bluuebunny/crossref_metadata_2025_split huggingface dataset:
P564 A qualitative exploration of acceptability of long-term use of oral nutritional supplement drinks as partial enteral nutrition in adolescent and adult Crohn’s Disease
Authors: Mu S , Wei Y , Weekes E , Keetarut K 
Published: January 2022

Abstract

Background
Evidence mainly from Japanese cohorts suggests replacing 35–50% of food intake with enteral nutrition known as partial enteral nutrition (PEN) either orally as oral nutritional supplements (ONS) or via nasogastric tube for &gt;1 year can prolong disease remission and increase drug effectiveness in CD. This study aimed to examine patients’ attitude towards the organoleptic properties and perceived barriers and benefits towards long-term ONS usage as PEN by analysing the free text comments from questionnaires. This study will help support our understanding of the feasibility of PEN as a treatment option in CD maintenance by exploring the factors affecting compliance and acceptability and help identify potential areas for improvement.

Methods
Data was obtained from 105 (55 males) aged 34.9 (±15.4) CD patients in remission (HBI&lt;5) from University College London Hospital. Questionnaires with free-text comments were transcribed and analysed using qualitative content analysis using NVivo software. Thematic analysis was used to identify patterns of meaning within and between questionnaires and to identify key themes. Codes were derived through inductive (i.e. data-driven) and deductive approaches, reflecting the thematic guidelines and objectives of the study.

Results
A total of 86 (81%) of participants left at least one free text comment. There was a total of 501 comments. Comments related to participants’ perceived attitudes towards taking ONS drinks as PEN were divided into six themes: motivation, sensory perceptions, physiological consequences, social impact, practical experience and perceived compliance. Most patients were willing to stick with ONS drinks as PEN for a short period of time ≤3 months and expected significant therapeutic benefits. Taste fatigue, prolonged use and requirement to drink large volumes may reduce long-term adherence. In addition, storage space, cost and the perceived negative impact on normal social life were also considerations for patients.

Conclusion
Long term use of ONS drinks as PEN in CD patients is influenced by a number of physiological, social and sensory factors suggesting a complex interaction of variables are involved in the perceived attitudes towards their long-term use. Consideration should be given to developing multiple flavours of ONS to prevent taste fatigue, adapting ONS formulations to improve palatability and improving convenience of use. Monitoring by healthcare staff and better education to inform patients on the clinical benefits are suggested as necessary components for future interventions to improve ONS drinks acceptability as PEN.
P580 Early intestinal ultrasound assessment predicts endoscopic response and remission on anti-TNF treatment in Crohn’s Disease – a prospective longitudinal cohort study
Authors: de Voogd F , Bots S , Gecse K , Gilja O H , D’Haens G , Nylund K 
Published: January 2022

Abstract

Background
In the assessment of treatment response in Crohn’s Disease (CD) objective measures are superior to clinical improvement. Intestinal ultrasound (IUS) is an emerging modality with high accuracy to detect CD disease activity. Less is known about early transmural changes at IUS in treatment follow-up. Therefore, we aimed to investigate conventional IUS and contrast-enhanced ultrasound (CEUS) parameters and how they are associated with endoscopic treatment response.

Methods
In this longitudinal prospective cohort study, consecutive patients with active CD according to the simplified endoscopic score (SES-CD≥3) starting anti-TNF-α treatment were included. We recorded clinical, biochemical, IUS and CEUS parameters at baseline (T0), after 4–8 weeks (T1) and at 12–34 weeks (T2). IUS parameters were scored as previously established1. The SES-CD was scored per segment by a gastroenterologist immediately after endoscopy. The bowel segment with highest SES-CD score and thickest wall on IUS was identified. At T2, endoscopic response (decrease SES-CD≥50%) and endoscopic remission (SES-CD=0) were scored per segment. IUS and CEUS were scored blindly by two readers using recorded videos.

Results
40 patients were included (Table 1) with 23 completing follow-up. The other 17 patients had side-effects and stopped treatment (n=9), underwent bowel surgery (n=5) or were lost to follow-up (n=3). At T2, 14 reached endoscopic remission, 17 had endoscopic response. The absolute decrease in BWT at T1 and T2 paralleled endoscopic response (Figure 1). Decrease in BWT of 18% at T1 (Fig 2) predicted endoscopic response accurately (OR: 10.8, 95%CI: 1.7–69.0, p=0.012). For T2, 29% decrease in BWT (Fig 2) was most accurate to determine endoscopic response (OR: 37.5, 95%CI: 2.8–507.5, p=0.006). At T2, a BWT of 3.2 mm was most accurate (AUROC: 0.940, 95%CI: 0.862–1.000, p&lt;0.0001, sensitivity: 92%, specificity: 85%) to determine endoscopic remission (OR: 39.4, 95%CI: 7.7–202.6, p&lt;0.0001). Normalization of Colour Doppler Signal (CDS) (no signal or single vessel) (OR: 13.8, 95%CI: 1.3–147.8, p=0.03) or Wash-out Rate (WoR) at CEUS (1 dB increase: OR: 0.8, 95%CI: 0.60–0.96, p=0.019) added significantly to BWT to determine endoscopic remission at T2.

Conclusion
Decrease of BWT 4–8 weeks after treatment initiation predicted endoscopic response later during follow-up. In addition, we have provided accurate cut-off values for (Δ)BWT associated with endoscopic response and remission at different time-points. CDS or WoR were both of additional value to determine endoscopic remission after 12–34 weeks. As CEUS is time consuming, CDS might be sufficient in the close follow-up of CD patients.

Reference
1. Novak et al, JCC 2021
P583 Ustekinumab during pregnancy in patients with inflammatory bowel disease: a prospective multicenter cohort study
Authors: Avni Biron I , Mishael T , Zittan E , Livne M , Zinger A , Tzadok R , Goldenberg R , Kopylov U , Ron Y , Hadar E , Helman S , Ollech J , Farkash R , Pauker M , Yanai H , Dotan I , Bar-Gil Shitrit A 
Published: January 2022

Abstract

Background
The prevalence of inflammatory bowel diseases (IBD) is high in women of childbearing age. Maintaining remission from conception to delivery is associated with improved pregnancy outcomes, and continued drug therapy throughout pregnancy is often needed. Data regarding pregnancy outcomes in patients with IBD treated with ustekinumab (UST) are limited. We aimed to assess maternal, pregnancy, and neonatal outcomes in patients with IBD treated with ustekinumab (UST).

Methods
In a multicenter, prospective, cohort study, women with IBD treated with UST during conception and pregnancy were recruited between 2019–2021. Outcomes were compared between patients treated with: UST, anti-tumor necrosis factor (TNF)-a, and non-UST,non anti-TNF therapy (thiopurines or mesalazine) or no therapy. UST treated patients were matched to controls in a 1:2 ratio according to age, BMI, and number of previous pregnancies. Newborns were followed up-to 12 months.

Results
Pregnant patients recruited: 129, 27-UST; 52- anti-TNF; 30-non-UST, non anti-TNF 20- no therapy (the latter 50=conventional control group).
The vast majority (96.9%) had Crohn’s disease (CD). Patients treated with UST compared to those treated with anti-TNF or conventional therapy, showed a trend towards longer disease duration (11 vs 7 vs 6 years, respectively, p=0.06), higher proportion of smokers (30.8% vs 5.9% vs 0%, respectively, p&lt;0.001), higher rate of previous exposure to infliximab(77.8% vs 52.0% vs 14.5%, p&lt;0.001), adalimumab (92.6% vs 66.7% vs 22.0%, p&lt;0.001), and vedolizumab (48.1% vs 5.8% vs 4.0%, p&lt;0.001) and higher rate of disease activity at conception (59.3% vs 15.4% vs 8%, p&lt;0.001). Most of the patients treated with UST(n=25, 92.5%), continued therapy throughout pregnancy. New flares during pregnancy were comparable (15.2% vs 45.5% vs.39.4%, p-0.92).
Among UST-treated patients, pregnancy outcomes included: two spontaneous abortions, 4% of of preterm labor and low birth weight, one congenital anomaly (tetralogy of Fallot) (4%), and 42% cesarean section. Maternal outcomes, specifically obstetric complications and hospitalizations, pregnancy, and neonatal outcomes were comparable between treatment groups. Rates of newborn 1st-year infections, hospitalizations, and developmental delay were also comparable.

Conclusion
Pregnant patients with IBD treated with UST comprise a highly refractory group, with high rates of disease activity at conception. Their pregnancy and neonatal outcomes were favorable, and comparable to those in patients treated with anti-TNF or conventional therapy.
P585 Examining faecal incontinence and its impact on health-related quality of life in patients with Crohn’s perianal fistulas: results from a multi-country burden of illness study
Authors: Karki C , Athavale A , Hantsbarger G , Lee K , Milicevic S , Perovic M , Raven L , Sajak-Szczerba M , Sharpe E , Tozer P 
Published: January 2022

Abstract

Background
Perianal fistulas (PAF) are a common complication associated with Crohn’s disease (CD), and patients with Crohn’s perianal fistulas (CPF) are more likely to experience faecal incontinence (FI) than patients with CD without PAF (non-PAF CD). A global study was conducted to assess the burden of illness in patients with CPF compared with patients with non-PAF CD. Here, we present data on the level of FI and its impact on quality of life (QoL).

Methods
This cross-sectional study was conducted in seven countries (France, Germany, Spain, UK, Canada, Australia and Japan) in patients aged ≥21 and ≤90 years with self-reported physician-diagnosed CD. Patients were classified as having non-PAF CD (cohort 1) or CPF without PAF-related surgery (cohort 2) or CPF with PAF-related surgery (cohort 3). Validated, general and disease-specific patient-reported outcome data were collected using a 45-min IRB/EC-approved web-enabled questionnaire. The level of FI was evaluated using the Revised Faecal Incontinence Score (RFIS) (1–20 scale, 0 = no incontinence, 4-week recall period) and the impact of FI on QoL in patients who had experienced FI using the Fecal Incontinence Quality of Life (FIQL) (1–5 scale, 1 = lower QoL). Data were analysed using descriptive statistics.

Results
Of the 929 patients recruited (cohort 1, n = 620; cohort 2, n = 174; cohort 3, n = 135), 58–69% were male and 55–67% were aged 21–40 years across all cohorts. A significantly higher proportion of patients in cohort 3 than cohort 1 had severe Crohn’s disease as classified by a physician (18% vs 9%, respectively; p &lt; 0.05). Overall, 47% of patients reported experiencing FI and completed both the RFIS and FIQL. Significantly higher proportions of patients in cohorts 2 and 3 had experienced FI than in cohort 1 (59% and 59% vs 40%, respectively; p &lt; 0.05), and a significantly higher proportion were currently experiencing FI in cohort 3 than in cohorts 1 and 2 (69% vs 37% and 45%, respectively; p &lt; 0.05). Mean RFIS scores were significantly higher (worse) in cohorts 2 and 3 than cohort 1 (9.5 [p &lt; 0.05] and 10.6 [p &lt; 0.001] vs 8.2, respectively). Patients in cohort 2 had significantly lower (worse) FIQL scores than those in cohort 1 across three FIQL domains (lifestyle [2.2 vs 2.4], depression/self-perception [2.1 vs 2.3], embarrassment [2.2 vs 2.4]; p &lt; 0.05), whereas patients in cohort 3 only reported significantly lower FIQL scores compared with cohort 1 in the embarrassment domain (2.2 vs 2.4; p &lt; 0.05).

Conclusion
In this study almost half of the patients experienced faecal incontinence. Among those who experienced faecal incontinence, patients with PAF experienced a significantly higher impact on their quality of life compared with patients without PAF.
P592 Effectiveness and safety of thioguanine in thiopurine-naïve Inflammatory Bowel Disease patients
Authors: Crouwel F , Bayoumy A B , Mulder C J J , Peters J H C , Boekema P J , Derijks L J J , De Boer S Y , van de Meeberg P C , Ahmad I , Buiter H J C , de Boer N K 
Published: January 2022

Abstract

Background
Currently thioguanine is considered as off-label rescue therapy for Inflammatory Bowel Disease (IBD) after conventional thiopurine failure. This study aimed to determine the safety, effectiveness and 12-month drug tolerability of thioguanine in thiopurine-naïve IBD patients.

Methods
We performed an analysis of our multicenter, retrospective cohort study including thiopurine-naïve IBD patients treated with thioguanine as first-line maintenance therapy without concomitant biological therapy. Clinical effectiveness was defined as a sustained clinical response (based on physician’s global assessment) without the (re-)initiation of concurrent biological therapy, corticosteroids or a IBD-related surgical intervention. All adverse events that occurred during follow-up were categorized by the Common Terminology Criteria for Adverse Events. Elevation of two concurrent liver tests were categorized as drug-induced liver injury.

Results
A total of 103 IBD patients (female 61%, Crohn’s disease 52%) were included with a median daily thioguanine dose of 20mg and median 6-thioguanine nucleotide (6-TGN) levels of 635 pmol/8x108 RBC (IQR 425–1100). Clinical effectiveness at 12 months was observed in 60 out of 99 patients (61%) and 80% of patients were still using thioguanine 12 months after initiation. Four patients did not reach the 12-month follow-up period but were in remission at time of data collection. Of the responding patients at 12 months 88% (N=53) remained responsive until the end of follow-up (median follow-up period 28 months, IQR 17–40 months).
Forty-nine patients (48%) developed adverse events (grade 1 or 2), of which 24% graded as moderate (grade 2) and none as severe. Seven patients ceased therapy due to the occurrence of adverse events. Adverse events consisted mainly of elevated liver tests (26%) and gastrointestinal complaints (17%). An infection was documented in three patients, none of them requiring hospitalization. Pancytopenia occurred in two other patients with 6-TGN levels of respectively 2900 and 140 pmol/8x108 RBC. None of the included patients had signs of (noncirrhotic) portal hypertension or underwent a liver biopsy during follow-up.

Conclusion
This is the first cohort study that reports on the safety and effectiveness of first-line thioguanine maintenance therapy in IBD. Thioguanine therapy was, 12 months after initiation, still used by 80% and clinically effective in 61% of thiopurine-naive patients. Adverse events were relatively common but mainly mild (grade 1) and the discontinuation rate related to adverse events was lower than observed during conventional thiopurine therapy. No signs of (noncirrhotic) portal hypertension were reported
P607 Efficacy and safety of tofacitinib in Ulcerative Colitis patients with extraintestinal manifestations in OCTAVE Open
Authors: Rubin D T , Vavricka S R , Armuzzi A , Dubinsky M C , Sharara A I , Modesto I , Fellmann M , Liguori G , Lawendy N , Cadatal M J , Lichtenstein G R 
Published: January 2022

Abstract

Background
Tofacitinib is an oral, small molecule JAK inhibitor for the treatment of ulcerative colitis (UC). Data from OCTAVE Induction 1&2 and OCTAVE Sustain demonstrated that a history of extraintestinal manifestations (EIMs) was shown not to influence the efficacy of tofacitinib 10 mg twice daily (BID).1 We explored the efficacy and safety of tofacitinib in patients (pts) with and without a history of EIMs in the open-label, long-term extension study, OCTAVE Open.

Methods
Efficacy and safety (treatment-emergent serious adverse events of interest) data from OCTAVE Open (NCT01470612) were analysed by history of EIMs. Tofacitinib dose in OCTAVE Open was based on baseline remission status; pts in remission received tofacitinib 5 mg BID; all others received 10 mg BID. The frequency of pre-defined prior and active EIMs at OCTAVE Open baseline (peripheral arthritis [PA]; sacroiliitis; ankylosing spondylitis [AS]; myopathy; pyoderma gangrenosum; erythema nodosum; scleritis, episcleritis; uveitis, iritis; oral ulcer/stomatitis; and thromboembolic disorder) and new occurrences of EIMs at Month (M)36, or at early termination, were evaluated in pts with non-missing data.

Results
In OCTAVE Open, 113/935 (12.1%) had EIMs at baseline (7/174 [4.0%] tofacitinib 5 mg BID; 106/761 [13.9%] tofacitinib 10 mg BID). Pts with EIMs were more likely to be female (61.1%), have a total Mayo score of ≥3 (93.8%) at OCTAVE Open baseline and have disease duration ≥6 years (60.2%), prior tumour necrosis factor inhibitor failure (61.9%), prior immunosuppressant treatment (86.7%) or corticosteroid use (54.0%) at induction study baseline, compared to those without EIMs (38.8%, 78.7%, 49.6%, 50.9%, 74.5% and 43.9%, respectively). There was no consistent trend in the proportions of pts with and without EIMs at baseline who met the OCTAVE Open efficacy endpoints (Table 1). Tofacitinib 5 and 10 mg BID had comparable safety in pts with or without EIMs at baseline (Table 2). In pts with EIMs at baseline, the most frequent active EIMs were PA (51/113 [45.1%]), sacroiliitis (6/113 [5.3%]), oral ulcer/stomatitis (5/113 [4.4%]), myopathy (4/113 [3.5%]) and AS (4/113 [3.5%]). At M36, 4/428 [0.9%] had new occurrences of PA and there were no new occurrences of sacroiliitis (0/468 [0%]), oral ulcer/stomatitis (0/460 [0%]), myopathy (0/469 [0%]) or AS (0/469 [0%]).

Conclusion
The presence or absence of a history of EIMs at baseline did not impact the long-term efficacy and safety of tofacitinib in pts with UC. New occurrences of EIMs were infrequent.

Reference
1. Rubin DT et al. Therap Adv Gastroenterol 2021; 14: 1–12.
P635 Incidence, prevalence, disease phenotype and maximal therapeutic step in Ulcerative Colitis patients in Western Hungary – a population-based study between 2007–2018, data from the Veszprem County cohort
Authors: Lakatos L , Gonczi L , Golovics P , Pandur T , David G , Erdelyi Z , Szita I , Lakatos P L 
Published: January 2022

Abstract

Background
Recent trends indicate a change in the epidemiology of inflammatory bowel disease (IBD) with previously low incidence areas now reporting progressive rise. The number of epidemiological population-based studies are still limited from Eastern Europe. The present study is a continuation of the Veszprem IBD population-based cohort with a follow-up of the incidence and disease course of IBD since 1977. Our aim was to analyze the incidence and disease phenotype at diagnosis, and the maximal therapeutic step distributions during follow-up in a prospective population-based database from Veszprem Province, including incident ulcerative colitis (UC) patients diagnosed between January 1, 2007 and December 31, 2018.

Methods
Data of 467 incident UC patients were analyzed (male/female:236/231; median age at diagnosis:36 years(y)[IQR: 25–54]). Both in-hospital and outpatient records were collected and comprehensively reviewed at diagnosis and during clinical follow-up. The source of age- and gender-specific demographic data for statistical analysis was derived from the results of a national population census in 2011.

Results
Adjusted mean incidence rate was 11.02(CI95%:10.1–12.1)/105 person-years in this 12 year period[males:11.53(CI95%:10.2–13.1)/105; females:10.54(CI95%:9.3–12.0)/105]. Prevalence rate was 283.51(CI95%:265.7–300.7)/105 persons in 2011 and 317.79(CI95%:298.8–335.8) in 2015. For detailed annual incidence rates and age-specific mean incidence rates see Figure 1 and 2. Peak onset age in UC was 20–29 years of age. Diagnostic delay from symptom onset was ≥1year in 19.1%, and ≥3 years in 4.1% of the patients. Disease extension was proctitis(E1) in 22.3%, left sided colitis(E2) in 43.9%, and extensive colitis(E3) in 33.8% of the patients at diagnosis. Patients with extensive colitis were younger(32.9y,SD:16.6) at diagnosis compared to patients with proctitis(40.1y,SD:15.9;p&lt;0.001) or left sided colitis(44.0y;SD:19.1;p&lt;0.001). Extraintestinal manifestations were as follows: hepatic5.4%(PSC 2.1%), arthritis10.7%, ocular0.9%, skin3.6%. Active smokers at diagnosis were 12.6%. Distribution of maximal therapeutic steps during the course of follow-up (8.34y,SD: 3.5) were 5-ASA in 46.9%, systemic corticosteroids in 16.3%, immunosuppressive therapy in 19.3%; anti-TNF biologic therapy in 12.2% and other biologic therapy in 4.3%.

Conclusion
The incidence of UC in this 12 year period was high, comparable to high-incidence areas in Western European countries, and comparable to previous data from the Veszprem cohort, while prevalence rates continue to rise compared to our previous data.(Lakatos 2011, IBD). Disease extension at diagnosis and distribution of highest treatment step was comparable to European population-based data.(Burisch 2019, JCC).
P660 Knowledge, attitudes, and awareness of contraceptive choices in women with Inflammatory Bowel Disease
Authors: Liu E , Jatale R , Farraye J , Cannon R , Woodhams E , Farraye F , Limdi J K 
Published: January 2022

Abstract

Background
Active inflammatory bowel disease (IBD) at conception is associated with adverse pregnancy outcomes. Published literature suggests that almost a quarter of women with IBD do not use any form of contraception putting them at risk of unplanned pregnancy. Recent guidelines emphasise the importance of antenatal care in IBD patients, but contraception counselling and risk assessment are not addressed. Our aim was to explore the contraceptive knowledge, attitudes and preferences of women with IBD.

Methods
A 34-item questionnaire was prospectively administered to 245 consecutive female IBD patients aged 18–45 attending gastroenterology clinics. Disease control was measured using the validated IBD Control questionnaire, and contraceptive preferences assessed by the Contraceptive Features Survey.

Results
Of the 245 participants (see table 1), mean disease duration was 6.5 years, median IBD control score was 16.9 (range 0- 26), and 152 (62%) respondents had previously been pregnant. Almost three quarters of respondents (n=176) reported currently using contraception, and 41 (17%) were using highly effective contraceptives. The most commonly used contraceptives were oral birth control pills (27%) and barrier methods (18%). Participants who identified as Caucasian (74%) were more likely than those who identified as Asian (37%) to use contraception (p=0.0009). Patients who did not plan to conceive in the future were more likely to use contraception (p=0.0365). However, of the 58% (n=143) who had either no plans to conceive in the future or were unsure, 23% were not using any form of contraception, and 83% were not using a highly effective contraceptive. Current biologic therapy was significantly associated with highly effective contraceptive use (p=0.0275). Contraceptive features most important to women were effectiveness (78%), ease of use (76%), few or no side effects (68%) and not detracting from sexual enjoyment (65%). Only 25% patients (n=61) recalled discussing reproductive issues with their IBD clinician, however, 86% stated they would feel comfortable having this discussion. Women wished to receive family planning counselling from their IBD nurse (81%), General practitioner (77%), IBD doctor (68%), and gynaecologist (47%).

Conclusion
A quarter of patients in our cohort were not using any contraception and the majority were not using a highly effective form potentially increasing their risk of unplanned or mistimed pregnancy. Participants desired a contraceptive that was effective, easy to use and with minimal side effects. Our findings reflect the need for further studies to improve informed decision making with contraceptive counselling, to improve the overall quality of care for women with IBD.