bluuebunny/crossref_metadata_2025_split huggingface dataset:
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.