary to inappropriate host immune responses, resulting in gastrointestinal inflammation. On that basis, many studies have established an association between IBD and opportunistic infections. No studies however have evaluated its association with influenza virus, a commonly seen pathogen.

METHODS:

We retrospectively analyzed patients hospitalized with the diagnosis of IBD, consisting of Crohns disease and Ulcerative Colitis, and patients with the diagnosis of influenza virus via ICD-9 codes in the year 2014 using the Nationwide Inpatient Sample (NIS) database. Our primary endpoint was to evaluate the morbidity and mortality associated with IBD and superimposed influenza virus. We looked at multiple variables including incidence, length of hospital stay (LOS), and mortality rate. Logistic regression models were developed using STATA software version 15.

RESULTS:

A total of 1,027,740 patients with IBD, 523,190 patients with influenza virus, and 358,400 patients with IBD and influenza virus were included in our study population. We found that patients with IBD were 111% more likely to have influenza virus than patients without IBD (OR: 112.772, CI: 108.778-116.808, P-value: 0.000). In addition, patients with IBD and influenza virus presented at a statistically significant younger age when compared to patients with IBD alone (56.31 years vs 58.47 years, P-value: 0.000). On the contrary, patients with IBD and influenza virus had statistically significant shorter LOS (4.4 days vs 4.7 days, P-value: 0.000) and lower mortality rate (1.5 vs 1.9, P-value: 0.004) than patients with influenza virus alone. Similarly patients with IBD and influenza presented at a later age than patients with influenza alone (56.31 years vs 55.99 years, P-value: 0.385), but these findings were not statistically significant.

CONCLUSION:

We conclude that IBD patients are more susceptible to develop infection with influenza virus than patients without IBD. Although this association is clear, the mortality rate and LOS were lower in IBD patients with influenza compared to patients with influenza virus alone. Limitations such as our retrospective study design, and sample size may explain this paradoxical finding. Conversely there may exist an age-related bias, in that older more frail patients with influenza virus are more likely to seek medical attention when compared to their younger counterparts.
792 Gastroenterologist-Led Management of Iron Deficiency Anemia—A Tertiary Care Experience
Authors: Dalal Robin , Coe Christopher , Meyers Matthew , Garrett Ailish , Duley Caroline , Wagnon Julianne , Annis Kim , Scoville Elizabeth , Beaulieu Dawn B. , Schwartz David A. , Horst Sara
Published: October 2019

INTRODUCTION:

Iron deficiency anemia (IDA) is a common extra-intestinal complication of inflammatory bowel disease (IBD) which includes both Crohn's disease (CD) and Ulcerative Colitis (UC). The objective of this study was to evaluate the effects of gastroenterologist-led management of IDA in the IBD population.

METHODS:

A retrospective chart review was conducted at a single tertiary care inflammatory bowel disease center. All patients with proven IBD (CD or UC) and anemia (defined as hemoglobin (Hgb) < 12 for women and <13 for men) treated through the IBD center with standard regimens of intravenous iron (iron sucrose 200 × 5 doses, ferric carboxymaltose 750 mg × 2 doses, ferumoxytol 510 mg × 2 doses) were included. Statistical analysis was performed using paired t test, pearson chi-squared test, and Wilcoxon rank sum test.

RESULTS:

351 pts (249 pts with CD, 102 pts with UC) were evaluated. Median age was 33 (IQR 25, 46) and 62% were female. The majority of pts (79%, n = 251) had active endoscopic disease prior to treatment for IDA. 60% of pts were on biologic therapy and 27% were on corticosteroids. Hgb and iron increased significantly after iron treatment in both CD and UC as seen in Table 1. SIBDQ improved significantly in both CD and UC as seen in Figure 1. After iron treatment, 41.2% of pts had resolution of IDA. Male pts were more likely to remain anemic than female pts (P = 0.016 using pearson chi-squared test); age and IBD type (CD vs. UC) did not affect anemia persistence. 53% of pts were re-treated with iron infusions. 3% of pts required blood transfusions for IDA. Only 8% of pts required hematology referral.

CONCLUSION:

In a large cohort of pts with IBD, IDA improves after gastroenterologist-led treatment but persists in the majority of pts, especially male pts. Treatment of IDA improves pts quality of life. Over half of pts required re-treatment. Only a minority of pts required hematology referral for management of IDA.
793 Persisting Malnutrition After Medical Therapy in Children With Crohn's Disease Is Associated With Increased Rates of Surgery and Complicated Disease Behavior
Authors: Ahmed Shahzad , Iskandar Heba , Liu Zijun , Mondal Kajari , Markowitz James , Hyams Jeffrey , Denson Lee , Walters Thomas , Dubinsky Marla C. , Kugathasan Subra
Published: October 2019

INTRODUCTION:

Although malnutrition in children diagnosed with Crohn's disease (CD) is common, the effect of malnutrition on clinical outcomes following diagnosis of CD has not been evaluated.

METHODS:

We used data from 948 CD subjects recruited from the RISK inception cohort to examine the impact of malnutrition on disease progression. Our primary exposures of interest were reported weight loss at diagnosis (reported as yes/no) as well as age specific body mass index (BMI) z-scores defined as the deviation of the value for an individual from the mean value of the reference population. Z-scores were stratified according 2015 guidelines of pediatric malnutrition to categorize the presence and severity of malnutrition over 3 years of follow-up. Our primary outcomes were development of complicated (stricturing or penetrating) disease, need for CD-related hospitalization, and surgery. Logistic regression models were used to define independent associations.

RESULTS:

Reported weight loss and malnutrition were present in 72.9% and 40.5% respectively of children diagnosed with Crohn's disease (Table 1). Following diagnosis at 6 months, BMI z-scores improved significantly such that only 13.2% remained malnourished and the rate of moderate/severe malnutrition declined from 17.6% to 2.2% (Figure 1). Failure to improve BMI z-score from 6 months was associated with increased risk of surgery (22% vs. 9%, P < 0.05) and B2/B2 phenotype (18% vs. 12%, P < 0.01) but not hospitalization (35% vs 28%, P > 0.05) at 3 years. The rate of overall malnutrition improved at 6 months but then remained stable until 3 years (range 13.9-15.9%, P > 0.05) and the association with increased rates of surgery and B2/B3 disease remained significant.

CONCLUSION:

Weight loss and malnutrition at diagnosis are common following diagnosis of CD in children. Failure to improve BMI z-score at 6 months and beyond correlates with increasing risk of surgery and complicated disease phenotype. We speculate that aggressive pharmacologic and nutritional management may improve/reverse the course in this narrow phenotype, and prospective studies are warranted to prove this concept.
796 Effect of Disease Location on Endoscopic and Radiographic Outcomes in Patients With Moderate to Severe Crohn's Disease Initiated on Vedolizumab
Authors: Kashani Amir , Pabla Baldeep S. , Eaddy Andre , Scoville Elizabeth , Dalal Robin , Beaulieu Dawn B. , Schwartz David A. , Horst Sara
Published: October 2019

INTRODUCTION:

Vedolizumab (VDZ), an integrin antagonist, is approved to treat moderate to severe Crohn's disease (CD). We aimed to investigate how CD location effected the endoscopic and radiographic outcomes of VDZ.

METHODS:

This is a retrospective study from a tertiary care center, in patients (pts) with CD initiated on VDZ between July 2014 and January 2018. Pts had endoscopic or radiographic evaluation before (index examination) and >3 months after (follow-up examination) VZD initiation. Endoscopic remission/response was defined as resolution (remission) or significant improvement (response) of CD features with respect to the index examination. Endoscopic remission/response rate was compared between ileal and colonic disease. Improvement in radiographic features of small bowel (jejunum/ileum) CD was evaluated on magnetic resonance imaging or computed tomography scan.

RESULTS:

140 pts were evaluated with a median follow-up 18 months (range: 3-55) (Table 1). 90% of the pts (n = 126) had prior anti-TNFα failure. 128 pts had endoscopic evaluation with a median follow up 27 months (3-55) (Table 2). Endoscopic remission/response rates between pts with ileal CD (62% [47/76]) and pts with colonic CD (49% [34/69]) were not statistically different (P = 0.13). Endoscopic remission/response rates in pts with isolated ileal CD (n = 59) and isolated colonic CD (n = 52) were similar (59% vs. 46% respectively; P = 0.17). Among pts with both ileal and colonic disease (n = 17), endoscopic remission/response rates were similar in ileal and colonic CD (71% vs. 59% respectively; P = 0.47). Endoscopic remission/response rate in the ileal disease in pts with prior ileocolic resection (ICR; n = 38) was lower than in pts with an intact anatomy (n = 22) (55.3% vs. 77.3% respectively; P = 0.05). Follow-up imaging was available in 30 pts with radiographic evidence of small bowel CD (median follow up 13 months [3-28]). Radiographic improvement was observed in 26.7% of pts.

CONCLUSION:

In this cohort of pts with CD, majority anti-TNF experienced, a significant number of pts had improvement in endoscopic features of CD on VDZ, regardless of CD location. Ileal disease in pts with prior ICR appears to be less responsive to VDZ as compared to in pts with an intact anatomy. Radiographic features of small bowel CD showed a low rate of improvement on VDZ. Further understanding of the impact of VDZ on small bowel CD is warranted.
798 Predictors of Delayed Response to Tofacitinib: Results of the OCTAVE Open Study for Delayed Responders
Authors: Regueiro Miguel , Kinnucan Jami A. , Ungaro Ryan , Quirk Daniel , Su Chinyu , Lawendy Nervin , Fan Haiyun , Woodworth Deborah A. , Neurath Markus F.
Published: October 2019

INTRODUCTION:

Tofacitinib is an oral, small molecule JAK inhibitor for the treatment of ulcerative colitis (UC). Tofacitinib efficacy and safety were shown in 3 Phase 3 trials in patients (pts) with UC.
1
Pts who received tofacitinib 10 mg twice daily (BID) for 8 weeks in OCTAVE Induction 1/2 (NCT01465763/NCT01458951) and did not achieve clinical response could receive tofacitinib 10 mg BID in a Phase 3, open-label, long-term extension (OLE) study (NCT01470612).
2
OLE data (up to 3 years) for pts achieving clinical response with an additional 8 weeks of tofacitinib (delayed responders) have been reported.
3

METHODS:

We evaluated potential predictors of delayed response (clinical response [≥3-point and ≥30% decrease from induction study baseline (BL) total Mayo score, and ≥1-point decrease in rectal bleeding subscore (RBS) or absolute RBS ≤1] after 16 weeks of 10 mg BID [8 weeks induction, 8 weeks in OLE]). Characteristics at OCTAVE Induction 1/2 BL and BL and Month 1 of the OLE study were evaluated in induction responders (clinical response to 8 weeks of 10 mg BID), delayed responders, or complete non-responders (non-response to 16 weeks of 10 mg BID).

RESULTS:

Characteristics at OCTAVE Induction 1/2 BL were generally similar between subgroups (Table 1). The proportion of pts with prior tumor necrosis factor inhibitor (TNFi) failure was numerically higher in complete non-responders vs delayed responders (Table 1). Induction study BL mean C-reactive protein was numerically higher in complete non-responders vs induction responders and delayed responders with a similar trend at OLE BL (Table 1). At OLE Month 1, stool frequency subscore (SFS) and RBS were numerically lower in delayed responders vs complete non-responders, and partial Mayo score (PMS) reduction from OLE BL was greater for delayed responders vs complete non-responders (Table 1).

CONCLUSION:

Numerically higher proportions of complete non-responders and delayed responders had prior TNFi failure vs induction responders. In pts with UC, early improvement at Month 1 during extended induction in SFS, RBS, and PMS may indicate likelihood of response to extended induction. The post-hoc data suggest tofacitinib 10 mg BID treatment beyond 8-week induction may be associated with clinical response in initial non-responders. Further evaluation with a larger sample size is needed.
801 Phenotypic Characteristics of Crohn’s Disease in Latin Americans Versus U.S. Hispanics: A Systematic Review With Meta-Analysis
Authors: Contreras Alberto , Satiya Jinendra , Zuckerman Marc J. , Alvarado Luis , Dwivedi Alok , Avalos Danny
Published: October 2019

INTRODUCTION:

Latin America is experiencing a rise in the prevalence and incidence of inflammatory bowel disease (IBD). Environmental and dietary changes may be contributing factors. In Latin America, Crohn’s disease (CD) is less common than ulcerative colitis (UC), but the predominant phenotype of CD is not established. Also, it is unknown whether there are regional differences in phenotype across Latin America. This systematic review aims to describe the phenotype of CD in Latin Americans as compared with U.S. Hispanics.

METHODS:

We conducted a systematic review with meta-analysis of population-based studies to compare the phenotype of CD across Latin America with U.S. Hispanics. Phenotype was defined according to the Montreal classification. A systematic search was conducted using MEDLINE and EMBASE. Inclusion criteria: (i) studies describing the phenotype of CD in Latin America and Hispanics in the U.S. (ii) age >18. Exclusion criteria: (i) prevalence or incidence studies not describing the phenotype. A random effects model was chosen “a priori” for analysis of pooled proportions.

RESULTS:

A total of 4,627 studies were screened. 34 studies from Latin America and 7 studies from the U.S met inclusion criteria. 2,877 Latin Americans and 233 U.S. Hispanics had the diagnosis of CD. The predominant phenotype in Latin America was ileo-colonic disease (L3) with a pooled proportion of 0.37 (95% CI 0.32-0.41, I2 82%), and for U.S. Hispanics, 0.46 (95% CI 0.31-0.61, I2 82.5%), P = 0.88. Inflammatory behavior (B1) was predominant for Latin America and U.S. Hispanics, 0.51 (95% CI 0.41-0.60, I2 94.3%) vs. 0.64 (95% CI 0.42-0.87, I2 91.7%), P = 0.24, respectively. Perianal involvement was similar between Latin Americans and U.S Hispanics with nearly one-third of patients showing this phenotype, P = 0.82. Phenotype across Latin America was similar except in Cuba, where ileal disease was present in nearly one-half of patients. Colonic CD (L2) was less frequently seen in Cuba, 0.15 (95% CI 0.10-0.21), P = 0.002. Disease behavior and perianal involvement were similar across Latin Americans, Table 1.

CONCLUSION:

The phenotype of Crohn's disease was similar between Latin Americans and U.S. Hispanics. This goes in line with current knowledge that ileo-colonic disease is the predominant disease location in Caucasians. Disease behavior and perianal involvement were similar between Latin Americans and U.S. Hispanics. In Latin America, the phenotype was homogeneous, except in Cuba where ileal disease was the predominant location.
804 Predictors of Colectomy in Patients Admitted With Inflammatory Bowel Disease: A Population-Based Study
Authors: Khoudari George , Singh Amandeep , Alkhadra Yasser , Baidoun Firas , Sarmini Muhammad Talal , Kirby Donald F. , Shen Bo , Regueiro Miguel
Published: October 2019

INTRODUCTION:

In patients with inflammatory bowel disease (IBD), colectomy is common inpatient requiring hospitalization. Although risk factors for colectomy have been previously assessed in IBD patients, most of these studies were confined to referral hospitals. We aim to identify the factors associated with colectomy in a population-based cohort of hospitalized IBD patients.

METHODS:

Using data from the National Inpatient Sample (NIS) database between 2002 and 2014, patients with the diagnosis of IBD were identified. Patients who underwent colectomy were then compared with patients who did not undergo colectomy. Multivariate logistic regression analysis was performed to identify predictors of colectomy in IBD patients.

RESULTS:

Out of 3,380,451 patients with IBD, 71,715 (2.1%) underwent a colectomy. There were more ulcerative colitis patients than Crohn’s disease, 52,534 and 19,980, respectively. Patients who underwent colectomy were younger (48.9 vs 50.4, P < 0.001), had more males (53% vs 43%, P < 0.001) and less African Americans (6.0% vs 10.1%, P < 0.001). In colectomy, patients had more clostridium difficile (C. diff) and cytomegalovirus (CMV) infections, primary sclerosing cholangitis, colon cancer, pulmonary circulation disorders, and coagulopathy (P < 0.001). On multivariate logistic regression, colon cancer had more than 5-times higher chances of colectomy (odd ratio [OR] 95% confidence interval {CI} 5.574 (5.364-5.792) (P ≤ 0.001). Risk of colectomy was higher in patients with C. diff infection, with coagulopathy, and CMV (OR [95% CI] 2.831 (2.748-2.915), 1.878 (1.813-1.946), and 1.537 (1.350-1.750), (P < 0.001 for all), respectively. Table 1 represents the patient's characteristics.

CONCLUSION:

In this large population cohort, IBD patients with an infection, specifically CMV and C. diff, or colon cancer had higher rates of colectomy. Patients with these risk factors should have an early consultation with surgery and evaluation for infections.
806 Long-Term Safety and Efficacy of Risankizumab Treatment in Patients With Crohn’s Disease: 3-Year Interim Results From the Ongoing Phase 2 Open-Label Extension Study
Authors: Ferrante Marc , Feagan Brian G. , Panés Julian , Baert Filip , Louis Edouard , Dewit Olivier , Kaser Arthur , Duan Weijiang , Gustafson Dawn , Liao Xiaomei , Wallace Kori , Kalabic Jasmina , D'Haens Geert R.
Published: October 2019

INTRODUCTION:

Efficacy/safety of the interleukin (IL)-23 inhibitor risankizumab (RZB) were previously assessed in patients (pts) with moderate-to-severe Crohn’s disease (CD) following induction and maintenance treatments.1,2 Pts who responded to RZB in the Phase 2 induction and maintenance study2,3 could enrol in an open-label extension (OLE) study4. Interim safety/efficacy of RZB maintenance treatment, up to 3 years, are reported from this ongoing OLE.

METHODS:

Pts who achieved clinical response (decrease from baseline [BL] in CD Activity Index [CDAI] ≥ 100) without remission (CDAI < 150) after Week (wk) 26 or clinical response and/or remission after Wk 52 of the preceding study 1 were enrolled to receive open-label 180 mg subcutaneous RZB every 8 wks for up to 206 wks. Pts who lost clinical response or remission after completing preceding study were re-induced with open-label 600 mg intravenous RZB at Wks 0, 4, 8. Ileocolonoscopy was performed yearly. Treatment-emergent adverse events (AEs) were collected throughout the study up to 20 wks after last dose of study drug or data cut-off date of Feb 04, 2019. Efficacy endpoints as listed and defined in the Table 1, are reported up to Wk 104.

RESULTS:

A total of 65 adults with CD were enrolled, including 4 pts who were re-induced. Median CD duration was 10 (range 2–38) yrs. Sixty pts (92.3%) were previously exposed to TNF antagonists; 13 pts (20%) and 21 pts (32.3%) were receiving corticosteroids only and immunomodulators only, respectively, and 9 (11.8%) pts were receiving both, prior to BL of the preceding study. At the data cut-off date, mean (SD) exposure to RZB was 866.8 (316.6) days, and 18 (27.7%) pts had prematurely discontinued from the study. The efficacy endpoints were sustained up to Wk 104 (Table 1). After a median follow-up of 31 months, AEs were reported for 58 (89.2%) pts; 22 (33.8%) pts experienced serious AEs. The most common AEs were nasopharyngitis (29.2%), gastroenteritis (20.0%), fatigue, abdominal pain, and worsening CD (18.5% each), and arthralgia (15.4%). Serious infections included anal or subcutaneous abscess (1 pt each), Campylobacter infection (1 pt), viral gastroenteritis (2 pts), and peritonitis (2 pts). No events of tuberculosis, malignancies, or deaths occurred in the study.

CONCLUSION:

In this 3-yr interim analysis, efficacy endpoints were sustained in pts with CD receiving long-term open-label RZB treatment. The safety profile of RZB remains consistent with previously results.2 No new safety signals were identified.
807 Superior Outcomes in Crohn’s But Not UC Admissions to Academic Hospitals
Authors: Lipcsey Megan , Maheshwari Rahul , Stein Daniel J. , Feuerstein Joseph
Published: October 2019

INTRODUCTION:

Inflammatory bowel disease (IBD) affects an estimated 3.1 million US adults and is increasing in prevalence. Recent data found lower mortality rates for common conditions in Medicare beneficiaries admitted to academic vs non-teaching hospitals. This study compares outcomes for patients admitted with IBD to academic vs non-academic hospitals.

METHODS:

The national inpatient sample (NIS) from 2016 was queried for all cases of Crohn’s disease (CD) or ulcerative colitis (UC) where this was the principle cause for admission (first ICD-10 code). Outcomes for patients admitted to academic (teaching) hospitals were compared to those admitted to non-academic rural or urban hospitals using survey-adjusted chi square and linear regression to examine mortality, length of stay (LOS), abdominal surgery, and hospitalization costs. Multivariable models adjusting for Elixahauser mortality score (an NIS-specified validated comorbidity measure) and surgery during admission were created. CD and UC patients were analyzed separately.

RESULTS:

In 2016, there were 35,950 admissions for UC and 71,040 for CD. No difference was seen in mortality for academic (0.4%) versus community (0.5%) hospitals in UC (P = 0.56). Mortality for CD patients was 0.2% in academic vs 0.4% in non-teaching hospitals (P = 0.06). Adjusting for surgery and Elixhauser score, patients admitted to a non-academic hospital had an OR for death of 0.95 in UC (P = 0.90) but 2.2 in CD (P = 0.03). Patients at academic hospitals were more likely to undergo surgery for both UC (19% vs 5.1%, P < 0.0001) and CD (22.9% vs 11.7%, P < 0.0001). Elixhauser scores were higher for UC (6.0 vs 5.4, P = 0.01) as well as CD (4.3 vs 3.8, P = 0.002) patients at non-academic hospitals. Regression analysis showed that UC patients at non-academic hospitals had shorter LOS (P = 0.001) with no significant differences in cost. In the CD regression, non-academic hospitals had shorter LOS (P < 0.0001) with lower cost (P = 0.01).

CONCLUSION:

After adjustment for comorbidities and surgery during admission, patients admitted to community hospitals had twice the odds of death in CD; no similar effect was seen with UC. Surgical interventions and LOS were significantly lower for all IBD patients at community hospitals despite higher Elixhauser scores. Further research is needed to investigate outcomes in IBD patients admitted to academic vs community hospitals.
809 Making Time for Health Maintenance: A Busy Clinic's Quality Improvement Study of the Inflammatory Bowel Disease Population
Authors: Beard Jasna I. , Patel Suril , Kahloon Arslan
Published: October 2019

INTRODUCTION:

Inflammatory bowel disease (IBD) patients require a special focus on health maintenance. However, many studies demonstrate surprisingly inadequate compliance in various categories. Surveys have shown that they are at an increased risk of acquiring influenza and are more likely to suffer its complications but vaccination rates remain low. Similarly, hepatitis vaccination remains inadequate despite the fact that most IBD patients regularly see a gastroenterologist. Other studies show that women with IBD are less likely to have updated cervical cancer screening but are more likely to have high-grade dysplasia or cancer. Additionally, despite advancements in IBD management, lifetime rates of osteoporosis remain as high as 70%. The current guidelines offer detailed recommendations but, despite the capable providers, motivated patients, and the many visits, prevalence of adequate preventive care remains low. We offer one example of a structured quality improvement study in a busy “real world” clinic using sustainable measures easily incorporated into the typical day.

METHODS:

Using the existing American College of Gastroenterology guidelines for preventive care, we evaluated our baseline compliance and developed quality improvement cycles. First intervention was a checklist incorporated into each IBD patient's visit note, regardless of the reason for the visit. We then assessed which areas, if any, demonstrated improvement. We used the following cycles to focus on the most clinically relevant (eg. tuberculosis screening prior to biologic therapy) and those with lowest baseline numbers (eg. use of symptom scores). Each 60-day cycle was then evaluated by a detailed review of at least 30 patient charts each averaging 1.25 visits during study period.

RESULTS:

Baseline data demonstrated low compliance with measures such as tuberculosis screening every 12 months (55.9%), TPMT enzyme assay (75%), vaccination (ranging 2.04-14.9%), among others. Despite the low utilization of the checklist at 23% in first 60 days, various categories improved, including rate of reproductive health counseling (from 10.2% to 31.4%), hepatitis B vaccination (from 14.9% to 30.7%), DEXA scans (4.08% to 15.4%), among others (see Table 1).

CONCLUSION:

Our quality improvement study shows that a step-wise use of simple interventions is a durable way to improve compliance with guidelines to offer comprehensive and thoughtful care. Future cycles will include increased patient engagement and collaboration with ancillary services.
815 Prevalence of Depression in African American Patients With a Diagnosis of Inflammatory Bowel Disease: Findings From a Large Safety Net Outpatient Center
Authors: Ajose Taiwo A. , Abe Temidayo , Kagbokue Suaka , Gboluaje Temitayo , Ajose Afolarin , Flood Michael , Richter Seth
Published: October 2019

INTRODUCTION:

Major depressive disorder (MDD) is a leading cause of disability and morbidity in the United States. Multiple observational studies have demonstrated an increased prevalence of MDD in patients with inflammatory bowel disease (IBD) with an associated increased morbidity. Compared with other ethnic groups African Americans are more likely to be depressed. No major studies have examined the prevalence of depression in AA with IBD.

METHODS:

Hypothesis/Objective: • To determine the prevalence of depression in AA with IBD. • AA with IBD will have a higher prevalence of depression. We retrieved electronic medical records from one of the outpatient departments of a large safety net hospital between November 2017, and March 2018. African American Patients with a diagnosis of IBD were identified and electronic medical records were reviewed. Data regarding screening with PHQ-9 score was obtained, depression was defined by PHQ-9 score >5. MS excel was used to determine the prevalence of depression while stratified analysis was used to determine the effects of age, sex, co-morbidites and marital status on depression. Two-sided P-value < 0.05 was considered statistically significant.

RESULTS:

A total of 157 AA patients were included in the study, out of which 125 (79.5%)AA patients with IBD were screened for depression with the PHQ-9 score. Mean age of the sample was 47 +/- 14 years, 56% (n = 70) were females while 44% (n = 55) were males. Depression was present in 8.8% (n = 11/125) of the study population. Out of the 11 depressed patients 72.9% (n = 8) were mild, 9.1% (n = 1) moderate and 18.2% (n = 2) were severe. Male and female show no statistically significant difference in the level of depression (P > 0.05). There was no association between depression and asthma, COPD, kidney diseases, CAD, diabetes mellitus and hypertension (P > 0.05).

CONCLUSION:

Contrary to our hypothesis, our study revealed that depression rate in AA with IBD is comparable to that of the general population which has been reported to be about 7%. Further studies will look to identify the clinical, sociodemographic and system level contributors to depression in patients with IBD at our center. Our study also revealed that our center has a good depression screening rate in IBD patients in accordance with national guidelines.
817 Identification of Biomarkers and Mechanistic Insight for Upadacitinib in Crohn’s Disease: Serum Inflammatory Mediator Analysis From the Phase 2b CELEST Study
Authors: Séverine Vermeire , Guay Heath , Verstockt Bram , Hong Feng , Lee Wan-Ju , Cataldi Fabio , Lacerda Ana , Danese Silvio
Published: October 2019

INTRODUCTION:

We report pharmacodynamic profiling of serum inflammatory mediators in CELEST (patients) pts with the aim of understanding UPA mechanism of action in CD and linking biomarkers to intestinal inflammation, abdominal pain (AP), and stool frequency (SF).

METHODS:

The CELEST Ph2 study evaluated the efficacy/ safety of multiple dosing regimens of UPA vs PBO in adults with moderately to severely active CD and inadequate response or intolerance to immunomodulators and/or TNF inhibitors.1,2 Serum samples from baseline (BL) visit and end of induction period (Wk16) were analyzed by OLINK® inflammation panel (92 proteins) and Singulex immunoassay for interleukin-17A(IL-17A), IL-17F, IL-22, and IL-23p19. Protein level changes (BL–Wk16) were analyzed by an ANCOVA model where BL protein level was adjusted as a covariate and treatment effect was considered significant when a false discovery rate < 0.10 was observed after multiplicity adjustment on F-test P-values. Spearman rank correlation coefficients(rs) determined relationships between BL levels or BL–Wk16 level changes of serum biomarkers (also including serum C-reactive protein and fecal calprotectin) and improvements in Simple Endoscopic Score for CD (SES-CD), AP, and SF.

RESULTS:

Paired BL and Wk16 serum samples were available from 104 pts (UPA 3 mg twice daily [BID], n = 18; 6 mg BID, n = 19; 12 mg BID, n = 13; 24 mg BID, n = 18; 24 mg once daily, n = 18; and PBO, n = 18). UPA treatment significantly reduced expression of serum pro-inflammatory mediators (Table). that are associated with immune cell migration, type I/II interferon (IFN) responses, T cell activation, T helper cell-1 (Th1) responses, and CD8+ T cell responses. UPA treatment did not significantly modulate expression of IL-23/Th17-related serum cytokines in CD. Correlations were observed for BL–Wk16 changes in serum proteins and SES-CD, AP, or SF. Importantly, oncostatin-M reductions correlated with SES-CD (rs = 0.35, P = 0.02) and SF improvement (rs = 0.33, P = 0.04), suggesting similar drivers of these aspects of disease. AP improvement correlated with reductions in CSF-1 (rs = 0.37, P = 0.01), TNFRSF9 (rs = 0.34, P = 0.03), IL-12B (rs = 0.31, P = 0.07), CXCL9 (rs = 0.31, P = 0.07), and CD8A (rs = 0.31, P = 0.09), which are all associated with the Th1/CD8/IFN-γ pathway.

CONCLUSION:

This analysis of inflammatory mediators in serum of CD pts from CELEST identifies potential pharmacodynamic biomarkers and mechanistic insights for the JAK-1 inhibitor, UPA.
818 Assessing the Level of Unmet Need Amongst Ulcerative Colitis Patients in the United States and Europe
Authors: Kershaw Jim , Lucas James , Naessens Dominik
Published: October 2019

INTRODUCTION:

To assess the level of unmet need within Ulcerative Colitis (UC) patients currently prescribed biologic treatment and patients prescribed conventional treatments in Europe and the USA.

METHODS:

This is a real-world survey of treating Gastroenterologists and their consulting UC patients conducted in 2017 after the introduction of vedolizumab to the UC market. Patients were included from France, Germany, Italy, Spain, the United Kingdom and the United States of America. Physicians completed patient record forms for the next seven eligible adult patients diagnosed with UC. Patient record forms contained details on patient demographics, clinical factors, satisfaction with control of condition and details on current treatment received. Only patients with a diagnosis of moderate-to-severe disease severity were included in the analysis. Patients currently receiving biologic treatment with a duration over 3 months allowing time for response to treatment where compared to patients receiving conventional treatments.

RESULTS:

A total of n = 1714 patients from the EU and n = 619 from the US were included in the analysis. In the EU n = 522/US n = 182 of UC patients were currently receiving biologic treatment and EU n = 1049 / US n = 389 were currently receiving conventional treatment. Physicians reported in the EU 34%/US 42% of biologic patients were not currently in remission, EU 44%/US 57% for conventional patients. 36% of biologic patients in the EU and 51% in the US had experienced in the last 12 months or were currently experiencing a flare, 36% EU and 28% US for conventional patients. In the EU 71%/US 75% of biologic patients currently experienced symptoms, suffering a mean EU 3.2/US 3.3 symptoms. For conventional patients EU 77%/US 85%. Patients with symptoms suffered a mean of EU 3.8/US 3.3 symptoms.

CONCLUSION:

A high proportion of UC patients receiving conventional treatments were not classed as currently being in remission by their physician, were currently experiencing symptoms and had currently or had suffered from a flare in the last 12 months. This was similar for patients who were currently receiving biologic treatment despite the introduction of vedolizumab to the market.
828 Effect of Obesity on Venous Thromboembolism-Related Morbidity Among Hospitalized Patients With Inflammatory Bowel Disease: A Nationwide Population Study
Authors: Shah Ishani , Bhurwal Abhishek , Mehta Harsh , Das Ananya
Published: October 2019

INTRODUCTION:

Obesity and inflammatory bowel disease (IBD) have been associated with an increased risk of venous thromboembolism (VTE). Limited data exists related to the effect of obesity on IBD-related complications, including VTE. The aim of our study was to assess the effect of obesity on VTE-related outcomes among patients with IBD.

METHODS:

All adults hospitalized with IBD and VTE during the years 2010 to 2014, were identified using the Nationwide Inpatient Sample (NIS). These patients were divided into two groups: patients who were overweight, obese or morbidly obese (study group) and those with a normal BMI (control group). We compared demographics, inpatient mortality, length of stay and total charges among both these groups.

RESULTS:

During the five-year study period, there were 295,592 hospitalizations for patients with IBD who also had a co-diagnosis of VTE. Compared with non-obese controls, obese patients were older (mean age 58.72 years vs 55.02 years; P < 0.001) and more likely to be females (53.24% vs 44.94%; P = 0.001). Patients in both groups were predominantly White (71.14% vs 73.17%) compared to African Americans (12.79% vs 13.49%) and Hispanics (11.25% vs 7.97%); P = 0.001. Comorbidities such as diabetes (45.55% vs 25.95%; P = 0.001) and hypertension (67.49% vs 55.97%; P = 0.001) were more prevalent in the obese group. Rates of colectomy were higher (3.98% vs 0.94%; P = 0.003) among obese patients. Complications associated with pulmonary embolism (PE) such as cardiogenic shock (1.16 vs 0.11; P = 0.67), right heart failure (9.83% vs 5.45%; P = 0.002) and respiratory failure (19.06% vs14.66%; P = 0.001) were also higher in the obese group of patients. Length of stay (9.72 days vs 5.18 days; P < 0.001), inpatient mortality (2.32% vs 1.11%; P < 0.001) as well as total cost of hospitalization ($21,469 vs $17,291; P = 0.001) were all higher among obese IBD patients with VTE as compared to non-obese controls. On multivariate logistic regression, obesity was an independent predictor of length of stay (OR 0.13 [0.10-0.16]; P < 0.001) and inpatient mortality (OR 1.78 [1.61-1.99]; P < 0.001) among hospitalized IBD patients with VTE.

CONCLUSION:

Obesity is associated with a significantly higher rate of VTE-related morbidity and mortality among patients with IBD. The total cost of hospitalization among these patients is also higher compared to non-obese individuals. Our study identifies obesity as a risk factor leading to poorer outcomes among IBD patients who are hospitalized with VTE.
838 Quality Assessment of Clinical Practice Guidelines (CPGs) for the Diagnosis and Treatment of Inflammatory Bowel Disease
Authors: Hidalgo Diego , Montesinos-Guevara Camila , Escobar Camila , Viteri Andrés , Franco Juan , Simancas-Racines Daniel , Hidalgo Jessica
Published: October 2019

INTRODUCTION:

Inflammatory bowel disease (IBD) comprises Crohn's Disease (CD) and Ulcerative Colitis (UC), which are chronic disorders characterized by inflammation of the gastrointestinal (GI) tract. IBD is caused by a combination of genetic and environmental factors and a deregulated immune system. While UC comprises a diffuse mucosal inflammation of the large bowel, CD presents as a patchy and transmural inflammation. The severity of IBD varies over time and urgent medical care is required when complications arise. Thus, clinical practice guidelines (CPGs) for IBD diagnosis and treatment have been created and updated over time. To our knowledge, only one study has assessed CPGs' quality for IBD, which were published in Japanese. The aim of this revision is to evaluate current CPGs for IBD diagnosis and treatment so healthcare professionals and patients can benefit from it.

METHODS:

We performed a systematic search in databases including Medline, Embase, CINAHL, Lilacs, NICE, SIGN, ACG, AGA, Portuguese Gastroenterology Society, and Australian Gastroenterology Society. Two reviewers were calibrated for the inclusion of CPGs by screening the same 25% of total records by title and abstract (Tiab), the Intraclass Correlation Coefficient (ICC) between reviewers was 0.7. The remaining 75% of total records was divided between the two reviewers, who independently assessed them. A similar process was performed for full-text assessment obtaining an ICC of 0.8. If reviewers disagreed, a third reviewer was involved and conflicts were solved by discussion. The authors using the AGREE II tool will evaluate all included CPGs.

RESULTS:

5134 records were retrieved and 5042 remained after de-duplication. 106 records were included after Tiab screening for full-text assessment and 16 CPGs were included for data extraction. According to the data obtained from the 16 included CPGs, they were published in English, Spanish, Japanese, German and Korean. 6 CPGs were focused on UC alone, 7 were focused on CD, and 3 addressed IBD. Moreover, the 16 CPGs were developed in Israel (4), Germany (1), Japan (1), Mexico (2), Canada (1), USA (2), South Korea (1) UK (1), Spain (1), and Multiple countries (2). CPGs' developers include: Professional Association/Society (7), University (3), Government (1), and International Organization (5).

CONCLUSION:

This evaluation of 16 CPGs for the diagnosis and treatment of IBD contributes to a better understanding of the quality of evidence-based clinical recommendations.
839 Response and Healthcare Resource Utilization in Inflammatory Bowel Disease Patients Treated With Either Infliximab or Vedolizumab
Authors: Sarles Harry E. , Hardin Thomas C. , Kuten Samantha A. , Van Anglen Lucinda J.
Published: October 2019

INTRODUCTION:

Both infliximab (IFX) and vedolizumab (VDZ) are FDA-approved for treatment of inflammatory bowel disease (IBD) in adults. Much of the published data on clinical outcomes for either IFX or VDZ compare the biologic agent against more traditional therapies rather than alternative biologics. The aim of this study was to evaluate clinical response and healthcare resource utilization (HRU) in IBD patients (pts) treated with either IFX or VDZ for 12 months (mos).

METHODS:

We performed a review of adult Crohn’s disease (CD) and ulcerative colitis (UC) pts who initiated treatment with either IFX or VDZ from 2016-2018 at a large multicenter, gastroenterology private practice. Those who persisted on therapy for 12 mos were identified. Pts were case-matched 1:1 based on age, gender, diagnosis, and baseline disease severity scores using the partial Mayo (pMayo) for UC and the modified Harvey-Bradshaw Index (mHBI) for CD. Primary endpoints were changes in disease activity at 3, 6, and 12 mos compared to baseline, and IBD-related HRU, defined as emergency department (ED) visits, and hospitalizations during the 12 mos. Additionally, adverse drug reactions (ADR) and infections were assessed.

RESULTS:

Case-matching yielded 35 IFX (16 CD, 19 UC) and 35 VDZ (16 CD, 19 UC) pts for further assessment. Demographics were similar between groups: mean age 38 ± 20 vs 40 ± 15, male gender 54% vs 51%. Baseline scores were similar as noted in Figure 1. In the overall assessment of response between groups, both IFX and VDZ in CD were associated with a reduction in HBI score of >60% at 3 mos. IFX and VDZ use in UC were associated with reductions in pMayo scores at 3 mos of 56% and 44%, respectively. These substantial reductions were sustained through 12 mos. IFX-treated pts had 4 IBD-related ED visits with 1 hospitalization, while VDZ-treated pts had 5 IBD-related ED visits and 4 hospitalizations. Infection rates were similar with 8 infections in IFX pts (23%) and 7 in VDZ pts (20%); 1 VDZ infection led to hospital admission. Thirteen (5 IFX, 8 VDZ) non-serious infusion-related ADRs were reported with no difference between treatment groups.

CONCLUSION:

The data demonstrate similarity in response and healthcare resource utilization over time with use of IFX or VDZ in the treatment of IBD patients. Although the number of case-matched patients in this study is limited and the population is restricted to responders, resource utilization was noticeably low. Additional study is warranted.
843 Crohn’s Strictures Open With Anti-Mycobacterial Antibiotic Therapy (AMAT): A Retrospective Review
Authors: Agrawal Gaurav , Collyer Rhys , Clancy Annabel , Gunaratne Anoja W. , Lampe Stephan , Borody Thomas
Published: October 2019

INTRODUCTION:

Approximately one third of patients with Crohn’s disease (CD) will develop strictures within 10 years of diagnosis, commonly in the terminal ileum and ileocecal valve (ICV). Strictures often lead to abdominal pain, obstruction and are a risk factor for developing internal fistulae and cancer. Current treatment involves endoscopic balloon dilatation or strictureplasty. However, this may result in postoperative complications or recurrence. Recent evidence suggests that Mycobacterium avium ssp paratuberculosis may be a causative agent of CD and anti-mycobacterial antibiotic therapy (AMAT) has been shown to induce remission significantly better than placebo. The effects of AMAT on strictures has not been reported.

AIM:

To report the outcomes of AMAT in patients with CD and an ileal stricture/s.

METHODS:

This is a single centre retrospective (January 1995-December 2018) case review of patients diagnosed with CD, who had ileal stricture on colonoscopy and were treated with AMAT which comprised a combination of clarithromycin, rifabutin, and clofazimine, some with added ethambutol, ciprofloxacin, metronidazole or tinidazole. Symptoms, colonoscopy reports, biochemistry and concurrent medications were reviewed and recorded at pre-treatment and 6, 12, 18 and >24 months on treatment.

RESULTS:

Forty-three patients (24 male, 16-56 yrs) with an average age of 31 yrs, and 5 yrs (0-27 yrs) after diagnosis were included. At pre-treatment, 17 patients had stricturing of the ICV, 25 had stricturing of the ileum and one had stricturing in both the ileum and ICV. Of the patients who had follow up colonoscopy data (N = 32), after >24 months of AMAT, 22/32 patients (69%) had complete resolution and 2/32 patients had partial resolution of their strictures. Interestingly, after resolution of stricture on AMAT one patient ceased treatment. At 36 month follow up post cessation of AMAT the patient’s ileocecal stricture had returned. Further treatment with AMAT resulted in resolution of the stricture.

CONCLUSION:

AMAT for CD is effective in opening Crohn’s strictures avoiding the need for repeated dilatations or surgery. These observations suggest that stricturing in CD may be mediated by mycobacterial infection, as reported in tuberculosis strictures. To our knowledge, CD strictures have not previously been reported to open using medical therapy. Further prospective documentation is required to better define this positive effect of AMAT, including rate of resolution.