bluuebunny/crossref_metadata_2025_split huggingface dataset:
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.