bluuebunny/crossref_metadata_2025_split huggingface dataset:
P374 Safety and drug survival of methotrexate versus tioguanine after failure of conventional thiopurines in patients with Crohn’s disease
Authors: Savelkoul E , Maas M , Bourgonje A , Crouwel F , Russel M , Römkens T , De Boer N , Dijkstra G , Hoentjen F 
Published: May 2021

Abstract

Background
Both methotrexate (MTX) and tioguanine (TG) can be considered as viable treatment options before initiating biological therapy following failure of conventional thiopurines for Crohn’s disease. It is unclear how safety and effectiveness compare for both therapies. This study aimed to compare tolerability and drug survival of MTX and TG therapy after failure of conventional thiopurines in patients with Crohn′s disease.

Methods
We conducted a retrospective, multi-centre study in five Dutch hospitals, including patients initiating MTX or TG for Crohn’s disease after failure (all causes) of conventional thiopurines. Patients with prior MTX or TG use, MTX or TG not primarily prescribed for Crohn’s disease, or patients receiving concomitant biological treatment at baseline were excluded. Follow-up duration from starting treatment was 104 weeks or until treatment discontinuation. Primary outcome was therapy discontinuation rate due to adverse events (AE). Secondary outcome was ongoing treatment without initiation of biological treatment.

Results
In total, 221 patients with failure of conventional thiopurines and subsequent therapy with either MTX (n=106) or TG (n=115) were included. Median follow-up was 89 weeks (IQR 28-104). Previous biological failure was present in 28 (26%) MTX and 17 (15%) TG treated patients (p=0.044). Sixty-four (29%) patients (MTX 41.5%, TG 17.4%, p&lt;0.001) discontinued their treatment due to AE during follow-up (Figure 1). Median time until discontinuation due to AE was 16.5 weeks (IQR 8.0–39.0) for MTX and 17.5 weeks (IQR 1.3–69.8) for TG (p=0.925). MTX use was associated with a significantly higher risk of treatment failure due to AE (OR 3.37 [95% CI 1.82–6.25] p&lt;0.001). Previous biological failure was not predictive for MTX or TG failure due to AE (OR 1.086, p=0.828). The most frequent discontinuation reasons were nausea for MTX (n=11) and abdominal pain for TG (n=4). In both groups, 8 (MTX 8%, TG 7%) serious adverse events (SAE) occurred. Infections comprised the majority of all SAE, 4 (50%) for MTX and 7 (88%) for TG. Discontinuation because of elevated liver enzymes occurred in 5 (11%) MTX and 4 (20%) TG treated patients. There were no cases of histological nodular regenerative hyperplasia, liver fibrosis, or cirrhosis. Initiation of concomitant biological therapy was not significantly different (MTX: n=26, TG: n=30, p=0.877). Total monotherapy drug survival after 104 weeks was 46% for TG and 25% for MTX (p&lt;0.001).

Conclusion
Forty-two percent of MTX, compared to 17% of TG treated patients, discontinued therapy due to AE in patients with Crohn’s disease with prior failure of conventional thiopurines. These data may aid in the selection of subsequent therapy after failure of conventional thiopurine therapy.
P482 Safety and efficacy of ustekinumab for Crohn’s disease in the elderly population
Authors: Fiske J , Liu E , Limdi J , Conley T E , Townsend T , Davies M , Brockwell R , Baig D , Abdelbadiee S , Uney A , Liaros A , Gaba W , Smith P J , Subramanian S 
Published: May 2021

Abstract

Background
The rising incidence of inflammatory bowel disease (IBD) worldwide and an ageing population has led to a marked increase in elderly IBD patients. Anti-tumour necrosis factor (TNF) agents are associated with an increased risk of serious infections and treatment discontinuation among elderly IBD patients but little is known about non anti-TNF biologics in this cohort. We aimed to examine safety and efficacy of ustekinumab in elderly Crohn’s disease (CD) patients.

Methods
Patients ≥60 years old commencing ustekinumab for CD were included in this retrospective multi-centre cohort study. We gathered data on adverse events, Harvey Bradshaw Index (HBI) and concomitant steroid therapy. The primary outcome was serious infections, defined as requiring hospitalisation. Efficacy was assessed by serial HBI measurement and treatment persistence.

Results
70 patients were included, with a median age of 68 years (range 60–87), a male:female ratio of 9:5 and a median Charlson co-morbidity index of 4 (range 2–9). 44 (62.9%) had prior anti-TNF exposure and 15 (21.4%) previous vedolizumab. Median treatment duration was 12 months (range 2–48), with a total of 84 patient years. 31 patients (41.3%) had steroids at initiation, and 33 (47.1%) required a course of steroids at a later date.
Seven patients (10%) had a combined 9 serious infections, of which 1 was life threatening requiring organ support. Incidence of serious infections was 0.107 per patient year. A further 18 patients had a combined 22 non-severe infections (Table 1). The overall infection rate was 0.417 per patient year. Charlson co-morbidity index was numerically higher among those who developed severe infections (median 5, range 3–7 vs. median 4, range 2–9, P=NS). 3 patients developed a malignancy; non-Hodgkin’s lymphoma, melanoma and prostate cancer.
Mean HBI improved from 8.13 at baseline to 4.64 at 6 months and 4.10 at last follow up (both P&lt;0.0001). Treatment persistence rate was 61.4% (N=43) and 36 (51.4%) were steroid-free. Reasons for discontinuation were primary non-response (42%), adverse event (32%), secondary loss of response (10%), malignancy (10%) and lack of funding (5%).

Conclusion
Ustekinumab was safe and effective in a cohort of elderly CD patients. Infections were mostly mild, not resulting in therapy discontinuation. The risk of serious infection was low at 0.107 per patient year of treatment.
P511 Disease-specific risk factors for malnutrition development in IBD
Authors: Einav L , Hirsch A , Ron Y , Aviv Cohen N , Anbar R , Lahav S , Maharshak N , Fliss Isakov N 
Published: May 2021

Abstract

Background
Patients with inflammatory bowel diseases (IBD) are at risk of malnutrition, which is associated with considerable disease related complications. Most available screening tools for malnutrition risk such as the malnutrition universal screening tool (MUST), do not incorporate malnutrition-promoting characteristics of IBDs. Therefore, we aimed to detect disease-specific risk factors for malnutrition development in IBD, which may be incorporated in future malnutrition screening tools.

Methods
A retrospective case-control study, in which detailed information regarding IBD patients treated at the IBD clinic of the Tel-Aviv Medical Center between 2010–2020 was collected.
Cases were patients who developed malnutrition between clinic visits (defined as BMI≤18.5/ weight loss ≥5% of body weight during 3 months/≥10% of body weight during 6 months) and controls were those who maintained a normal nutritional status. Cases and controls were matched by age, gender, disease and disease duration. Data was collected from medical files included reported medical history, clinical manifestations of disease, disease activity, and nutritional status including MUST evaluation during clinic visits. The association between the clinical data and malnutrition development was evaluated using a logistic regression model, with adjustment for MUST components: weight loss of ≥5% of body weight and multiple (≥2) reasons for inadequate nutritional intake.

Results
We collected data from 118 IBD patient (cases, n=59 and controls n= 59, Crohn’s disease n=76, ulcerative colitis n=28, pouchitis patients n=14). All patients were at normal nutritional status at baseline. Patients were followed for a period of 6.2±3.0 months during which, cases lost 5.3±2.3 kg (10.4±4.8 % body weight) and controls gained 0.2±2.3 kg )0.2±3.5 % body weight) (p&lt;0.001). MUST screening misclassified 34% of cases as low risk for malnutrition. Development of malnutrition was positively associated with baseline endoscopic disease activity [Odds ratio (OR)=6.06, 95% Confidence interval (CI) 1.91–19.18], repeated physician/nurse clinic visits ≥4/year (OR=5.26, 1.20–22.98), and negatively associated with advanced therapy (biologics and small molecules) (OR=0.151, 0.03–0.70), and BMI at baseline (OR=0.24, 0.13–0.44). The fit of this model was evaluated by an area under the curve of AUC=0.961 CI 0.93–0.99, p&lt;0.001.

Conclusion
Current tools for prediction of malnutrition among IBD patients are not sensitive enough. Parameters, such as increased disease activity should prompt nutritional assessment among patients to prevent mal-nutrition. The importance of these findings should be evaluated in prospective studies.
P531 SARS-CoV-2 infection in Elderly patients with Inflammatory Bowel Disease with or without immunosuppressants during the first year of the pandemic. An observational, descriptive, cohort study
Authors: Calafat Sard M , González-Muñoza C , Fortuny M , Roig C , Calm A , Mombiela A , Teller-Martin M , Cañete F , Bertoletti F , González-González L , Gordillo J , Mañosa M , Garcia-Planella E , Domènech E 
Published: May 2021

Abstract

Background
Older age has been confirmed as a risk factor for severe clinical presentation of SARS-CoV-2 disease (COVID-19). The prevalence of confirmed SARS-CoV-2 infection in Catalonia among people over 60 years is 6.6%. Biological agents have not been associated with a higher incidence nor a worse prognosis of COVID-19. However, the role of immunosuppressants (IMS) on this issue is still to be elucidated. Moreover, there are scarce data related about COVID-19 in inflammatory bowel disease (IBD) patients under IMS, and none focusing in elderly IBD. Our aim was to describe and to compare the incidence and severity of COVID-19 in patients over 65 years of age with IBD, particularly in relation to the use of IMS.

Methods
We performed a retrospective cohort study including IBD patients over 65 years since January 2020, from two referral centres in the Barcelona metropolitan area (Catalonia, Spain). Patients were grouped in two cohorts regarding the use or not of IMS (thiopurines or methotrexate). Patients on biological treatment were excluded. We identified those cases with confirmed infection with SARS-CoV-2 (positive PCR) during the period from 1st of March 2020 (the beginning of the pandemic in Catalonia) to 1st March 2021 (the beginning of vaccination in the elderly). Demographic data, IBD comorbidities, concomitant non-IBD related treatments, and SARS-CoV-2 infection outcomes were recorded.

Results
Four-hundred and eighteen elderly IBD patients were included. The median age was 74 years (IQR 69–78), 52% were male; 70% had ulcerative colitis, 28% Crohn’s disease and 2% IBD unclassified, 62% had arterial hypertension, 22% diabetes mellitus, 22% cardiovascular disease, 15% chronic obstructive pulmonary disease, 10% chronic renal disease, 5% were active smokers. There were no differences regarding comorbidities and non-IBD treatments between the two study groups. From the whole cohort, 89 (21.3%) patients were on IMS (86 with thiopurines, 3 with methotrexate). The median time on IMS was 121 months (IQR 60–162). During the study period, 32 patients (7.7%) had confirmed SARS-CoV-2 infection (7 of whom were on IST; 7.6% not on IMS vs. 7.9% on IMS, P=0.933). Seventeen (53%) patients required hospital admittance (4% not IMS vs. 4.5% on IMS; P=0.818); 4 of them developed COVID-19 related complications (3 patients not on IMS vs. 1 on IMS), and 7 (22%) patients died (6 not on IMS vs. 1 patient on IMS).

Conclusion
The rate of SARS-CoV-2 infection among elderly IBD patients is quite similar to that reported in the elderly background population. In elderly IBD patients, SARS-CoV-2 infection was associated with a high admission rate and mortality, regardless of the use of IMS.
P541 Efficacy, efficiency and aceptability of telemedicine for inflammatory bowel disease patients follow-up care during the COVID-19 pandemic lockdown
Authors: Ramos Lopez L , Reygosa C , Carrillo-Palau M , Alonso-Abreu I , González Y , de la Barreda R , Amaral C , Hernández A , Benítez-Zafra F , Hernández-Guerra M 
Published: May 2021

Abstract

Background
During COVID-19 pandemic, numerous initiatives have been established to reduce disease transmission but ensure care for patients with inflammatory bowel disease (IBD). Ambulatory clinic visits were replaced by the implementation of telehealth modalities in most of IBD units during the pandemic lockdown. However, the efficacy, efficiency, and patient′s acceptability of using telemedicine by telephone consultation has not been evaluated.

Methods
A prospective cohort study was performed in IBD patients who underwent telephone consultation during lockdown due to COVID-19 pandemic between 16th march and 13th April 2020. To assess the efficacy of this telephone consultation (COVID-visit), change in disease′s activity and treatment, non-scheduled visits, emergency consultation, hospital admission and non-elective surgery from COVID-visit to the next scheduled consultation (postCOVID-visit) were checked. To evaluate efficiency, the time period between COVID-visit and postCOVID-visit were compared with previous consultation (preCOVID-visit). Only patients with a confirmed diagnosis of IBD, regular follow-up in our IBD unit and with full available requested test results were included. A telephone survey was designed (5 questions) and conducted in all patients to rate satisfaction for using telemedicine.

Results
Out of a total of 274 patients, 220 patients (52.2% male; mean age 49±16 years; crohn′s disease n=126/ ulcerative colitis n=83/ indeterminate colitis n=11) were included. During the COVID-visit 41% patients were using biologic agents, 15% had active disease and 6.8% changed treatment (40% initiated corticosteroids; 30% started immunomodulators or biologic agents; 30% upgraded usual treatment). Only 1 patient consulted at the emergency department, 11 patients needed to rearrange the visit and none patient underwent surgery before the scheduled post-COVID visit. The interval to post- COVID visit compared to pre-COVID visit was reduced in 28.6%, remained equal in 33.6% and increased in 37.7% of patients. The satisfaction survey (n=185) revealed that 81.1% patients rated care as excellent, 94.6% perceived it was effective and solved doubts in 96.2% of patients. However, 44.4% of patients rather prefer on-site consultation for follow-up and only 52% considered that incorporating video would improve care.

Conclusion
Telemedicine care during the lockdown and despite been abruptly and rapidly implemented in IBD units, shows to be effective and efficient to care IBD patients. In addition, telephone consultation is well accepted by patients for short follow-up periods. Further follow-up studies should be carried out to determine the patient profile that will benefit most from this monitoring.
P571 Optimal biologic management of endoscopic postoperative recurrence following ileocecal resection in Crohn’s disease
Authors: Bachour S , Shah R , Lyu R , Rieder F , Cohen B , Qazi T , Lashner B , Achkar J P , Philpott J , Lightner A , Holubar S , Regueiro M , Click B 
Published: May 2021

Abstract

Background
Endoscopic postoperative recurrence (POR) of Crohn’s Disease (CD) following ileocolonic resection (ICR) is common; however, optimal treatment strategies of identified POR are unknown. We assessed the role of biologic therapy to treat endoscopic POR in a real-world cohort.

Methods
Retrospective cohort study of adult CD patients who underwent ICR from 2009–2020 at a tertiary center. Patients with endoscopic POR detected on postoperative colonoscopy and a subsequent follow-up colonoscopy were included. Patients were categorized by biologic therapy at time of POR and further sub-grouped by therapy modification after POR detection (no change, therapy optimization, or change in biologic class). Therapy optimization included: starting or modifying immunomodulator therapy, corticosteroids, or budesonide. POR was defined by Rutgeerts’ ≥ i2b.

Results
203 CD patients (49.8% female, 15.4% &gt; 1 prior ICR, 49.0% pre-operative biologic exposure) were included. Of these, 137 (67%) patients were not on biologic therapy at POR detection: 43% subsequently started a biologic, 23% optimized therapy, and 34% had no change. 66 (33%) patients were on anti-TNF at POR identification: 24% subsequently changed biologic class, 48% optimized anti-TNF, and 27% had no change (Figure 1). There was no difference in median time from ICR to POR detection (483 days, p=0.08) or inter-colonoscopy interval (483 days, p=0.25) between groups. In patients not on biologics at POR detection, those who started a biologic saw a 21% increase in subsequent endoscopic remission compared to those who optimized therapy (49.2% vs 28.1%, p=0.09) and a 12% increase compared to those who received no change (49.2% vs 37%). In patients not on biologics with severe POR (i3/i4, n=62), there was significantly higher remission rate by starting biologic therapy compared to optimizing existing therapy (53.3% vs 16.7%) or no change (53.3% vs 35.7%), p=0.04. In individuals receiving anti-TNF at time of POR, there was a 25% increase in endoscopic remission in patients who switched biologic class compared to those who optimized therapy (56.2% vs 31.2%) and a 34% increase compared to those with no change (56.2% vs 22.2%), p=0.1. Furthermore, significantly higher rates of improved Rutgeerts’ score were observed in switching biologic class compared to therapy optimization (68.8% vs 43.8%) or no change (68.8% vs 27.8%), p=0.04.

Conclusion
After endoscopic POR detection following ICR, initiating biologic therapy in individuals not previously receiving it, and changing mechanism of action in those already receiving anti-TNF, may improve clinical outcomes compared to alternative management strategies. If confirmed, these findings may inform optimal management strategies for endoscopic POR.
P630 Inflammatory bowel disease in immigrants to Spain: results of the EIIMIGRA study from GETECCU (ENEIDA registry)
Authors: Gutiérrez Casbas A , Zapater P , Ricart E , González-Vivó M , Gordillo J , Olivares D , Vera-Mendoza I , Mañosa M , Gisbert J P , Aguas M , Sánchez-Rodríguez E , Boscá M , Laredo V , Camps B , Marín-Jíménez I , Zabana Y , Martín-Arranz M D , Muñoz R , Navarro-Llavat M , Sierra E , Madero L , Vela M , Pérez-Calle J , Sainz E , Calvet X , Sicilia B , Morales V , Bermejo F , Fernández-Salazar L , Van Domselaar M , De Castro L , Rodríguez C , Muñoz-Villafranca C , Lorente R , Rivero M , Iglesias E , Herreros B , Barreiro-de-Acosta M , Domènech E , Francés R 
Published: May 2021

Abstract

Background
Previous studies comparing inflammatory bowel disease(IBD) features between migrant and native patients have shown clinical phenotype differences. To date, no study has focused on IBD immigrants(MP) in Spain. The aim of this study was to explore the features of MP in Spain and to compare age of disease onset, IBD phenotype and therapeutic requirements with native-born IBD patients(NP).

Methods
This was an observational, multicentric and case-control study of the nationwide ENEIDA registry. We selected all IBD patients who were born outside of Spain and compared with a control cohort of NP. All included patients were diagnosed with IBD before 2015.

Results
A total of 13,524 patients were included(1864 MP and 11660 NP).The most prevalent ethnic migrant group was Caucasian(771, 41%), followed by Latin American(572, 31%) and Arabian(341,18%), whereas Asian represented only 6%. Table 1 summarizes the demographic and phenotypic features. 71% of MP were diagnosed with IBD in Spain. There was not a gender predisposition to IBD in the overall migrant group, however more female UC MP were detected compared to UC NP(52 % vs 45%, p&lt;0.001). MP were younger at the onset of the disease and had a shorter disease duration compared to NP, in both UC and CD patients. Significantly more CD patients were diagnosed under 16 years(A1) among MP, and more patients over 40 years(A3) among NB. More NB patients had CD stricturing phenotype(24% vs 19%, p=0,002) compared to MP. Disease extension in CD and UC did not differ between groups. The overall proportion of abdominal or perianal surgery was similar in both groups but the use of biologic therapy was more common in MP(36% vs 30%, p=0,001).

Conclusion
In the largest cohort of migrant IBD patients in Spain, immigrants were younger, had a shorter disease duration and required a higher use of biologics than natives, pointing phenotypic differences in this population and a universal access to the healthcare system all over the country.
P641 Impact of lockdown period due to COVID-19 pandemic in patients with Inflammatory Bowel Disease
Authors: García Mateo S , Refaie E , Martínez-Domínguez S J , Gargallo-Puyuelo C J , Lario Quilez L , Carrera-Lasfuentes P , Arroyo Villarino M T , Aso Gonzalvo M C , Gomollón García F 
Published: May 2021

Abstract

Background
The lockdown period due to the coronavirus disease 2019 (COVID-19) in Spain was established from 16th March to 21th June 2020. Therefore, the authorities controlled personal movements and private and public non-essential activities were cancelled. It has probably had an important emotional impact on chronic patients and hence in those who are suffering from Inflammatory Bowel Disease (IBD) due to their high risk of emotional disorders.
The aim of this study is to know how COVID 19 influenced to the patients suffering from IBD during the quarantine period, focusing heavily on the psychological distress through the Perceived Stress Scale-10 (PSS-10), and also the impact of the pandemic on therapeutic adherence using Visual Analogue Scale (VAS).

Methods
This is an unicentric and analytical observational study carried out in IBD unit of a large public teaching Hospital (University Hospital “Lozano Blesa”) during August 2020. Patients were contacted and interviewed by phone by two trained researchers not involved in the patient′s medical care. Inclusion criteria were age ≥ 18 years old and confirmed diagnosis of Crohn′s Disease (CD), Ulcerative Colitis (UC) or Indeterminate Colitis. A descriptive analysis was carried out and, subsequently, the factors associated with the loss of therapeutic adherence and higher-moderate levels of stress were analyzed through Logistic regression multivariate analyses.

Results
Of the 426 patients included, 217 (50.9%) were women, 249 (58.4%) had UC and 177 (41.6%) had EC. During the Spanish lockdown period, most of patients did not have symptoms related to their IBD (302; 72.1%). Among those who had symptoms, the most frequent was diarrhea and abdominal pain (11.5%). Most of subjects were not diagnosed of SARS-CoV2 infection (93%), whereas 2.1% suffered confirmed infection and 4.9% had compatible symptoms without test confirmation. Regarding economic situation of patients, most of them did not have economic difficulties (87.6%). Moreover, 74.4% of participants referred a very good physician-patient relationship and 21.8% a good relationship.
People who participated in the study had a median PSS-10 score of 12 (10–16). A higher level of stress was reported between those who were not married, women, and those who experimented an increase of IBD related symptoms. Adherence to treatment was not associated with stress level based on PSS-10 questionnaire.

Conclusion
Although the lockdown period due to COVID-19 pandemic has probably had an important emotional impact on Spanish population, IBD patients had in general lower PSS-10 scores. It could be due to a good patient-physician relationship, which contributed to maintaining a good adherence to medications in those patients.