bluuebunny/crossref_metadata_2025_split huggingface dataset:
P485 Development and implementation of a remote monitoring tool for real-world assessment of mild, moderate and severe infectious complications in Inflammatory Bowel Disease patients
Authors: Rezazadeh Ardabili A , Wintjens D S J , Mujagic Z , Cilissen M , Stassen L P S , Haans J J L , Jonkers D M A E , Pierik M J 
Published: May 2021

Abstract

Background
Immunomodulators and biologicals are cornerstones in the current management of Inflammatory Bowel Disease (IBD), but are associated with increased risk of infections. Post-marketing surveillance studies are important to assess the risk for infectious side effects in real-world populations, yet mainly focus on severe infections. Data on mild and moderate infections in IBD patients are scarce, primarily since self-limiting infections and infections treated by the general practitioner are not systematically captured in surveillance registries. Mild and moderate infections take longer to clear in immunosuppressed patients, have a large impact on (work) disability and quality of life, and potentially precede severe infections. In the current study, we aimed to develop and implement a remote monitoring tool for real-world assessment of infections in IBD patients.

Methods
Through a structured iterative process with input from IBD specialists, nurse practitioners, and a comprehensive literature review, a 7-item Questionnaire comprising 15 different types of infections (covering e.g. upper/lower respiratory tract; urinary tract; eye; and skin infections) was developed to measure Patient-Reported Infections (PRIQ) with a recall period of 3 months. Infection severity was defined as either mild (self-limiting or requiring topical/local treatment), moderate (requiring oral antibiotic, antiviral or antifungal drugs) or severe (requiring hospitalization and/or IV treatment). To ascertain comprehensiveness and comprehensibility in the intended study population prior to implementation, in three rounds a total of 36 randomly selected IBD patients visiting the outpatient clinic were interviewed individually until saturation was reached.

Results
Overall, patient understanding of the PRIQ was good and cognitive interviews did not result in reduction of questionnaire-items. Analysis of feedback from interviews resulted in addition of definitions to certain response options (e.g. definition for antivirals) and minor linguistic adjustments to further improve patient understanding. A total of three patients (8.3%) raised concerns on the recall period of 3 months, which after expert consensus, did not result in alteration of the recall period. Next, the PRIQ was digitized and implemented in myIBDcoach, an established telemedicine platform for management of IBD.

Conclusion
We developed a remote monitoring tool (PRIQ) to assess patient-reported infections in IBD and ascertained patient understanding through cognitive interviewing. A prospective multicentre study using the myIBDcoach platform is ongoing to validate the PRIQ and subsequently report the risk of mild and moderate infections across different treatment regimens in IBD patients (NCT04151420).
P500 Assessing physical activity, fatigue and quality of life in an outpatient cohort of IBD patients
Authors: Janssen L M , Hendrix E M B , Spooren C E G M , Stassen L P S , Pierik M J , Jonkers D M A E 
Published: May 2021

Abstract

Background
Inflammatory bowel disease (IBD) has a substantial impact on quality of life (QoL). This can further be affected by modifiable psychosocial and lifestyle factors, like physical activity (PA). In the current study, we aimed to determine whether PA activity levels were associated with patient and disease characteristics, fatigue and QoL in IBD patients.

Methods
In this cross-sectional study, consecutive adult IBD outpatients were included. PA was assessed by the Short QUestionnaire to ASsess Health-enhancing physical activity (SQUASH). Patients were considered to have adequate PA levels when exercising with moderate intensity during minimal 30 minutes for at least five days per week according to the Dutch Standards for Healthy Physical Activity. Body composition was assessed by body mass index (BMI) and fat-free mass using BodPod. Fatigue was measured with the Shortened Fatigue Questionnaire (SFQ) and QoL was determined using the SF-36. Patient and disease characteristics, fatigue, and QoL between patients with and without adequate PA levels were analyzed by a student’s t-test or X2-test when appropriate.

Results
Of the 200 patients (139 Crohn’s disease (CD), 61 ulcerative colitis (UC)), 53.3% were female, and 21.5% were active smoker. Mean disease duration was 11.4 [SD 9.9] years, and 28.6% had an exacerbation at inclusion. The Dutch Standards for Healthy Physical Activity were not met by 41.7%. CD patients (53.2%) were less likely to have adequate PA levels compared to UC (70.0%) patients (p=0.028). There were no other significant differences in patient and disease characteristics stratified by adequate PA level (i.e. sex, active smoking, age at inclusion, disease duration, Montreal classification, previous bowel resection, and disease activity). BMI and fat-free mass index were not associated with PA levels. However, patients not meeting PA standards were significantly more tired compared to patients meeting the standards (mean 17.4 [SD 7.0] vs. 13.5 [SD 7.2], p=0.015), and had lower physical and mental component scores (PCS: mean 43.5 [SD 9.7] vs. 46.0 [SD 8.5]; MCS: mean 46.2 [SD 11.3] vs. 52.3 [SD 9.5]) for QoL, reaching significance for SF-36 MCS (p=0.012).

Conclusion
IBD outpatients with low physical activity levels showed significantly higher fatigue and lower quality of life scores, regardless of disease characteristics. More research is necessary to identify contributing factors to further improve patients’ well-being by holistic management.
P521 Correlation between physician disease assessment in Ulcerative Colitis and burden of disease: ICONIC 2-year data of 120 patients in Turkey
Authors: Sezgin O , Atug O , Gonen C , Can G , Duman A E , Erzin Y Z , Yurci M A , Alkim C , Unal Ozcelik N G , Yildirim B , Kayacetin E , Beyazit Y , Tayfur Yurekli O , Kiyici M 
Published: May 2021

Abstract

Background
Ulcerative colitis (UC) is a chronic inflammatory bowel disease (IBD), and the overall burden is increasing at the global level. Differences in perceptions of UC-related burden may highlight dramatic degree insufficient patient-physician communication. ICONIC is a prospective, non-interventional, observational study assessing disease burden in adults with UC using Pictorial Representation of Illness and Self Measure (PRISM). The local results of ICONIC study for Turkey are presented.

Methods
Patients aged ≥18 years with early UC (diagnosed ≤36 months) were enrolled. At baseline and every 6 months, patient and physician reported outcomes were collected using PRISM, the Simple Clinical Colitis Activity Index (SCCAI and P-SCCAI), The Rating Form of IBD Patients’ Concerns (RFIPC), the Short Inflammatory Bowel Disease Questionnaire (SIBDQ), and the Patient Health Questionnaire-9 (PHQ-9). Correlations between the patient assessed PRISM and other measurement tools were evaluated with Pearson correlation coefficient.

Results
One hundred and twenty patients were included (77 [64.2%] female; mean age 35.2 years). Physician-assessed disease severity was: severe 23 [19.2%], moderate 42 [35.0%], mild 40 [33.3%], in remission 15 [12.5%]. The mean ± SD physician- and patient-assessed PRISM scores were 4.8 ± 2.3 cm (range: 0.0–9.0) and 4.1 ± 2.6 cm (range: 0.0–8.5) at baseline and increased to 6.1 ± 2.3 cm (range: 0.1–8.5) and 5.5 ± 2.7 cm (range: 0.0–9.3) at the final visit, respectively, indicating an improvement in the perceived disease burden. The mean values of physician-SCCAI and P-SCCAI were 3.8 ± 3.5 and 5.5 ± 4.3 at baseline and decreased to 1.4 ± 2.5 and 2.7 ± 3.2 at the final visit, respectively, showing a decrease in disease activity. At baseline, the RFIPC and PHQ-9 values were 2.7 ± 1.7 and 8.0 ± 5.5 and decreased to 2.2 ± 2.0 and 5.2 ± 4.5 at the final visit, respectively. Patient-assessed SIBDQ was 43.8 ± 14.5 at baseline and increased to 54.0 ± 13.0 at the final visit. The strongest correlation of patient-assessed PRISM was with the physician-assessed PRISM (Spearman rho = 0.69, p&lt;0.0001), followed by SCCAI (rho = -0.56, p&lt;0.0001). Differences between physician- and patient-assessed PRISM scores were statistically significant (baseline: p=0.0010 vs. final visit: p=0.0206), highlighting an underestimation of patient’s suffering by physicians.

Conclusion
In the Turkish ICONIC sub-study, majority of patients on treatment showed improved outcomes during the follow-up period. A moderate correlation between patient-assessed PRISM and other measurement instruments represents that PRISM may be used as surrogate marker for patient suffering.
P555 Outcomes of multiswitching from original infliximab to biosimilars in patients with inflammatory bowel disease
Authors: Nascimento C , Revés J , Morão B , Frias Gomes C , Gouveia C , Palmela C , Roque Ramos L , Fidalgo C , Cravo M , Glória L , Torres J 
Published: May 2021

Abstract

Background
Since 2013 multiple Infliximab (IFX) biosimilars became available in the market. While there is evidence that switching from original IFX (RemicadeÒ) to an approved biosimilar product is safe and effective, little is known about outcomes of reverse switching and multiple switching among biosimilars in IBD patients. As the access to biosimilars at competitive prices increases, it is necessary to evaluate multiple switches to provide data on their interchangeability. Our aim was to evaluate the efficacy, safety and pharmacokinetic profile in a cohort of IBD patients who experienced multiple switches.

Methods
This is a cohort retrospective observational study, enrolling patients with IBD who were successively switched from original IFX to one or more biosimilars (multiswitching). We compared clinical disease activity, assessed using the Harvey-Bradshaw index (HBI) and partial Mayo Score (pMS), biochemical markers (hemoglobin, C-reactive protein (CRP) and albumin), IFX trough levels (ITL) and anti-IFX antibodies (ADA) immediately before and after multiswitching. Adverse and infusion-related events leading to drug discontinuation were registered.

Results
We included 26 patients (59% male, mean age 35±12 years), 85% (n=22) with Crohn’s Disease (CD) and 15% (n=4) with ulcerative colitis (UC) or indeterminate colitis. The mean disease duration from diagnosis was 9±6 years. According to Montreal classification, most patients were A2 (68%), had ileocolonic disease (L1 51%; L2 9%; L3 50%) and an inflammatory phenotype (B1 41%; B2 23% and B3 36%). Perianal disease was present in 44%. Half of patients had pancolitis (E3). About 51% of the patients had a prior resection surgery and 27% was on combination therapy when the first switch occurred. In 35% (n=9) of the patients three switches were observed. The mean follow-up from the first switch was 15±18 months. There was no significant difference in the proportion of patients in clinical remission (HBI &lt; 5; Mayo score &lt; 3) (91% vs 96%, p=NS). We found no differences in laboratory markers such as CRP (0,79 vs 0,67 mg/dl, p=NS), hemoglobin (13,83 vs 13,75g/dl, p=NS) and albumin (3,98 vs 4,37mg/dl, p=NS) before and after the multiswitching. No significant difference was observed in mean ITL (4,9 vs 4,05 μg/mL, p=NS) or in the proportion of patients with ITL&gt;3ug/ml (p=0.205). None of patients developed ADA, infusion-related events or loss of response leading to drug discontinuation. During our follow-up none of patients was operated. Drug persistence was 100%.

Conclusion
In our cohort, no significant changes in efficacy, safety or immunogenicity were observed when IBD patients experienced multiple switches between the original IFX and its biosimilars.
P621 Lactose intolerance assessed by analysis of genetic polymorphism, breath test and symptoms in patients with inflammatory bowel disease
Authors: Nardone O M , Manfellotto F , D’Onofrio C , Rocco A , Annona G , Sasso F , De Luca P , Imperatore N , Testa A , de Sire R , Biffali E , Castiglione F 
Published: May 2021

Abstract

Background
Many patients with inflammatory bowel disease (IBD) make restriction of dairy products to control their symptoms. We aimed to investigate the prevalence of lactose intolerance assessed with hydrogen breath test (H-BT) in IBD patients in clinical remission with symptoms suggestive for lactose intolerance, compared to a sex- age- and BMI-matched control population. We further detected the prevalence of three single nucleotide polymorphisms of the lactase (LCT) gene: the lactase non persistence LCT-13910CC (genetic wildtype) and the intermediate phenotype LCT-22018AG, LCT-13910CT and we assess the correlation between genotype and H-BT

Methods
We performed a prospective study enrolling IBD patients in clinical remission: Crohn disease (CD) activity index CDAI&lt;150 for CD and pMayo score≤1 for ulcerative colitis (UC) and controls. All of them underwent clinical evaluation, H-BT and genetic test analysing lactase gene polymorphisms located on chromosome 2. Statistical analysis was performed using chi-square, Student’s t-test and ANOVA.

Results
A total of 54 IBD patients and 69 matched controls were enrolled. H-BT was positive in 35(64.8%) IBD patients and 43 (62.3%) controls (p=0.3). No significant difference in lactose intolerance rate, assessed by H-BT and symptoms,was found between CD and UC patients (p =0.8). The wild-type genotype was found in 46 (85.2%) IBD patients , CT22018, AG13910 and CT22018/AG13910 polymorphisms were found in 9.3%, 1.8% and 3.7% respectively. While in the control group, the wild-type genotype, CT22018, AG13910 and CT22018/AG13910 polymorphisms were found in 87%, 5.8%, 5.8% and 1.4% of cases, respectively. The wild type and polymorphisms’ prevalence did not differ between IBD population and control group (85.2%vs 87%, p=0.1) (14.8% vs 13%, p=0.7) [Fig.1] and between CD and UC (p&gt;0.05) [Fig.2]. The correlation between positive H-BT and genetic analysis showed that the wild-type genotype was associated with higher rate of lactose intolerance in the total population (OR 5.31, 95%CI 1.73–16.29, p=0.003) and in the IBD population (OR 7.61, 95%CI 1.36–42.7, p=0.02), even thought not in the control group (OR 4, 95%CI 0.90–17.68, p=0.07)
Fig.1

Fig.2

Conclusion
The prevalence of lactose intolerance in IBD is high but not dissimilar from that of the general population. The prevalence of the wild-type genotype in patients with IBD does not differ from the general population and it correlates with higher rate of lactose intolerance assessed with H-BT.
Despite suggestive symptoms, about 1/3 of IBD patients is not lactose intolerant, not needing elimination diet. These can lead to promote a rationale and balanced dietary management in IBD and thereby preventing the occurrence of calcium phosphate metabolism disorders.
P623 The impact of SARS-CoV-2 outbreak on the treatment adherence and clinical outcome of patients with inflammatory bowel disease treated with biological agents
Authors: Martino G , Carparelli S , Marseglia A , Pastore M R , Placentino M , Nardella M , Guerra M , Palmieri O , Latiano A , Perri F , Ercolino F , Bossa F 
Published: May 2021

Abstract

Background
The SARS-CoV-2 pandemic has led to a remodeling of care activity, including the inflammatory bowel disease (IBD) centers. According to international recommendations, we did not discontinue immunosuppressive or biologic drugs and reorganized biologic drug infusions’ administration to minimize the risk of infection. The aim of this study is to describe the clinical outcome of SARS-CoV-2 infection and the adherence to the scheduled biologic therapies in a single tertiary center including both IBD adult and pediatric patients treated with biological agents during COVID-19 pandemic.

Methods
Demographic information, clinical data and the adherence to the therapy were collected in all consecutive IBD patients treated with biologic agents from March 2020 to February 2021. Moreover, we reported the clinical outcome of IBD patients infected with SARS-CoV-2.

Results
A total of 278 subjects (171 male) treated with a biologic agent (34 children) were included. The mean age was 41.6 ± 17.3 years (range 5 – 88), and the mean disease duration was 12.7 ± 10.1 years (range 0.2 – 49). One hundred eleven patients (39.9 %) had ulcerative colitis, and 167 (60.0 %) had Crohn’s disease. About the therapy: 73 patients were receiving infliximab, 93 adalimumab, 20 golimumab, 59 vedolizumab, 29 ustekinumab, and 4 an experimental compound. 31 patient, including 1 child, (11.1 %) were treated with combination therapy. The mean Charlson Comorbidity Index was 1.5 (range 0 – 8). Twenty one patients (2 pediatrics and nineteen adults) (7.5 %) had a confirmed diagnosis of SARS-COV-2 infection. Only one of them (an adult man) was hospitalized but did not require intensive care unit measures. Compared to cumulative SARS-CoV-2 infection in the general population in our Region, the cumulative incidence of SARS-CoV-2 infection in our cohort was significantly higher (7.5% vs 4.0%, p &lt; 0.002). Twelve adult patients (4.3%) postponed biologic therapy for fear of SARS-CoV-2 infection during the first wave of the pandemic, and two of them (16.6%) experienced a clinical relapse.

Conclusion
In our cohort, the adherence to biologic therapy was high during the pandemic, but the rate of clinical relapse in patients who postponed the scheduled administration of therapy was relevant. Although the incidence of SARS-CoV-2 infection was significantly higher than in general population, the clinical impact was mild as no patients experienced a severe form of COVID-19.
P629 Rural-urban inequities in Inflammatory Bowel Disease health care access: a population-based retrospective cohort study from a Western Canadian Province
Authors: Peña-Sánchez J N , Osei J A , Rohatinsky N , Lu X , Risling T , Boyd I , Wicks K , Quintin C L , Dickson A , Fowler S A 
Published: May 2021

Abstract

Background
Inflammatory bowel disease (IBD) is a chronic digestive condition with significant complications if left untreated. Rural dwellers face barriers to access specialised health care, which is located in larger urban centres. We aimed to contrast health care utilization (outpatient gastroenterology visits, colonoscopies, claims for IBD medications, IBD-specific and IBD-related hospitalizations, and surgeries for IBD) between rural and urban residents diagnosed with IBD in the Canadian province of Saskatchewan (SK).

Methods
We completed a population-based retrospective study using SK administrative health databases (hospital discharge abstracts, medication claims, and physician billings) between the 1999 to 2016 fiscal years. A validated IBD algorithm requiring multiple health care contacts was used for case ascertainment. IBD incidence cases were identified by requiring eight years of continuous health care coverage without IBD health care contacts before the date of diagnosis. Cases were assigned to a rural or urban location based on their residential postal codes at the date of IBD diagnosis. Study outcomes were measured from IBD diagnosis to the end of the study period or end of health care coverage. Cox proportional regression models were used to evaluate the associations between rural-urban residence and each study outcome. Models were adjusted by sex, age, neighbourhood income quintile at IBD diagnosis, and disease type (Crohn’s disease and ulcerative colitis). Adjusted hazard ratios (HR) and 95% confidence intervals (95%CI) were reported.

Results
We identified 5,173 IBD incident cases in SK between 1999 and 2016; 1,544 (29.8%) individuals were living in rural locations at the date of diagnosis. Compared to urban dwellers, rural residents had lower gastroenterology visits (HR=0.82, 95%CI 0.77–0.88) and higher 5-aminosalicylic acid (5-ASA) claims (HR=1.10, 95%CI 1.02–1.18). Furthermore, rural residents had a higher risk of IBD-specific (HR=1.23, 95%CI 1.13–1.34) and IBD-related (HR=1.20, 95%CI 1.11–1.31) hospitalizations than their urban counterparts. We did not observe significant rural-urban differences in the access to colonoscopies, biologic and immune modulator therapies, and surgeries for IBD.

Conclusion
We identified rural-urban disparities in IBD health care access, specifically, lower outpatient gastroenterology visits, higher 5-ASA claims, and a higher risk of hospitalizations for individuals living in rural locations at IBD diagnosis. Our findings reflect rural-urban inequities in the access to IBD care that require the attention of health care providers and decision-makers to promote health care innovation and equitable management of patients with IBD living in rural areas.
P642 Effects of Covid-19 on employment in IBD patients
Authors: Sciberras M , Nascimento C , Tabone T , Karmiris K , Nikolaou P , Theodoropoulou A , Mula A , Goren I , Yanai H , Amir H , Mantzaris G , Georgiadi T , Foteinogiannopoulou K , Koutroubakis I , Allocca M , Fiorino G , Furfaro F , Katsanos K H , Fousekis F , Michalopoulos G , Torres J , Ellul P 
Published: May 2021

Abstract

Background
There is an ongoing concern over the impact of COVID-19 on IBD patients. A significant proportion of IBD patients are treated with immunosuppressive medications and their effects on COVID-19 susceptibility and outcomes remain of concern to patients and physicians alike. Apart from the clinical outcome, the pandemic may have other psychosocial effects on this vulnerable cohort such as employment stability.
The primary aim of this study was to analyze the percentage of COVID-19 patients who tested themselves for COVID-19 and the outcome of those who tested positive. A secondary aim was to assess their employment status.

Methods
This was a multicentre international study whereby IBD patients (&gt;18 years) in clinical remission over the last year, were asked to answer an anonymous questionnaire. Demographic data, type of IBD, current and previous medication, admissions to hospital, were collected.
Exclusion criteria included patients with IBD flares requiring corticosteroids in the previous 12 months.

Results
573 patients (CD: 55.5%) from 8 European Centres and Israel participated in the study. The mean patient age was 39.9 years (SD+/- 13.0). 21.6% were current smokers and 48.5% were non-smokers. The rest were ex-smokers.
44.5% (n=255 ) of patients were tested for Covid-19 and 5.1% (n=13) were positive. The majority were treated at home (92.3%) with only one patient requiring hospital admission. This was a 33 year old female smoker with UC (E3 disease activity) on anti-TNF therapy. 66.7% of positive cases were on anti-TNF medication and 22.2% were on thiopurines. None of the positive cases were on dual antiTNF/thiopurine therapy. 7.2% of patients had family members who also tested positive for Covid-19.
Almost half of all patients (45.2%) had their job affected during the pandemic and this was more prevalent in the UC cohort (P&lt;0.05). 70% of patients switched to remote work from home and 21.4% became unemployed. The average age of patients becoming unemployed was 39.3years (SD+/- 11.9).

Conclusion
Nearly half of our cohort (45.2%) underwent testing and the majority (92.3%) were treated at home even though two thirds of them were on Anti-TNF medication. Unemployment rates affected 1 in 5 individuals and measures promoting remote work have been taken up wisely by IBD patients. Though the clinical outcomes were excellent, the psychological effects of unemployment have yet to be considered.