bluuebunny/crossref_metadata_2025_split huggingface dataset:
684 Crohn's Disease and Risk of Surgery Based on Disease Location and Phenotype
Authors: Young Chase K. , Jahandar Donya R. , Hamdeh Shadi , Kalot Mohamad , Makki Maha , Olyaee Mojtaba 
Published: October 2019

INTRODUCTION:
Crohn's disease (CD) is a chronic inflammatory disease that can affect any segment of gastrointestinal tract. Over 50% of patients develop complications like strictures or fistula formation and past studies report 50% of Crohn's disease patients require surgery within ten years from disease diagnosis. We aim in this study to determine the risk of surgery in Crohn's disease based on disease location and phenotype.

METHODS:
A retrospective study was conducted evaluating CD patients on anti TNF agents seen at the University of Kansas Medical Center from data inceptions until May, 2018. Patients were stratified by disease location (ileum, colon, ileocolon, or upper GI tract) as well as phenotype (stricturing, fistulizing, luminal or mixed patterns). The primary outcome was the need of surgery based on phenotype and disease location. The secondary outcome was the time to start anti TNF therapy in each category based on disease location and phenotype.

RESULTS:
Data from 229 patients with CD was analyzed. From which, 128 underwent surgery. Our analysis showed that Patients with the fistulizing type had the highest rate of surgery with 51/62 patients (82% P < 0.0001) with (mean = 5.69 ± 9.3 years to start anti TNF) and patients with the luminal subtype had the lowest rate of surgery with 26/89 patients (29%, P < 0.0001) with (mean = 3.77 ± 8.88 years to start anti TNF) in comparison to patients with other subtypes stricturing, stricturing + fistulizing, stricturing + luminal, fistulizing + luminal or Stricturing + fistulizing + luminal who had 31/50 (62%, P = 0.33, mean = 7.02 ± 8.89 years), 11/15 (73%, P = 0.16 mean = 10.9 ± 13.2), 2/3 (66% P = 1, mean = 0.33 ± 0.58), 6/9 (66%, P = 0.74 mean = 4.89 ± 6.), and 1/1 (100% P = 1, mean = 2) respectively. Regarding the location of Crohn's disease, patients with ileocolonic involvement had the highest rate of surgery with 64.2% and with a mean of 6.15 ± 9.95 years to start anti TNF, Whereas patients with only colonic involvement have the lowest rate of surgery of 37.5% with a mean of 4.33 ± 8.41 years to start anti TNF. Patients with the disease in other locations; ileal and upper GI had 39% rate of surgery (with a mean of 2.64 ± 4.25 years to start anti TNF) and 61.9% % rate of surgery (with a mean of 8.43 ± 11.74 years to start anti TNF) respectively.

CONCLUSION:
Patients with CD with fistulizing phenotype and ileocolonic location are at the highest risk for surgery, whereas patients with luminal phenotype and colonic location are at the lowest risk for surgery.
687 Epidemiology of Older-Onset Inflammatory Bowel Disease in the United States Between 2014 and 2019: A Population-Based National Study
Authors: Mansoor Emad , Saleh Mohannad Abou , Sarmini Muhammad Talal , Chouhan Vijit , Regueiro Miguel , Katz Jeffry , Cooper Gregory S. 
Published: October 2019

INTRODUCTION:
Recent studies have described the rising incidence of older-onset IBD (>60 yo) in the Western world. However, the epidemiology of older-onset IBD in the United States (US) has not been studied extensively and is subject to debate. We sought to describe the prevalence and incidence of older-onset IBD in the US between 2014 and 2019 utilizing a large population based database.

METHODS:
We queried a commercial database (Explorys Inc, Cleveland, OH), an aggregate of Electronic Health Record data from 26 major integrated healthcare systems in the US from 1999 to 2019. We identified an aggregated patient cohort of eligible patients with a "first-ever" diagnosis of “Crohn's disease” or “Ulcerative Colitis” at age >60 years between June 2014 and 2019, based on Systemized Nomenclature of Medicine – Clinical Terms. We calculated the 5-year prevalence older-onset IBD overall, among different patient groups and stratified by decades. Furthermore we also calculated the incidence of older onset IBD over last 1 year between 2018 and 2019.

RESULTS:
Of the 10,726,480 individuals aged >60 yo active in the database from June 2014-2019, we identified 38,730 and 40,230 individuals with a diagnosis of CD and UC with an overall prevalence rate of 0.36% and 0.38% respectively. The prevalence of older-onset CD was increased in females at 0.38% [OR: 1.13, 95% CI: 1.11-1.16, P < 0.0001] compared to males at 0.34%, and Caucasians at 0.45% [OR: 1.65, 95% CI: 1.59-1.72, P < 0.0001] compared to African-Americans at 0.27%. The prevalence of older-onset UC was increased in females at 0.39% [OR: 1.07, 95% CI: 1.04-1.09, P < 0.0001] compared to males at 0.36%, and Caucasians at 0.47% [OR: 1.67, 95% CI: 1.60-1.74, P < 0.0001] compared to African-Americans at 0.28% (Figure 1). Among age-stratified analyses, as expected, the prevalence of both CD and UC was lowest in the 60-69 yo decade, increased with subsequent decades and downtrended in the 90+ age group (Figure 2). The incidence of older onset CD and UC over last 1 year between 2018 and 2019 was 0.21% and 0.20% respectively.

CONCLUSION:
This is one of the first large studies to date that has described the prevalence and incidence of older-onset IBD in the US. We found that the prevalence of older-onset CD and UC is higher in females and Caucasians. We further identified that older-onset CD and UC is most prevalent in the 80-89 yo decade of life and decreases thereafter.
691 Risk Factors for and Frequency of CT Scans in Inflammatory Bowel Disease Patients Seen in the Emergency Department
Authors: Glassner Kerri , Euers Lindsay , Gajula Prianka , Jones-Pauley Michelle , Ezeana Chika F. , Puppala Mamta , Wang Lin , Wong Stephen T. , Oglat Ayah , Nickerson Stephanie , Abraham Bincy 
Published: October 2019

INTRODUCTION:
Patients with inflammatory bowel disease (IBD) frequently have CT scans performed during emergency department (ER) visits and hospitalizations. Previous studies found that the younger a patient is when a CT scan is performed, the higher the risk of malignancy over a lifetime. Younger IBD patients have also been shown to have an increased frequency of ER visits, thus placing them at risk for repeat CT scans. Our aim was to determine the risk factors for and frequency of CT scans performed in all IBD patients seen in our ER.

METHODS:
A retrospective analysis of IBD patients seen at Houston Methodist Hospital ER from 2014 to 2017 was performed using ICD codes to identify patients with Crohn's disease (CD), ulcerative colitis (UC) or indeterminate colitis from the EMR. There were 559 unique patients with 1489 unique visits confirmed after individual chart review. Data was collected on demographics including age, sex, and ethnicity; medications; and imaging (CT of the abdomen/pelvis).

RESULTS:
Of the 559 patients with ER visits, 61% were female with an average age of 50 (range 18-95). There were 65% with CD, 34% with UC, and less than 1% had indeterminate IBD. Of these, 23% were on a biologic, 15% on an immunomodulator, and 27% were treated with steroids for IBD. There were 325 patients (58%) with 599 visits during which a CT scan was performed, and of these 88% were ordered in the ER. The average age was 46, and 60% were female. IBD was the primary reason for the visit in 66%. There were 68% with CD, 31% with UC, 24% on a biologic medication, 17% immune modulator, and 35% received steroids. Older age was associated with a decreased risk of CT scan P = <2.2 × 10-16, R -0.002, as well as UC compared to CD, P = 0.009, R -0.06. There was an increased risk of CT scan in patients on a biologic, P = 0.038, R 0.04, immunomodulator, P = 0.039, R 0.029, or when steroids were given for IBD, P = 1.44 × 10-13, R 0.102. There was an increased risk of undergoing a CT scan when the primary reason for the visit was for IBD, P = <2.2 × 10-16, R 0.372.

CONCLUSION:
Over half of the IBD patients in our study population had CT scans performed, which almost always occurred in the ER. There was an increased risk of a CT in those on a biologic, immunomodulator, or steroids for IBD, suggesting that more severe disease may contribute. Younger patients and those with CD also had an increased risk. Guidelines are needed to limit repeat CT scans in young IBD patients to reduce the risk of increased malignancy over their lifetime.
692 Low Levels of Ustekinumab Despite Dose Escalation Is a Risk Factor for Surgery
Authors: Glassner Kerri , Perry Caroline , Wilhite Amanda , Abraham Bincy 
Published: October 2019

INTRODUCTION:
Ustekinumab is an IL-12/23 inhibitor used for the treatment of Crohn's disease (CD). Previous studies have suggested that dose escalation to every 4-week intervals can be beneficial in patients who do not achieve a clinical response on every 8-week maintenance dosing. However, safety and efficacy is unknown in CD patients escalated to more frequently than every 4-week intervals in patients who continue to have low trough drug levels.

METHODS:
We performed a retrospective chart review of patients on ustekinumab for CD who had dosing escalation to every two weeks (Q2) due to persistent low drug levels (<5 µg/mL) despite being on q4 weeks (Q4) maintenance dosing and clinically losing response.

RESULTS:
Out of 200 CD patients on ustekinumab 90 mg subcutaneous (SQ) maintenance in our IBD program, 112 underwent reactive therapeutic drug monitoring for loss of response or incomplete response to therapy. Of the 112 with drug levels, none had anti-drug antibodies, but 80 patients had levels <5 mcg/mL. All 80 patients were frequency escalated to q4 week dosing. Of these, 12 patients continued to have low ustekinumab trough levels at week 4 (<5 mcg/mL) and thus were escalated to Q2 week dosing. Eight of the 12 patients had IV reinduction dosing prior to dose escalation to Q2 frequency. Of the 12 patients, 6 (50%) required surgery for their active Crohn's disease. These patients were on Q2 week dosing for median of 16 weeks (range 1-68) prior to surgery. All 6 (100%) were able to be de-escalate to less frequent dosing after surgery. Two patients that were unable to de-escalate their dosing frequency are planning for surgery in the near future. The remaining four patients were able to de-escalate to Q4 dosing after clinical response. See full details in Table 1. No adverse events unrelated to their Crohn's disease, including infections or other safety markers were noted.

CONCLUSION:
Low levels of ustekinumab despite escalation of dosing to every 2 weeks may suggest a need for Crohn's disease related surgery. In our study, all patients who underwent surgery were able to de-escalate to lower dosing frequency suggesting that high inflammatory disease burden contributed to the low levels of ustekinumab. Further studies are needed to assess the safety and efficacy of high frequency dosing of ustekinumab.
697 Safety of Ustekinumab in Inflammatory Bowel Diseases: Integrated Safety Analysis of Results From Phase 2 and 3 Studies in Crohn's Disease and Ulcerative Colitis
Authors: Sandborn William J. , Ghosh Subrata , O'Brien Christopher D. , Ott Elyssa , Marano Colleen , Zhou Yiying , Volger Sheri , Tikhonov Ilia , Gasink Christopher , Danese Silvio , Sands Bruce E. 
Published: October 2019

INTRODUCTION:
Ustekinumab (UST) is a well-established therapy in Crohn's disease (CD) and psoriatic diseases. UST was safe and effective in phase 3 ulcerative colitis (UC) studies. Pivotal studies of UST in CD (UNITI, IMUNITI) and UC (UNIFI) had similar designs, which allows for integrated analysis across both indications. We present an integrated safety analysis of UST in inflammatory bowel disease (IBD).

METHODS:
Data from 6 phase 2/3 studies were pooled, and safety was evaluated through 1 year of follow-up. In phase 3, pts received a single IV placebo (PBO) or UST (130 mg or ∼6 mg/kg) induction dose followed by SC maintenance doses of PBO or UST (90 mg q8w or q12w). Concomitant immunomodulators (IMM) and corticosteroids were permitted. All pts who received ≥1 dose of UST were included. Safety outcomes through 1 year are presented as the number of pts with events per 100 patient-years (PY) of follow-up.

RESULTS:
At induction baseline (2370 pts in pooled phase 3 IBD studies), median age was 38.0 years, 46.9% were receiving corticosteroids, 30.8% were receiving IMM, 53.0% had failed biologics, and 37.1% were naïve to biologics. In phase 3 IBD studies, through Wk8 of PBO-controlled induction, the frequency of key safety events was similar between UST and PBO (Table 1). In addition, through 1 year across phase 2/3 IBD studies (Table 2), numbers of pts per 100 PY with key safety events were similar between treatment groups. The most frequently occurring AEs (excluding diseases under study) were arthralgia (PBO 16.93 vs UST 16.56), headache (16.43 vs 16.50), nausea (13.25 vs 11.94), and abdominal pain (14.59 vs 11.54); infections were nasopharyngitis (16.26 vs 18.11) and upper respiratory tract infection (11.40 vs 11.36). For serious infections, the CD-specific event of anal abscess occurred in PBO 2.02 and UST 0.90 pts per 100 PY. When CD-specific events were excluded, overall rates of serious infections were similar between UC and CD. The only malignancy (excluding NMSC) reported in >1 UST-treated patient was prostate cancer; no lymphomas were reported through 1 year. Two pts receiving UST (0.12 per 100 PY; both had UC) died from events that investigators considered to be unrelated to study agent (esophageal varices hemorrhage and acute respiratory failure during thyroid surgery).

CONCLUSION:
The safety profile of UST in pts with UC and across integrated IBD indications through 1 year was favorable and consistent with the established safety profile in pts with CD and psoriatic disease.
699 Role of C-Reactive Protein as a Marker for Disease Course in Obese Patients With Inflammatory Bowel Disease
Authors: Ye Chengcheng , Higgins Ixavier , Iskandar Heba 
Published: October 2019

INTRODUCTION:
Currently, the disease course and clinical outcomes of obese patients with inflammatory bowel disease (IBD) have been mixed. This study aims to compare biomarkers of inflammation such as erythrocyte sedimentation rate (ESR) and c-reactive protein (CRP) in both obese and non-obese African American (AA) and Caucasian populations.

METHODS:
We conducted a prospective observational study of consecutive Crohn's disease (CD) and ulcerative colitis (UC) patients in the outpatient setting at a tertiary referral center between 2014-2017. Body mass index (BMI), ESR, CRP, hemoglobin (Hgb) were measured at 2 consecutive visits. Obesity was defined as a BMI ≥30. The Wilcox signed rank test was used to compare continuous variables, and the Chi square test for categorical variables. A multivariate logistic regression model was created to look at change in CRP (no change, increase by half, decrease by half) from initial to follow-up visit. The regression model analysis included ethnicity, gender, BMI, type of IBD (CD versus UC), age, alcohol use, tobacco use, hypertension, kidney disease, heart disease, and treatment as covariates.

RESULTS:
The study included 92 subjects, 65% had CD and 30% were AA (Table 1). The average time between visits was 136 days. In the obese group, 33% were AA and 70% were female. Also, a larger portion of CD patients were obese compared to UC patients (37% and 11% respectively with P = 0.03). There was a significant decrease in the CRP in the obese group (P = 0.029) whereas non-obese individuals had an increase in CRP (Table 2). There was no significant difference in ESR and hemoglobin (Hgb) between obese and non-obese individuals. 63 patients where included in the regression model, which showed that a decrease in CRP was significantly associated with obesity (P = 0.0081) when adjusted for the above covariates. Overall, obese individuals were more likely to experience no change in CRP or a decrease in CRP while non-obese individuals were more likely to have a rise in CRP. There was no difference in clinical disease activity indices (HBI/SCCAI) between obese and non-obese patients.

CONCLUSION:
In our study, the obese patients were more likely to be female, have CD, and be Caucasian. While there was no difference in Hgb or ESR in obese versus non-obese, there is a difference in CRP. CRP could have importance as a sensitive marker for disease course in patients whose BMI ≥30. A larger cohort may provide further insight into this observation.
700 Mild Endoscopic Activity Is Associated With an Increased Risk of Relapse in Patients With Ulcerative Colitis
Authors: Feldman Harris , George Lauren A. , Abutaleb Ameer , Hine Ashley M. , Zullow Samantha , Axelrad Jordan E. , Hudesman David P. , Cross Raymond K. 
Published: October 2019

INTRODUCTION:
Currently, endoscopic remission in ulcerative colitis (UC) is defined using the Mayo Endoscopic subscore (MES), with a score of 0 (normal mucosa) or 1 (erythema, decreased vascular pattern, mild friability) representing mucosal healing. However, it is not clear if clinical outcomes differ between patients with a MES of 0 and 1. The aim of our study was to evaluate differences in relapse rates between patients with MES of 0 and 1.

METHODS:
UC patients who underwent colonoscopy at 2 IBD referral centers from 2012 to 2017 were identified. Inclusion criteria consisted of patients with a MES score of 0 or 1, no prior colectomy, and outpatient follow up for a minimum of 1 year after colonoscopy. Data was collected for demographics, disease characteristics, medications, time from last disease flare and inflammatory biomarkers. The primary outcome was defined as a composite of relapse requiring change in medical therapy, new steroid use, UC-related hospitalization, and colectomy. Chi Square, Fisher's exact and logistic regression modeling were used in statistical calculations.

RESULTS:
446 UC patients were identified, with 228 (51%) and 218 (49%) having a MES of 0 and 1 respectively. 78% were Caucasian, 52% were female and mean age was 40 ± 15 years. 20, 34, and 46% had proctitis, left sided colitis and extensive or pancolitis, respectively. 46% of patients were on either a 5-ASA alone or no medical therapy, while 46% were on biologics and 27% were on biologic therapy with an immune suppressant. Within 1 year from colonoscopy, 97 (22%) had a change in medical therapy and 66 (15%) were prescribed steroids. Only 8 and 4 patients were hospitalized for UC or underwent colectomy, respectively. UC patients with a MES of 1 were more likely to experience a relapse (P < 0.01) (Table 1). After adjusting for race, disease extent, and medication use, a MES of 1 was the only factor associated with an increased the risk of relapse (aOR 2.54, 1.61-4.01) (Table 2).

CONCLUSION:
Patients with mild endoscopic activity by MES were at increased risk for relapse compared to patients with no endoscopic activity. In this population of UC patients, MES score was the only variable that predicted future relapse. Future studies are needed to classify low and high risk patients with mild endoscopic activity through evaluation of novel biomarkers and histology. Gastroenterologists should consider enhanced monitoring and/or changes in medical therapy based on the presence of even mild inflammation.
702 Knowledge, Perception, and Use of Cannabis Therapy in Patients With Inflammatory Bowel Disease
Authors: Cruz-Cruz Jorge , Muñiz Luis , Negron Frances , Ramos Luis , Oquendo Kimberly Hernández , Emanuelli Natalie I. , Garau Fabiola , Torres Esther 
Published: October 2019

INTRODUCTION:
Cannabis has been proposed as a therapeutic option for Inflammatory Bowel Disease (IBD), but its benefit is controversial. Because of the chronic nature of IBD and lack of a cure, patients are turning to complementary and alternative medicine, including cannabis, to achieve symptom control. In 2017, the government of Puerto Rico legalized medical cannabis for several indications including IBD. Prevalence of cannabis use in our patients with IBD is unknown. The aims of this study were to estimate the prevalence of cannabis use in patients with IBD, and evaluate patient knowledge and perception regarding cannabis use and effects.

METHODS:
A cross-sectional study was performed in a sample of 100 individuals with IBD from the clinics at the UPR Center for IBD. A voluntary anonymous questionnaire survey was provided. It consisted of 19 questions including demographics, diagnosis and cannabis use. For patients who reported cannabis use, specific questions regarding mode, frequency, purpose, source, and cost of cannabis were assessed. The study was approved by the MSC IRB.

RESULTS:
Most subjects were young patients between 21-30 years old (39%) with Crohn's Disease (78%). Male to female ratio was 1:1. Although the largest group (39%) reported moderate knowledge about medical cannabis, 37% reported lack of knowledge about possible therapeutic properties in IBD. Of the 63% that had considered cannabis use, only 21% had consulted with their physician and 27% reported use of cannabis. Of these, only 37% are licensed for medical cannabis use. Among users, 56% reported that the purpose was to relieve IBD related symptoms. The most frequent formulations used were vaporized and smoked. Among cannabis users, 30% reported daily use. Most patients (30%) spend between $51-100 monthly. Only 15% reported severe IBD. The majority (63%) reported an improvement of symptoms and 67% an improvement in quality of life; 81% of users would recommend cannabis use for IBD. The probability of wanting physician approval of medical cannabis for IBD was related with its use (P = 0.03) but not related to perceived knowledge (P = 0.36).

CONCLUSION:
This study provides insight about estimated prevalence, knowledge, purpose, pattern of use, costs and perception about cannabis use in patients with IBD. Physician awareness and strategies to address the issue with patients are needed.
703 Fatigue Is Inversely Associated With Endoscopic but Not Histologic Remission in IBD Patients
Authors: Lakhani Komal , Durbin Laura , Agrawal Manasi , Bhardwaj Richa , Swaminath Arun 
Published: October 2019

INTRODUCTION:
Fatigue is a subjective and underdiagnosed symptom prevalent in nearly half of all inflammatory bowel diseases (IBD) patients and can be highly debilitating. It is more common in Crohn's disease (CD) than in ulcerative colitis (UC) and is associated with disease activity. The purpose of our study was to determine patient and disease variables associated with fatigue in a tertiary referral center in New York City.

METHODS:
IBD patients were asked to complete the validated 8-item PROMIS Fatigue Short Form 8a, with a T-score of ≥50 and <50 indicating high and low levels of fatigue over the previous 7 days. Variables such as age, sex, IBD type, body mass index (BMI), and disease remission status (clinical, endoscopic, and histologic) were determined on chart review at the same time.

RESULTS:
Of 187 IBD patients included in the study, 113 had CD (Table 1). In our sample, 48.7% of all IBD patients reported high fatigue. Fatigue was not associated with age, sex, BMI, or IBD type (Table 2). In multivariable models, adjusted for age and sex, clinical remission (OR 0.42, 95% CI 0.23-0.76) and endoscopic remission (OR 0.44, 95% CI 0.22-0.88), but not histologic remission (OR 0.43, 95% CI 0.18-1.01), were inversely associated with fatigue.

CONCLUSION:
Fatigue is a common symptom in IBD patients and is inversely associated with clinical and endoscopic, but not histologic, remission in this single-center cross-sectional study. These findings corroborate the role of disease activity in fatigue in IBD and emphasize the impact of achieving clinical and endoscopic remission.