bluuebunny/crossref_metadata_2025_split huggingface dataset:
701 Item-Level Improvements in Inflammatory Bowel Disease Questionnaire Scores in Patients With Ulcerative Colitis Treated With Tofacitinib Induction Therapy
Authors: Dubinsky Marla C. , DiBonaventura Marco , Fan Haiyun , Bushmakin Andrew G. , Cappelleri Joseph C. , Maller Eric , Thorpe Andrew J. , Salese Leonardo , Panés Julian 
Published: October 2019

INTRODUCTION:
Tofacitinib is an oral, small molecule Janus kinase inhibitor for the treatment of ulcerative colitis (UC). Significant improvements have been reported in all Inflammatory Bowel Disease Questionnaire (IBDQ) domains for tofacitinib vs placebo (PBO) in patients (pts) with UC in OCTAVE Induction 1 & 2 and OCTAVE Sustain.
1
The effect of tofacitinib on items within each IBDQ domain has not yet been analyzed.

METHODS:
We examined the effect of tofacitinib induction (10 mg twice daily [BID]) on individual IBDQ items in adults with moderate to severe UC. Data were pooled from the randomized, Phase 3 OCTAVE Induction 1 & 2 studies (NCT01465763 & NCT01458951).
2
Pts self-administered the IBDQ at baseline (BL), Week (Wk) 4, and Wk 8. IBDQ domains are: bowel symptoms (10 items), systemic symptoms (5 items), emotional function (12 items), and social function (5 items); higher scores indicate better health-related quality of life (HRQoL).
1,3
Change from BL (CFB) in IBDQ items was analyzed for tofacitinib vs PBO using a linear mixed-effects model, with fixed effects (treatment, study, prior tumor necrosis factor inhibitor treatment, BL corticosteroid use, geographical region, week, treatment-by-week interaction, and BL score) and a random effect (pts). No multiplicity adjustment was performed.

RESULTS:
Significant improvements (P < 0.05) were observed in all IBDQ items with tofacitinib 10 mg BID vs PBO at Wks 4 and 8. The largest treatment differences (CFB; domain) were: “bowel movements been loose” at Wks 4 and 8 and also “problem with rectal bleeding” at Wk 8 (all 1.1 points) for the bowel symptoms domain; “getting a good night's sleep” at Wk 4 (0.8) and 8 (0.9) for the systemic symptoms domain; “fear of not finding a washroom” at Wk 4 (0.6) and 8 (0.8) and also “felt embarrassed” and “felt angry” at Wk 4 (both 0.6) for the emotional function domain; and “avoid attending events” at Wk 4 (0.8) and 8 (1.0) and also “difficulty doing leisure/sports” at Wk 8 (1.0) for the social function domain (Table 1).

CONCLUSION:
Tofacitinib improved all bowel-related and systemic symptoms, and all emotional and social functioning IBDQ items vs PBO, highlighting the broad impact of tofacitinib on HRQoL. This analysis provides a useful perspective on the most improved IBDQ domains with tofacitinib induction therapy, which may facilitate patient-physician dialogue.
707 Platelet to Albumin Ratio: An Early Predictor of Colectomy in Acute Ulcerative Colitis
Authors: Paknikar Raghavendra , Dwadasi Sujaata , Goens Donald , Zafer Maryam , Micic Dejan 
Published: October 2019

INTRODUCTION:
Acute ulcerative colitis (UC) is associated with significant morbidity and comes with a high risk of surgery. Prior clinical predictors have often included Day 3 laboratory values to assess risk of colectomy. Utilization of readily available data on admission may expedite medical decisions allowing for prompt initiation of therapies. Our aim was to identify early laboratory predictors of colectomy at the time of admission.

METHODS:
We designed a retrospective study including patients >18 years old with an admission for acute UC at a single academic center between 1/1/2013 and 4/1/2018. Cases were identified using the ICD-9 code 556.X and ICD-10 code K51.X and separately manually verified. Clinical variables of interest and laboratory values were obtained via chart review or extracted from the electronic medical record. Statistical analysis was conducted using JMP ® 13.1.0. Data was analyzed using Wilcoxon rank-sum test for continuous variables, Fischer's exact test for categorical variables, followed by multivariate logistic regression for predictive modeling of in-hospital colectomy.

RESULTS:
262 patients admitted with acute UC were reviewed. 59 (22.5%) required inpatient colectomy. 188 of these patients had complete platelet and albumin laboratory data. Basic demographic variables and significant predictors of colectomy in univariate analysis are described in Table 1. Platelet to Albumin ratio (PAR) was found to be the strongest assessed univariate predictor of colectomy (AUC = 0.72, P-value < 0.0001). The optimal PAR cutoff to predict colectomy was 129 (Sensitivity = 70%, Specificity = 72%). Final multivariate logistic regression model with only significant covariates included PAR score (categorical), outside hospital transfer, and number of prior biologics with an area under curve (AUC) = 0.84. PAR remained statistically significant in this model (OR: 6.48, 95% CI: 2.73-15.34). Admission platelet count and admission albumin were also predictors of colectomy in both univariate and separate multivariate analyses, whereas CRP on admission, CRP on Day 3, and CRP to Albumin ratio were not predictive of colectomy (Table 2).

CONCLUSION:
PAR ratio was found to be a robust predictor of in-hospital colectomy in acute UC. This simple laboratory tool may provide a means to quantify early risk of in-hospital colectomy. As such, an elevated PAR identified on admission can help guide therapeutic strategies aimed at mitigating risk for colectomy in high risk groups.
708 History of Clostridium difficile Infection Predicts Late Colectomy in Patients With Acute Ulcerative Colitis
Authors: Paknikar Raghavendra , Dwadasi Sujaata , Goens Donald , Zafer Maryam , Pekow Joel , Micic Dejan 
Published: October 2019

INTRODUCTION:
Studies have identified a significant prevalence of enteric pathogens (EP), most prominently clostridium difficile (CD), in patients with Ulcerative Colitis (UC). The clinical role of these EPs remains debatable, as in patients with UC they often can represent the sole reason for acute presentation, asymptomatic carrier status, or a comorbid presentation with UC. We aimed to study the prevalence of testable EPs in hospitalized UC patients and assess the impact of these pathogens on colectomy outcomes.

METHODS:
We designed a retrospective study including patients >18 years old with an admission for UC at a single academic center between 1/1/2013 and 4/1/2018. Cases were identified using the ICD-9 code 556.X and ICD-10 code K51.X and separately verified. Clinical variables of interest and laboratory values were obtained via chart review or extracted from the electronic medical record. Logistic regression was performed in order to identify predictors of in-hospital and 90 day colectomy. Statistical analysis was conducted using JMP ® 13.1.0.

RESULTS:
262 patients admitted with UC were reviewed. Our study identified 48/251 (19.1%) patients with positive CD testing. 11/91 (12.1%) patients had Non-CD EPs and only 1/91 (1.1%) patient was positive in both tests. The identified infections are outlined in Table 1. We also identified 31/261 (11.9%) who had a positive CD test in 8 weeks prior to admission. Basic demographic and clinical variables are listed in Table 2. History of CD infection in the past 8 weeks before admission predicted Colectomy at 90 days in univariate analysis (P-value = 0.0015). Multivariate logistic regression model with all covariates in Table 2 (excluding non-CD EP status and in-hospital CD infection status) revealed an area under curve = 0.80. History of CD infection in the past 8 weeks remained the only significant predictor within this model of late colectomy at 90 days (P-value = 0.0063, OR = 10.53, 95% CI 1.95-57.0).

CONCLUSION:
Prior to admission diagnosis of CD infection is a strong predictor of late colectomy at 90 days in hospitalized patients with UC. Multiple explanations are possible including outpatient management of CD delaying initiation of inpatient management of acute UC flares. Conversely, accumulated adverse effects of gut dysbiosis from EPs may occur over weeks before leading to adverse outcomes. Future work is needed to optimally characterize the pathogenicity of both CD and non-CD EPs in UC patients via current testing and treatment strategies.
718 The Experience of and Access to Rapid Infliximab Infusions at an Academic Tertiary Medical Center
Authors: Pusateri Antoinette , Patel Nisha , Hatcher Ashley , Lehman Joy , Afzali Anita 
Published: October 2019

INTRODUCTION:
Infliximab (IFX) induces and maintains remission in patients with inflammatory bowel disease (IBD) and rheumatologic disease (RD). It is time-intensive, which places great burden on patients and health systems. Rapid infusions (RI) reduce infusion time from 2 hours to 1 hour, theoretically can alleviate this burden and enhance access to care defined by effectiveness (safety), availability (capacity) and utilization (patient characteristics). We aimed to describe the RI experience at our center, with the hypothesis that RI enhance access to care for all patients regardless of indication for IFX.

METHODS:
All patients treated with IFX for IBD or RD at our outpatient infusion center from February 2016 to August 2017 were included. Demographic and clinical information including IFX indication, history of infusion reaction, use of pre-medication, number of standard and RI were collected.

RESULTS:
There were 348 patients, 212 (60.92%) were female, 193 (55.5%) had IBD and 143 (41.1%) had RD. In terms of safety, 21 (6%) had a history of infusion reaction, 7.8% with IBD and 3.5% with RD (P = 0.1127). 33.6% were premedicated for infusions. For only RD, a lower number receiving RI received pre-medications (P = 0.0002). The history of infusion reaction was 5.7% in the RI group and 6.3% in the standard infusion group (P = 1.000). Only 2 patients required switch back to standard infusion after reaction with RI. In terms of capacity, 40% of patients were converted to RI during the study period. This resulted in a 16.1% decrease in average daily infusion time and 9.8% increase in average daily available scheduled chair time or an additional 261.2 (±19.7) minutes per day (P = 0.72). In terms of patient characteristics, a larger number of RD patients received RI versus IBD patients (P = 0.0261). Only for the RD group a lower number of patients receiving RI were female (P = 0.0491). For patients with RD and IBD, a lower number of patients receiving RI versus standard infusions were on public insurance (P = 0.011 and P = 0.0151) and patients receiving RI had been on IFX for a longer period of time (P = 0.0002, P < 0.0001).

CONCLUSION:
RI were safe and increased available chair time. There were differences in patient characteristics: females with RD and public insurance patients were less likely to receive RI. Future directions include creation of a prospective registry and patient quality of life surveys to understand if implicit bias against disease, gender, socioeconomic status, or other factors impact access to RI.
721 Risk Factors for Recurrence vs. Reinfection of Clostridioides difficile Infection in Inflammatory Bowel Disease: Single Center Retrospective Study
Authors: Dickson Zachary , Hunold Thomas , Baray Merwise , Hays R. Ann 
Published: October 2019

INTRODUCTION:
Patients with inflammatory bowel disease (IBD) are at greater risk for development of Clostridioides difficile infection (CDI) than the general population, ulcerative colitis (UC) more so than Crohn's disease (CD). Although the data regarding risk factors for development of CDI in IBD patients is conflicting, a 2019 meta-analysis suggested recent antibiotics, colonic involvement in CD, and biologic therapy to be significant risk factors. This study investigated the role of these risk factors and the use of proton pump inhibitors (PPI), opiates, and steroids in the development of recurrence vs reinfection of CDI in IBD patients.

METHODS:
A retrospective cohort of patients age 18-75 with a history of IBD diagnosed with CDI from January 1, 2012–December 31, 2016. Recurrence defined as CDI diagnosis within 3 months of the index CDI. Reinfection defined as second episode of CDI between 3 months to 3 years of the index CDI. Patient demographics, antibiotics used to treat index CDI, presence of colonic involvement, and use of PPIs, opiates, biologics, and steroids at the time of second CDI were recorded. Data was analyzed with Fisher's exact test and student t-tests using SAS 9.4 software.

RESULTS:
A total of 121 IBD patients with CDI were identified: 60 with Crohn's and 61 with UC. 59.5% of IBD patients had either recurrent CDI or CDI reinfection. Recurrent CDI occurred in 32.7% of UC patients and 23.3% of Crohn's patients. CDI reinfection was observed in 36.6% of Crohn's patients and 26.2% of UC patients. Colonic involvement was documented in 100% (n = 14) of Crohn's patients with CDI recurrence and 81.8% (n = 18) of Crohn's patients with CDI reinfection. CDI recurrence and reinfection were not associated with gender, race, or the use of steroids, biologics, PPIs, opiates, or antibiotics.

CONCLUSION:
Compared to Crohn's patients, there was a greater proportion of UC patients who experienced recurrent CDI. Additionally, colonic involvement occurring in all Crohn's patients in this cohort with recurrent CDI suggests that the extent of colonic disease may predispose to recurrent CDI. Further investigation examining the incidence of recurrent CDI in Crohn's patients without colonic involvement is warranted. This study suggests that therapy with biologics, opiates, PPIs, and steroids are not risk factors for the development of CDI in IBD patients.
727 Clinical Epidemiology of Inflammatory Bowel Disease in Los Angeles County: A Study of a Predominantly Latino Population
Authors: Zhornitskiy Alex , Fung Brian M. , Tabibian James H. 
Published: October 2019

INTRODUCTION:
The body of research pertaining to the epidemiology, features, and treatment of inflammatory bowel disease (IBD) continues to grow; however, relatively little remains known about IBD in minority populations. Hispanics and Blacks have been understudied in most population studies, often comprising <2% of the sample size. This disproportion limits the ability to formulate reliable conclusions regarding ethnoracial influences on incidence, phenotype, severity of disease, and outcomes in these minority groups. To help address this void, we initiated a population-based study of the clinical epidemiology of IBD in Los Angeles County Department of Health Services (LADHS), the second largest municipal healthcare system in the United States. The ethnoracial makeup of the county is comprised predominantly of Latino patients, which provides a unique opportunity to evaluate IBD in a population that has not been well-studied to date.

METHODS:
We conducted a retrospective cohort study of all biopsy-proven cases of IBD diagnosed between November 2015 and June 2018 at Olive View-UCLA Medical Center, one of three hospitals comprising LADHS. Patient and disease-related data such as age, gender, ethnicity, presenting symptoms and laboratory values, and complications, were collected using a standardized data collection tool and tabulated.

RESULTS:
One hundred and twenty-six cases of IBD were found, of which 42 were new diagnoses, suggesting an incidence and prevalence of 160 and 481 per 100,000 person-years, respectively. Among these 126 patients, 79% were Latino, with the average age of diagnosis at 36.4 years. 54% of patients were female. The most common diagnosis was ulcerative colitis (43%), with Crohn's and indeterminate colitis making up 29% and 28% of patients, respectively. The most common presenting symptoms were bloody diarrhea and abdominal pain, both of which occurred more frequently in patients diagnosed with Crohn's disease.

CONCLUSION:
Both the prevalence and incidence in this predominantly Hispanic cohort are significantly higher than reported rates for IBD by the Center of Disease Control (CDC), Furthermore, this cohort appears to have unique clinical characteristics, with UC more common in females, Crohn's disease more common in males, and a large proportion of patients having indeterminate colitis. Further evaluation is needed to better understand the characteristics, etiopathogenesis, and outcomes of IBD, as well as reduce healthcare disparities in this historically understudied population.
729 The Impact of Anemia on Venous Thromboembolism and Short Term Outcomes Among Hospitalized Patients With Inflammatory Bowel Disease
Authors: Wade Francis , Mohammed Kahee , Schroeder Katie S. 
Published: October 2019

INTRODUCTION:
Inflammatory bowel disease (IBD) patients have increased venous thromboembolism (VTE) risk and commonly have iron deficiency anemia (IDA) and anemia of chronic inflammation (ACI). Anemia can signal increased inflammation and disease severity in IBD patients. Pro-inflammatory diseases, like IBD, and IDA have been independently associated with VTE. VTE chemoprophylaxis is sometimes withheld in hospitalized IBD patients with minor rectal bleeding or severe disease due to safety concerns. This study aimed to assess the impact of anemia on VTE, in-hospital mortality, and length of hospital stay in hospitalized IBD patients.

METHODS:
Using the Nationwide Inpatient Sample database, a cross-sectional analysis was performed of hospitalized IBD patients between 2008 and 2014 aged ≥18 years stratified by VTE diagnosis based on ICD-9 code. Multivariate hierarchical logistic regression analyses were performed to evaluate the impact of IDA and ACI on VTE and short-term outcomes.

RESULTS:
Of 434,834 hospitalized IBD patients, 2.8% had diagnosis of VTE. Characteristics of hospitalized IBD patients are described (Table 1). ACI and IDA were independently associated with VTE in IBD patients. In a subgroup analysis using a multivariate hierarchical logistic regression model, IBD patients with IDA had higher odds of VTE (OR, 1.35; 95% CI, 1.27–1.43), deep vein thrombosis (OR, 1.36; 95% CI, 1.27–1.46), and pulmonary embolism (OR, 1.40; 95% CI, 1.27–1.54). IBD patients with ACI also had higher odds of VTE (OR, 1.28; 95% CI, 1.20–1.37) and deep vein thrombosis (OR, 1.42; 95% CI, 1.32–1.53), but not pulmonary embolism (OR, 0.94; 95% CI, 0.83–1.05). Higher odds of in-hospital mortality were seen in IBD patients with IDA (OR, 2.03; 95% CI, 1.82–2.28) and ACI (OR, 1.43; 95% CI, 1.30-1.58). Prolonged hospitalization was also more common in IBD patients with IDA (OR, 1.36; 95% CI, 1.33-1.40) and ACI (OR, 1.54; 95% CI, 1.49-1.59) (Table 2).

CONCLUSION:
The presence of anemia due to IDA and ACI independently predicts the occurrence of VTE, prolonged hospitalization, and in-hospital mortality in hospitalized IBD patients. Higher odds of in-hospital mortality and prolonged hospitalization suggests increased disease severity among hospitalized IBD patients with anemia. Providers should adhere to VTE chemoprophylaxis guidelines for hospitalized IBD patients, including those with severe disease or minor rectal bleeding, to mitigate VTE risk.
732 Laboratory Parameters Related to Monitoring in Patients With Ulcerative Colitis Treated With Tofacitinib for up to 3 Years in the OCTAVE Open-Label, Long-Term Extension Study
Authors: Melmed Gil Y. , Chang Shannon , Kulisek Nicole , Fan Haiyun , Lawendy Nervin , Maller Eric , Soonasra Arif , Irving Peter M. 
Published: October 2019

INTRODUCTION:
Tofacitinib is an oral, small molecule JAK inhibitor for the treatment of ulcerative colitis (UC). Monitoring of liver enzymes, lipids, absolute neutrophil count (ANC), absolute lymphocyte count (ALC), and hemoglobin (Hg) is recommended in patients (pts) with UC treated with tofacitinib.
1

METHODS:
Changes in laboratory parameters (liver enzymes, lipids, ANC, ALC, and Hg) from baseline at Month 36 were investigated in pts with moderately to severely active UC treated with tofacitinib in OCTAVE Open, an ongoing Phase 3, open-label, long-term extension (OLE) study (NCT01470612; data as of Sep 2018, database not locked). Pts who completed or demonstrated treatment failure in the OCTAVE Sustain maintenance study, or those who were non-responders after completing OCTAVE Induction 1 or 2, were eligible for the OLE study. Pts in remission at the end of OCTAVE Sustain were assigned to tofacitinib 5 mg twice daily (BID); all other pts were assigned to tofacitinib 10 mg BID in the OLE study. The proportions of pts with laboratory values meeting protocol criteria for discontinuation (Table 1), with investigator-defined hyperlipidemia treatment-emergent adverse events (TEAEs), and with a change in lipid-lowering agent (LLA), were evaluated.

RESULTS:
For pts treated with tofacitinib 5 and 10 mg BID, changes from OLE study baseline in liver enzymes, lipids, ANC, ALC, and Hg at Month 36 and the proportion of pts meeting protocol criteria for discontinuation are presented in the Table 1. Hyperlipidemia TEAEs were experienced by 1.7% and 1.2% of pts treated with tofacitinib 5 and 10 mg BID, respectively. Furthermore, 8.0% and 6.6% of pts treated with tofacitinib 5 and 10 mg BID, respectively, had a new LLA added, and 2.3% and 1.7% of pts treated with tofacitinib 5 and 10 mg BID, respectively, had their LLA dose increased.

CONCLUSION:
No major changes from OLE study baseline were observed in the laboratory parameters recommended for monitoring in pts treated with tofacitinib up to Month 36. In addition, the proportions of pts meeting protocol criteria for discontinuation for liver enzymes, ANC, ALC, or Hg, with hyperlipidemia TEAEs or with a change in LLA, were evaluated and were low in both tofacitinib treatment groups. Due to the dose assignment in the OLE study, the pt populations in the treatment arms differ in terms of their baseline remission status.