bluuebunny/crossref_metadata_2025_split huggingface dataset:
P440 First results of the BELCOMID study: BELgian Cohort study of COVID-19 in Immune Mediated Inflammatory Diseases (IMID)
Authors: Geldof J , Truyens M , Sabino J , Ferrante M , Lambert J , Lapeere H , Hillary T , Van Laethem A , De Vlam K , Verschueren P , Lobaton T , Vermeire S 
Published: May 2021

Abstract

Background
It has been suggested that 100% of SARS-CoV2 infections leads to development of specific IgG antibodies that remain detectable for a long period of time. Targeted Immune-Modulating Therapies (TIMT) such as anti-TNF, anti-interleukins and Janus Kinase inhibitors (JAKi) for treatment of Immune Mediated Inflammatory diseases (IMID) could theoretically interfere with cytokine storm and humoral immune response against COVID19. We investigate the seroprevalence of SARS-CoV2 IgG in relation to previous exposure to COVID19 and ongoing IMID treatment in a Belgian, real-life population of IMID patients.

Methods
A cross-disciplinary, prospective, observational cohort study was set up at two university hospitals. Between 17/12/2020 and 29/02/2021, all patients with IMIDs of the gut (Crohn’s disease (CD), ulcerative colitis (UC)), joints (rheumatoid arthritis, psoriatic arthritis, spondyloarthritis) and skin (psoriasis, hidradenitis suppurativa, atopic dermatitis) visiting the respective clinics were asked to participate. Both patients under conventional treatment and/or TIMT were included. Patients were asked to fill out an electronic survey (REDCap®, based on WHO-ISARIC) and blood samples were drawn for serology testing (SARS-CoV-2 IgG Abbott – Architect kit®). Statistical analyses were performed with SPSS26.

Results
In total 2166 IMID patients consented to take part. Of these, 1913 responded to the survey, including 218 dermatology patients, 415 rheumatology patients and 1217 IBD patients (64.7% CD, 34.3% UC, 1% undifferentiated colitis). There were 372 patients (19.5%) who reported having experienced symptoms suggestive of COVID19 (Fig. 1). Fatigue (61.3%), headache (48.1%), throat ache (46.9%) and dry cough (38.7%) were most frequent. Gastrointestinal symptoms such as diarrhoea or abdominal pain were present in less than 20.0% (Fig. 2). Ninety-six IMID patients (5.04%) had a positive SARS-CoV2 PCR test on nasal or throat swab. In 44/96 (45.8%) anti-SARS-CoV2 IgG seroconversion was confirmed. There was no significant difference in seroconversion rate between patients treated with TIMT compared to conventional therapy (P=0.192). Of the seroconverted group, 75.0% were treated with TIMT. The interval between reported positive PCR date and serology test date ranged from 3 to 24 weeks with a mean of 10 weeks. Of all survey responders, 25 were hospitalized for respiratory symptoms since 01/02/2020, six of these had positive SARS-CoV2 PCR.

Conclusion
Prevalence of COVID19 symptoms and number of confirmed COVID19 cases by PCR in this cohort of IMID patients remain low regardless of treatment modality. There was no significant difference in SARS-CoV2 IgG seroconversion rate between TIMT or conventional treatment in patients with positive PCR.
P478 Effectiveness of ustekinumab dose escalation in Crohn’s disease patients with insufficient response to standard-dose subcutaneous maintenance therapy: an observational multicentre study
Authors: Olmedo-Martín R , Martín-Rodríguez M D M , Lorenzo-González L , Lázaro-Sáez M , Lopez-Vico M , Hernández-Martínez Á , Argüelles-Arias F , Vázquez-Morón J M 
Published: May 2021

Abstract

Background
Ustekinumab is a human monoclonal antibody that targets interleukin (IL)-12 and IL-23 and it is effective for the treatment of Crohn’s disease (CD). However, a group of patients will not respond or over time will experience loss of response (LOR) to ustekinumab. Evidence supporting the effectiveness of ustekinumab dose escalation for LOR is scarce. The aim of this study was to assess the effectiveness of ustekinumab dose escalation in a cohort of patients with active CD

Methods
Multicentric retrospective cohort study conducted in 5 tertiary Andalusian centers. Patients with active CD who received a standard-dose intravenous (IV) induction and at least one subcutaneous (SC) ustekinumab dose were included. All enrolled patients received dose escalation by either shortening the interval between the maintenance doses to every 4 or 6 weeks, IV reinduction or a combination of strategies. The primary outcome of the study was to assess corticosteroid (CS)-free clinical remission (HBI ≤4) at week 16. Secondary outcomes were CS-free clinical response (decrease of HBI ≥ 3 points from baseline) at week 16 and on the last follow-up, CS-free clinical remission on the last follow-up and ustekinumab persistence after dose escalation

Results
A total of 84 patients were included (54,8% female, median duration of CD 13,5 years). A 47,5% of the patients had history of previous abdominal surgery and 55% had been treated with 2 or more biologics. Patients were dose-escalated after a median treatment duration of 37 weeks (IQR 23–54). The most frequent type of dose escalation was the 90 mg every 4 weeks regimen (58%). A 25% of the patients were on concomitant immunomodulators at escalation. At week 16 from dose escalation the proportion of patients in CS-free response was 50/84 (59%) including 18/84 (21,4%) in CS-free remission. Follow-up data beyond week 20 were available for 61/84 patients (72.6%). On the last follow-up visit, 29/61 (47,5%) patients responded to treatment without concomitant CS of which 19/61 (31%) were in CS-free clinical remission. Systemic CS were discontinued in 21/44 (47.7%) patients who were on CS at the time of dose escalation. Ustekinumab was discontinued in 14/84 (17%) of the patients due to clinical non-response (ustekinumab persistence was 81% at 14 months of follow-up). Adverse events following dose escalation were reported in 4 of the 84 patients (7.7%), none of them were serious.

Conclusion
Dose escalation of ustekinumab maintenance was effective in over 50% of the patients and the treatment persistence was high. This strategy should be considered in patients who are not responsive or have LOR to ustekinumab on an 8-week dose maintenance interval
P489 Rescue treatment with original versus biosimilar infliximab in biologic-naïve patients with moderate-severe Ulcerative Colitis and corticosteroid failure
Authors: Muñoz-Villafranca C , Ogueta M Á , Ramírez de la Piscina P , Álvarez-Herrero B , Loizate A , Gómez-Zabala J M , De La Maza-Ortiz S , Aresti U , Gorostiza I , Arreba P , Irigoyen M , Ortiz de Zárate J 
Published: May 2021

Abstract

Background
Infliximab is effective as rescue therapy in moderate-severe Ulcerative Colitis (UC). Subsequently, a biosimilar of infliximab has been approved for the same indications, as its effectiveness is considered similar to the original infliximab. Our aim was to analyse the colectomy rate and the efficacy of original infliximab (Remicade®) versus biosimilar infliximab (Inflectra®) in patients with moderate-severe UC who failed to respond to intravenous corticosteroids.

Methods
We performed a retrospective and observational study in two hospitals in the Basque Country. All patients hospitalised between 2010–2020 with moderate-severe UC, without response to intravenous corticosteroids and rescue treatment with infliximab were consecutively included. Two cohorts were established: the first one from 2010 to 2015 in patients treated with Remicade®, and the second one from 2015 to 2020 in patients with Inflectra®. We assessed all patients that had received at least one dose of infliximab. Patients were followed for a period of one year until loss of response or colectomy. Early colectomy is the surgery performed until week 12, and late colectomy between week 12 and one year. At the moment of hospitalisation all patients were clinically and endoscopically evaluated by Mayo Score. The clinical response was assessed in week 14 and 52.

Results
A total of 85 patients were evaluated, 53 (64.4%) in Remicade® group and 32 (37.6%) in Inflectra® group. 21.17% (18/85) of the patients had a colectomy in one year. 77.7% of the colectomies took place in the first 12 weeks (14/18, 7 patient in each group). Rates of early (13.8% vs 21.9%, p=0.297) and late colectomy (17% vs 28.1%, p=0.223) showed a numerical but non-statistically significant difference in favour of Remicade®.
Transfusion (OR=4.20, IC 95% [1.38–12.77], p=0.011) and the presence of cytomegalovirus in the colonic mucosa (OR=4.07, IC 95% [1.31–12.63], p=0.015) were univariate predictors of colectomy. A statistically significant difference was found in clinical remission at week 14 (49.1% vs 25%, p=0.040) but not at week 52 (73.7% vs 50%, p=0.074) in patients with Remicade® versus Inflectra®. Neither clinical activity nor mucosa activity showed relationship with risk of colectomy.

Conclusion
1. The rescue therapy with infliximab in patients with moderate-severe Ulcerative Colitis who failed to respond to intravenous corticosteroids could show a favourable trend for Remicade® against Inflectra®. However, further research is needed to confirm it.
2. The need of transfusion and the presence of cytomegalovirus in the colonic mucosa could be predictive factors of colectomy.
P564 Validation of the IBD-Disk instrument in a Portuguese cohort
Authors: Silva Mendes S , Ferreira P , Antunes P , Gonçalves M , Leal T , Gonçalves B , Rebelo A , Arroja B , Caetano A C , Gonçalves R , Soares J B 
Published: May 2021

Abstract

Background
Inflammatory bowel disease (IBD) affects several dimensions of health-related quality of life. The IBD-Disk scale was designed to provide immediate illustration of disability reported by patients with IBD, previously validated in two cohort studies. The aim of this study is to validate the IBD-Disk in a Portuguese cohort in a clinical setting according to the COnsensus-based Standards for the selection of the health Measurement INstruments (COSMIN) recommendations.

Methods
After translation to Portuguese, a group of IBD patients was invited to fill-in the IBD-Disk at baseline (T0), after 2 weeks (T1), and after 3 months (T2), from July 2020 to February 2021. At T0 and T2 the patients also completed the IBD-Disability Index. We evaluated reliability (internal consistency, test-retest, and inter-rater reliability and measurement error), construct validity, responsiveness, and interpretability.

Results
At baseline, 154 patients (107 - Crohn′s disease; 46 - ulcerative colitis) completed the IBD-Disk. After 2 weeks and 3 months, 64 and 114 patients repeated the questionnaire, respectively. Factor analysis confirmed the unidimensionality of the scale and reduced the final version to 10 items. Internal consistency was excellent with a Cronbach’s α of 0.916. The intraclass correlation coefficient was 0.95 for test-retest (baseline and 2 weeks). To evaluate construct validity, the IBD-Disk was compared with the IBD-Disability Index with a significative positive correlation (r=0.850; p&lt;0.001). IBD-Disk scores ranged from 0 to 93 with a mean of 38.18±25.39. Female gender (β =0,3; p&lt;0,001) and professional inactivity (β=0.28, p=0.014) were associated with higher IBD-Disk scores. Neither floor nor ceiling effects were observed.

Conclusion
The Portuguese version of IBD-Disk is a reliable, valid, and responsive tool to assess disability in Portuguese IBD patients. This study confirms the utility of this instrument in the evaluation of IBD patients in diverse populations.
P577 Withdrawal of thiopurines in patients with Ulcerative Colitis in remission
Authors: Amor Costa C , Suárez Ferrer C , Poza Cordón J , Rueda García J L , Sánchez Azofra M , Martín Arranz E , González Diaz I , Amiama Roig C , García Ramirez L , Martín Arranz M D 
Published: May 2021

Abstract

Background
Thiopurines (TP) are widely used in monotherapy in patients with ulcerative colitis (UC), mainly for the maintenance of remission in case of corticodependence or corticoresistance after cyclosporine use. However, these are drugs with significant side effects, especially in the long term.
The optimal duration of treatment with TP remains unknown, so it is important to determine the risk factors for relapse in order to identify the group of patients in which treatment can be withdrawn.

Methods
A retrospective study was performed. Patients with UC in remission, in maintenance treatment with TP, who had discontinued the drug due to either maintained remission or the onset of adverse effects were included.

Results
26 patients were included, 1 with proctitis, 9 with left colitis and 16 with pancolitis. 24 (92.31%) were treated with azathioprine and 2 (7.69%) with mercaptopurine. The mean treatment time with TP was 68.09 months (standard deviation 56.65). 11 patients (42.31%) discontinued TP due to adverse effects and the remaining patients (57.69%) discontinued it by medical decision because they were in prolonged remission. After withdrawal of TP, 92.34% of patients continued treatment with mesalazine and the remaining 7.69% without concomitant treatment.
During follow-up, 10 patients (38.4%) relapsed and 16 patients (61.53%) had no relapse until the end of follow-up. The mean time from TP withdrawal to the onset of relapse was 69.15 months (standard deviation 52.53). Of the 10 patients who presented a flare, 5 (50%) were controlled by optimizing the dose of mesalazine, 4 (40%) required the addition of oral corticosteroids and 1 (10%) required biologics.
No significant differences were found when comparing the time to relapse if the reason for discontinuation of TP was having had an adverse effect (65.05 months) or maintained remission (79.79 months) (p=0.42). No statistically significant differences were found in time to relapse when comparing time on TP treatment, presence of concomitant treatment with mesalazine or active smoking.

Conclusion
One third of patients relapsed after TP withdrawal. Discontinuation of TP in patients with UC in remission should be individualized according to the patient’s risk factors, the indication and the duration of treatment.
P604 Evaluation of management heterogeneity and complications of Crohn’s disease in Catalonia. A population quality care study
Authors: Brunet E , Melcarne L , Llovet L , Vela E , Cleries M , Pontes C , Garcia-Iglesias P , Albert V , Calvet X 
Published: May 2021

Abstract

Background
Heterogeneity in the treatment of a disease is a marker of suboptimal quality of care. Recent studies suggest that there is a marked heterogeneity in the management of inflammatory bowel disease.
The aim of this study is to evaluate the heterogeneity in the treatment used and the outcomes (rate of hospitalization and surgery) for Crohn’s disease (CD) in the different health areas of Catalonia.

Methods
All patients with CD included in the Catalan Health Surveillance System (CHSS) including data on more than 7 million individuals from 2011 to 2017 were identified using with the ICD-9-CM codes. The different Catalonian health areas were grouped into 19 groups according to the reference hospital (figure 1). Exposures to different treatments were retrieved from the electronic dispensation records.
Data on hospitalizations and surgeries were also extracted from the CHSS according to ICD-9-CM codes. Treatment used rates (systemic corticosteroids, non-biological and biological immunosuppressant) and outcome rates (hospitalization and surgery) were calculated.

Results
The use of systemic corticosteroids presented a decreasing trend over the study period, with an average rate of use of the total number of patients in the different territories between 10% and 16% (figure 2). The use of non-biological immunosuppressant treatment has remained stable, with an average rate of use ranging from 20% to 40% (figure 3). On the other hand, the use of biological immunosuppressant treatment increased, with an average rate of use in the different territories ranging from 10 to 22% (figure 4).
Hospitalizations for any reason showed an increasing trend between 2011–2017 with an average rate between 19% and 30% per year depending on the area. Contrarily, hospitalizations for CD presented a decreasing trend, with an average rate between 5% and 10% per year.
Surgical treatment (both resections and ostomies) remained stable over time. Rates per year were between 1% and 2%.

Conclusion
In this population study we appreciated an important heterogeneity in the use of non-biological and biological immunosuppressant treatments, identifying use rates of almost the double in some of the areas. There is also a remarkable variability in the rate of hospitalizations for CD between certain areas of Catalan territory.
P634 Trajectories of oral budesonide use in Crohn’s disease cohort of Tuscan patients
Authors: Bertani L , Ferraro S , Bartolini C , Convertino I , Giometto S , Cappello E , Valdiserra G , Tillati S , Blandizzi C , Lucenteforte E , Gini R , Tuccori M , Costa F 
Published: May 2021

Abstract

Background
Crohn’s disease (CD) is an immune-mediated inflammatory chronic disorder of the gastrointestinal tract. The therapeutic approach includes firstly oral budesonide (OB), followed by immunomodulatory drugs and biologics. The aim of the present study was to identify and characterize adherence trajectories of OB in CD patients and related patterns.

Methods
In this retrospective cohort study, data was retrieved from administrative healthcare databases in Tuscany, an Italian region. Patients were included if they had a first record of a diagnosis of ICD-9 or disease exemption or a first record of dispensation of OB as CD patient, in the period from 6/1/2011 to 6/30/2016 (index date, ID). Patients &lt; 18 years old at ID or with history of data before ID &lt; 5 years or follow-up of data after ID &lt; 3 years were excluded. Patients with autoimmune hepatitis, cancer and no dispensation of OB were excluded from CD cohort. We considered as covariates sex, age, and number of concomitant drugs during the month before ID. We estimated adherence to OB monthly through the Medication Possession Ratio and computed trajectory of adherence treatment with a procedure consists into 3 steps: 1) computation of 24 statistical measures; 2) factor analysis; 3) cluster analysis. We described the adherence in the clusters.

Results
3333 patients were included CD cohort, among them 1262 were excluded for no dispensation of OB. 2071 were patients included the computation of trajectory of OB use. Trajectories’ curves showed three difference clusters of adherences to OB, which identify two main subgroups of OB users: 925, 603 and 543 were the patients in each cluster. Cluster 1 is represented by a curve of adherence that rapidly decreased to 20–30% of adherence within 5 months. Instead, cluster 2 and 3 described patterns of a short therapy timing, with discontinuation within about 4 months, likely referring to an acute treatment of CD, typical treatment approach used in mild to moderate CD. Statistically significance differences were evidenced between covariates across the clusters.

Conclusion
Trajectories’ curves showed three difference clusters of adherences, which identify two main subgroups of OB users. Further analyses need to characterize the identified clusters in order to evaluate possible inappropriate use of drug (cluster 1) and potential switch to other therapies (cluster 2 and 3). Finally, these results could clarify drug use in patients with CD and provide new insights in order to improve management of patients by clinicians.
P658 Is vitamin D deficiency related to fat malabsorption or inflammation in Inflammatory Bowel Disease? Preliminary results from the Fat-D study
Authors: Müller C , Aksan S , Farrag K , Schröder O , Aksan A , Stein J M 
Published: May 2021

Abstract

Background
Vitamin D deficiency is highly prevalent in patients with inflammatory bowel disease (IBD). The question of whether vitamin D status is a contributory factor or a consequence of IBD, or maybe both, remains unanswered, and is confounded by the complexity of inflammation, IBD and vitamin D. Fat malabsorption has been proposed as a possible reason for deficiencies of vitamin D in IBD. The aim of this study was to further understanding of vitamin D deficiency in IBD by investigating possible causal relationships of fat malabsorption and inflammation on vitamin D levels in this complex context.

Methods
In a comparative, cross-sectional study in IBD patients, 25(OH)D was analysed by LCMS/MS. Serum β-carotene levels were used as a biomarker for fat malabsorption. Vitamin K1, another fat-soluble vitamin, was used to affirm a possible causative relation between β-carotene and vitamin D in case of fat malabsorption. β-carotene and vitamin K were measured in serum by HPLC. Inflammation was characterised by serum hsCRP&lt;5mg/L.

Results
51 IBD patients (30f;20CD/18UC;45.3±16.3y; 21 with inflammatory activity) were enrolled. In patients with vs. without inflammation, serum 25(OH)D levels were significantly lower (26.5±14.6ng/mL vs. 36.8±12.6ng/mL, p&lt;0.05), while serum vitamin K1 (1.4±0.5µg/L vs. 1.2±0.4µg/L) and β-carotene (28.5±0.6.0µg/dL vs. 35.9±5.4µg/dL) levels were similar (p&gt;0.05). 36/51 of the patients had low serum β-carotene levels, indicating steatorrhoea. Neither 25(OH)D (32.1.5±13.8ng/mL vs. 33.6±15.8ng/mL) nor vitamin K1 (1.3±0.5µg/L vs. 1.2±0.4µg/L) levels differed according to the presence vs. absence of steatorrhoea (p&gt;0.05). Similarly, no correlation was found for 25(OH)D (r=0.024, p=0.875) or serum vitamin K1 (r=0.111, p=0.462) with β-carotene levels. On the other hand, 25(OH)D levels were significantly inversely correlated with hsCRP (r=-0.338, p=0.015), whereas vitamin K1(r=0.050, p=0.731) and β-carotene (r=-0.118, p=0.438) did not show a similar relation.

Conclusion
Vitamin D levels were confirmed to be related to inflammation in IBD. A lack of correlation with fat malabsorption, as indicated by β-carotene levels, or with steatorrhoea, was found for vitamin D and confirmed by measuring and comparing serum levels of an additional fat-soluble vitamin, K1. We conclude that low vitamin D levels in patients with IBD are related to inflammation rather than fat malabsorption.