bluuebunny/crossref_metadata_2025 huggingface dataset:
741 Low Serum Levels of IgG4 Antibodies May Function as a Biomarker of Severity in Inflammatory Bowel Disease
Authors: Koutroumpakis Filippos , Philipps Anna E. , Yadav Dhiraj , Rivers Claudia Ramos , Schwartz Marc , Proksell Siobhan , Johnston Elyse , Dueker Jeffrey , Hashash Jana G. , Barrie Arthur , Harrison Janet , Din Hassieb , Babichenko Dmitriy , Tang Gong , Binion David
Published: October 2019

INTRODUCTION:

Immunoglobulin G subclass 4 (IgG4) is hypothesized to play an immunoregulatory role which effectively decreases humoral immune responses. The presence of high serum IgG4 levels is considered a biomarker for IgG4 related diseases. On the other hand, low levels of IgG4 have been reported mainly in infectious diseases but also in healthy individuals. The role of abnormal serum IgG4 in inflammatory bowel disease (IBD) has not been fully characterized. We sought to define alterations in serum IgG4 in IBD patients and its association with multiyear disease severity.

METHODS:

We analyzed a prospective, longitudinal IBD registry of consented patients followed at a tertiary center over a 10-year time period. IBD patients with IgG4 serum levels available formed the study population. Demographics and multiyear clinical data were collected and analyzed. Disease severity was approximated with patterns of healthcare utilization metadata. We compared IBD patients with low, normal or high serum IgG4 levels.

RESULTS:

There were 1213 IBD patients with IgG4 levels tested [females 54%, Crohn Disease (CD) 65%, Ulcerative Colitis (UC) 33%, IBD unclassified 2%, median age at diagnosis 25 years]. Low IgG4 levels were seen in 245 patients (20%) and elevated IgG4 levels occurred in 65 (5%). In univariate analysis, low IgG4 was associated with CD (P = 0.028) and lifetime IBD surgeries (P < 0.001). During the 10-year observation period, low IgG4 patients had higher rates of new IBD surgeries (P = 0.012), office visits (P = 0.007), requirement for biologic agents (P = 0.009), steroid use (P = 0.021) and higher cumulative healthcare charges (P = 0.015) compared with normal IgG4 patients. In the multivariate analysis (MVA), low IgG4 was associated with IBD surgeries (P = 0.003) and requirement for biologic therapy (P = 0.017) during the 10-year period as well as higher rates of lifetime IBD surgery (P = 0.002). High IgG4 levels were associated with younger age (P = 0.006), male gender (P < 0.001) and lower steroid use (P = 0.043) (univariate analysis) but were not associated with primary sclerosing cholangitis (P = 0.112); in MVA only male gender (P = 0.001) remained significant.

CONCLUSION:

Low IgG4 is four times more common than IgG4 elevation in IBD and is associated with multiple markers of disease severity. Further investigation is required to determine whether this finding represents the loss of a potential anti-inflammatory molecular mechanism which contributes to more severe illness in IBD.
742 Quality Improvement in IBD Care: The Influence of a QI Specific Conference for Fellows
Authors: Afolabi Olayinka , Faber Alexis , Kutaimy Raya , Naylor Paul , Ehrinpreis Murray N.
Published: October 2019

INTRODUCTION:

Given the complexity of management of inflammatory bowel disease (IBD), medical societies such as the American Gastroenterological Association (AGA) and Crohn's and Colitis Foundation of America (CCFA) have established measures aimed at defining quality of care. In 2011, the AGA proposed 10 quality metrics for IBD, eight of these measures relate to outpatient management and two focus on inpatient management. Our objective was to evaluate compliance with these measures in our own general GI practice and determine whether a GI conference discussing quality improvement (QI) in 2017 was effective.

METHODS:

The 8 AGA IBD core measures related to the outpatient management of IBD were assessed. From a list of patients with ICD-9 codes for IBD, We identified 104 patients with well documented Crohn's disease (CD) or ulcerative colitis (UC) and multiple visits through 2018. For this quality assessment, we used the most recent GI visit and. The patients were divided into two groups (most recent visit prior (Pre) or after (Post) a GI conference in 2017. Significant differences were defined using student's t-test or Pierson Chi-square.

RESULTS:

There were 40 patients in the pre group and 64 patients in the post group. The gender and racial distribution were not significantly different between pre and post (70% pre vs 61% post female; 75% vs 73% AA). There were more CD patients in the post group (48% vs 70% P < 0.05) and more patients were on an anti-TNF biologics (18% vs 41%). Table 1 details the results of the quality measures before and after the QI conference. Prior to the QI conference in 2017, there were areas for improvement (i.e., <75% compliance) in 4 of the categories Bone density screening, screening for Vit D deficiency, documenting disease severity, vaccinations and tobacco cessation counseling (Table 1). Following the QI conference discussion in 2017, there was good improvement seen several areas. Although, there were small improvements in vaccinations, the numbers are still very low.

CONCLUSION:

We demonstrated improved compliance with the AGA IBD quality metrics after the QI conference, though there are still areas of improvement for documenting immunizations and tobacco cessation counselling. To help improve compliance with core measures, we propose advocating for our current EMR systems to have the ability to trigger alerts regarding specific measures and improve compliance as well as educating new fellows on proper documentation and standardization of the AGA IBD quality metrics.
750 Incidence and Risk Factors of Constipation in Inflammatory Bowel Disease Patients During Remission
Authors: Tabbaa Mumtaz , Tunzi Matthew
Published: October 2019

INTRODUCTION:

The incidence of constipation in long term follow-up of chronic IBD patients during remission hasn't been studied. Though constipation was observed in patients with proctitis, and hard stools reported in 27% of patients with active UC (1), constipation was not the focus of IBD studies in the past. The overlap of IBS with IBD was studied, a small and similar incidence of constipation was reported in both groups (2). This five-year follow-up study documented the incidence of constipation in IBD patients during remission, analyzing the risk factors related to the IBD Illness.

METHODS:

259 Patients with IBD in the GI clinic were followed for 5 years, between 2013-2018. Patients who developed constipation during the remission period were studied to find the incidence of constipation and risk factors related to IBD. The remission was identified as clinical remission for more than 6 mo, or by endoscopic or histologic remission. All patients had KUB documented the high fecal load without obstruction at the time of clinical presentation with constipation. Factors related to IBD illness were analyzed, including gender, type of IBD, period of illness, and intestinal involvement. Those with Proctitis only and those with previous surgeries were extracted.

RESULTS:

89/259 patients (34%) developed constipation. 43/89 with UC vs 41/89 with CD (P > 0.1). No statistical significance also found for the gender (54M Vs 35F) and the period of the illness (52 < 5 years, vs 37 > 5 years). The involvement of the distal colon including pancolitis involvement was significantly higher than the involvement of the right side of the colon (67/89 had distal involvement vs 3/89 proximal involvement), to the point of statistical significance (P < 0.05). Patients with skipping lesions with distal involvement were 19/89.

CONCLUSION:

This study showed a high incidence of constipation in patients with inactive IBD (34%), it was higher than the incidence of patients with hard stools at the time of diagnosis (4/50). The clinical setting of this study with long term observation was different from the clinical setting of the 2 surveillance that reported constipation in IBD patients in the medical literature. Though constipation is a functional symptom, the risk factor of IBD involvement is not related to the IBS. The successful treatment of constipation in this group impacted the quality of life and the management of IBD with medications, only 3 patients in this group required treatment with immunosuppressive or biologic medications.
755 Histology and Endoscopy Discordance in Inflammatory Bowel Disease Varies by Phenotype and Location of Disease
Authors: Serigado Soares Da Costa Joao M. , Quintero Maria A. , Koru-Sengul Tulay , Poveda Julio , Damas Oriana , Deshpande Amar , Kerman David , Abreu Maria T.
Published: October 2019

INTRODUCTION:

Mucosal healing is currently the ultimate target in the treatment of inflammatory bowel disease (IBD). It has become increasingly evident that mucosal healing assessed during endoscopy may not imply histological healing. It is important to define which patients are more likely to have underlying microscopic inflammation in the setting of a normal appearing mucosa in order to tailor treatment approaches and minimize unnecessary biopsies.

METHODS:

Patients were included if they have a diagnosis of either Crohn's or ulcerative colitis, based on standard criteria and had provided consent to have clinical data and tissue collected as part of our IRB-approved IBD biorepository. Endoscopies were performed as part of routine clinical care and biopsies taken and endoscopy findings recorded in a protocolized fashion. The endoscopist rated each area biopsied as “no inflammation,” “mild,” “moderate” and “severe” inflammation. Clinical pathology results were reviewed from the matching endoscopic area. Multiple univariate and multivariate analyses with ordinal logistic regression were used to examine the relationship of endoscopic and histologic scores.

RESULTS:

There is an association between inflammation on endoscopy and inflammation on biopsy (OR, 2.97; 95% CI, 2.75-3.18; P < 0.0001). There is an incremental effect of the probability of having an inflamed biopsy as the degree of inflammation on endoscopy increases (mild inflammation OR, 2.50; P < 0.0001; moderate OR 4.28; P < 0.0001; severe OR 4.81; P < 0.0001). A subgroup of patients had normal appearing endoscopies but inflamed biopsies (9% of the sample). Sub group analysis revealed that biopsies taken from the neo-terminal ileum compared to native terminal ileum were two times more likely to be discordant on histology (OR 2.01; 95% CI, 1.27-3.16; P = 0.0027).

CONCLUSION:

The treatment goal for patients with IBD is mucosal healing. The definition of mucosal healing varies and encompasses both macroscopic and microscopic healing. We describe an overall good correlation between endoscopic inflammation and histologic inflammation. These findings are important as they may lead to a decrease in the number of biopsies taken in endoscopically normal appearing tissues. Interestingly, the neo-TI in CD patients was most frequently discordant with normal appearing endoscopy yet inflammation microscopically. Longer follow up studies are needed to determine whether patients with microscopically inflamed neo-TI have a worse outcome than those without inflammation.
756 Novel Risk Factors and Outcomes in Inflammatory Bowel Disease Patients With Clostridium difficile Infection
Authors: Voth Elida , Solanky Dipesh , Loftus Edward V. , Pardi Darrell , Khanna Sahil
Published: October 2019

INTRODUCTION:

Patients with inflammatory bowel disease (IBD) are at significantly increased risk for Clostridium difficile infection (CDI). CDI in IBD is associated with increased in-hospital mortality, IBD treatment failure, re-hospitalization and high CDI recurrence rates. The existing literature on predictors of these adverse outcomes is limited. We evaluated four potentially modifiable novel risk factors (BMI, statin use, opioid use, and antidepressant use) on the risk and outcomes of CDI in patients with IBD.

METHODS:

CDI disease severity and other clinical outcomes, including colon surgery, CDI recurrence, CDI-related hospitalization, IBD exacerbations, and mortality were abstracted using the electronic medical record. Additionally, variables including BMI, statin use, opioid use, and antidepressant use at the time of CDI were abstracted from records for patients with IBD and CDI from 2008 and 2013. Statistical analysis comprised of descriptive statistics and univariate and multivariate logistic regression analyses.

RESULTS:

There were 137 patients with IBD and CDI included in this study: 70 with ulcerative colitis (51%), 63 with Crohn's disease (46%), and 4 with indeterminate colitis (3%). The median age was 46 years, and 55% were female. On multivariate analysis controlling for age, 43% of patients in the overweight BMI category had severe or severe complicated CDI, compared to 22% of patients in the underweight/normal BMI (OR, 2.85, P = 0.02) and 19% in the obese category (OR, 3.95, P = 0.04). Statin use was associated with severe or severe complicated CDI when controlling for age and BMI (OR, 5.66, P = 0.01). On multivariate analysis controlling for age and CDI severity, there was no association between statin use and post-CDI IBD exacerbations. Opioid and antidepressant use were not associated with CDI disease severity or IBD exacerbations. BMI category, statin use, opioid use, and antidepressant use were not associated with colon surgery, CDI recurrence, CDI-related hospitalizations, or mortality at 1 year.

CONCLUSION:

An overweight BMI and statin use were associated with severe or severe complicated CDI. There was no association between statin use and IBD exacerbations following CDI. Opioid and antidepressant use were not associated with disease severity or frequency of IBD exacerbations following CDI. Further studies are needed to better understand how these results could impact management of patients with IBD to improve clinical outcomes and potentially reduce the risk of CDI.
757 Histologic Improvement With Vedolizumab vs. Adalimumab in Ulcerative Colitis: Results From VARSITY
Authors: Peyrin-Biroulet Laurent , Colombel Jean-Frédéric , Loftus Edward V. , Danese Silvio , Abhyankar Brihad , Chen Jingjing , Rogers Raquel , Lirio Richard A. , Bornstein Jeffrey D. , Sands Bruce E. , Schreiber Stefan
Published: October 2019

INTRODUCTION:

Histologic remission is associated with superior long-term clinical outcomes in ulcerative colitis (UC). VARSITY, the first head-to-head comparison of biologic agents in UC (NCT02497469; EudraCT 2015-000939-33), showed superior clinical remission and endoscopic improvement at Week 52 with vedolizumab (VDZ), a gut-selective, humanized, α4β7 integrin monoclonal antibody, vs adalimumab (ADA), a systemic, human, anti-tumor necrosis factor (anti-TNF) monoclonal antibody.
1
Both VDZ and ADA were generally safe and well-tolerated.
1
This analysis compared histologic improvements with VDZ vs ADA in VARSITY.

METHODS:

Patients with moderately to severely active UC were randomized 1:1 to active VDZ intravenous (IV) infusions (300 mg)/placebo subcutaneous (SC) injections or placebo IV/active ADA SC (160/80/40 mg). Prespecified histologic exploratory endpoints included histologic remission (Geboes score < 2 or Robarts Histopathology Index [RHI] score < 3) and minimal histologic disease activity (Geboes score < 3.2 or RHI score < 5) at Week 14 and Week 52. Histologic remission was also assessed based on previous anti-TNF use.

RESULTS:

A total of 769 patients received ≥1 dose of VDZ (n = 383) or ADA (n = 386). Median (range) duration of exposure was 477 (127, 630) days for VDZ and 420 (71, 454) days for ADA. Mean (standard deviation) baseline histologic disease activity was similar between groups (Geboes: VDZ, 15.0 [4.92]; ADA, 15.1 [5.03]; RHI: VDZ, 19.5 [8.74]; ADA, 19.6 [8.89]). Histologic remission induced by VDZ at Week 52 was greater than with ADA in the overall (Geboes or RHI), anti-TNF naïve (Geboes or RHI), and anti-TNF failure (RHI only) groups (Table 1). Histologic remission at Week 14 favored VDZ over ADA, with larger differentiation when using RHI (Table 1). VDZ also outperformed ADA in achieving minimal histologic disease activity at Weeks 14 and 52 (Table 1).

CONCLUSION:

VARSITY showed that use of VDZ, compared with ADA, achieved higher rates of histologic remission and minimal histologic disease activity at Weeks 14 and 52 in patients with moderately to severely active UC. These data support the use of VDZ over ADA in UC.
761 Increased Risk of Preeclampsia in Women With Inflammatory Bowel Disease on Anti-TNF Therapy
Authors: Kattah Andrea , Becker Brenda , Kane Sunanda
Published: October 2019

INTRODUCTION:

Women with inflammatory bowel disease (IBD) are at an increased risk of adverse pregnancy outcomes. Some observational studies have demonstrated a possible association between IBD and the risk preeclampsia. There is evidence of immune dysregulation in preeclampsia; in particular, upregulation of TNF-α. Our hypothesis was that anti-TNF therapy in pregnancy may decrease the risk of preeclampsia in women with IBD.

METHODS:

We identified cases of preeclampsia from among patients with IBD followed at a tertiary care center. We selected two random controls with a normotensive pregnancy for each case, matched only on disease type (ulcerative colitis vs. Crohn's). We collected data on age, race, pre-pregnancy hypertension, diabetes, smoking, medication use and disease activity.

RESULTS:

We identified 9 women with preeclampsia and 18 controls as reported during patient interviews. Demographic and clinical characteristics are shown in Table 1. There was no significant difference in age of diagnosis of IBD, previous diagnoses of hypertension or diabetes, tobacco use, age at delivery, or nulliparity. The majority of women (8/9) stopped their anti-TNFα therapy in the third trimester. Women who developed preeclampsia were more likely to be on thiopurine or biologic therapy during pregnancy (100% vs. 39%, P < 0.01). Other pregnancy complications included preterm delivery in 6 participants (3 in each group) and 1 participant with each of the following: Clostridium difficile colitis, small bowel obstruction, post-partum hemorrhage and intrauterine growth restriction. There was no significant difference between cases and controls in regard to the number of flares during pregnancy. Using univariate logistic regression, we found a significant increase in the odds of having preeclampsia in women on anti-TNF therapy as compared to women not on anti- TNF therapy (OR 6.25; 95% CI 1.09-43.7).

CONCLUSION:

Women with inflammatory bowel disease on anti-TNF therapy are at an increased risk of developing preeclampsia. This finding suggests that the risk of preeclampsia in IBD may be associated with the severity of the underlying disease and degree of inflammation necessitating the biologic therapy. Despite therapy targeting TNFα, a possible pathologic actor in preeclampsia, women on anti- TNF therapy remain at an increased risk of preeclampsia, though this may be in part due to the fact that most women discontinue anti-TNF therapy in the third trimester.
763 Relationship Between Crohn's Disease Activity Index and Patient-Reported Outcomes for Crohn's Disease Patients in the United States
Authors: Obando Camilo , Ding Zhijie , Izanec James , Sikirica Mirko , Lucas James , Kemp Jessalyn , Muser Erik
Published: October 2019

INTRODUCTION:

Measuring Patient-Reported Outcomes (PROs) is important in understanding how Crohn's disease (CD) patients perceive their own health status and emotional well-being. This study aims to establish the association between PROs and the Crohn's Disease Activity Index (CDAI) using real-world data.

METHODS:

Data were drawn from the Adelphi Disease Specific Programme, a real-world survey of gastroenterologist-completed retrospective chart reviews and patient self-completed questionnaires conducted in the US in 2015 and 2017. CD patients self-completed a form containing the EQ-5D and the SIBDQ. Comparisons between patients with a CDAI of 0-150 (remission), 151-220 (mild) and >220 (moderate to severe [mod/sev]) at the time of the survey were made using Kruskal-Wallis and Chi-squared tests for continuous and categorical variables, respectively.

RESULTS:

Of the 468 CD patients included, 291 were in remission, 105 mild and 72 mod/sev. Patients had a mean duration of 7.5 (remission), 6.9 (mild) and 5.5 (mod/sev) years since diagnosis, respectively (P = 0.055). There was no significant difference in mean age or gender distribution amongst disease severity states. 13.8% of remission patients, 26.9% mild and 48.0% of mod/sev were currently experiencing a flare or flare-like symptom (P < 0.001). Remission patients had a higher mean overall SIBDQ score compared with mild and mod/sev (Table 1), and higher subdomain scores of systemic, social, bowel and emotional score, respectively (Table 1). Remission patients had higher mean EQ-5D and EQ-5D VAS scores compared with mild and mod/sev, and reported lower impact on usual activities, social care, and mobility, as well as lower levels of pain/discomfort and anxiety/depression in the EQ-5D subdomains (Table 2).

CONCLUSION:

CD patients with more severe disease according to the CDAI self-reported lower quality of life in terms of mean overall SIBDQ score and across all subdomains compared to mild patients and patients in remission. Patients with more severe disease were also more likely to report lower mean EQ-5D score, particularly in the subdomains of social care, usual activities, pain/discomfort, and anxiety/depression, compared to mild patients and patients in remission. Physicians reported percentages of patients currently experiencing a flare-like symptom may present an opportunity to further improve disease control for all subgroups of patients.
785 Real World Application of the “Prometheus IBD Sgi Diagnostic” as a Baseline Test at a Tertiary Care IBD Referral Center
Authors: Lysek Michael , Zhang Nan , Talha Malik
Published: October 2019

INTRODUCTION:

Prometheus IBD sgi Diagnostic (SGI) is an Inflammatory Bowel Disease (IBD) advanced diagnostic test developed by Prometheus Laboratories. It employs a diagnostic algorithm combining serologic, genetic, and inflammatory markers to help with clinical decision making in determining the accuracy of a diagnosis of IBD in patients suspected to have the disease. Moreover, among those it identifies as having IBD, it also seeks to assist in distinguishing those with Crohn's vs. those with ulcerative colitis (UC). In this observational clinical decision making study, we sought to examine the real world application of the SGI at a single tertiary care IBD practice especially in correctly identifying those with Crohn's vs. those with UC.

METHODS:

We included all adult IBD patients seen at a single tertiary IBD center practice from 2014 to 2017 that had baseline SGI done and during care at the practice, had a diagnosis of IBD (Crohn's or UC) established. We calculated sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), accuracy, and area under the curve based on results of SGI at baseline visit and the eventual established diagnosis of UC or CD.

RESULTS:

Of a total of 275 patients, there were 96 (34.9%) male patients and 179 (65.1%) female patients. The median age of these patients was 45.8. There were a total of 201 patients with biopsy proven CD. Of these, 104 were identified as having CD based on the baseline SGI and 97 who were identified as not having CD. Based on these data, the sensitivity of the SGI for CD at the practice was 52%, specificity was 88%, PPV was 92%, NPV was 40.1%, diagnostic accuracy was 61.5%, and Area under ROC was 70%. There were 66 patients with biopsy proven UC. Of these, 44 were identified as having UC based on the baseline SGI and 22 were identified as not having UC. Based on these data, the sensitivity of the SGI for UC at the practice was 67%, specificity was 85%, PPV was 58%, NPV was 89%, accuracy was 80%, and Area under ROC was 76%.

CONCLUSION:

Based on the results of this study, we conclude that the SGI is not a robust initial test in identifying those with Crohn's or those with UC. However, in a cohort of IBD patients seen at a tertiary care IBD practice, it is reasonably specific and accurate when it comes to correctly confirming Crohn's and even more so UC in patients with a caveat that the results should be interpreted in the proper clinical context and with the backing of other clinical indicators.
795 Real World Safety of Vedolizumab and Anti-TNF Therapies in Biologic-Naïve Ulcerative Colitis and Crohn's Disease Patients: Results From the EVOLVE Study
Authors: Yarur Andres , Mantzaris Gerassimos J. , Kopylov Uri , Bassel Marielle , Brett Neil R. , Lissoos Trevor , Lopez Claudia , Natsios Athanasios , Kifnidi Christina , Saha Sumit , Demuth Dirk , Patel Haridarshan , Bressler Brian
Published: October 2019

INTRODUCTION:

The GEMINI phase III clinical trials showed a favorable safety profile for vedolizumab (VDZ) in treating patients (pts) with moderate-to-severely active ulcerative colitis (UC) and Crohn's disease (CD). Real-world studies are needed comparing the safety of VDZ to anti-tumor necrosis factors (anti-TNF) agents in biologic (bio)-naïve pts.

METHODS:

This was a multi-country (Canada, Greece and the United States) and multi-center, retrospective study including bio-naïve pts (≥18 years old) with ≥6 months follow-up, initiating treatment (Tx) with VDZ or an anti-TNF (adalimumab, infliximab, golimumab, certolizumab pegol) as standard of care between May 2014-March 2018. Data were collected from Tx initiation to earliest of death, chart abstraction date or 6 months post-Tx discontinuation (Canada only). Serious adverse events (SAEs) and serious infections (SIs) (defined as either life threatening, requiring hospital admission, resulting in significant disability/incapacity, or recorded in the chart as an important medical event) occurring from Tx initiation up to five half-lives post-Tx discontinuation were assessed. Incidence rates (per 100 person-years [PYs]) of SAEs and SIs were estimated. A Cox proportional hazards model adjusted for baseline characteristics was used to compare incidence rates between Tx cohorts. Adjusted hazard ratios (HR) with 95% confidence intervals (CI) are reported.

RESULTS:

This study included 1,095 pts (VDZ: 598 [UC: 380; CD: 218]; anti-TNF: 497 [UC: 224; CD: 273]) from 42 sites. Compared to anti-TNF pts, the VDZ cohort were older (mean [SD] age [years]: VDZ, 47.9 [17.4]; anti-TNF, 39.6 [15.2] [P < 0.01]), were proportionately more male (VDZ, 56.9%; anti-TNF, 49.9% [P = 0.02]) and had a longer disease duration (median [range: min-max] disease duration [years]: VDZ, 5.0 [0.04– 54.0]; anti-TNF, 2.0 [<0.1–49.0] [P < 0.01]). Median (range: min-max) follow-up (months) was: VDZ, 15.3 (3.0-47.0); anti-TNF, 16.3 (3.5-51.0). Incidence rates of first occurrence of SAEs and SIs (Table 1) were significantly lower in VDZ versus anti-TNF pts (adjusted HR: SAE, 0.42 [0.27-0.66]; SI, 0.33 [0.18-0.58]). Similar trends were shown when data were stratified by UC and CD, separately (Table 1).

CONCLUSION:

Bio-naïve pts treated with VDZ were significantly less likely to experience SAEs and SIs than those treated with anti-TNF therapies. These data support a favourable safety profile of VDZ versus anti-TNF in bio-naïve inflammatory bowel disease pts in real-world clinical practice.
810 Disparities in Objective Sleep Quality as Assessed by Wrist Actigraphy in Minority Patients With Inflammatory Bowel Disease
Authors: Qazi Taha , Smith Alexander J. , Alexander Megan , Jones Eric , Weinberg Janice , Hammer David , Wu Ting , Noronha Ansu , Farraye Francis A.
Published: October 2019

INTRODUCTION:

Inflammatory Bowel Disease (IBD) is associated with a reduced quality of life, including a high incidence of poor sleep. Minority patients with IBD describe poorer subjective symptoms of disease. Minority patients are more likely to report poorer sleep quality compared to Caucasian patients. There are limited data on the assessment of sleep in minority patients with IBD. In this prospective cohort study, we aim to compare objective sleep parameters assessed by wrist actigraphy in minority IBD patients compared to Caucasian IBD patients.

METHODS:

73 patients with a diagnosis of IBD were recruited to take part in this IRB approved study. Subjects were stratified into two cohorts by self-identification: minority subjects (Blacks and Non-Black Hispanic subjects) and Caucasian, non-minority individuals. Subjects were excluded based on significant co-morbidity, a history of a sleep disorder, or demographics which did not fit into categorized cohorts. Subjects completed sleep surveys and were provided with an accelerometer that estimated sleep patterns. Comparisons of actigraphic parameters were performed between minority and non-minority cohorts. Regression analyses were performed to determine whether minority status was independently associated with poorer sleep parameters assessed by actigraphy. Predictors that were found to be different by < 0.1 between cohorts were included in the models.

RESULTS:

Of the recruited subjects, 64 subjects completed 3 days of actigraphy data. 33 subjects were minority patients and 31 individuals were non-minority patients. The demographics of the cohorts are provided in Table 1. Table 2 details the univariate analyses. A higher proportion of minority patients had poorer sleep efficiency (SE) and fragmented sleep compared to Caucasian patients (90.9% vs. 67.7%, P = 0.03 and 87.8% vs. 61.3%, P = 0.02). Minority status was independently associated with both poor SE (OR: 6.41 CI: 1.48-28.17, P = 0.0139) and fragmented sleep (OR: 4.98, CI: 1.09-22.89, P = 0.0389), (Tables 3.0A and 3.0B).

CONCLUSION:

In our study minority subjects were found to have poorer objective measures of sleep assessed by actigraphy compared to non-minority subjects. Culturally relevant care addressing psychosocial issues, including sleep are important in the care of minority patients with IBD. Further studies investigating the role of sleep in diverse populations with IBD are warranted to determine the etiologies of poor sleep in these patients.
813 Incidence and Indicators of Suboptimal Response to Tumor Necrosis Factor Antagonist Therapy in Inflammatory Bowel Disease in Newly Industrialized Countries: Results From the EXPLORE Study
Authors: Al Harbi Othman , Armuzzi Alessandro , Chan Webber , Ponce de Leon Enrique , Qian Jiaming , Shapina Marina , Toruner Murat , Tu Chia-Hung , Ye Byong Duk , Guennec Morgane , Sison Cecilia , Demuth Dirk , Fadeeva Olga , Khan Rana Qasim , Yamamoto-Furusho Jesús
Published: October 2019

INTRODUCTION:

Inflammatory bowel disease (IBD) patients in Western countries frequently experience suboptimal response to anti-tumor necrosis factor (TNF) treatment (Tx). The EXPLORE study aimed to assess the incidence and indicators of suboptimal response to first-line anti-TNF agents in IBD patients in real-world practice in newly industrialized countries, where data are limited.

METHODS:

A retrospective chart review study was conducted in Asia-Pacific (APAC; South Korea, China, Taiwan, Singapore), Latin America (LatAm; Argentina, Colombia, Mexico) and Russia-Middle East (RME; Russia, Saudi Arabia, Turkey) in adult patients diagnosed with ulcerative colitis (UC) or Crohn’s disease (CD), who initiated anti-TNF Tx between March 2010 and March 2015. The cumulative incidence (CI) of suboptimal response (Kaplan-Meier method) was assessed over the first 24 months of Tx, as the occurrence of a first indicator of: IBD-related hospitalization, dose escalation (increase in frequency and/or dose), discontinuation including switch to another anti-TNF, non-biologic Tx augmentation, or IBD-related surgery. Primary non-response (PNR) and secondary loss of response (SLOR) were defined as any suboptimal response indicator at < 4 and ≥4 months after anti-TNF initiation (excluding PNR patients), respectively.

RESULTS:

Overall, 1674 first-line anti-TNF treated patients (570 UC; 1104 CD) were included: male, UC 56.1%, CD 61.2%; median (min-max) age (years), UC 39.0 (18-82), CD 31.0 (19-83); median (min-max) disease duration (years), UC 3.0 (0-34), CD 1.0 (0-33); median (min-max) follow-up (months), UC 45.9 (24-60), CD 46.5 (14-60). At 24 months, the CI of suboptimal response to first anti-TNF Tx was 32.9% in UC and 41.2% in CD patients (unadjusted log-rank: P < 0.01); the APAC region had the highest CI (UC 45.1%; CD 54.1%) (Table 1). The CI of PNR was 13.6% and 16.9% in UC and CD patients, respectively. The CI of SLOR was 22.3% in UC and 29.2% in CD patients at 24 months. The most frequent first suboptimal response indicator was ‘IBD-related hospitalization’ (UC 33.0%; CD 36.1%) followed by ‘non-biologic augmentation’ (UC 30.3%; CD 23.8%) (Table 1).

CONCLUSION:

Suboptimal response to first-line anti-TNF agents is common in IBD patients in newly industrialized countries and is more frequently experienced in CD than in UC. Observed regional differences in the rates of suboptimal response, PNR and SLOR, may reflect local practice variations and restrictions in the management of anti-TNF treated patients.
822 Assessing the Effectiveness of an Educational Series on Prior Authorization of IBD Treatments
Authors: Faler Whitney E. , Perez Jan S. , Tordoff Shari , Gross Tara , Salinas Gregory D.
Published: October 2019

INTRODUCTION:

Prior authorization (PA) poses a burden to HCPs and their staffs when prescribing biologic therapy for patients with IBD. Our aim was to determine the effectiveness of 3 CME activities on clinician knowledge, confidence, and performance related to PA processes and success rates for biologic therapy.

METHODS:

Outcomes measurements were taken directly before (n ≥ 241) and after the activities (n ≥ 229), as well as 3-months after activity completion. This 3-month follow-up sample (n = 30) was matched at the same time to a control sample of clinicians who did not participate in the education (n = 30).

RESULTS:

4,840 learners completed the 3 modules, including 1,195 downloads of the podcast version. Key knowledge improvements were shown in helping patients with medication co-pays, use of specialty pharmacists, standardizing EHR clinical documentation of patients with IBD, requesting peer-to-peer review, and expediting submissions with the use of templates. Prior to participation, confidence in the current processes to manage prior authorizations was low. Three months following education, nearly all clinicians surveyed indicated that they were “confident” or “extremely confident” in these elements of care.Comparative analysis shows a large effect when comparing the educational learners pre- vs. post-activity (Cohen’s d = 1.37) and pre- vs. 3 –month follow-up (d = 0.55). However, comparing post-participation vs. a non-participant control is smaller (d = 0.20, 15%). This shows that our particular educational learners were coming at this program with more knowledge and practice gaps in the pre-authorization process than the general clinician population. Predictive modeling utilized a regression analysis showed increasing confidence in the use of AGA Care Pathways will significantly increase documentation of pertinent lab results and imaging related to IBD and significantly increase use of a template.

CONCLUSION:

This program achieved large reach with education targeted specifically to those clinicians who needed it most. The education increase clinician knowledge and confidence in the use of this knowledge to acquire prior authorization for biologics. For future PA initiatives, learners may benefit from a mock review of a PA request to best explain individual elements of the decision-making process.
823 Fecal Calprotectin Levels, C-Reactive Protein Levels, and Partial Mayo Score as Early Predictors of Clinical and Endoscopic Outcomes in Patients With Ulcerative Colitis Treated With Tofacitinib in a Phase 2 Study
Authors: Dubinsky Marla C. , Hudesman David P. , Kulisek Nicole , Salese Leonardo , Paulissen Jerome , Su Chinyu , Magro Fernando
Published: October 2019

INTRODUCTION:

Tofacitinib is an oral, small molecule Janus kinase inhibitor for the treatment of ulcerative colitis (UC). Fecal calprotectin (FCP) levels correlated with clinical and endoscopic outcomes at Week (Wk) 8 in patients (pts) with moderately to severely active UC receiving tofacitinib in a Phase 2 study (1). In these post hoc analyses, we aimed to determine if FCP levels, C-reactive protein (CRP) levels, or partial Mayo score (PMS) can be early predictors of clinical or endoscopic outcomes in a Phase 2, randomized, double-blind, placebo-controlled study (NCT00787202) (2).

METHODS:

FCP levels and PMS at baseline, Wk 2, and Wk 4, and CRP levels at baseline and Wk 4 were analyzed based on whether pts with moderately to severely active UC treated with tofacitinib 10 mg twice daily (BID) had clinical response, clinical remission, mucosal healing, or endoscopic remission at Wk 8. Univariate logistic regression analyses were used to evaluate if FCP levels (log transformed), CRP levels (log transformed), or PMS were associated with each outcome.

RESULTS:

In pts treated with tofacitinib 10 mg BID (N = 28), numerically greater decreases from baseline were observed in FCP levels and PMS at Wks 2 and 4 in pts who achieved clinical response, clinical remission, mucosal healing, and endoscopic remission at Wk 8 vs those who did not. FCP levels at Wk 2 decreased by >50% from baseline in pts who achieved endoscopic remission. Numerically greater decreases from baseline were observed in CRP levels at Wk 4 in pts who achieved clinical response and mucosal healing at Wk 8 vs those who did not (Table 1). In pts treated with tofacitinib 10 mg BID, logistic regression results (shown as odds ratio [95% confidence interval]) showed that PMS at Wk 2 (0.496 [0.288, 0.856]; P = 0.0117) and Wk 4 (0.463 [0.251, 0.853]; P = 0.0135), and CRP levels at Wk 4 (0.582 [0.342, 0.990]; P = 0.0460), were significantly associated with clinical remission at Wk 8, and that PMS at Wk 4 (0.572 [0.345, 0.948]; P = 0.0302) was significantly associated with clinical response at Wk 8.

CONCLUSION:

These post hoc analyses of a Phase 2 study showed that decreases as early as Wk 2 in FCP levels and PMS, and as early as Wk 4 in CRP levels, may be predictors of improved clinical and endoscopic outcomes in pts with moderately to severely active UC treated with tofacitinib 10 mg BID, although definitive conclusions cannot be drawn due to low pt numbers.
825 Ulcerative Colitis Experiences Among a Pediatric Population: A Qualitative Study Reviewing the Agreement of Symptoms Discussed by Children and Their Parents
Authors: Randall Jason , Guobyte Aiste , Delbecque Laure , Newton Louise , Symonds Tara , Hunter Theresa
Published: October 2019

INTRODUCTION:

Although key symptoms of UC are well-known, exploration of these in children and the level of agreement between child reported and those observed by parents/caregiver have not been well documented and is important to understand if patient reported or observer reported outcome measures should be used.

METHODS:

Children with UC aged 5–11 years and their parents were recruited from US clinical sites for face-to-face concept elicitation interviews. Collages and play-doh models were used during child interviews. Interview transcripts were subjected to thematic analysis using NVivo.

RESULTS:

In total 24 participants were interviewed, three children aged 5–7 years, nine children aged 8–11 years, and their parents/caregivers. All children and parents/caregivers reported that they/their child experienced abdominal pain. Among the younger children, all children and parents/caregivers also discussed blood in stool and there was general agreement (>66%) for stool urgency and incontinence. However, parents/caregivers in this age group were more likely to mention a symptom that was not reported by their child, e.g., stool frequency, constipation, and mucus in stool. The agreement in the description of the experience of symptoms was much higher in 8–11-year olds. There was a high level of agreement (>75%) for blood in stool frequency, diarrhea, incomplete evacuation, and feeling gassy or passing gas. Constipation, bloating, and cramping all had a moderate level of agreement (>50%).

CONCLUSION:

The findings showed a high level of agreement between children and their parents/caregivers in reporting the child’s symptoms. Children aged 8–11 years demonstrate higher agreement with their parents/caregivers than younger children. To obtain an accurate picture of symptoms experienced, an observer-reported measure should be used for the 5–7-year olds, but 8–11-year olds could self-report own symptoms. Limitations: only three 5-7-year olds were interviewed.
831 Serum Biomarkers Are Associated With Endoscopic and Clinical Outcomes in Crohn’s Disease Patients Receiving Vedolizumab Therapy
Authors: Holmer Ariela , Battat Robert , Dulai Parambir , Casteele Niels Vande , Neill Jennifer , Le Helen N. , Miralles Ara , Jain Anjali , Hester Kelly , Singh Siddharth , Rivera-Nieves Jesus , Sandborn William J. , Boland Brigid , Nguyen Nghia
Published: October 2019

INTRODUCTION:

Vedolizumab is a selective monoclonal antibody directed against a4b7 integrin on lymphocytes and is safe and effective for the induction and maintenance of remission in Crohn’s disease. Serum biomarkers are needed to help guide therapy and predict patient outcomes. This study evaluated biomarker concentrations and patient outcomes during vedolizumab treatment.

METHODS:

Serum was collected from patients with Crohn’s disease receiving vedolizumab infusions at weeks 0, 2, 6, 14 and ≥26. Biomarkers including soluble(s)-a4b7, s-vascular cell adhesion molecule (VCAM)-1, s-intracellular adhesion molecule (ICAM)-1, and s-mucosal addressin cell adhesion molecule (MAdCAM)-1 were measured and evaluated as surrogate markers associated with clinical and endoscopic outcomes. Statistical analysis was performed using the Mann-Whitney U test for continuous data.

RESULTS:

Twenty-two patients with Crohn’s disease were included (Table 1). In all patients, s-MAdCAM significantly decreased over time as compared to baseline, and s-a4b7 increased compared to baseline (Figure 1). Overall, s-ICAM1 and s-VCAM1 did not change significantly over time in the entire cohort, however, differentially changed in patients with remission. At week 2, median concentrations of s-ICAM1 were higher in patients with compared to those without clinical remission: 675.1 ng/mL vs. 270.1 ng/mL, respectively (P = 0.046). At week 6, median s-ICAM1 concentrations were higher in patients with compared to without endoscopic remission: 545.7 ng/mL vs. 286.2 ng/mL, respectively (P = 0.027) and clinical remission: 669.1 ng/mL vs. 291 ng/mL, respectively (P = 0.034). At week 6, median s-VCAM1 concentrations were higher in patients with compared to without endoscopic remission: 859.6 vs. 460.31, respectively (P = 0.027) and numerically higher in patients with clinical remission: 859.6 ng/mL vs. 460.6 ng/mL, respectively (P = 0.1). At week 26, there was no difference in median s-VCAM1 or s-ICAM1 concentrations between remitters vs. non-remitters (Table 2).

CONCLUSION:

Higher concentrations of s-ICAM-1 and s-VCAM-1 early in treatment with vedolizumab may be predictive of subsequent remission in patients with Crohn’s disease. During maintenance, there was no association between serum biomarkers and endoscopic or clinical outcomes. These findings may help predict early patient response to treatment with vedolizumab in Crohn’s disease but will require further validation.
833 The Impact of Trainee Physician Experience on Costs and Treatment Outcomes Among Patients Hospitalized With Ulcerative Colitis
Authors: Kachru Sumyra , Abougergi Marwan S.
Published: October 2019

INTRODUCTION/AIM:

The efficiency and the delivery of care have been at the center of the current healthcare debate and reform. We sought to investigate the “July effect” on resource utilization among patients admitted to teaching hospitals with ulcerative colitis.

METHODS:

This was a retrospective cohort study using the 2016 Nationwide Inpatient Sample (NIS), the largest public inpatient database in the US. Patients with a principal diagnosis of Ulcerative colitis (UC) were included. Patients were excluded if they were younger than 18 years or treated at non-teaching hospital. The primary outcome was total hospitalization charges associated with the hospital admission for UC. Secondary outcomes were 1) length of stay 2) in-hospital mortality and 3) surgical intervention. Patient outcomes at the start of the academic year (July- September) were compared with those at the end of the academic year (April -June). Proportions were compared using fisher’s exact test and continuous variables using student t- test. Multivariate analysis was used to adjust for gender, age, Charlson Comorbidity Index, income in patient zip code, hospital region, location, size and teaching status.

RESULTS:

24,650 patients were included in the study. The mean age was 46 years and 54% were females. Compared with patients admitted in July/August/September, those admitted in April/May/June had an adjusted mean difference in total hospitalization charges of 7,380$, (95% Confidence Interval (CI: $14,160 - $599, P = -0.03). Similar results were obtained for Length of Stay: Compared with patients admitted in July/August/September, those admitted in April/May/June, had an adjusted mean difference in length of stay of 0.7 days, CI: 1.3 -0.1, P = 0.02. There was no statistically significant difference in in-hospital mortality rate (adjusted odds ratio (aOR): 0.60, CI: 0.13-2.80, P = 0.51) or surgery rate (aOR: 0.91, CI: 0.59- 1.40, P = 0.68) among the two patient groups.

CONCLUSION:

The experience of the physician in training affects efficiency of care among patients admitted to the hospital with ulcerative colitis, but does not seem to impact treatment outcomes including in-hospital mortality and colectomy rate.