bluuebunny/crossref_metadata_2025_split huggingface dataset:
782 Pathological Findings of Resected Inflow Limbs in Patients With Pouches for Ulcerative Colitis
Authors: Plietz Michael , Rubin Peter , Polydorides Alexandros , Mui Alex , Kayal Maia , Hao Yansheng , Bauer Joel 
Published: October 2019

INTRODUCTION:
Approximately 30% of ulcerative colitis (UC) patients require surgery during their disease course. Patients will commonly undergo total proctocolectomies with subsequent creation of a “pouch,” such as a J-pouch (pelvic pouch with ileal pouch-anal anastomosis) or a Kock pouch. A small portion of patients undergoing “pouch” procedures for UC will develop severe symptoms related to the inflow limb of the pouch requiring operative intervention. A clear understanding has not been established as to the pathological mechanism by which these pouch inflow problems develop and what pathologic entity they belong.

METHODS:
Methods: A retrospective chart review was conducted at a single tertiary medical center. A database was created of all patients who underwent subsequent pouch-related surgical procedures between 2006 and 2018. Patients with requiring operative intervention of the inflow limb were identified among this cohort. Operative and pathological data were collected.

RESULTS:
178 patients were identified who underwent procedures yielding a surgical pathologic specimen related to their pouch. 15 of these procedures reported significant pathology of the inflow limb to the original pouch (9 J-pouches and 6 Kock pouches), occurring on average of 19.6 years after the creation of the original pouch. The most common diagnosis requiring reoperation was obstruction due to stricture formation (n = 11). Reoperations for inflow limb pathology included pouch excision (n = 3), inflow limb resection with ileo-pouch anastomosis (n = 9), stricturoplasty (n = 1), and bypass of the inflow limb (n = 1). In addition, 3 patients required a temporary, diverting loop ileostomy as part of their reoperation. The pathologic findings of the inflow limb were consistent with Crohn's ileitis in 6 patients (40%). 3 other patients (20%) were diagnosed with Crohn's disease and had diagnostic findings suspicious of Crohn's on inflow limb pathology. Remaining patients (n = 6) were found to have chronic, nonspecific enteritis/serositis. There was one case of poorly differentiated adenocarcinoma.

CONCLUSION:
A small proportion of patients who have undergone a “pouch” procedure require eventual surgery for a problem with the inflow limb of the pouch. These patients were found to have a high rate of Crohn's disease of the inflow limb and overall change in diagnosis to Crohn's disease.
786 Efficacy of Vedolizumab in Older IBD Patients Based on Prior Biologic Exposure
Authors: Patel Devin B. , Cohen Erica , Ha Christina 
Published: October 2019

INTRODUCTION:
Evaluating the safety and efficacy of therapeutics for older patients with moderate to severe IBD is challenging as they are often excluded from clinical trials. Medication recommendations have primarily focused on risks of adverse effects, thus vedolizumab has emerged as the preferred first line therapy for these patients. However, there is a paucity of data regarding its clinical and endoscopic efficacy for the older population compared to other biologics. The aim of this study was to characterize the response rates and adverse effects to vedolizumab in older IBD patients based on prior medication and/or biologic exposure.

METHODS:
A retrospective cohort study of 55 consecutive older IBD patients, >60 years, treated at a tertiary care referral center from 1/2016 to 12/2018 with exposure to vedolizumab during the study period was performed. The primary outcome of interest was clinical response rates (defined as >50% improvement in abdominal pain and stool frequency) to vedolizumab induction in biologic-exposed vs biologic-naïve older patients. The secondary outcome was to compare adverse effects to vedolizumab in biologic-exposed vs biologic-naïve older patients within 1 year of initiation of therapy.

RESULTS:
Patients with prior biologic exposure were younger in age (69.1 ± 6.2 vs 74.6 ± 8.4 yrs, P = 0.01) and more likely to have also been treated with immunomodulators (76.2%) than naïve (30.8%) patients, P = 0.006. More bio-exposed patients had stricturing disease (60.0% vs 0%, P = 0.04) and were treated with combination therapy at induction (29.3% vs 0%, P = 0.05) compared to bio-naïve patients (Table 1). There were no differences in clinical response to induction (P = 0.76), vedolizumab dose escalation (P = 1.0), steroid use after induction (P = 0.36), and adverse effects (P = 1.0) between bio-exposed and naïve older patients (Figure 1). The addition of immunomodulators did not yield better outcomes for the older bio-exposed patients 50.0% combination therapy vs 55.2% monotherapy response rates, P = 1.0.

CONCLUSION:
These results suggest similar efficacy and safety of vedolizumab for older IBD patients regardless of prior biologic exposure based on clinical symptom assessment. Combination therapy did not add incremental benefit for this higher-risk age group or complications associated with additive immunosuppression. Further studies are needed to determine appropriate positioning of vedolizumab prior to or after anti-TNF agents or ustekinumab.
800 Indirect Treatment Comparison of the 1-year Efficacy for Ustekinumab Versus Other Advanced Therapies in Moderate to Severe Ulcerative Colitis
Authors: Welty Margaux , Mesana Laura , Padhiar Amie , Naessens Dominik , Diels Joris , Van Sanden Suzy , Pacou Maud 
Published: October 2019

INTRODUCTION:
In the absence of head-to-head comparisons, indirect treatment comparisons (ITC) on the relative efficacy of ustekinumab (UST) vs other therapies were performed, comparing 1-year response and remission of therapies in non-biologic failure (NBF) & biologic failure (BF) patients with moderate-severe UC, in order to inform clinical and HTA decision-making.

METHODS:
Randomised controlled trials reporting induction & maintenance efficacy of anti-TNFs (infliximab [IFX], adalimumab [ADA], golimumab [GOL]), vedolizumab (VDZ), tofacitinib (TOF) or UST were identified by a systematic literature review through MEDLINE, MEDLINE IN PROCESS, Embase & Cochrane up to the 28th March 2019. Analyses were conducted for clinical response (decrease in baseline total Mayo score ≥30% & ≥3 points, decrease in rectal bleeding subscore (RBS) ≥ 1, or RBS 0 or 1) & clinical remission (total Mayo score ≤2 points, no individual subscore >1 [definitions with RBS of 0 were also included]) by population. To mimic an ITT-based approach, maintenance data from trials with re-randomised response designs were re-calculated to correspond to treat-through arms. For trials with only short-term PBO rates or missing data for PBO non-responders, end of 1-year PBO-to-PBO rates were externally imputed. UST efficacy was calculated for patients starting the ∼6 mg/kg IV regimen. Bayesian ITCs were conducted to obtain posterior distribution probabilities for UST to perform better than its comparators by population. In the NBF population, maintenance doses were pooled as no dose-response was apparent.

RESULTS:
Six trials were included in the NBF population ITC, & four included in the BF ITC. For the NBF group, UST given as a 1-year regimen showed higher probabilities of both clinical response & remission vs all treatments, with Bayesian probabilities of UST being better than active therapies ranging between 91% (VDZ) to 100% (ADA) for response & 82% (VDZ) to 99% (ADA) for remission, respectively. In the BF group, UST was also shown to be the most effective treatment for response and remission (for the Q8W dose), however the effect sizes were smaller compared to the NBF population.

CONCLUSION:
ITC Results indicate a higher likelihood of response & remission at 1 year on UST in NBF population vs comparators, especially vs anti-TNFs. In BF patients, a higher likelihood of response to UST vs most comparators was observed as well, though results were more uncertain due to smaller sample sizes & data limitations.
805 Improving Chromoendoscopy Utilization in Dysplasia Surveillance of Patients With Inflammatory Bowel Disease
Authors: Fan Katherine , Greeff Yesenia , Browne Alexander , Rich Harlan 
Published: October 2019

INTRODUCTION:
Given the increased risk of colon cancer, patients with longstanding inflammatory bowel disease (IBD) of at least 8 years are recommended to undergo screening every 1-2 years. Chromoendoscopy has been shown to provide up to 9-fold detection of dysplastic lesions versus standard-definition endoscopy. However, it has not yet been widely adopted. A background needs assessment at our institution suggested that lack of familiarity and comfort with chromoendoscopy in our endoscopy ancillary staff had contributed to its low implementation rate. Our baseline data also showed that a majority of endoscopy ancillary staff preferred in-person, small group educational sessions to learn more about chromoendoscopy, as opposed to mandatory online training. We aim to improve the implementation of chromoendoscopy at our institution via in-person, small group education of endoscopy ancillary staff.

METHODS:
Two in-service small group sessions with endoscopy nurses at Rhode Island Hospital (RIH) focusing on chromoendoscopy were held in December 2016 and January 2017. A pre-intervention survey was sent to the staff. Staff were asked whether they had ever heard of/personally participated in chromoendoscopy and how comfortable they were with it. Possible concerns, including safety, time constraint, and cost of procedure, were also evaluated in the pre-intervention assessment. A post-intervention survey, consisting of the same questions, was sent after the two education sessions. The number of chromoendoscopy performed over a 22-month period prior to the sessions and following the sessions were evaluated.

RESULTS:
Prior to the intervention, 31% staff had never heard of chromoendoscopy and 22% reported feeling very uncomfortable with it. Post-intervention, less than 10% reported never having heard of chromoendoscopy or feeling very uncomfortable with it. While less than half of the staff reported they would want a physician to use chromoendoscopy for dysplasia surveillance if they themselves had IBD prior to the educational sessions, more than two-thirds after the sessions reported they would. Three cases of chromoendoscopy were done in the 22 months prior to the sessions, compared to 16 cases in the 22 months following.

CONCLUSION:
In-person, small group education of endoscopy ancillary staff on chromoendoscopy decreased their unfamiliarity and discomfort with assisting physicians in chromoendoscopy procedures. The number of chromoendoscopies done at our institution was also higher post-intervention.
821 Presence of Obstructive Symptoms and Absence of Perianal Crohn’s Disease Is Predictive of Surgery After Endoscopic Balloon Dilation
Authors: Sivasailam Barathi , Manski Scott , Wentz Alicia , Cross Raymond K. 
Published: October 2019

INTRODUCTION:
Patients with Crohn’s disease (CD) often develop strictures that require surgery. Endoscopic balloon dilation (EBD) is an alternative treatment which can be safe and effective. The objective of this study was to assess factors associated with need for repeat EBD and surgery after initial EBD for stricturing CD.

METHODS:
Patients with stricturing CD who underwent EBD from 2007-2017 were identified. Demographic and clinical information was obtained from a review of electronic medical records. Outcomes of interest included adverse events, repeat EBD, and surgery. Cox proportional hazards regression model and Kaplan Meier curves were generated for variables associated with repeat EBD and surgical resection.

RESULTS:
99 patients underwent a total of 240 EBD; 63% were women, 75% were Caucasian, and 20% were active smokers. 54% had ileocolonic disease, 35% had a history of perianal disease, and 63% were on a biologic at time of initial EBD. 51% of patients had obstructive symptoms at the time of initial EBD. The stricture location varied but anastomotic (52%) and ileal were most common (17%). 48% of strictures had an inflammatory component. 75% of EBD were successful. Complications occurred in 13 EBD (5%) and included abdominal pain (n = 5), bleeding (n = 3) and perforation (n = 2). 51 patients underwent repeat EBD. Repeat intervention after EBD was more likely in patients on biologics at baseline EBD (76% vs. 54%, P = 0.029). 33% of patients had surgical resection a median of 5 months (IQR 2.0-13.0) after initial EBD. The presence of obstructive symptoms at time of EBD was associated with surgical resection [HR = 3.18, 95% CI 1.28-7.86] (Figure 1). Conversely, a history of perianal disease was negatively associated with surgical resection [HR = 0.27 95% CI 0.10-0.68] (Figure 2).

CONCLUSION:
EBD is an alternative to surgery with good short-term response rates. With experienced gastroenterologists, EBD is safe with perforation rates of < 1%. Patients on biologic treatment at the time of EBD are more likely to need an intervention in the future, either EBD or surgery. One third of patients are referred to surgery after initial EBD; patients with obstructive symptoms at time of initial EBD and those without a history of perianal involvement are more likely to undergo surgical intervention. Gastroenterologists can consider these factors when offering EBD or surgery for treatment of stricturing CD.
834 Early Symptom Improvement With Risankizumab Treatment in Patients With Moderately to Severely Active Crohn’s Disease: Analysis From a Phase 2 Study
Authors: Feagan Brian G. , Sandborn William J. , D'Haens Geert R. , Panés Julian , Kaser Arthur , Ferrante Marc , Louis Edouard , Dewit Olivier , Seidler Ursula , Kim Kyung-Jo , Kligys Kristina , Wallace Kori , Liao Xiaomei , Lee Wan-Ju , Neurath Markus F. 
Published: October 2019

INTRODUCTION:
Risankizumab (RZB), an IL-23 p19 inhibitor, has shown safety and efficacy in inducing clinical remission in patients with Crohn’s disease (CD) in a Phase 2 study.1 Here we assessed early symptom improvement during the randomized, double-blind, placebo-controlled induction phase of the trial.

METHODS:
This Phase 2 study enrolled adult patients with moderate-to-severe CD with a Crohn’s Disease Activity Index (CDAI) of 220–450, ulcers in the ileum and/or colon, and a Crohn’s Disease Endoscopic Index of Severity (CDEIS) ≥7 (≥4 for patients with isolated ileitis) assessed by ileocolonoscopy confirmed by a blinded central reader. Patients were randomized 1:1:1 to receive intravenous RZB (200 mg or 600 mg) or placebo at Weeks 0, 4, and 8. Endpoints examined in this post hoc analysis included changes from baseline at Weeks 2, 4, 8, and 12 in CDAI, average daily stool frequency (SF) and average daily abdominal pain score (AP) for all patients with available data, and newly defined clinical remission at Week 12, based on symptom improvement, defined as SF ≤ 2.8 and AP ≤1, both not worse than baseline, in patients with baseline SF ≥ 4 or AP ≥2. Continuous endpoints were analyzed using observed case; non-responder imputation was used for missing data of binary endpoints. Statistical comparisons of median change were based on Wilcoxon rank sum test.

RESULTS:
121 patients were randomized in the induction phase. Baseline characteristics were similar among treatment arms.1 Mean (SD) disease duration at baseline was 13.4 (9.4) years; 94.2% of patients received previous anti-TNF therapy. Significant improvements in CDAI and AP were observed with RZB (600 mg) versus placebo as early as Week 2 and in SF at Week 8 (Table 1). The proportion of patients with clinical remission based on symptom improvement was significantly higher in the 600 mg RZB group versus placebo at Week 12 (23.7% versus 6.1%; P < 0.05), supporting the previously reported superiority of RZB versus placebo for inducing CDAI remission at Week 12 (36.6% of 600 mg RZB versus 15% of placebo; P < 0.05).

CONCLUSION:
RZB induction treatment was associated with significant early improvements in clinical symptoms and disease activity in a highly refractory patient population with moderately to severely active CD.
844 Improvement of Osteoporosis Screening Among IBD Patients at GI Fellows’ Clinics
Authors: Wehbeh Antonios , Phatharacharukul Parkpoom , Fayad Nabil F. 
Published: October 2019

INTRODUCTION:
Individuals with IBD have an increased risk of osteoporosis compared to the general population. Gastroenterologists should screen at-risk IBD patients for osteoporosis, since those patients often consider their gastroenterologist to be their primary provider. We aimed to improve the osteoporosis screening rate in the IBD patient population of the GI fellows’ continuity clinics.

METHODS:
Baseline pre-intervention data were collected on patients seen over a 12-week period. Simplified criteria for osteoporosis screening were extrapolated from 3 guidelines (ACG 2017, USPSTF 2018 and NOF 2014) and included: females ≥65 years, males ≥70 years, use of oral corticosteroid therapy for >3 consecutive months in a dose ≥ 7.5 mg/day, and a previous bone fracture in adult life occurring spontaneously or from minor trauma. Among patients who met any of these criteria, we determined the baseline screening rate (proportion of patients who had a bone DEXA scan in the past 2 years). Fellows were then educated with a didactic session and handout material, and a standardized template was incorporated into clinic notes. Following this intervention, screening rates were reassessed over another 12-week period (by charts’ reviews performed after those 12 weeks).

RESULTS:
During the pre-intervention phase, fellows saw 743 patients, 80 of whom had IBD. DEXA scan was obtained in 44% of IBD patients who qualify for screening at the County hospital clinic, compared to only 21% of Veterans’ clinic IBD patients. The most common indications for screening were age criteria and steroid use. In the post-intervention period, 81 patients with IBD were seen. Screening rates (DEXA scans performed within past 2 years, or ordered in clinic during intervention) remarkably improved to 100% in the County hospital clinic and to 75% in the Veterans’ clinic. Overall, the screening rate increased by 56% (Table 1).

CONCLUSION:
A large percentage of IBD patients at risk for osteoporosis did not have appropriate bone mass density testing. Educating GI fellows and adding a template to clinic notes was effective in significantly improving the number of patients at risk of osteoporosis to receive appropriate screening test, a DEXA scan. This potentially could lead to identifying more patients with osteoporosis and referring them early for pharmacotherapy. The rate in the County clinic was higher, possibly because of a higher proportion of female patients compared to the Veterans’ clinic.
854 Comparison of Injection Site Pain With Citrate Free and Original Formulation Adalimumab in Pediatric IBD Patients
Authors: Patel Ashish S. , Luu Phuong 
Published: October 2019

INTRODUCTION:
Adalimumab is a fully-humanized anti-tumor necrosis factor antibody FDA approved in 2014 for the treatment of pediatric patients between 6 and 17 years of age with moderately to severely active Crohn's disease. Across all indications, the most commonly reported adverse event was injection site reaction. Citrate free adalimumab was specifically designed to reduce injection pain by removing the citrate acid monohydrate from the formula, using less volume and a smaller needle. The study supporting decreased perception of pain was conducted in adult rheumatological disease patients. The perception of pain in children is very complex and involves psychological, physiological, behavioral and developmental factors. Complications associated with sub-optimally controlled disease is more detrimental for children because the impact on their growth potential. For those patients on dose intensification with adalimumab, the implications of compliance is even more important and the experience with injection site reaction is even more impactful.

METHODS:
Patients with pediatric inflammatory bowel disease were asked to rate their injection site pain comparing the original adalimumab formulation verses the citrate free adalimumab formulation. We collected patient’s specific inflammatory bowel disease type, gender, and age. We evaluated changes in pain between the original formulation verses the citrate free adalimumab using a pediatric visual analog scale (VAS) pain scale.

RESULTS:
The pain score deviated significantly from normal distribution by both Shapiro-Wilk and Kolmogorov Smirnov tests (P < 0.05). Therefore, Wilcoxon Signed Rank test was used to test the difference in pain score between the two types of injection medication. The median pain score was 7.5 in the original formulation injection group and 1 in the citrate free formulation injection group. The median pain reduction was 6 scales when switching from original formulation to citrate free injection. Wilcoxon Signed Rank test showed significant difference in pain score between the two types of the injections (P < 0.0001).

CONCLUSION:
The citrate free adalimumab formulation is associated with statistically significant less injection site pain which provided an overall improved experience for pediatric IBD patients and their families. Alleviating the burden of treatment may improve the quality of adherence for pediatric patients and positively influence treatment outcomes for patients with IBD.