bluuebunny/crossref_metadata_2025_split huggingface dataset:
P227 High prevalence of mental health illness in IBD patients with high caregiver burden in the developing world: An analysis of risk factors from the IBD Emerging Nations Consortium (IBD-ENC)
Authors: Banerjee R , Pal P , Hilmi I , Rahman M , Aye T T , Joshi N , Ghoshal U , Alavinejad P , Peddi K , Mudigonda S 
Published: January 2022

Abstract

Background
Mental health is an important yet most neglected part of IBD care more so in developing countries.Left unaddressed, psychological factors can portend worse disease outcomes and poor quality of life. Caregiver burden including QOL and coping strategies have not been evaluated.

Methods
The study was conducted under IBD ENC (www.ibdenc.com). Consecutive IBD patients from 8 centers in 6 countries (Nepal, Bangladesh, India, Thailand, Myanmar, Malaysia, Iran) were enrolled after informed consent. For patients, a proforma including demographics, disease severity (Harvey Bradshaw Index: HBI- Crohn’s disease (CD), Simple Clinical Colitis Activity Index: SCCAI- Ulcerative Colitis), Morisky medication adherence scale (MMAS-8), Patient Health Questionnaire 9 (PHQ-9) for depression
Generalised anxiety disorder 7 (GAD7) for anxiety, Short inflammatory bowel disease questionnaire (SIBDQ) for quality of life (QOL) and IBD COPE was used. For caregivers the Zarit Burden Interview (ZBI), the Ferrans & Powers QOL index and Brief COPE survey were analysed.

Results
192 (age 14–79 yrs, median 33, 54% male) IBD patients and 168 (age 18–70, median-45, 41% male) caregivers were recruited. Depression and anxiety were noted in 72% and 67% patients respectively. On multivariate analysis, active disease was associated with increased risk of depression (p &lt;0.001,OR-6.7,95%CI-2.8–16.3); Risk factors for anxiety were higher education (p=0.002, OR-2.17, 95% CI-1.32–3.55), married (p=0.001,OR-6.78, 95% CI- 2.27–20.26), comorbidities (p=0.022, OR- 3.9, 95% CI-1.22–13.12) and active disease (p&lt;0.001, OR-14.2, 95% CI-4.8–41.5). Drug adherence was associated with lower risk of depression (p=0.001,OR-0.59, 95% CI: 0.43–0.87) and anxiety (p=0.002, OR-0.63, 95% CI- 0.47–0.84). Both Depression and anxiety scores (PHQ-9 and GAD-7) correlated negatively with QOL (SIBDQ) (r= —0.653, p&lt;0.001;r=—0.653, p&lt;0.001). but there was no significant association with good or bad coping scores (IBD COPE). Disease activity scores correlated positively with PHQ-9 (r=0.55, p&lt;0.001,CD; r=0.52,p&lt;0.001, UC) and GAD-7 (r=0.47, p&lt;0.001, CD; r=0.36, p=0.001, UC).

66.7% of caregivers reported high care giver burden (ZBI score≥ 21) which correlated with poor QOL (r=—0.373, p&lt;0.001). Higher occupational status was associated with lower care giver burden (p=0.028,OR-0.88, 95% CI-0.79–0.99). Positive reframing and self distraction were the most common adaptive and maladaptive coping strategies.

Conclusion
Depression and anxiety is highly prevalent in IBD patients in developing countries with high caregiver burden. Clinicians need to make assessment of psychiatric comorbidity in IBD patients a priority.
P240 Influence of Covid-19 infection in patients with inflamatory bowel disease with biological and no biological therapy
Authors: Herrador Paredes M , Fernández Cano M C , Sánchez Capilla A D , Martín Rodrírguez M D M , Cabello Tapia M J , Redondo Cerezo E 
Published: January 2022

Abstract

Background
Inflammatory bowel disease (IBD) patients undergoing treatments that act on the inmune system and present an increased risk of infections. For this reason, we could consider that these patients may have an increased risk of severe SARS-CoV-2 infection, however, it remains unclear. We aimed to analyze the cumulative incidence, the severity of the infection and its influence on the natural history of IBD in patients under biological treatment and also evaluating the possible differences with another group without these therapy.

Methods
Retrospective observational study about our IBD patients followed from March 2020 to January 2021 divided into two groups: patients on treatment with biological drugs (anti-TNF, vedolizumab, ustekinumab and tofacitinib) and patients without biological drugs (thiopurines or 5-ASA). We evaluated: the cumulative incidence in 10 months for COVID-19 in the 2 cohorts; clinical variables considered risk factors for the infection, the infection severity and influence on the course of IBD employing Harvey-Bradshaw index in Crohn′s disease and Mayo partial index in ulcerative colitis before and after infection.

Results
It collected 755 IBD patients. 89 were infected by SARS-COV-2, 43 in the biological group and 46 in non biological group. The cumulative incidence in 10 months was 10.85% in the first group (figure 1) and 12.81% in the second group with no significant differences. We verified comparability of the groups discarded the existence of statistical differences in all of the risk factors (sex, age, hypertension, diabetes, dyslipidemia, cardiovascular disease and BMI). In most cases, the infection was mild (94.4%) and the required treatment was symptomatic in 86.4% of the total (Figure 2), without significant differences between groups. Pneumonia was diagnosed in 5 patients, whose required hospital admission (3 belonged to the biological group and 2 to the other). The maximum respiratory support required was FIO2 36%, no patient required admission to ICU and there were no deaths. Additionally, the course of IBD was not affected because of COVID-19, considering no significant differences were observed in clinical scores in each group before and after infection, even taking into account 14 patients discontinued biological therapy temporarily during infection.

Conclusion
Our study suggests that IBD patients under biological therapy do not have an increased incidence of SARS-COV-2 infection and also do not have a higher risk of severe disease than IBD patients without this therapy. Furthermore, COVID-19 does not affect the natural history of IBD. These data go in the same direction as those published to date, however, we need multicentre registries with a larger sample size in the future
P246 Persistent burden of disease in patients with Crohn’s disease treated with biologic therapy: results from a real-world survey in the United States (US), France, Germany, Italy, Spain, and United Kingdom (5EU)
Authors: Sikirica M , Lynch J , Kershaw J , Lukanova R , Baker S , Milligan G 
Published: January 2022

Abstract

Background
Crohn’s disease (CD) requires life-long disease management. The study objective was to investigate the burden of CD in patients who have only partially responded to biologic therapy.

Methods
Data were drawn from two waves (Nov 2014-Mar 2015; Sep 2017-Jan 2018) of the Adelphi Inflammatory Bowel Disease (IBD) Disease Specific Programme™, a point-in-time survey of gastroenterologists (GEs) and their IBD patients, in the US, and 5EU. GEs completed a physician-reported questionnaire (PRF) for 5–10 consecutively consulting patients with CD, covering demographics, clinical characteristics, and health care resource use (HCRU). Same patients completed a voluntary patient-reported questionnaire (PSC) covering the Short IBD Questionnaire (SIBDQ), EuroQol 5-dimension (EQ-5D), and Work Productivity and Activity Impairment (WPAI) questionnaires. Crohn’s Disease Activity Index (CDAI) score, derived per patient from the PRF and PSC, was used to stratify patients into four groups by degree of disease activity (DA). Since clinical remission (CDAI &lt;150) and moderate to severe (mod/sev) (≥221) are well known in clinical trials, we explored stratification in between, creating a ‘mild’ group (CDAI 150 - &lt;180) and a ‘partial responder’ (PR) group (CDAI 180 - 220).
Outcomes were compared between DA groups using linear regression (or logistic for binary outcome) that included the potential confounding variables age, gender, body mass index (BMI), comorbidities (using Charlson Comorbidity Index), and severity at diagnosis. From each regression, least square (LS) means were generated for each DA group and pairwise Wald tests were conducted to compare pairs of DA groups. Base sizes varied due to the voluntary PSC element.

Results
319 GEs and 853 CD patients receiving a biologic for at least 12 weeks at data collection were included in the analysis (mean age 38.1 years, proportion of female patients 52.3%, 65.3% employed, mean BMI 24.1). CDAI groups are reported in Table 1.

Levels of pain, sleep disturbance and fatigue were significantly lower in patients in remission (Table 2).

SIBDQ, EQ-5D, and WPAI Health-Related Quality of Life (HrQoL) measures indicated significantly better outcomes amongst remission patients (Table 3).

HCRU in the past 12 months, in terms of hospitalisations and surgery rates, was significantly lower amongst remission patients (Table 4).

Conclusion
Patients in remission showed significantly better outcomes compared with mild, PR and mod/sev. Patient stratification by CDAI demonstrated that patients in remission may considerably benefit from fewer symptoms and improved HrQoL, even vs ‘mild’ patients. The latter had unaddressed symptoms, which may negatively impact their wellbeing.
P247 Comparison of discontinuation/switching between infliximab biosimilar and originator among Inflammatory Bowel Disease patients: a real-world analysis of two Canadian cohorts
Authors: Moura C S , Lukusa L , Wong E C , Lakatos P L , Afif W , Narula N , Bernatsky S 
Published: January 2022

Abstract

Background
Biosimilar infliximab (INF-B) has been approved in Canada for Inflammatory Bowel Disease (IBD) for over five years, but real-world descriptions of therapy persistence (discontinuation/switching) comparing INF-B to bio-originator (INF-O) are still scarce. Our objectives are to describe and compare therapy discontinuation/switching of INF-B and INF-O in IBD.

Methods
We used data from two IBD tertiary care clinics in Canada, in Montreal (QC) and Hamilton (ON). We studied biologic-naïve and biologic-experienced IBD adult initiating INF-B or INF-O between Jan. 2015 and Jul. 2020. We assessed time to discontinuation/switching through Kaplan-Meier curves (right-censoring due to loss to follow-up or end of the observation period). Reasons for discontinuation were assessed. Multivariable Cox regression models were performed to assess difference in time to discontinuation/switching between the two infliximab types. Model variables included age at infliximab initiation, sex, underlying condition (Ulcerative Colitis or Crohn’s Disease), disease duration, race/ethnicity, calendar year of infliximab start, current smoking, clinical centre, and previous use of other biologics, as well as previous/current use of corticosteroids, non-biologic immunosuppressants, budesonide, or 5-aminosalicylates.

Results
We studied 306 patients followed an average of 1.4 (standard deviation, SD=0.99) years. Patients were 46.7% female, with median age at infliximab initiation of 32 (interquartile range, IQR 21 to 47) years and median disease duration of 3.5 (IQR 0.9 to 11.7) years. Age, sex, and other baseline characteristics were comparable between the two groups, though there was a trend towards more INF-B initiation in recent years (Table 1). We identified 70 discontinuation/switching events; the main reasons for discontinuation/switching were adverse events (37.1%) and secondary loss of response (28.6%). The median time to discontinuation/switching was 4.1 (95% confidence interval, CI 3.4–5.5) years among INF-O and 3.0 (95% CI 2.2–3.5) years in the INF-B group. In the multivariate model, risk of the main outcome was not clearly different between the two groups (hazard ratio, HR 1.21, 95% CI 0.64–2.32 – Table 2). Older age and corticosteroids were significantly associated with discontinuation/switching of the initial infliximab therapy.

Conclusion
In this real-world analysis, we were unable to demonstrate differences in risk of discontinuation/switching among initiators of infliximab biosimilar or originator in IBD.
P261 Burden of bowel urgency across specific treatment groups among Ulcerative Colitis patients – real world global study analyses
Authors: Atreya R , Redondo I , Hill J , Streit P , Hartz S , Knight H , Barlow S , Hennessy F , Hunter T 
Published: January 2022

Abstract

Background
Bowel urgency, the sudden and immediate need to have a bowel movement, is a common symptom in ulcerative colitis (UC) and is associated with higher disease activity, decreased work productivity and markedly reduced quality of life1. This study explored differences in disease burden among UC patients with bowel urgency based on their treatment pathway.

Methods
Data were extracted from the Adelphi Disease Specific Programme for UC, a point-in-time survey of gastroenterologists (GIs) and patients from Jan 2020-Mar 2021 in Germany, France, Spain, Italy, UK and US. GIs provided patient demographics, clinical characteristics and treatment history. The same patients were invited to complete the Short Inflammatory Bowel Disease Questionnaire (SIBDQ), EQ-5D and Work Productivity and Activity Impairment (WPAI) questionnaire. Three patient subgroups were identified: never received targeted therapy (biologics and JAK inhibitors) (TT-naïve), receiving first TT currently (1L TT) and receiving TT with prior TT use (TT-exp). Within these groups, patients currently experiencing day- or nighttime bowel urgency, reported by physicians, with current treatment duration &gt;3 months, were included. ANOVA, chi-squared and Kruskal-Wallis tests were used to compare the groups.

Results
Of the UC patients in the TT-naïve (n=595), 1L TT (n=851) and TT-exp (n=321) groups, 23%, 17% and 26% experienced bowel urgency, respectively. Of those with bowel urgency, TT-naïve patients were younger with lower BMI and the lowest proportion of never smokers vs. the 1L TT and TT-exp groups (Table 1). 70–80% of patients across the three groups remained in non-remission based on the derived Mayo score, while 19% of the TT-naïve group were flaring vs. 18% 1L TT and 32% TT-exp patients (p=0.0324). Steroid use was highest in the TT-naïve group (43%) vs. 10% 1L TT and 17% TT-exp (p&lt;0.0001). 1L TT had the highest number of visits to healthcare professionals in the last 12 months. The patient reported outcome measures indicated substantial and similar quality of life impairment across all patients with bowel urgency (Table 2). The only significant difference was across impairment while working (31% TT-naïve, 17% 1L TT, 28% TT-exp; p=0.0232).

Conclusion
This study confirmed that a substantial proportion of patients across all three groups still experience bowel urgency despite receiving treatment. Since bowel urgency is known to negatively impact patients’ quality of life, there is a therapeutic need to address this symptom.

Reference
1. Ha, C, et al. Rectal Urgency Among Ulcerative Colitis and Crohn’s Disease Patients: Analyses from a Global Survey. Poster presented at: Digestive Disease Week; 2021 May 21–23; Online event.
P269 Spaciotemporal machine learning analysis of complete small bowel capsule endoscopy videos for prediction of outcomes in Crohn’s disease
Authors: Kellerman R , Bleiweiss A , Samuel S , Barzilay O , Margalit Yehuda R , Zimlichman E , Eliakim R , Ben-Horin S , Klang E , Kopylov U 
Published: January 2022

Abstract

Background
Capsule endoscopy (CE) is a prime modality for diagnosis and monitoring of Crohn’s disease (CD). However utilization of CE for monitoring of CE is hampered by prolonged reading time and interobserver variability. Machine learning (ML) techniques such as convolutional neural networks (CNN) are capable of accurate detection and grading of inflammatory findings on isolated images from CE in CD patients, with accuracy above 95%. However, ML-based analysis of complete CE films have not yet been reported; moreover, the predictive utility of ML of CE in CD for disease outcomes has not been examined so far.

Methods
The study cohort included treatment-naïve CD patients that have performed CE (SBIII, Medtronic) within 6 months of diagnosis of CD and had a minimal follow-up of 6 months. Complete small bowel videos (first duodenal to first cecal image) were extracted using the RAPID reader software, V9.0. Prior to extraction, CE videos were scored using the Lewis score (LS). Clinical, endoscopic and laboratory data were extracted from the electronic medical records. All patients were classified as per start of biological therapy during follow-up. Machine learning analysis was performed by Intel Inc. using TimeSformer computer vision algorithm developed by Facebook. Timesformer algorithm utilizes spaciotemporal

Results
The patient cohort included 103 patients (54 (52%) female, median age- 25 years, interquartile ratio (IQR) 21–40). The median duration of follow-up was 941 (363–1644) days. The median LS was 450 (IQR-225–900). Biological therapy was initiated by 41(39.8%) of the patients (adalimumab -20 (48.7%), infliximab-14 (34,1%), vedolizumab- 7 (17%) patients, respectively). TimeSformer algorithm achieved training and testing accuracy of 91% and 79% respectively, with area under the curve (AUC) of 0.79 for prediction of the need for biologic therapy. In comparison, the AUC for LS was 0.69. The required time for analysis per complete video was 440ms on a single GPU.

Conclusion
Spaciotemporal analysis of complete small bowel CE videos of newly diagnosed CD patients achieved accurate prediction of the need for biological therapy. The accuracy was superior to that of human reader index. Following future validation, this approach will allow for fast and accurate personalization of treatment decisions in CD.
P286 Sustained improvement in health-related quality of life outcomes in patients with Ulcerative Colitis with long-term tofacitinib treatment in the open-label extension study, OCTAVE Open
Authors: Biedermann L , Dubinsky M C , Vermeire S , Fellmann M , Gardiner S , Hur P , Mundayat R , Panés J , Rubin D T 
Published: January 2022

Abstract

Background
Tofacitinib is an oral, small molecule JAK inhibitor for the treatment of ulcerative colitis (UC). Tofacitinib induction and maintenance therapy has previously been shown to improve health-related quality of life (HRQoL) outcomes. Here, we present HRQoL data from patients (pts) with UC who received tofacitinib 5 or 10 mg twice daily (BID) in the Phase 3 open-label, long-term extension (OLE) study (OCTAVE Open; NCT01470612), up to Month (M)72.

Methods
Proportions of pts with an Inflammatory Bowel Disease Questionnaire (IBDQ) total score ≥170, and EuroQol-5D (EQ-5D) and Short Form-36 Health Survey (SF-36) scores were analysed up to M72 in 4 subpopulations in the OLE study: ‘maintenance remitters’ completed OCTAVE Sustain in remission and received tofacitinib 5 mg BID in the OLE study; in contrast, ‘maintenance treatment failures’ (induction responders who experienced treatment failure), ‘maintenance non-remitters’ and ‘induction non-responders (IndNR)’ received tofacitinib 10 mg BID in the OLE study (Figure 1). Data were analysed for each subpopulation overall and stratified by prior tumour necrosis factor inhibitor (TNFi) failure, prior immunosuppressant failure and baseline corticosteroid use.

Results
Baseline demographics and clinical characteristics for each subpopulation are shown in Table 1. Among the 163 maintenance remitters, HRQoL outcomes were maintained up to M72: 80.0% of pts had an IBDQ total score ≥170 (Figure 1); changes from baseline in EQ-5D scores up to M72 and SF-36 scores up to M33 were minimal (eg M72 EQ-5D utility score -0.07 [standard deviation 0.10]; M33 SF-36 physical functioning score -1.3 [8.3]). Among pts continuing long-term tofacitinib treatment, improvement in IBDQ total score was maintained/achieved by M2 (first post-baseline assessment), and was stable up to M72, with maintenance treatment failures and IndNR subpopulations experiencing the largest improvements from baseline (Figure 1). Similar trends were observed for improvement in EQ-5D and SF-36 scores. Improvements in HRQoL outcomes were independent of prior TNFi failure, prior immunosuppressant failure or baseline corticosteroid use, eg in maintenance remitters with prior TNFi failure, 90.9% of pts had IBDQ total score ≥170 at M60 vs 88.9% of pts without prior TNFi failure.

Conclusion
Sustained beneficial effects in HRQoL were observed among pts continuing long-term tofacitinib treatment in OCTAVE Open. In maintenance remitters, improvements in all HRQoL outcomes were maintained with tofacitinib therapy. In pts who entered the OLE study not in remission and received tofacitinib 10 mg BID, HRQoL improvements were observed within the first 2 months, and were maintained up to M72, regardless of treatment history including prior TNFi failure.
P298 Pregnancy in Crohn’s and Colitis - Observations, Levels and Outcomes Extension (PICCOLO-X) Study: Biological therapy reduces faecal calprotectin and the need for corticosteroids in pregnant women with Inflammatory Bowel Disease
Authors: Prentice R , Wright E , Flanagan E , Goldberg R , Prideaux I , Ross A , Burns M , Bell S 
Published: January 2022

Abstract

Background
Active Inflammatory Bowel Disease (IBD) in pregnancy is associated with adverse obstetric and neonatal outcomes. PICCOLO-X is an ongoing prospective cohort study of pregnant women with IBD, aiming to describe rates of biochemically active IBD in the current therapeutic landscape, and associations with adverse outcomes.

Methods
Participants were evaluated preconception, in each trimester and postpartum with clinical and biochemical data collected. Univariate and multivariate logistic regression was performed to identify the relative risk (RR) of adverse outcomes by relevant exposures. Fischer’s exact test was used to compare group medians.

Results
164 completed pregnancies were included, with 62% exposed to biologic therapy and 56% having Crohn’s Disease (Table 1).

Clinically active disease (PGA ≥1) was reported in 23.9% in trimester 1 (T1), 18.8% in trimester 2 (T2) and 17.5% in trimester 3 (T3), and was less common in biologic exposed patients (Table 2 & 3).

The median faecal calprotectin (FC) was &lt;50μg/g in all trimesters, and was lower in those receiving biologics (24.9 vs 86μg/g T1 p=0.02, 26.25 vs 46μg/g T2 p=0.02, 30 vs 58μg/g T3 p=0.04) (Table 3). Adverse pregnancy outcome rates were equivalent to the normal population (Table 2). Corticosteroid (CCS) exposure in T2 was associated with an increased risk of preterm delivery (PTD) on multivariate analysis (RR 8.12, 95%CI 1.23–53.72, p=0.03). T1 FC ≥250μg/g (RR 2.41 95% CI 0.5–4.31, p=0.01), clinically active disease in T3 (RR 4.7, 95% CI 1.02–26.61, p&lt;0.01) & T3 FC 100–250 (RR 6.8 95% CI 1.71–26.0, p&lt;0.01), but not T3 FC ≥250μg/g (RR 1.6, 95% CI 0.41–8.25, p=0.6) were associated with an increased risk of PTD on univariate analysis (Table 4).

Biologic exposure was associated with a reduced need for CCS; no participants on a biologic had CCS in T1, with RR 0.14 (95% CI 0.03–0.66, p=0.01) in T2 and 0.11 (95% CI 0.02–0.46, p=0.003) in T3. On multivariate analysis, FC &gt;100μg/g in T2 was associated with an increased risk of emergency caesarean section (RR 1.65, 95% CI 0.47–2.82, p&lt;0.01), whilst FC &gt;100μg/g in T2 (RR 1.65 95% CI 0.4–2.91 p=0.01) and T3 (RR 2.47,95% CI 1.36–8.82, p&lt;0.01) were associated with an increased risk of neonatal intensive care unit admission.

Conclusion
PICCOLO X describes low rates of biochemical and clinical active disease in pregnant women with IBD as compared to historical cohorts, possibly due to the cohort’s high rate of biologic use. Pregnancy outcomes were favourable overall. Clinical and biochemical inflammation and CCS exposure were associated with an elevated risk of adverse pregnancy outcomes. Biologic therapy reduces FC and the need for steroids.