bluuebunny/crossref_metadata_2025_split huggingface dataset:
P341 Perceived risks and psychosocial burden during the COVID-19 pandemic in a large cohort of pediatric and adult patients with Inflammatory Bowel Disease
Authors: Koletzko L , Klucker E , Le Thi G , Breiteneicher S , Rubio-Acero R , Neuhaus L , Stark R , Standl M , Hölscher M , Török H , Koletzko S , Schwerd T 
Published: May 2021

Abstract

Background
The COVID-19 pandemic induced restrictions in daily life and anxiety especially in vulnerable parts of the population. We investigated the psycho-social burden of the pandemic and self-perceived risk and harm in a large IBD cohort.

Methods
In this monocentric prospective observational study, pediatric (pIBD) and adult patients completed questionnaires related to their IBD (phenotype, disease activity, treatment), comorbidities, demographic and socioeconomic factors, validated tools on Perceived Stress (PSQ) and quality of life (sIBDQ). They judged perception of harm in case of acquiring COVID-19 using ratings from 1 to 7. We used number and type of established conditions for severe COVID-19 outcome to categorize patients in 5 risk groups. SARS-CoV2 antibodies were determined by Elecsys Roche anti-N pan-Ig. All comparisons were made by using t-test, Mann-Whitney-U-test or Chi-square-test where applicable with 2-sided significance levels of 5%. Univariate and multiple logistic regression was performed to determine associations between factors and perceived harm.

Results
Between mid-July to mid-October, 504 (62%) of 820 invited IBD patients and 86 pIBD parents completed the survey. Age ranged from 6-85 years, 80% received mono- or combo-therapy with immunomodulator, biologic, JAK-inhibitor or corticosteroids. Remission, mild, moderate and severe disease activity were reported by 46, 39, 12 and 3%, respectively. High harm of potential COVID-19 (&gt;3) was perceived by 75.4%, rates increased with age (p=0.0019). After adjusting for age and gender, high perceived harm was significantly associated with immunosuppressive drugs, number/type of comorbidities, sleep disturbance, unintended gain or loss of weight, higher PSQ and lower sIBDQ scores. PSQ scored lower in males &gt;60 years vs age matched females or younger adults, and in patients in remission vs active disease. PIBD mothers’ total PSQ was similar with even higher subscores for demands (P=0.0004) as adults with moderate/severe disease. Compared to pre-pandemic, 58-93% of pIBD decreased physical activities (at home, sports, outdoor) with minor changes in adults. SARS-CoV-2 serology was positive in 0.4% of IBD patients compared to 2% of our city population.

Conclusion
Prior to 2nd infection wave, even IBD patients aged &lt;40 years suffer from a high degree of worries, stress and perceived harm for potential COVID-19. Most elderly patients and those with comorbidities adequately estimate their risks. In pIBD, pandemic restrictions substantially impacted on physical activity. The low seropositivity rate indicates high adherence to social distancing or altered immune response due to IBD drugs. Results of the follow up survey in March 21 are underway.
P367 Weight patterns in biologicals treated Inflammatory bowel disease cohort
Authors: Kaazan P , Tan Z , Maiyani P , Mickenbecker M , Edwards S , McIvor C , Andrews J M 
Published: May 2021

Abstract

Background
Biologic therapies are effective at inducing and maintaining remission in patients with inflammatory bowel disease (IBD). Previous studies have associated TNF-a inhibitors with weight gain, however it is unclear if this is a class-related effect or a manifestation of clinical remission. We performed this retrospective study to compare weight changes from baseline across different biological classes, examine weight patterns over time and assess characteristics and associations within each (sub)groups.

Methods
Adult patients with IBD who received any biological therapy for at least 12 months, between 2008 and 2020, were identified from prospectively maintained records at two IBD units in Australia. Data collected included demographics; weight and BMI at baseline, 6, 12, 24 and 48 months; IBD type and phenotype; baseline endoscopy, baseline haemoglobin, C-reactive protein (CRP) and albumin; combination or monotherapy; initial steroid therapy and frequency of biologic infusion. Patients with missing data were excluded.
A linear mixed-effects model was performed for the outcome of weight change from baseline, including the interaction of treatment group and time period. A latent class analysis was then performed, assigning patients to weight trajectory groups, and univariate ordinal logistic regressions were used to explore possible associations between membership of each group (the outcome) against various predictive factors.

Results
Of 294 patients (156 females), 165 received Infliximab (IFX), 68 Adalimumab (ADA), 36 Vedolizumab (VDZ) and 25 Ustekinumab (UST). There was a statistically significant interaction between time and treatment group with a significant weight gain over time in both the IFX and VDZ groups. After adjusting for baseline weight and inflammatory markers, significant weight gain was found for IFX vs ADA and VDZ vs ADA at most time points (Fig.1). Significantly less weight gain was seen in those with a higher initiation weight. Each 10kg increase in baseline weight resulted in 0.5kg less weight gain. This effect also held true for BMI.
Latent class analysis identified three weight trajectories: 57.4% of patients had small weight loss (-2.3kg), 37.8% small weight gain (6.6 kg) and 4.8% large weight gain (24.3 kg). Baseline BMI inversely influenced weight gain; with every 1 unit increase in BMI, reducing the odds of large weight gain by 8%. Being female, having an initiation CRP£5 or albumin&gt;35 also reduced the odds of large weight gain.

Conclusion
Weight gain in biological-treated IBD patients appears to be associated with male gender, active baseline inflammation and the type of drug used.
P404 Healthcare utilization and expenditures for patients with Ulcerative Colitis on advanced therapies in Germany
Authors: Picker N , Bokemeyer B , Wilke T , Rosin L , Patel H 
Published: May 2021

Abstract

Background
Ulcerative Colitis (UC) is a chronic inflammatory condition, which significantly impacts patients’ health-related quality of life and burdens healthcare budgets. Our objective was to provide an overview of the healthcare resource use (HCRU) for the treatment of moderate to severe UC in Germany.

Methods
A retrospective analysis was conducted using claims data from a German sickness fund (AOK PLUS). Patients were included if they had ≥2 outpatient diagnoses in different quarters and/or one inpatient UC diagnosis (ICD-10: K51), were aged ≥18 years and initiated an advanced therapy (anti-TNFs, vedolizumab, tofacitinib) between 01/01/2015-30/06/2019.
HCRU associated with UC treatment was assessed in terms of outpatient visits, work-related sick leave days, and UC caused hospitalizations. Direct UC-related costs (inpatient, outpatient and medication costs based on pharmacy sales price at prescription date) were calculated from the perspective of the German statutory health insurance.
All patients were followed from the start of treatment until the end of the study period, or loss to follow-up. In case of treatment discontinuation or change of index therapy, patient follow-up was censored 90 days after the last prescription of index therapy. UC-related HCRU and cost were reported per observable patient-year (PY) and stratified according to prior use of advanced therapies (naïve vs. experienced).

Results
574 patients were included (adalimumab: 230, infliximab: 172, golimumab: 56, vedolizumab: 113, tofacitinib: 3). Mean age was 41.9 years; 53.5% were female. On average, 2.5 outpatient visits per PY were billed by general practitioners and 1.4 by gastroenterologists. 27.0% of patients had at least one UC-related hospitalization (mean length of stay: 11.2 days). The mean number of documented UC-related sick leave days amounted to 13.1 per PY. HCRU was similar in therapy-naïve vs. experienced patients (Table 1).
Inpatient costs for any cause amounted on average to €4,522/PY, with UC accounting for €3,190/PY (70.5%). Total UC costs amounted to €34.068/PY (Table 2). Expenses for prescribed UC-related drugs amounted to €28,885/PY (95.6% of total drug costs), and outpatient treatment to €511/PY with only €123/PY for Gastroenterologists’ visits (0.4% of total UC-costs/PY). In addition, indirect cost resulting from sick leave due to UC were estimated at €2,979/PY.

Conclusion
Our study indicates a high economic burden in UC patients who initiated treatment with advanced therapies. UC-related medication was identified as the main cost driver. Furthermore, a substantial proportion of UC patients required hospitalization in the first 12 months after starting new advanced therapy.
P418 Does capsule endoscopy impact clinical management in established Crohn’s Disease?
Authors: Elosua Gonzalez A , Rullan Iriarte M , Rubio Iturria S , Oquiñena Legaz S , Rodríguez Gutiérrez C , Macías Mendizábal E , Borda Martín A , Fernández-Urién Sainz I , Nantes Castillejo Ó 
Published: May 2021

Abstract

Background
Capsule endoscopy (SBCE) has developed a relevant role in different indications in patients with established Crohn’s Disease (CD). However, evaluation of its impact in clinical management in CD specific modification strategies has been scarce. The purpose of our study was to question therapeutic impact of SBCE in an 11-year real-life cohort of established CD patients.

Methods
Retrospective single center study including all consecutive patients with CD submitted to SBCE from January 2008 to December 2019. Small bowel patency was evaluated with patency capsule in selected patients. A conclusive procedure was defined as the one that allowed clinical decision-making. Mucosal inflammation was graded as mild (few aphtoid ulcers), moderate (multiple aphtoid ulcers/isolated deep ulcers) or severe (multiple deep ulcers/stenosis). Therapeutic impact was defined as a change in CD related treatment including escalation, de-escalation, dose adjustment or referral to surgery recommended based on SBCE results within the next 3 months after the SBCE. Patients were assigned to four groups regarding CE indication: staging, flare, post-op and remission (fig 1).

Results
From the 432 CE performed, 378 (87.5%) were conclusive and allowed clinical decision-making. SBCE results guided changes in 51.3% of patients: 199 (46.1%) with escalation and 23 (5.3%) with de-escalation of treatment. Active disease was present in 310 (71.8%) patients; 131 (30.3%) presented mild, 126 (29.2%) moderate and 53 (12.3%) severe activity. Disease activity demonstrated by SBCE correlated with therapeutic changes. With mild activity 24.1% increased therapy, whereas 77.8% and 84.9% increased therapy with moderate or severe disease, respectively (p&lt;0.001). De-escalation was conducted in 12.8% patients with mucosal healing and 6.1% with mild disease but not in moderate or severe activity (p&lt;0.001). Treatment before and after SBCE is shown in the table.

Conclusion
SBCE is a safe and useful tool when approaching established CD patients guiding therapeutic management in a real-life setting. Its positive impact does not limit to treatment escalation but also helps to de-escalate in patients who can benefit from it.
P432 MyChart application in addressing Inflammatory Bowel Disease patients’ concerns and impact on service utilisation
Authors: Raman K P , Agorogianni A , Hadjinicolaou A , Nightingale A , Mayhew A , Munro R , Raine T , McDermott E 
Published: May 2021

Abstract

Background
MyChart is a novel electronic portal within the electronic patient record provider EPIC. IBD patients were asked to complete an electronic questionnaire via MyChart prior to their infliximab infusions. A threshold was set that any patient who recorded a severe disease activity score (Mayo &gt;/3, Harvey-Bradshaw Index (HBI) &gt;/8) or signalled a concern created an automatic message that was routed to our clinical nurse specialists.

Methods
Electronic notes of all IBD patients who received infliximab in the month of September 2020 were reviewed. Demographics, activity status of My Chart, type of concerns raised and outcomes, number of inpatient admissions and outpatient appointments pre- and post- the introduction of the online questionnaire were recorded. Clinical remission was defined as Mayo score of &lt;3 or HBI score of &lt;5. Statistical comparisons were performed in GraphPad Prism software using the exact Fisher’s test and student t-test accordingly. Values were deemed significant if p&lt;0.05.

Results
140 IBD patients on infliximab were identified; 2 were excluded due to incomplete data. The cohort comprised of 77 males (55.8%) with mean age of 27 years (SD of 15.1).110 (78.70%) patients had a diagnosis of Crohn’s disease whereas 24 (17.0%) had ulcerative colitis and 4 (2.8%) unspecified type IBD. 104 (75.1%) patients were active on MyChart and 83 (58.9% of total; n=138) completed the infliximab questionnaire.
Significantly fewer of the patients active on MyChart required scheduled outpatient reviews when compared to those that were inactive (59.6% vs 94.1%; p=0.0001; Table 1). There were no significant differences in terms of demographics, IBD type or clinical remission between the two groups.
Strikingly, patients who did not fill in the questionnaire were significantly more likely to have scheduled outpatient review in comparison to those that filled it (83.6% vs 67.4%; p=0.047) despite a higher proportion of the first being in clinical remission at baseline (86.6% vs 67.4%; p=0.047).
Furthermore, we evaluated the impact of introducing the online questionnaire by looking at the outpatient reviews and inpatient admissions before and after patients filled it in. The group was significantly less likely to require outpatient reviews (67.5% vs 87.3%; p=0.0061) or inpatient admissions (6.0% vs 17.5%; p=0.03) following introduction of the online questionnaire (Figure 1).

Conclusion
Overall, patients active on MyChart seemed to be significantly less likely to require outpatient review. This impact seemed particularly evident after filling in an online questionnaire which effectively addressed patient concerns and prevented unwarranted outpatient reviews and inpatient admissions.
P442 Serum vedolizumab trough levels are associated with remission rate but not with extra-intestinal manifestations in IBD patients
Authors: Tzadok R , Fliss-Isakov N , Aviv Cohen N , Ron Y , Maharshak N , Hirsch A 
Published: May 2021

Abstract

Background
The correlation between vedolizumab trough levels and inflammatory bowel diseases (IBD) remission rates has not yet been fully defined. We aimed to evaluate the association between vedolizumab serum trough levels and disease clinical and extra-intestinal manifestations (EIMs) and biomarker activity in IBD patients.

Methods
Forty-six patients (31 ulcerative colitis, 15 Crohn’s disease) who started vedolizumab therapy were retrospectively followed. Clinical and laboratory data were collected before treatment, during induction and maintenance until week 52 from initiation. Documentation of EIMs included peripheral and axial arthropathy, cutaneous and ocular manifestations and perianal disease. Clinical remission was defined as a Harvey-Bradshaw Index (HBI)&lt;5 or a Simple Clinical Colitis Activity Index (SCCAI)&lt;3. Biomarker normalization was defined as C-reactive protein level&lt;5 mg/L and fecal calprotectin level&lt;250 µg/g. Two-sample t-tests were used to find correlations between drug levels and disease activity.

Results
Higher week-2 trough serum vedolizumab levels were associated with week 14 clinical remission compared to patients with an active disease (30.55±2.22 µg/ml vs 22.28±3.57µg/ml, p=0.05) and with weeks-14 and -30 biomarker normalization (33.77±2.98 µg/ml vs 23.6±3.19 µg/ml, p=0.05 and 30.33±1.95 µg/ml vs 19.66±6.83 µg/ml, p=0.05, respectively).
Week-6 vedolizumab levels were associated with week-30 clinical remission (30.52±3.48 µg/ml vs 15.35±4.94 µg/ml, p=0.03) and biomarker normalization (28.44±2.36 µg/ml vs 15.76±4.87µg/ml, p=0.02), and week 14 vedolizumab levels were associated week 30 biomarker normalization (14.81±1.64 µg/ml vs 6.23±2.25 µg/ml, p=0.03).
Throughout the follow-up period, 24% of patients presented with EIMs (n=11). No association was found between vedolizumab levels and endoscopic outcomes or EIMs activity.

Conclusion
Trough serum vedolizumab levels at induction is associated with remission induction and maintenance but not with EIMs improvement. Assessment of early vedolizumab trough levels may be considered for prediction of response to therapy.
P447 Combined fibrin glue with infliximab therapy of postoperative anastomotic fistula in patients with Crohn’s disease: A Pilot study
Authors: Li Y , Yao D 
Published: May 2021

Abstract

Background
Postoperative anastomotic fistula is one of the most frequent and potentially life-threatening complications following gastrointestinal resections in patients with Crohn’s disease. The purpose of this study was to report the results of infliximab promoting healing of postoperative anastomotic fistula in patients with Crohn’s disease.

Methods
In this randomized controlled trial, 37 patients with postoperative fistula were assigned to combined(n=18) or control(n=19) groups and followed up for 6 months. The combined group received usual management protocol for fistula plus an intravenous infliximab therapy for 6 months. The control group received usual fistula protocol. The primary outcome was fistula closure time. The secondary outcome was any infectious complication such as recurrence of ECF, abdominal abscess, pneumonia, infectious diarrhea and other signs of infection.

Results
Thirty-seven patients with postoperative anastomotic fistula were evaluated. There were18 patients randomized to the combined group who received fibrin glue combined with infliximab therapy. There were 19 patients randomized to the control group who received fibrin glue sealant therapy alone. No significant differences in demographic or clinical characteristics were found between the two groups( P&gt;0.05). The combined group had a shorter closure time than the control group(50.5±11.1 vs 76.2±26.2 days, P=0.011). The combined group did not show higher infectious complications than the control group(P=0.167).

Conclusion
Infliximab strategy with combining fibrin glue is a safe and effective treatment alternative in the management of postoperative anastomotic fistula in Crohn’s disease, offering the advantage of reduced heal time of fistula.
P469 The PROPER study: interim analysis of a pan-European real-world study of SB5 adalimumab biosimilar after transition from reference adalimumab in patients with Crohn’s disease
Authors: Dignass A , Gisbert J , Freudensprung U , Addison J 
Published: May 2021

Abstract

Background
SB5, a biosimilar to reference adalimumab, received EU marketing authorisation in August 2017, based on pre-clinical and clinical Phase I and III studies that demonstrated bioequivalence, similar efficacy, and comparable safety and immunogenicity to the reference. The ongoing real-world study ‘PROPER’ is designed to provide insights into outcomes of the transition from reference to SB5 outside the controlled, randomised, clinical trial setting, and under an umbrella design has enrolled 1,000 patients with immune-mediated inflammatory disease, treated at centres in Belgium, Germany, Ireland, Italy, Spain and the UK. The objective of this interim analysis is to describe clinical characteristics and outcomes in patients with Crohn’s disease transitioned from reference to biosimilar adalimumab SB5.

Methods
Eligible patients had been transitioned to SB5 as part of routine treatment following a minimum of 16 weeks’ treatment with reference adalimumab. Data are captured from patient charts retrospectively for 24 weeks prior to and prospectively and/or retrospectively for 48 weeks after SB5 initiation. This first interim analysis of the Crohn’s disease cohort reports outcome measures including baseline clinical characteristics, disease activity, persistence on SB5, clinical management and safety for patients enrolled at 32 specialist sites and followed up to the data extract date of February 5th, 2021.

Results
Of the 459 patients included in this interim analysis, at time of data extract 108 had completed 48 weeks on SB5, 45 patients had discontinued SB5, and 10 had withdrawn from study. A disease flare was reported for 29 (6.3%) of patients, of whom 22 had no subsequent change in biologic treatment; 7 had a change, of whom 5 switched to a different biologic; 2 had secondary loss of response (physician reported). Twelve patients reported 13 serious adverse events, of which 4 (anal fistula, 2 perianal abscesses and subileus) were considered by study physician to be related to SB5 administration. In Table 1 below, baseline refers to the time of SB5 initiation.

Conclusion
This interim analysis provides a first insight into clinical management of patients in a contemporary study cohort of European patients with long-standing Crohn’s disease, transitioned from reference to biosimilar adalimumab SB5 and followed in clinical practice. The majority of patients showed no meaningful difference in disease activity or SB5 dosing regimen by Week 48 post-transition, and the Covid-19 pandemic seems to have had no impact on SB5 use in this cohort. No new safety concerns were detected.
P568 Effectiveness of ustekinumab after vedolizumab failure in patients with anti-TNF-refractory Crohn’s disease
Authors: Dussias N , Rizzello F , Calabrese C , Sanna Passino A , Melotti L , Scaioli E , Belluzzi A , Gionchetti P 
Published: May 2021

Abstract

Background
Both vedolizumab (VDZ) and ustekinumab (UST) are indicated in the treatment of Crohn’s disease (CD) when anti-TNF treatment fails. While there are some studies regarding the efficacy of these two drugs in this setting, data are lacking regarding the effectiveness of UST in the treatment of VDZ-refractory disease. We aim to address this particularly challenging clinical picture in a real-world single-centre study.

Methods
CD patients from a single tertiary IBD referral centre receiving treatment with UST after failure to VDZ with a minimum follow-up period of 6 months were included. All patients had previously failed anti-TNF treatment. The primary outcome measure was achievement of steroid-free clinical remission, defined as HBI &lt; 5 at 6 months. We also assessed rates of partial response, defined as a reduction in HBI by ≥ 3 points and/or cessation of steroid treatment in patients who required corticosteroids at baseline for symptom control.

Results
A total of 32 patients (20 male, mean age ± SD 40.7 ± 14.2, range 21–75) receiving UST treatment after VDZ failure were analysed. Complete steroid-free clinical remission at 6 months from starting UST therapy was achieved in 19 patients (59.4%). Nine patients (28.1%) had partial response, while in the remaining 4 patients (12.5%) no response was achieved. No adverse events were recorded during the follow-up period.

Conclusion
Preliminary results suggest that UST is effective and safe in the treatment of VDZ-refractory CD.