bluuebunny/crossref_metadata_2025_split huggingface dataset:
P091 Switching to TNFi versus non-TNFi biologics in Crohn’s Disease patients: Real-world outcomes from a German claims data analysis
Authors: Antolin-Fontes B , Borsi A , Nissinen R , Bravatà I , Barthelmes J N , Le Bars M , Lee J , Maywald U , Bokemeyer B , Wilke T , Ghiani M 
Published: May 2021

Abstract

Background
Determining the best treatment path for Crohn’s Disease (CD) patients following loss of response (LoR) to a tumour necrosis factor inhibitor (TNFi) is challenging for clinicians. This study seeks to provide real-world evidence on treatment failure, treatment discontinuation and corticosteroid-free drug survival in CD patients with LoR to a first TNFi, switching to another TNFi compared to a non-TNFi biologic.

Methods
Adult CD-patients without biologics therapy in the last 6 months who started treatment with adalimumab or infliximab and switched due to LoR to another biologic between 01/10/2014–31/12/2018 were identified from German claims data (AOK PLUS). The identified patients were classified as either within-class switchers (WCS) (if they switched to adalimumab or infliximab) or outside-class switchers (OCS) (if they switched to vedolizumab or ustekinumab). The date of first treatment switch was set as the index date. Patients were followed for at least one year after treatment switch. To compare WCS and OCS, baseline covariate adjustment through inverse probability of treatment weighting (IPTW) of the propensity scores was conducted. Time-to-event analyses were performed using Cox Proportional Hazard regressions adjusted for an indicator of primary non-response and secondary LoR (if the first switch happened within or after 6 months from the initial TNFi).

Results
112 patients (53 WCS and 59 OCS) were identified. Upon IPTW, 43 WCS and 54 OCS satisfying the common support assumption were included for comparative analyses with adjustment for primary non-response and secondary LoR. WCS were significantly more likely to receive corticosteroid therapy, more likely to fail and to discontinue the treatment they had switched to; and more likely to switch again to another biologic compared to OCS (Figure 1). Having switched due to primary non-response or due to secondary LoR was not significantly associated with any outcome.

Figure 1: Kaplan-Meier curves and Cox proportional hazard models adjusted for an indicator variable of primary non-response/secondary loss of response
Abbreviations: CD, Crohn’s disease; CI, confidence interval; HR, hazard ratio

Conclusion
Whilst small sample size is a limitation, these results suggest that following loss of response to a TNFi, patients may benefit from switching to vedolizumab or ustekinumab rather than switching to a different TNFi.
P109 Impact of ethnicity on colorectal cancer incidence in a cohort of colitis-associated dysplasia patients
Authors: Kabir M , Curtius K , Kalia P , Al Bakir I , Choi C H R , Hartono J L , East J E , Lindsay J O , Vega R , Thomas-Gibson S , Graham T A , Hart A , Wilson A 
Published: May 2021

Abstract

Background
Racial disparities in inflammatory bowel disease (IBD) phenotypic presentations and outcomes are recognised. However, there are conflicting data from Western population-based cohort studies as to whether racial differences in colitis-associated colorectal cancer (CRC) incidence exists. To our knowledge this is the first study to investigate the impact of ethnicity on the natural history of dysplasia in ulcerative colitis (UC).

Methods
We performed a retrospective multi-centre cohort study of adult patients with UC whose first low-grade dysplasia (LGD) diagnosis within the extent of colitis was made between 1 January 2001 and 30 December 2018. Only patients with at least one follow-up colonoscopy or colectomy by 30 August 2019 were included. The study end point was time to CRC or end of follow-up. Statistical differences between groups were evaluated using Mann-Whitney U tests and Chi-squared tests. Survival analyses were performed using Kaplan-Meier estimation and multivariate Cox proportional hazards models.

Results
408 patients met the inclusion criteria (see Figure 1 for patient and clinical demographics). More patients from a Black or Asian (BAME) background progressed to CRC [13.4% vs. 6.4%; p=0.036] compared to their White Caucasian counterparts, despite having surveillance follow-up. Figure 2 displays Kaplan-Meier curves demonstrating the probability of remaining CRC-free after LGD diagnosis and categorised by ethnicity. BAME patients were more likely to have moderate-severe inflammatory activity on colonic biopsy within the 5 preceding years [42.0% vs. 28.9%; p=0.023], but no significant differences in medication use and a longer median time interval from LGD diagnosis to colectomy date [32 months vs. 11 months; p=0.021]. After adjusting for sex, age and UC duration at time of LGD diagnosis and presence of moderate-severe histological inflammation, being Black or Asian was a predictive factor for CRC progression on multivariate Cox proportional hazard analysis [HR 2.97 (95% CI 1.22 – 7.20); p = 0.016]. However, ethnicity was no longer predictive of CRC progression on sub-analysis of the 317 patients who did not have a colectomy during the follow-up period.

Conclusion
In this UK multi-centre cohort of UC surveillance patients diagnosed with LGD, delays in receiving cancer preventative colectomy may contribute to an increased CRC incidence in certain ethnic groups. Further work is required to elucidate whether these delays are related to institutional factors (e.g. inequity in the content of decision-making support given or access to healthcare) or cultural factors.
P111 Cross-sectional imaging is highly sensitive in detecting endoscopic post-operative recurrence in Crohn’s disease patients
Authors: Bachour S , Shah R S , Lyu R , Nakamura T , Shen M , Li T , Rieder F , Cohen B , Qazi T , Lashner B , Achkar J P , Philpott J , Lightner A , Holubar S , Regueiro M , Dane B , Baker M , Axelrad J , Click B 
Published: May 2021

Abstract

Background
Postoperative Crohn’s disease (CD) surveillance relies on endoscopic monitoring. The role of cross-sectional imaging in post-operative CD surveillance is less clear. We aimed to evaluate radiographic characteristics, endoscopic concordance, and the predictive ability of imaging for postoperative recurrence (POR).

Methods
Multi-institution retrospective cohort study of adult CD patients who underwent ileocolonic resection (ICR) between 2009–2020. Patients with a CT or MR enterography within 90 days of a postoperative surveillance colonoscopy were included. Imaging studies were interpreted by blinded expert CD radiologists. Endoscopic activity was assessed by Rutgeerts’ scoring (POR ≥ i2b). Patients were categorized by presence of endoscopic POR (E+ or E-) or radiographic disease activity (R+ or R-) and grouped by endoscopic and radiographic concordance.

Results
201 CD patients (57.7% female, mean age 31 years, 81.2% stricturing CD, 17.9% &gt;1 prior ICR, 22.5%) with paired colonoscopy and imaging were included. Median time from ICR to paired endoscopy was 23.2 months. Imaging was highly sensitive for detecting POR (84.2%), but poorly specific (32.8%). The plurality (41.8%, N=84) were discordant E-/R+, 32.8% concordant positive (E+/R+), 20.4% concordant negative (E-/R-), and 5% discordant E+/R-. In patients with endoscopic POR, imaging detected intestinal wall thickening (86.8%; p=0.004) and hyper-enhancement (84.2%; p=0.003) at higher rates and corresponded with endoscopic severity (Figure 1). Multiple correspondence analysis showed association between severe endoscopic (i3/i4) disease and advanced radiographic disease. The majority (58.3 %) of E+/R- patients (N=12) had a Rutgeerts’ score of i2b. Majority of E-/R+ (N=84) had minimal/mild radiographic disease (81%). Differences in characteristics between the E-/R+ and E+/R+ was most pronounced in length of disease &gt;10 cm (26.1%, 45.3%). Subsequent colonoscopies were performed in 74 E-/R+ (i0=28, i1=12, i2a=34) and 35 E-/R- (i0=20, i1=9, i2a=6) patients with 18 E-/R+ (24.3%; i0=8, i1=3, i2a=7) and 4 E-/R- (11.4%; i0=1, i1=2, i2a=1) patients developing POR (p=0.09). However, survival analysis between E-/R+ and E-/R- showed no difference to time to subsequent POR (p=0.24) (Figure 2). Imaging features at time of paired negative endoscopy did not predict subsequent endoscopic POR.

Conclusion
Cross-sectional imaging is highly sensitive to detect endoscopic POR; advanced radiographic disease correlates with increased endoscopic severity. Patients with no endoscopic recurrence in the presence of radiographic activity may require increased surveillance, though larger study cohorts are needed. Imaging compliments, but should not supplant, endoscopic POR surveillance paradigms.
P139 Significant Changes In Routine Biochemical Markers Occur Up To 5 Years Prior To Inflammatory Bowel Disease Diagnosis: A Case-Control Study
Authors: Cohen N A , Kliper E , Zamstein N , Ziv-Baran T , Ben Tov A , Kariv R 
Published: May 2021

Abstract

Background
Early diagnosis of inflammatory bowel diseases (IBD) is associated with improved response to treatment and disease outcomes. Predicting patients at risk of developing symptomatic IBD would provide a window of opportunity to treat patients before irreversible bowel damage is caused. Our aim is to determine whether there is a pattern of change in use of health resources, medications and laboratory results in the years prior to diagnosis.

Methods
This is a retrospective study performed using electronic medical records (EMR) of Maccabi Health Services (MHS) which insures 25% of the Israeli population with a nationwide distribution. Data was extracted using MDClone (MDClone Ltd). IBD patients ≥ 16 years of age and minimum of 5 years follow up were identified by entry into the MHS IBD registry and included in the study. Demographic, clinical, medication and laboratory data was collected. Generalized estimating equation (GEE) model was applied to study trends and compare between years.

Results
A total of 5643 IBD patients were included. Of these, 3039 (53.8%) had Crohn’s disease (CD), 2322 (41.1%) had ulcerative colitis (UC) and 282 (5%) had indeterminate colitis (IC). The mean age of the total IBD population at inclusion to the registry was 39.3 ± 16.5 years. Overall, CD patients had significantly increased visits to general practitioners, emergency rooms and admissions compared to UC patients (33.2 vs 30, p&lt;0.0001; 0.2 vs 0.17, p&lt;0.0001 and 0.88 vs 0.71, p&lt;0.0001, respectively). CD and IC patients had similar patterns of medical professional/institution visits. Laboratory parameters such as haemoglobin and mean corpuscular volume showed significant decrease and white blood count, platelets and c-reactive protein showed significant increase in mean values primarily in the 2 years prior to diagnosis with stable values prior to that (p&lt;0.0001 for all parameters). In contrast, parameters such as creatinine, total protein, albumin and calcium showed earlier significant and progressive decreases in mean values starting 5 years prior to diagnosis (p&lt;0.0001 for all parameters) (Figure 1). Use of medications such as nonsteroidal anti-inflammatory drugs, etanercept, steroids, proton pump inhibitors and antibiotics significantly increased in the 2 years prior to IBD registry entry (P&lt;0.0001 for all).

Conclusion
There are clear changes from baseline in uptake of medical resources, medication usage and laboratory results in the 5 years prior to IBD diagnosis. Parameters such as creatinine and albumin give earlier signal than others. This data may allow the development of an algorithm stratifying patients into those who need more intensive follow-up or investigations to enable earlier disease diagnosis.
P178 Remote monitoring as an effective management strategy in inflammatory bowel disease: the lesson from COVID-19 pandemic
Authors: Busacca A , Sinagra E , Guida L , Carrozza L , Melodia M , Maida M , Battaglia S , Celsa C , Cammà C , Cappello M 
Published: May 2021

Abstract

Background
During the COVID-19 outbreaks many IBD clinics in Italy adopted a remote monitoring approach both to ensure an adequate follow-up of patients with inflammatory bowel disease (IBD) and respect the rules of social distancing, while access to hospital was restricted. Aim of the study was to perform a survey on IBD patients submitted to remote monitoring in our tertiary referral center in order to assess adherence and patients’ perceptions and satisfaction as well as their opinions for future monitoring. Changes in disease activity and Quality of Life were also evaluated.

Methods
Consecutive patients with IBD scheduled for follow-up visits were switched to remote monitoring through e-mail from March 2020 to February 2021, Patients were asked to complete a questionnaire focusing on 3 elements of the intervention: (1) self-assessment questions, (2) action plans, and (3) educational messages. With regards to self-assessment questions, we used the SIBDQ (to evaluate the QoL) and the IBDSI (to evaluate symptoms as patients’ reported outcomes). All patient sent by email results of blood texts: ESR, CRP, CBC, faecal calprotectin, ferritin, serum iron. HBI Index and Mayo UC score were calculated by the treating physicians.

Results
424 subjects, 100% Caucasians, completed the survey. 233 (55,1%) were male, 220 (52.0%) had Crohn’s Disease (CD). Median baseline Mayo Score and Harvey Bradshaw Index were 3 and 4, respectively. 9 (2,1%) patients were referred to emergency department because of disease flares. 2 (1%) UC patients needed to add topical therapy, 9 (4%) CD patients started therapy with systemic steroids and 3 (1,3%) with biologics. 410 (96,9%) patients were satisfied about telemedicine, and 320 (76,5%) patients reported that would maintain this approach also after COVID-19 outbreak. On univariate logistic regression analysis, only a high ferritin value was found to be related to patients’ satisfaction (p=0.001). Lower calprotectin (p=0.012) and need for treatment change (p&lt;0001) were found to be related to QoL, while CD (p=0.052), age (p=0.027), disease duration (p=0.046) and higher calprotectin (p=0.021) were associated to the need for treatment change. None of the variables were significant on multivariate analysis.

Conclusion
Our results confirm in an homogeneous cohort of IBD patients from southern Italy that a telemedicine approach can substitute face-to-face consultations at least for patients in remission or mild clinical activity. Patients’outcomes were not affected as far as concerns referral to emergency services or the use of steroids for disease flares. A high proportion of patients would maintain this management strategy.
P266 The impact of vedolizumab and ustekinumab on arthropathy and arthralgia in IBD patients: a real-life multicentric cohort study
Authors: Truyens M , De Galan C , Peeters H , Mesonero Gismero F , Elorza A , Torres P , Vandermeulen L , Jauregui Amezaga A , Ferreiro-Iglesias R , Holvoet T , Zabana Y , Peries Reverter L , Geldof J , Varkas G , De Vos M , Lobaton T 
Published: May 2021

Abstract

Background
Extra-intestinal manifestations (EIM) are frequently reported in inflammatory bowel diseases (IBD). Although the efficacy of TNF inhibitors is well documented, data regarding the effect of vedolizumab (VDZ) and ustekinumab (UST) are limited. Theoretically, the advantage of VDZ, i.e. gut-selectivity, may reduce the efficacy on EIM while the systemic effect of UST may be of benefit. Therefore, we evaluated the differences in new onset and evolution of EIM during both treatments.

Methods
An international multicentric retrospective study was performed on IBD patients who started VDZ or UST between May 2010 and December 2020. EIM were assessed at baseline and during follow-up. Arthropathy was defined as joint inflammation (arthritis/sacroiliitis) and arthralgia as articular pain without confirmed inflammation. Skin EIM included erythema nodosum (EN), pyoderma gangrenosum (PG) and Sweet syndrome. Ocular EIM included (epi)scleritis and uveitis. Uni- and multivariate analyses were performed.

Results
In total 856 patients were included: 528 treated with VDZ and 328 with UST. At baseline, arthropathy was more prevalent in UST treated patients (12.2% vs 7.2%; p=0.037; Table 1). No differences in rates of new onset (Fig 1) or evolution of pre-existing arthropathies could be identified between VDZ and UST. In multivariate analyses new onset arthropathy was not associated with smoking, IBD type, sex nor studied biological. In 5 out of 48 (10.4%) VDZ patients and 2 of 46 (4.3%) UST patients with either pre-existing or new arthropathy, treatment was stopped due to articular disease (difference not significant).
In contrast, new arthralgia onset within 1 year of follow-up was significantly associated with VDZ treatment (OR 2.1 (1.1–4.0); p=0.022; Fig 1). Arthralgia was the reason to stop treatment in 2 of 87 (2.3%) VDZ patients and never in UST patients.
Beside joint EIM, 2 patients developed EN, 1 PG and 1 episcleritis during VDZ treatment. Under UST treatment 1 patient developed EN. No patients developed new Sweet syndrome, scleritis nor uveitis.

Conclusion
No differences in the rate of new arthropathy onset were observed between VDZ and UST. In contrast, VDZ treatment did increase the risk of new onset arthralgia.
P324 Predictors of corticosteroid-free remission after initiation of ustekinumab for ulcerative colitis: a real-world, multicenter cohort study in the United States
Authors: Dalal R , Esckilsen S , Barnes E , McClure E , Goodrick H , Allegretti J 
Published: May 2021

Abstract

Background
Clinical trial data has demonstrated the efficacy of ustekinumab (UST) for the treatment of ulcerative colitis (UC), however real-world clinical outcomes data are limited. We therefore performed a real-world multicenter cohort study to identify predictors of corticosteroid-free clinical remission after initiation of ustekinumab for UC.

Methods
This is a retrospective cohort study of adult UC patients initiating UST between 1/1/2016 and 11/1/2020 at three large IBD referral centers in the United States. Patients with prior colectomy and those receiving UST for primarily non-UC indications were excluded. Electronic health records were reviewed to obtain clinical data. Independent variables present at UST induction included demographics, disease duration, extraintestinal manifestations, current/prior IBD medications, substance use (cigarettes, cannabis, or opioids), last endoscopic extent/severity, last serum albumin and C-reactive protein (within 3 months prior to induction), and daily bowel frequency. The primary outcome was corticosteroid-free remission (i.e. simple clinical colitis activity index [SCCAI] or 9-point Mayo score of &lt;3) 12-16 weeks after induction. Secondary outcomes included clinical response (reduction of SCCAI or Mayo score by &gt;2 points from baseline) 12-16 weeks after induction and UST failure (i.e. UST discontinuation or colectomy due to uncontrolled disease) within 52 weeks after induction. Multivariable logistic regression was used to identify factors associated with remission.

Results
We identified 108 UC patients who initiated UST. Median age at induction was 39 years (IQR 30-56 years), 91.7% (99/108) of patients had prior anti-TNF exposure, and 60.2% (65/108) had prior anti-TNF and anti-integrin exposure (Table 1). Of 101 patients with available clinical follow-up data, 39.6% achieved remission and 51.5% had clinical response 12-16 weeks after induction. UST failure occurred in 41.1% (23/56 with sufficient follow-up) within 52 weeks. Adverse events were reported in 3.0% (3/101; rash, urinary tract infection, and C. difficile infection). After multivariable logistic regression, prior anti-TNF and anti-integrin exposure (OR 0.31, 95% CI 0.11-0.86), Mayo endoscopic severity &gt;1 (OR 0.30, 95% CI 0.10-0.88), and bowel frequency (OR 0.84, 95% CI 0.72-0.98) were inversely associated with remission (Table 2).

Conclusion
In this multicenter cohort, nearly 40% of UC patients achieved corticosteroid-free remission 12-16 weeks after UST induction. Prior exposure to both anti-TNF and anti-integrin therapies, endoscopic severity, and daily bowel frequency were associated with failure to achieve remission. Prospective studies are needed to optimize management strategies for UC patients with failure of two biologic classes.
P416 Use of DXA in children with Inflammatory Bowel Disease – a large single centre study
Authors: Jois A , Perera S , Simm P , Alex G 
Published: May 2021

Abstract

Background
Low bone mineral density (BMD) is a complication in children with Inflammatory Bowel Disease (IBD). Dual-energy X-ray absorptiometry (DXA) is an established screening tool for BMD, yet there are limited data to guide its use in children with IBD. We performed a single site retrospective analysis of the use of DXA and evaluated factors associated with low BMD.

Methods
Children 3-18 years with IBD diagnosed between 2013-2018 at The Royal Children’s Hospital, Melbourne, Australia, were included. Patient, disease and treatment demographics were collected alongside vitamin D, calcium, CRP, ESR, albumin and faecal calprotectin (FCP) (averaged over 6 months before and after DXA). Rates of corticosteroid use, vitamin D and calcium supplementation, bisphosphonate use and fractures were also collected. Mann-Whitney and Fisher exact tests were used for continuous and categorical group comparison, respectively. Data are presented as median (interquartile range).

Results
239 children diagnosed at a median age of 12 (9.1-14.2) were followed for 5.1 (4-6.4) years. 72/239 (30%) children had at least one DXA at 11 (1.25-28.8) months post diagnosis. 28/72 (39%) children had a follow-up DXA 2.3 (1.9-2.9) years post diagnosis. Children referred for DXA had a lower weight centile (48.7 (17.1-78.2) vs 59.7 (31.4-84.7), p=0.03), and were more likely to have Crohn’s disease (OR 2.18, p=0.01). At first DXA, median lumbar spine (LS) Z score was -0.80 (-1.65-0.08), height adjusted LS Z score was -0.65 (-1.18-0.10), hip Z score was -1.30 (-1.80--0.35) and total body less head Z score was -1.40 (-2.55--0.70). 18/72 children had LS Z score &gt; 0. Children with LS Z score &lt; -2.0 (n=14) had lower weight (6.57 (1.78-23.7) vs 51.1 (26.5-68.7), p=0.0002) and height centiles (3.62 (1.17-17.1) vs 42 (16.9-67.1), p&lt;0.0001), higher FCP (3041 (1182-4192) vs 585 (139-2419), p=0.009) (Figure 1), and higher odds of calcium supplementation (OR 16 (95% CI 2.93-89.1), p=0.003) and endocrinology review (OR 9.61 (95% CI 2.65-31.0), p=0.001). No fractures were reported. Of the 28 children with serial DXAs, there was no significant change in Z scores. When comparing children with a worse (16/28) Z score at second DXA to those with improvement (12/28), there was a trend toward lower vitamin D levels (37 (25.2-58.3) vs 62 (46.3-87), p=0.06) at first DEXA, and higher ESR at second DEXA (23.4 (19.3-29) vs 8.20 (3.5-21.9), p=0.02).

Conclusion
Almost one third of children with IBD at a tertiary referral centre underwent DXA, with lower BMD than age and sex matched controls. Disease activity markers FCP and ESR were associated with lower BMD. There was no significant change in DXA score over time. No fractures were identified over the study period.