bluuebunny/crossref_metadata_2025 huggingface dataset:
P158 Diagnostic yield of different imaging modalities (VCE, MRE and SBUS) in paediatric Inflammatory Bowel Disease patients
Authors: Kurteva E , Rendo G , Ahmad T , Watson T , Jones K , Gaynor E , Kiparissi F
Published: May 2021

Background

Wireless Video Capsule Endoscopy (VCE), Magnetic resonance enterography (MRE) and Small Bowel ultrasound (SBUS) are well-established diagnostic tools, used in the evaluation of small bowel disease in paediatric inflammatory bowel disease (IBD) patients.The aim of this study was to compare VCE findings with those of MRE and SBUS and evaluate discrepancies between them.

Methods

VCE examinations were conducted in histologically confirmed paediatric IBD patients in a period of 19 months (March 2018 – November 2019) in a tertiary center. The VCE findings were retrospectively compared to relevant findings on MRE and SBUS, collected from electronic data records.

Results

34 patients were included in the study (16 males,18 females) with an age range at the moment of diagnostic assessment between 4–17 years (median 12 years). 21 patients were diagnosed with Crohn disease (CD), 9 patients with Ulcerative Colitis (UC) and 4 patients with IBD Unclassified (IBD-U). 8/34 (23.5%) patients were found to have all three diagnostic investigations, 21/34 (61.8%) had MRE and 21/34 (61.8%) had SBUS. Concordance between the three modalities were seen in 5/8 (62.5%) patients. Of these, 3/5 (60%) had no small bowel disease identified on VCE, MRE and SBUS, while in 2/5 patients (40%) the same distribution of small bowel disease was identified using all three diagnostic modalities. When comparing VCE to MRE, differing distributions of disease were seen in 10/21 patients (47.6%). 6/10 (60%) had terminal ileitis, 2/10 (20%) had ceacal disease and 3/10 (30%) jejunal disease noted on MRE, but with no disease identified on VCE. 1/10 patient (10%) had a normal MRE but duodenal and proximal jejunal ulceration was reported on VCE. VCE and SBUS had a higher concordance (71.4%) in identifying disease distribution. In 6/21 patients (28.5%) there was a discrepancy in the findings reported on SBUS when compared to VCE.Of these, 4/6 (66.7%) had a normal SBUS but small bowel disease (jejunal and ileal disease) on VCE.1/6 patient (16.7%) had caecal inflammation and 1/6 (16.7%) had active terminal ileitis on SBUS, which was not reported on their VCE.

Conclusion

The identification of small bowel disease is essential in the diagnosis and subsequent management of paediatric IBD. VCE, MRE and SBUS are established modalities to detect intestinal disease. This study demonstrates that performing all three diagnostic modalities may have important practical significance and increase diagnostic yield in detecting small bowel inflammatory bowel disease.
P197 The effect of a positive family history on the phenotype and course of paediatric Inflammatory Bowel Disease
Authors: Ruban M , Cohen S , Yerushalmy-Feler A
Published: May 2021

Background

Previous studies have suggested that adult patients with inflammatory bowel disease (IBD) that have a positive family history of IBD may be at risk for a more aggressive clinical course, compared with sporadic cases. The role of a positive family history in paediatric IBD, however, has not been elucidated.

Methods

We retrospectively reviewed the medical records of children with IBD and retrieved demographic and clinical characteristics, including IBD phenotype, course and therapy. We have documented the presence of a positive family history of IBD, and compared the clinical data of children with a positive family history to that of children with a negative family history.

Results

Overall, 325 children with a median (IQR) age of 13.9 (11–15) years at diagnosis were included: 194 (59.7%) with Crohn’s disease (CD) and 131 (40.3%) with ulcerative colitis. A positive family history of IBD was observed in 82 children (25.2%). Of them, 36 (43.9%) had a first-degree family member with IBD, and 23 (28%) had more than one family member with IBD. Children with a positive family history had a higher risk for stricturing phenotype (11.3% versus 2.8%, P=0.05) and were treated more often by nutritional therapy (53.7% versus 36.6%, P=0.007) and less by corticosteroids (36.6% versus 52.7%, P=0.012). Children with a negative family history had a higher need to intensification of biologic therapy [Hazard ratio (HR)=1.792, 95% confidence interval (CI) 1.005–3.195, P=0.041 and HR=2.597, 95% CI 1.224–5.525, P=0.008 for CD) (Figure 1). No difference in the risk for IBD exacerbation, hospitalization and operation was found between the groups.

Conclusion

A positive family history of IBD may have a mild impact on the phenotype and course of paediatric IBD.
P198 Practical deep learning tool for the scoring of ulcerative colitis disease activity in central reading
Authors: Byrne M , East J , Iacucci M , Travis S , Kalapala R , Duvvur N , Rughwani H , Singh A , Berry S , Monsurate R , Soudan F , Laage G , Cremonese E , Canaran L , St-Denis L , Nikfal S , Asselin J , Henkel M , Panaccione R
Published: May 2021

Background

Central Reading Org.& the pharma industry employ subject matter experts(SMEs)to score videos from sites participating in clinical trials for Ulcerative Colitis(UC).As we are developing Artificial Intelligence(AI)models for scoring purposes,we need to build a new software interface that can incorporate these AI models to aid SMEs,making their determination of the scores for each segment of the video & for the video as a whole.We propose a system that reduces the time for SMEs to review & score videos,improving the accuracy of scoring,with the help of our AI models.

Methods

We built a web-based interface supported by our AI models which can read,write multiple databases & data stores to read & display videos to be scored by a central reader, as well as the associated metadata required to improve the process.User interface shows a timeline with markers for the segments of the colon,with sections that are blurry,poorly prepped,or unscorable highlighted in different colours.While we could also highlight sections of the video with the precise score assigned to it by the AI,this would bias the central reader’s opinion.We hide the precise score generated by our AI models & instead display 3 colours for low,medium or high disease activity.When a video is loaded to be read by the user,the playback marker is set to the first high disease activity section based on known medical indexes such as the Mayo Endoscopic Subscore(MES) & UCEIS(Ulcerative Colitis Endoscopic Index of Severity),usually consists of a few seconds of video & that video is played back continuously in a loop until the reader selects the appropriate score for that section.When the reader saves the section,the software immediately moves the video cursor to the highest scored section of the video.That way the central reader can review only the relevant portions of the video to confirm the score assigned to each segment.If the central reader’s scores do not align well with the AI scores then the software continues to show more sections of the video to the user,including sections it may have labeled as unscorable,that may be scorable.

Results

The review of the system by 3 key opinion leaders,user experience was positive.Not only does the system allow the reader’s attention to be more efficiently used,but the interface allows both AI & central reader scores to be saved,allowing for the latter to be used iteratively to re-train & improve the underlying AI model(s).Our tool was also used by a gastroenterologist specialist in order to perform video quality assessment & colon sections scoring.

Conclusion

We developed an AI tool that can be used to improve the efficiency & accuracy of the central reading process in clinical trials for UC.Further work is ongoing to improve the interface.
P222 Heart rate variability is a predictor to disease exacerbation in paediatric Inflammatory Bowel Disease
Authors: Yerushalmy-Feler A , Cohen S
Published: May 2021

Background

Previous studies have shown a lower level of parasympathetic activity in patients with inflammatory bowel disease (IBD) compared to healthy subjects. Heart rate variability (HRV) oscillations are used to detect autonomic instability and was found to be lower in adults with IBD compared to controls. Nevertheless, the data on the relation between the autonomic function and IBD outcome are scarce. The aim of the study was to evaluate HRV as a predictor to paediatric IBD outcome.

Methods

Children (<18 years of age) with IBD were prospectively recruited. For each patient, a 10-minute measurement of HRV was conducted by Pulse Oximeter (BM1000A/Shanghai Berry Electronic Tech Co., Ltd). The square root of the mean squared differences of successive RR intervals (RMSSD) was calculated. Clinical data, including demographic variables, disease activity and course, medications and laboratory results were collected during a follow-up of 12 months. The relation between RMSSD and clinical measures was evaluated.

Results

Overall, 34 IBD children with an average age of 15.32±2.18 years were included: 21 (61.8%) children with Crohn’s disease and 13 (38.2%) with ulcerative colitis. Children in clinical remission had a significantly higher RMSSD compared to patients with active disease (67.72±27.81 and 45.76±22.04, respectively, p=0.022). In addition, patients with normal serum C-reactive protein (<5 mg/L), patients with normal serum hemoglobin and patients with long duration of IBD (more than a year from diagnosis) had a significantly higher RMSSD (Figure 1). Children that experienced disease exacerbation during the follow-up had a significantly lower RMSSD compared to children that kept clinical remission (Figure 2). In a multivariate analysis, higher RMSSD was a significant and independent predictor of lower risk of IBD exacerbation [OR (odd ratio) = 0.941, 95% CI (confidence interval) 0.887–0.998, p=0.044)].

Conclusion

HRV may not only reflect IBD activity, but also serve as a predictor to disease exacerbation in paediatric IBD.
P240 Clinical diagnostics of fecal calprotectin: a comparative study of a semi-quantitative rapid test and a quantitative lab test
Authors: Miettinen J , Vuolteenaho O , Hedberg P
Published: May 2021

Background

The non-specific and heterogeneous clinical symptoms complicate the diagnosis of Inflammatory bowel disease (IBD). Colonoscopy, the primary method in IBD diagnostics, is costly and invasive, and not optimal for routine disease monitoring. Fast, user-friendly, and cost-effective diagnostic tests facilitate the timely identification of inflammation and disease monitoring. Calprotectin is a pro-inflammatory protein released by neutrophils at the intestinal mucosa, and detectable in feces. Fecal calprotectin (fCal) is a sensitive biomarker that helps to detect IBD, as its concentration is directly proportional to the degree of intestinal inflammation. Furthermore, fCal analysis helps to confirm disease activity in suspected flares and guides decision-making in drug therapy allocation.

Methods

In this study the accuracy of fCal detection by the semi-quantitative Actim Calprotectin rapid test and the quantitative automated LIAISON Calprotectin assay was assessed on a panel of 119 clinical stool samples. Actim Calprotectin is a visually interpreted, semi-quantitative dipstick test that is hygienically performed in a single tube. LIAISON Calprotectin is an automated quantitative chemiluminescence immunoassay (CLIA). Analyses were performed at NordLab Oulu clinical laboratory (Oulu University Hospital, Finland).

Results

fCal testing took only about 15 min of hands-on time with Actim Calprotectin, and 40 minutes with LIAISON Calprotectin. The mean fCal concentration in the 119 analyzed clinical samples was 191.8 μg/g (median 41.9 μg/g; range 0-6,290 μg/g) as quantified by LIAISON Calprotectin. The Actim Calprotectin and LIAISON Calprotectin assays agreed on 94 samples (79.0%) (Figure 1). The fCal concentration range-specific inter-assay agreement was as follows: 81.2% at < 50 µg/g, 65.6% at 50–200 µg/g, and 94.4% at >200 µg/g. The sensitivity of Actim Calprotectin was 94.0% (n=47) for the 50 µg/g cut-off when compared to the quantitative LIAISON Calprotectin. The three samples with fCal concentrations above 50 µg/g in the LIAISON Calprotectin test but interpreted as having fCal concentration below 50 µg/g in the Actim Calprotectin test, had an fCal concentration very close to the 50 µg/g cut-off (< 70 µg/g).

Conclusion

Actim Calprotectin is a suitable method for fCal detection in a clinical setting, supporting fast disease activity and treatment response monitoring in patients with gastrointestinal inflammation. The rapid test can be utilized for the initial differentiation between negative and positive samples in an outpatient setting, thus helping to limit the use of more laborious quantitative methods to positive samples. Future investigations could focus on evaluating the utility of Actim Calprotectin in routine disease monitoring.
P289 A French nationwide prospective study on patients with Crohn’s disease and ulcerative colitis treated with Infliximab-biosimilar CT-P13 in a real-life setting: two-year follow-up of the ReFLECT study
Authors: Bouhnik Y , Nancey S , Assing M , Mammar N , Laharie D
Published: May 2021

Background

ReFLECT study was carried out to investigate real-life use of CT-P13, the first monoclonal antibody biosimilar to infliximab (IFX) originator.

Methods

This multicentre, prospective, observational study was conducted in France to assess characteristics of patients (pts) receiving CT-P13, its effectiveness and safety in a real-life setting. Eligible were both pts who had been switched from IFX originator (IFXS) and IFX-naïve pts started on CT-P13 (IFXN). These interim descriptive statistical analyses are about pts with Crohn’s disease (CD) and ulcerative colitis (UC).

Results

Among the 1370 adult pts included between October 2016 and April 2019, data were analysed for 508 CD pts (48.6% males; mean age ± SD: 37.7±13.7; median [Q1;Q3] disease duration: 6.2 [1.9;13.7] years; 323 IFXN/145 IFXS) and 213 UC pts (54%; 42.9±17.2; 5.4 [1.6;12.8]; 154 IFXN/46 IFXS). Previous biologics other than IFX were taken by 32.9% of CD and 39.0% of UC pts; 31% (CDS) and 23% (UCS) of pts were switched from IFX originator to CT-P13. At the time of the first administration of CT-P13, disease had been more active in IFXN vs IFXS pts: 52.9% vs 13.3% in CD with a median [Q1;Q3] Harvey Bradshaw Index (HBI) of 4 [1;8] vs 1 [0;2] and, 82.9% vs 33.3% in UC with a median Mayo Score of 7 [3;10] vs 2 [0;4]. In IFXS pts, disease activity remained stable after 2 years of treatment with median differences of HBI and Mayo score since first administration of 1 [0;2] and 0 [-4;1]. In IFXN pts, median differences of HBI and Mayo score since first administration were -2 [-7;1] and -7 [-8;-5]; CT-P13 brought disease activity down to levels below or comparable to those seen in IFXS pts. Reasons for CT-P13 withdrawing and safety data are reported in Tables 1 and 2.

Conclusion

Year 2 follow-up data indicate that CT-P13 effectively induced improvement in disease activity in IFXN pts with CD or UC and maintained stable activity in IFXS pts. This real-life study did not highlight any new safety concerns.
P331 The safety of tioguanine exposure during pregnancy: a case series of seventy-three pregnancies
Authors: Crouwel F , Simsek M , De Boer M A , Mulder C J J , Buiter H J C , De Boer N K
Published: May 2021

Background

Azathioprine and mercaptopurine exposure during conception and pregnancy has been considered safe in patients with inflammatory bowel disease (IBD). Its use is not associated with a higher risk of preterm birth or low birthweight. Data on the safety of tioguanine, an alternative thiopurine-derivate, in pregnant IBD patients is limited. In a small case series, tioguanine appeared safe for both mother and fetus. In this study, we describe the teratogenicity and safety of tioguanine during pregnancy in a large group of IBD patients.

Methods

We performed a preliminary analysis of our ongoing multicenter descriptive case series of female IBD patients who were treated with tioguanine at some point during their pregnancy. Data regarding disease and medication history, pregnancy course and neonatal outcomes, such as preterm birth, miscarriage, birthweight, Apgar scores and congenital abnormalities were collected by the treating physician.

Results

Seventy-three pregnancies, including three twin pregnancies were collected. Most women (80%) had Crohn’s disease and the mean age during delivery was 31 years (range 21-42). Tioguanine was used throughout the entire pregnancy in 89% with a median daily dose of 20 mg. Five (6.8%) of these pregnancies resulted in a miscarriage, all within the first 13 weeks. No congenital abnormalities were reported in all seventy-one live born children.

In the singleton pregnancies the median birthweight was 3375 gram (IQR 3075-3739, N=61, 4 missing values) with a median gestational age of 39.0 weeks (IQR 38.3-40.0, N=61). Four children (6.5%) were born prematurely (<37 weeks). Two of them were born after a spontaneous onset of labor with respectively 33 + 6 and 35 + 6 weeks, while in the other two labor was induced due to a placental abruption (32 + 1 weeks) or HELLP syndrome (31 + 4 weeks). Three children (4.9%) had a low birthweight (<2500 gram), all of them born prematurely, and five patients (8.3%, N=60, 5 missing values) were born small for gestational age (<10th percentile).

The median Apgar score after 1 and 5 minutes was respectively 9 (IQR 8-9, N=58) and 10 (IQR 9-10, N=59). Two neonates (3.4%), one born pre-and dysmature and the other a premature second-born twin, had an Apgar score (<7) after 5 minutes.

Conclusion

In this large case-series, tioguanine exposure during pregnancy was not associated with an increased risk of congenital abnormalities, low birthweight or preterm birth in IBD patients. These data support the safe use of tioguanine during pregnancy in IBD.
P351 SARS-CoV-2 infection and seroconversion in pediatric patients on biological therapy for Crohn’s disease: single tertiary center experience
Authors: Sładek M , Krucka-Kawalec M , Wojtas E , Jagielski P , Stochel-Gaudyn A
Published: May 2021

Background

It is still unclear how SARS-CoV-2 infection affect Crohn’s disease (CD) patients and how seroconversion against the virus might take place depending upon disease states and treatments. While the clinical guidance recommended to continue the biological maintenance therapy, some suggestions advice postponing the start of biologic agents.

Materials and methods

Medical records of all patients undergoing biologic therapy with infliximab, adalimumab, or vedolizumab for mild-to moderate CD followed in our institution were enrolled in the analysis. Demographic parameters, disease characteristics, clinical course, concomitant medications, COVID-19 related symptoms were examined. A naso-pharyngeal swab based RT-PCR testing for SARS-CoV-2 was taken and SARS-CoV-2 serology test was performed using SARS-CoV-2 Immunoassay (Abbott Core Laboratory) in children treated between March 4th 2020 and March 3rd 2021. Every time before hospital admission parents or patients completed a questionnaire exploring the presence of symptoms suggestive of SARS-CoV-2 infection.

Results

Of the 62 children (35 boys, 56%) aged 2-19 years, median 15 ±3,51 years, 47 (76%) were treated with infliximab, 12 (19%) with adalimumab, and 3 (5%) with vedolizumab including 23 (37%) patients on the induction regiment. Of the entire cohort 11 (18%) patients were on a concomitant immunemodulator, including 6 (55%) on thiopurines, and 5 (45%) on methotrexate. A total of 19 (30%) CD patients tested positively for SARS-CoV-2. Only 5 (26%) patients reported symptoms including fever (n=3, 16%), sore throat (n=1, 5%), cough (n=2, 11%), loss of smell (n=2, 11%), loss of taste (n=1, 5%), and 14 (74%) were asymptomatic. All symptomatic patients had mild clinical presentation, and no patients required hospitalization. Swab test was positive in 8 (13%) patients, including 3 (5%) patients with nonreactive antibody titers. Of the 19 patients, 5 (23%) had elevated SARS-CoV-2 IgG titers, while 14 (74%) had elevated SARS-CoV-2 IgM. Four had elevated both IgG and IgM titers, and 2 of them had acute, mild and resolved symptoms. Biologic agent administration was postponed for 6±5,4 days in 6 patients due to positive swab test, but no other management alteration was needed. No exacerbation of CD was observed attributed to SARS-CoV-2 infection during either induction or maintenance therapy in the studied cohort

Conclusion

Many patients with SARS-CoV-2 infection remained asymptomatic or presented mild symptoms, and did not develop COVID-19. Biologic therapy did not worsen CD course. Serological testing might provide an accurate estimate of the cumulative prevalence of SARS-CoV-2 infection by detecting subclinical and asymptomatic infected individuals.
P398 Effect of Intravenous versus Oral Iron Therapy on Physical Fitness and Haemoglobin in Paediatric IBD Patients with Anaemia
Authors: Bevers N , van de Vijver E , Aliu A , Rezazadeh Ardabili A , Rosias P , Busari J , Stapelbroek J , Bertrams I , van der Feen C , Oudshoorn A , Teklenburg S , Escher J , Vande Velde S , Winkens B , Raijmakers M , Vreugdenhil A , Pierik M , van Rheenen P
Published: May 2021

Background

In children and teenagers with Inflammatory Bowel Disease (IBD) and iron deficiency anaemia, administration of iron is recommended to replete empty iron stores, but the most effective route of administration remains unknown. We compared intravenous (IV) and oral iron therapy and evaluated physical fitness and haemoglobin (Hb) improvement over time.

Methods

We performed an international multicentre randomized controlled trial (NTR: 4487) in patients aged 8-18 years with IBD and anaemia (defined as Hb > 2 standard deviations (SD) below the reference mean according to WHO cut-offs). Children with severely active disease (PUCAI ≥ 65 or PCDAI ≥ 30) at baseline were excluded. Patients were randomly assigned to receive either IV iron via a single infusion of ferric carboxymaltose (15 mg/kg, maximum 750 mg) or oral iron using ferrous fumarate 9 mg/kg/day in 2 doses (maximum 600 mg) for 12 weeks. The primary outcome was improvement of physical fitness, defined as an increase in 6-minute walking distance (6MWD) over time and expressed as z-score to allow correction for age and gender. Secondary outcome was an increase in Hb z-score. Linear mixed models were used to analyse effect of treatment on 6MWD and Hb z-score at each follow-up visit controlling for disease activity, IBD diagnosis, study centre and outcome at baseline.

Results

We randomised 64 patients (33 IV iron; 31 oral iron). One month after the start of iron therapy, increase of 6MWD z-scores was significantly larger in the IV group compared to the oral group (0.75 SD vs. -0.16 SD, P=0.006, Figure 1). At 3- and 6-months follow-up, no significant differences in 6MWD z-scores were observed between groups. Hb z-scores gradually increased over time in both groups, but there was no significant difference in change from baseline between groups at 1, 3 and 6 months after initiation of iron therapy (overall P=0.97, Figure 2).

Figure 1: Mean 6-minute walking distance (6MWD) z-scores in relation to start of iron treatment

Figure 2: Mean haemoglobin (Hb) z-scores in relation to start of iron treatment

Conclusion

In this head-to-head randomized controlled trial involving paediatric patients with IBD and anaemia, IV iron was superior to oral iron with respect to early improvement of physical fitness. However, this effect subsided over time and improvement of Hb was similar for both types of iron therapy.
P406 A retrospective analysis of the efficacy of vedolizumab on extra-intestinal manifestations in patients with inflammatory bowel disease across five European countries
Authors: Kopylov U , Burisch J , Ben-Horin S , Braegger F , Fernández-Nistal A , Lara N , Vavricka S
Published: May 2021

Background

Vedolizumab is an α4β7 integrin monoclonal antibody indicated for moderately to severely active Crohn’s disease (CD) and ulcerative colitis (UC). There are limited data on how vedolizumab impacts extraintestinal manifestations (EIM) in inflammatory bowel disease (IBD).

The aim of the study was to analyse the effect of vedolizumab on EIM in a real-world cohort of IBD patients.

Methods

A multicentre retrospective study was conducted in Belgium, Denmark, Israel, the Netherlands and Switzerland. Adult patients with moderately to severely active IBD and concurrent active EIM with at least 6 months follow-up after vedolizumab initiation (index date) were enrolled. Improvement of EIM was defined as absence of symptoms (resolution) or partial response (reduction of symptoms).

Results

99 patients were included (UC: 44, CD: 55); the majority of active EIM at index were musculoskeletal (Table 1). Median disease duration at index was 9 (IQR: 3-19) years and 77% of patients had been exposed to 1+ biologic.

Overall, after 6 and 12 months of vedolizumab, 37% and 50% of EIM respectively were reported as improved, 22%, 25% as stable (no change) and 1% and 3% as worsened (Table 2), missing values were 5% and 4%, respectively. Median time since first EIM improvement was 0.5 months (Figure 1).

At 6 and 12 months, 48% (10/21) and 33% (6/18) of patients experienced clinical response/remission of their IBD, respectively.

Vedolizumab treatment persistence at 12 months was 83% overall (Figure 2).

Adverse Events were reported for 18% patients; 96% of them non-serious.

Conclusion

Vedolizumab treatment was associated with an improvement in 37% and 50% of EIM at 6 and 12 months, respectively, in a real-world IBD cohort.
P423 Treatment escalation and associated cost in German Ulcerative Colitis patients treated with advanced therapies
Authors: Picker N , Patel H , Wilke T , Rosin L , Bokemeyer B
Published: May 2021

Background

Advanced therapies used in moderate-to-severe Ulcerative Colitis (UC) may show a secondary loss of response (LOR) over time, requiring patients to undergo dose escalation or switching. Our study aimed to investigate the frequency of dose escalation in real-world practice and evaluated the associated cost.

Methods

Using German claims data (AOK PLUS) including prescription data, we identified UC patients by either at least two confirmed outpatient diagnoses or one primary inpatient diagnosis (ICD-10 K51). Analyzed patients initiated an advanced therapy (anti-TNF, vedolizumab, tofacitinib) between 01/01/2015-30/06/2019.

Therapy escalation was defined as dose increase exceeding the recommended maintenance dose according to product labels by more than 150%. Time to first escalation was analyzed using a Kaplan-Meier estimation. The observation ended with the discontinuation of index therapy + 90 days, or loss to follow-up, whatever occurred first. End of therapy was determined in case of a supply gap of >60 days or switch of the advanced therapy. Patients with a follow-up < 6 months were excluded.Direct UC-related resource use and costs accounting for hospitalizations, outpatient treatment, drug costs according to pharmacy sales prices were reported per patient-year (PY).

Results

Among 574 UC patients who initiated an advanced therapy, 328 patients (median age: 37 years; female: 52.1%; biologic-naïve: 85.4%) with sufficient follow-up time (median: 12.2 months) were identified.

Out of these, 59 patients (19%) were dose-escalated within the first year, whereas 73 patients (22%; anti-TNF: 61; vedolizumab: 12) were found to experience a therapy escalation during the whole follow-up time (average daily dose during maintenance therapy: adalimumab: 5.3 mg, infliximab: 14.6 mg, golimumab: 3.7 mg, vedolizumab: 11.1 mg, tofacitinib: n/a). Total observed direct cost related to UC amounted to €39,514/PY (95%-CI: 37,469-41,558), with €37,369/PY (34,852-39,885; Figure 1) caused by UC-related medication (95%). In comparison, UC-related total direct costs and drug costs for patients without any observable escalation were much lower (€30,425/PY [29,672-31,178]; p-value <0.001 and €28,066/PY [27,230-28,902]; p-value <0.001). Frequency of hospitalizations due to UC (0.3 [0.2-0.5] vs. 0.4 [0.3-0.5]; p-value: 0.947) and gastroenterologist visits (2.1 [1.6-2.6] vs. 2.3 [2.1-2.5]; p-value: 0.361) were similar among both groups.

Conclusion

Nearly one-fifth of observed patients required therapy escalation in the first year, most likely due to secondary LOR. This results in higher UC-related costs. Payers should consider rates and costs of dose escalations when evaluating the cost-effectiveness of advanced therapies.
P524 Endoscopic dilations of intestinal stenosis in Crohn’s disease
Authors: Badre W , Bahlaoui O , El Rhaoussi F Z , Tahiri M , Haddad F , Hliwa W
Published: May 2021

Background

The occurrence of intestinal stenosis is a common and potentially serious complication of Crohn’s disease (CD). These strictures represent 20% of the surgical indications in CD. Endoscopic dilation is an alternative to surgery for endoscopically accessible stenosis. The aim of this study is to evaluate the effectiveness of endoscopic balloon dilation (EBD) in CD intestinal stenosis.

Methods

This retrospective, descriptive study realized between January 2015 and October 2020, included CD patients diagnosed at least 6 months before and complicated with symptomatic intestinal stenosis (abdominal pain, bloating, nausea and vomiting). Anorectal strictures were excluded. All patients had a cross-sectional imaging before intestinal dilation to determine the characteristics of the stenosis and exclude abscess and fistula tract near the stenosis which constitute a contraindication of EBD. All patients underwent an EBD during a colonoscopy under sedation by propofol. The short-term success of EBD has been established on both technical (passage of the endoscope across the site of stenosis after dilation) and clinical level (relief of intestinal obstructive symptoms). The long-term efficacy was defined by no need for surgery within 6 months after dilation.

Results

Twelve patients (6 males and 6 females), with an average age of 32 years +/-7.7, were included. The average interval between onset of CD and the onset of intestinal stricture was 8 years. Eight patients had a history of bowel resection. The stenosis was located at the terminal ileum or ileocaecal valve in 4 cases, ileocolic anastomosis in 8 cases. The stenosis was ulcerated in 9 cases, inflammatory in 5 cases and polypoid in 3 cases. All patients were on medical treatment corticosteroids, Azathioprine and / or Anti TNF. We performed 18 EBD, divided into several sessions depending on the degree of stenosis (1 EBD, 2 EBD and 3 EBD in respectively 11, 3 and 2 patients). Two patients required surgery for persisting symptoms.

Technical success was obtained in 11 patients (92% of cases). Clinical success, defined by a disappearance of clinical symptoms with an HBI score of less than 4, was obtained in 9 patients (75% of cases). The mean follow-up after dilation was 23 months (range from 8 to 42 months). No major complications were observed in this study.

Conclusion

EBD is an effective therapeutic technique relatively safe for intestinal CD stenosis, allowing to delay or better, to avoid surgical treatment when the stenosis is well selected (stenosis<4cm, single, anastomotic, non-angled, and without adjacent abscess or fistula).
P537 Anemia in Crohn’s Disease: Response to treatment and risk of recurrence
Authors: Gharbi G , Bibani N , Sabbah M , Nawel B , Trad D , Ouakaa A , Elloumi H , Gargouri D
Published: May 2021

Background

Anemia is common in Crohn’s Disease (CD). Iron deficiency and inflammation are the most common etiologies.

The aim of our study is to assess the response of patients with CD to anemia treatment , as well as the predisposing factors for recurrence after treatment.

Methods

This is a retrospective study including patients with CD complicated by anemia, treated in the gastroenterology department between January 2015 and December 2019.

Iron deficiency anemia is defined by a ferritin level <50 ng /ml, it is inflammatory if the CRP level is high with a ferritin level which exceeds 100 ng/ml and mixed if this later ranges between 50 and 100 ng/ml.

Results

Fifty-four patients were included with a M / F sex ratio of 1.3. The mean age was 40.5 years old with a mean age at diagnosis of CD of 29 years old. Patients had ileal or ileocolic involvement in 82.2% of cases and pure colonic involvement in 16.7%. The main symptoms of anemia were asthenia (64.8%) and mucocutaneous pallor (42.6%).

Severe anemia was noted in 64.8% of patients. The factors statistically associated with severe anemia were: the number of relapses before the diagnosis of anemia (p= 0.012), an active disease (p = 00.024) assessed by the CDAI score, the presence of a deficiency syndrome, in particular hypocholesterolemia (p= 0.007) and hypocalcemia (p= 0.006).

The anemia was inflammatory in 44.4% of patients, iron deficiency in 31.7%, mixed in 20.4% and vitamin B12 deficiency in 16.7% of them.

Treatment of anemia depending on the etiology was effective in 72% of patients. The response was partial in 24% of cases. Only 4% of patients did not respond to treatment.

The predictive factors of a poor response to anemia treatment were: the disease duration (p= 0.05), an active disease at the time of diagnosis of anemia (p= 0.025) and an extended ileal resection (p= 0.005).

Patients with inflammatory anemia responded better to treatment (p= 0.006).

A longer duration of iron suplementation (p = 0.02), as well as the route of administration (IV) (p= 0.014) were correlated with a better response to therapy in case of iron deficiency anemia.

Recurrence of anemia was observed in 84.3% of patients with a mean time after anemia correction of 11.5 months.

Serum ferritin levels <20 ng/ml during follow-up was the main risk factor for recurrence of anemia (p= 0.01).

Conclusion

Even after treatment, recurrence of anemia is common especially in patients followed for CD with ileal involvement. A clinical-biological remission, a sufficient duration of iron treatment and the control of the response to treatment by the dosage of the ferritin level even after the correction of the anemia is necessary in order to avoid this recurrence and thus ensure a better quality of life .
P548 Drug Survival in Patients with Inflammatory Bowel disease: An observational study
Authors: Kubesch A , Grimm L , Stratmann K , Knabe M , Filmann N , Sprinzl K , Hausmann J , Blumenstein I
Published: May 2021

Background

Although the therapeutic array has significantly widened, over the past decades predicting treatment persistence in IBD patients is still a challenge. In this study we collected longitudinal data to determine drug survival on the medications currently available for IBD.

Methods

Patients treated in the IBD outpatient clinic of the Goethe University Hospital were retrospectively analyzed. Laboratory parameters and data on treatment adherence were collected via the electronic patient file. We investigated how many patients continued on the respective substances after the induction period and after the 1-year mark.

Results

A total of 601 patients were included. 321 patients were female (53.4), 280 patients were male (46.6). The median age was 43 (range 19–86). The median disease duration was 14 years (range 1–52). 320 patients (53.2) suffered from CD and 281 (46,8) patients suffered from UC.

95 patients were treated with Infliximab (IFX) with a median duration of 912 days (20–5273). 91 patients (96.8) were still on IFX after the induction period. 73 patients (76.8) patients reached the 1-year mark. At the endpoint of this investigation, 39 patients (41.9) were still on IFX. 172 patients were started on Adalimumab (ADA) with a median of 1054 (48–4458) days on the medication. Of this collective, 172 (100%) patients continued on ADA after the end of the induction period. 136 patients (79.1) reached the 1-year mark. At the endpoint of this investigation, 90 patients (52.3) were still on ADA. Of the entire cohort, 124 patients were treated with Vedolizumab (VDZ) with a median of 745.50 (0-2204) days on the medication. After the induction period for this medication, 123 patients (99.2%) were still on VDZ. 89 patients (71.8%) achieved the 1-year mark. At the endpoint of this investigation, 82 patients (66.1%) were still on VDZ. Lastly, 66 patients were treated with Ustekinumab (UST) with a median duration of 720 days (50–1777). 64 patients (98.5%) achieved clinical remission. 48 patients (72.7%) achieved the 1-year mark. At the endpoint of this investigation, 54 patients (83.1%) were still on UST. As we provided longitudinal data some patients have been exposed to several medications which in part explains the lower patient numbers in the more recently approved drugs.

Conclusion

Conclusion: The majority of patients were still on the medication after the respective induction in all treatment groups. 1-year treatment persistence was higher for and ADA in comparison to VDZ and UST. Our study provides further evidence on drug survival in IBD and may aid in advising patients in this matter.
P562 Web-based questionnaire survey about self-management for patients with Inflammatory Bowel Disease in Japan
Authors: Nagahori M , Imai T , Tairaka A
Published: May 2021

Background

The importance of self-management (SMN) has been widely recognized in chronic diseases but the concept remains complex and its evaluation diverse. There is a limited number of studies evaluating SMN in Inflammatory Bowel Diseases (IBD), and notably in Japan. We have therefore explored the actual utilization of SMN in IBD, the type of supports needed by the IBD patients, and the phenotypic differences between patients with and without SMN.

Methods

We conducted a web-based survey considering SMN components as diet, treatment, symptoms/physical conditions, stress, financial worries, and support services from February to March 2020. Subjects were recruited from the Japanese IBD patients’ panel and solicited by email for participation. SMN patients were defined as those responding positively to 3 questions about (1) habit of checking nutrition labelling (2) adjustment of their diet (3) modification of their daily life behavior according to the health conditions. Factors associated with the SMN utilization were also analysed by logistic regression analysis.

Results

Among 371 evaluable patients [Ulcerative Colitis (UC): n=210, Crohn’s Disease (CD): n=161, mean age=42 years, mean disease duration=10.2 years], 59.6% composed the SMN group (UC: 54.3% CD: 66.5%). 87.9% responded “able to live well with IBD” (UC: 90.5% CD: 84.5%, SMN: 92.3% vs non-SMN: 81.3% p=0.002), and 74.4% responded “checking nutrition labelling when buying food” (UC: 67.1% CD: 83.9%) but only 18.3% kept a regular record of diet (UC: 16.7% CD: 20.5%, SMN: 24.9% non-SMN: 8.7%) and 26.1% for symptoms record (UC: 29.5% CD:21.7%, SMN: 29.9% non-SMN: 20.7%). Doctors and families were the most consulted partners for lifestyle, symptoms and treatment by all patients, while CD patients, compared to UC ones, privileged nurses and other IBD patients. As between patients treated or not with biologics and janus kinase inhibitor (Bio/JAKi), there were more items demonstrating significant differences such as the utilization of SMN in UC than in CD. Patients with Bio/JAKi significantly responded more often to be “satisfied with their current treatment”. Meanwhile, patients with hospitalization or surgery histories as well as UC patients with Bio/JAKi showed higher proportions of SMN utilization. “Having 3 or more kinds of people to consult about lifestyle” in UC and “History of hospitalization” in CD were the most influential factors of SMN utilization. Financial/Employment aspects (77.4%) was the most desired support for all patients.

Conclusion

This is the first survey to reveal the actual utilization of SMN and its possible benefits in IBD patients in Japan. Our results suggested that SMN contributes to a better living with IBD for Japanese IBD patients.
P582 Insights on the sphingolipid profile in patients with short bowel syndrome and consecutive intestinal failure
Authors: Kubesch A , Knauer F , Thomas D , Jakobi K , Filmann N , Zeuzem S , Pfeilschifter J , Grammatikos G , Blumenstein I
Published: May 2021

Background

Short bowel syndrome (SBS) is a rare condition, and providing care for these patients can be challenging. Investigating the serologic sphingolipid profile has enhanced the understanding of various pathophysiologic conditions. However, data on the serologic sphingolipid profile in patients with SBS are –to date- not available.

Methods

Serum probes from patients with SBS treated in the outpatient clinic of the Department of Gastroenterology and Hepatology of the University Hospital Frankfurt were included and analyzed retrospectively. Serologic sphingolipid (SL) and especially ceramide (Cer) levels were assessed by LC-MS/MS and correlated with clinical and laboratory chemical parameters.

Results

A total of 37 (16 male) patients with SBS were included, 11 with Crohn’s disease (CD) (29.73%). Patients’ median age was 62 (24–88), with a median weight of 59 kilograms (42–75). Patients with less than 100 centimeters of small intestine had significantly higher creatinine and lower total protein levels, whereas the serologic SL-profile was not significantly affected. Furthermore, Sphingosine-1-Phosphate (S1P) and C18-Cer were increased in patients with SBS with CD as the underlying etiology. No significant differences in the sphingolipidomic profile were observed between patients on total parenteral nutrition than patients with oral and parenteral nutrition and patients with associated elevation of the liver enzymes.

Conclusion

Conclusion: Our study provides first insights into the serologic SL profile of patients with SBS. We showed that patients with CD present with an altered SL profile compared to other aetiologies, while the occurrence of liver disease in this single-center cohort does not appear to affect the serologic SL profile in respective patients.
P592 Costs savings associated with ferric maltol and the reduced use of intravenous iron based on real world data
Authors: Howaldt S , Becker C K , Becker J A , Poinas A C
Published: May 2021

Background

Intravenous (IV) iron is frequently used in patients with iron deficiency (ID) when conventional oral ferrous products are ineffective or cannot be used (e.g. due to poor tolerability). Oral ferric maltol is a new iron ferric product registered in Europe and US. The aim of this study was to quantify the use of IV iron before and after the introduction of the new oral ferric maltol in real world settings and extrapolate the overall costs involved.

Methods

Data were collected from a single centre German clinical practice, MVZ für Immunologie, in inflammatory bowel disease (IBD) patients treated with iron therapy for ID with or without anaemia between 2013 and 2019 through the systematic CEDUR IBD registry and local medical records. The first cohort was formed of patients treated between 2013 and 2015, receiving only IV iron as ferric carboxymaltose (FCM). The second cohort was formed of patients treated between 2017 and 2019, receiving either oral ferric maltol only or ferric maltol in combination with FCM. Costs involved in each cohort were extrapolated using a societal perspective.

Results

Following the introduction of oral ferric maltol, the actual total number of FCM infusions observed was 138, showing a decrease of 70% compared to the first cohort in which oral ferric maltol was not available. This decreased number of infusions between the two cohorts was associated with total costs-savings of €56,933. In the first cohort, the administration costs were €44,536, the drug acquisition costs were €59,536 and the productivity loss were €30,944. In the second cohort, the administration costs were €13,597 the drug acquisition costs were €55,028 and the productivity loss were €9,447. A secondary scenario strictly applying the doses taken from respective SmPCs was tested and resulted in greater costs-savings.

Noteworthy, the mean (SD) haemoglobin (Hb) level at baseline in the first cohort was lower with 11.5g/dl (1.19) vs. 12.2g/dl (1.18) in the second cohort. Three to six months after the treatment had been stopped, the mean (SD) Hb level was 13g/dl in both the first and second cohort with a SD of 1.31 and 1.37 respectively, showing that Hb levels were maintained in both cohorts.

Conclusion

The introduction of the new oral ferric maltol resulted in a decrease of 70% in terms of number of FCM infusions which was associated with costs-savings of €56,933 in terms of administration, drug acquisition and productivity loss costs. Considering that Hb levels were maintained in both cohorts, these results indicate that ID patients with or without anaemia previously treated with IV iron can also be managed effectively with oral ferric maltol resulting in overall societal cost-savings.
P600 Real-world clinical characteristics and therapeutic strategies in patients with moderate-to-severe Inflammatory Bowel Disease in Argentina: Data from the RISE AR study
Authors: Lasa J S , Sambuelli A , Zubiaurre I , Correa G J , Lubrano P , Balderramo D C , Ruffinengo O , Brion L , Leonardi D B , El-Hakeh J , Guimaraens P N , Olivera Sendra P
Published: May 2021

Background

Evidence on the adoption of different pharmacologic strategies in inflammatory bowel disease (IBD) in the real-world setting in Latin America is scarce. Herein, we describe the clinical characteristics and therapeutic strategies of IBD patients (pts) in Argentina.

Methods

RISE AR (NCT03488030) was a multicentre, non-interventional study with a cross-sectional evaluation and a 3-year retrospective data collection period conducted in Argentina (12/2018-05/2019) to assess the use of IBD treatments. Adult pts (≥18 years old) with a previous diagnosis of moderate-to-severe ulcerative colitis (UC) or Crohn′s disease (CD) based on clinical, endoscopic or imaging criteria at least 6 months prior to enrolment, were included.

Results

Overall, 101 CD and 145 UC pts were included. Median (range) age (years) at enrolment was 39.5 (18.2–74.0) for CD (51.2% female) and 41.9 (18.0–80.4) for UC (55.2% female); median (range) disease duration (years) was 7.4 (0.6–36.9) for CD and 5 (0.7–33.8) for UC. At enrolment, 51.5% of CD pts had colonic involvement, 32.7% ileocolonic, 8.9% ileal, 1% isolated upper tract and 5.9% had combined L4/other. In UC, 46.2% had extensive colitis, 44.7% left-sided colitis and proctitis 9.1%. 51.6% of CD pts had non-inflammatory behaviour (37.7% stricturing; 13.9% penetrating), and 34% had perianal disease (13.9% as B1p), resulting in a total of 65.5% pts with complicated disease. Only 9.3% of CD (Harvey Bradshaw Index ≥8) and 7.7% of UC (partial Mayo Score ≥5) pts showed moderate-to-severe disease activity at enrolment. In CD, 70.3% of pts were receiving a biologic agent vs. 29.7% of UC pts. Immunosuppressant (IMM) use was similar between groups (CD 39.6%, UC 40.0%); nearly one-third of the pts on a biologic were receiving concomitant IMM (CD 33.8%, UC 34.9%). Aminosalicylates (5-ASA) were used for most UC pts (89.0%) vs. 47.5% of CD pts, mainly in those with L2 disease. 5-ASA monotherapy was prescribed in 32.1% of UC vs. 5.3% of CD pts, but were also used with IMM (UC 25%, CD 11%), biologics (UC 15%, CD 11.6%) or all three therapies combined (UC 6.4%, CD 17.9%). Corticosteroids (CS) were the least prescribed therapy (CD 7.9%, UC 13.8%).

IBD treatments ever prescribed during the retrospective period were (CD, UC): biologics: 79.2%, 33.8%; IMM: 65.3%, 58.6%; 5-ASA: 62.4%, 97.9%; CS: 55.4%, 69.7%.

Conclusion

In this cohort of IBD patients, biologics use was high, especially among CD patients, in line with disease behaviour, and possibly by their increased availability in these reference centres. This study also highlights country-specific clinical features such as the low proportion of CD pts and the high prevalence of colonic involvement in CD.