bluuebunny/crossref_metadata_2025_split huggingface dataset:
P438 Real-life effectiveness and safety of ABP501, an adalimumab biosimilar, in inflammatory bowel disease: a multicentre Italian study
Authors: Barberio B , Zingone F , Ferronato A , Buda A , Melatti P , Gubbiotti A , Massimi D , Casadei C , Cingolani L , Savarino E V 
Published: January 2020

Abstract

Background
Recently, various adalimumab (ADA) biosimilars have been approved by the EMA with the same indications of the reference product (Humira), despite the lack of data in terms of efficacy and safety in patients with inflammatory bowel disease (IBD). The aim of our study was to verify the effectiveness and tolerability of ABP501, an ADA Biosimilar, in IBD in the short-term.

Methods
All consecutive moderate-to-severe IBD patients who completed induction with ABP501 at three Italian IBD Units (Padua, Santorso, Feltre) were included. We collected data on partial Mayo (p-Mayo) Score, Harvey–Bradshaw Index (HBI), C reactive protein (CRP), faecal calprotectin (FC), concomitant steroid and azathioprine therapy at baseline (T0), after induction (T1) and at six months (T2). Information on the need for optimisation and adverse events (AEs) were also collected. Continuous and categorical variables were expressed as mean with standard deviation and frequency with percentages, respectively. Comparisons between variables were conducted using a t-test and chi-square test. Data were analysed using STATA11.1 software.

Results
Thirty-three IBD patients [17 with ulcerative colitis (CU), 18 with Crohn’s disease (CD)] that completed induction (T1) were considered, with 18 of them who completed at least six months of therapy (T2). Clinical remission was achieved by 14/33 (45.5%) and 8/18 (44.4) patients at T1 and T2, respectively. Steroid-free clinical remission was obtained by 14/33 (42.4%) and 8/18 (44.4) patients at T1 and T2, respectively. After induction FC tended to decrease from baseline to T2, without reaching statistical significance (p = 0.1). However, a significant decrease in CRP levels (p &lt; 0.02) was observed. After induction, AEs occurred in 11 (33.3%) patients: 2 had an infection, 8 reported headache or myalgia or arthralgia, and one experienced a local infusion reaction. Moreover, AEs were observed in 6/18 (33.3%) at T2: 5 had arthralgia and 1 had a local infusion reaction. After induction 4/33 (12.12%) stopped therapy for lack of response, whereas the dropout occurred in 6/12 (33.3%) at six months (4 for loss of response and 2 for adverse events). Finally, 7/33 (21.2%) and 5/18 (27.7%) patients needed therapeutic optimisation at T1 and T2, respectively.

Conclusion
ABP501 seemed to be successful in achieving clinical remission and steroid-free clinical remission, but further data are required. Overall the therapy was well tolerated.
P439 Patient’ recruitment for a Phase 3 inflammatory bowel disease (IBD) programme is significantly increased when accessing the CT-SCOUT™ platform
Authors: Bouhnik Y , Roblin X , Mrad R , Hebuterne X , Laharie D , Tanasa Stefanescu C , Nancey S , Boureille A , Amiot A , Sebbah N , Peyrin Biroulet L 
Published: January 2020

Abstract

Background
The main issue when validating new molecules in the field of IBD is insufficient patient recruitment into clinical trials, resulting in a considerable delay and cost increase. The selection of the best recruiting sites is a long and difficult process, especially since study sponsor has no visibility on the activity of the sites, and the sites have no penalties if the objectives are not achieved. The CT-SCOUT™ platform is a web-based solution to help clinicians to pre-screen potential candidate, facilitating the coordination of the research team and providing sponsor and principal investigator visibility into patient recruitment efforts and status on the site. We aimed to compare the recruitment rate in sites using the application according to Premium or Freemium modalities and in sites not equipped with CT-SCOUT™ for IBD clinical trials.

Methods
We conducted a prospective, multicentre, open-label, observational and comparative study in 25 sites participating in a selected phase 3 IBD clinical trials in France. All sites were proposed to be equipped with CT-SCOUT™, and the recruitment rate was compared according to 3 modalities: a) the Premium mode, giving access to all the functionalities of the application (including specific inclusion/exclusion criteria, possibility of sending notification to the team) in counterpart of which they undertook to use the application; b) the Freemium mode, a basic functionality that only gives the name of the study in the first selection phase; c) sites who were not interested to be equipped. The primary endpoint was the mean number of patients randomised per site per month. Patients screened and those finally randomised were compared in sites equipped (Premium or Freemium) and non-equipped using one-way ANOVA followed by post-hoc Tukey test.

Results
During the recruitment period from 4 to 36 months (mean 24.8 months), 221 and 130 patients were screened and randomised, respectively. The mean number of patients screened and randomised per site per month according to CT-SCOUT™ equipment is reported in the figure below.

Conclusion
This study shows that sites not equipped with CT-SCOUT™ recruit only a few patients. Among the equipped sites, those with Premium access have a significantly higher randomisation rate than those with limited functionality. Sites equipped with digital pre-screening support to facilitate patient recruitment and provide the sponsor visibility are the best candidates for trials.
P440 Polimedication in patients with inflammatory bowel disease: prevalence and outcomes in a retrospective unicentric series
Authors: Mesonero Gismero F , Fernández C , Sánchez-Rodríguez E , García-García de Paredes A , Albillos A , López-Sanromán A 
Published: January 2020

Abstract

Background
Polymedication (PM) can complicate course and management of chronic diseases, and is currently a poorly explored issue in patients with inflammatory bowel disease (IBD).
Our aims were to determine the prevalences of PM, and of inappropriate and high-risk drugs use (APINCH) in a clinical series of IBD patients, describing epidemiological factors associated with PM, and evaluating a possible association of PM with poor disease outcomes.

Methods
A retrospective observational study of a unicentric series, including patients with IBD visited at our Unit (September-October 2018). Prescriptions, demographic data, and clinical features were collected reviewing clinical files and electronic drug prescriptions. PM was defined as the simultaneous use of more than 5 drugs (Gnjidic D, J Clin Epidemiol. 2012). APINCH drugs included insulin, antibiotics, anticoagulants, chemotherapies, narcotics, and potassium supplements (Clinical Excellence Australian Commission 2017). Disease outcomes (flares, hospitalisations, surgeries), non-adherence to treatment and undertreatment were evaluated 12 months after the index visit.

Results
We included 407 patients (56% males, median age 48 yo, range 17–92, 60.2% Crohn′s disease, 38.8% ulcerative colitis). Chronic comorbidity was present in 54% (29% metabolic, 25.5% cardiovascular, 12.8% psychiatric), and 27% presented multiple comorbidities (≥3). Median patient number of prescriptions was 3 (r 0–15); 14.3% were on more than three drugs, and 15.7% between four and five drugs. Most frequent prescriptions are represented in Figure 1. PM was identified in 18.4% of cases, inappropriate medication in 8.8%, and high-risk drugs in 6.1% (mainly opioids). In multivariate analysis, factors significantly associated with PM were chronic comorbidity (OR 11, CI 2.3-51,2, p˂0.002), multiple comorbidities (OR 4.02, CI 1.93–8.38, p˂0.001), and age &gt;62 years (OR 3.66, CI 1.7–7.7, p˂0.001). In univariate analysis, both undertreatment (54% vs. 16%, p˂0.01) and non-adherence (26% vs. 12%, p˂0.02) were associated with PM after 12 months. No association of PM with poor disease outcomes was found. In multivariate analysis, only undertreatment was significantly associated with PM (OR 5.9, CI 1.4–29.4, p˂0.014).

Conclusion
PM occurs in around one of the five patients with IBD, mainly in the elderly and in those with comorbidity. This scenario could interfere with appropriate IBD treatment and therapeutic success.
P441 Efficacy of biosimilar infliximab CT-P13 among inpatients with severe steroid-refractory colitis
Authors: Ollech J , Normatov I , Dwadasi S , Dalal S , Micic D , Israel A , Labas J , Joel P , Cohen R , Rubin D , Atsushi S 
Published: January 2020

Abstract

Background
The infliximab biosimilar CT-P13 has been reported to have similar clinical effect compared with its originator. In this study, we evaluated the efficacy and safety of CT-P13 in the treatment of inpatients with severe steroid-refractory colitis.

Methods
Adult colitis patients (UC or isolated Crohn’s colitis; Montreal classification E2-3, or L3, respectively) admitted to the University of Chicago IBD inpatient service between January 2018 and December 2018 for management of severe colitis refractory to IV steroids who received CT-P13 were included in the study. Patients diagnosed with active small bowel Crohn’s disease were excluded. CT-P13 was given as a single or several infusions of 5 to 10 mg/kg. For all patients, demographic, clinical, laboratory, and endoscopic data were attained by a comprehensive review of their electronic medical records. The primary endpoint was colectomy-free survival.

Results
Twenty-one patients, 14 with ulcerative colitis and seven with Crohn’s colitis, were included. Fourteen (66%) of patients were female. The median age was 32.2 years (IQR 24.1–43.2). The median disease duration was 4.3 years (IQR 2–10.3), and the median follow-up time was 5.9 months (IQR 1.8–9.1). Patients had a median CRP of 23 (IQR 6–74). All patients had moderate to severe disease on flexible sigmoidoscopy. Three patients (14%) underwent colectomy during their index hospitalisation. Colectomy free survival was 76% at three months and 70% at six months (Figure 1). No severe adverse events were reported in this patient cohort.

Conclusion
A significant proportion of patients with severe colitis failing IV steroids responded to induction therapy with CT-P13. Colectomy free survival rates were similar to previous randomised trials using originator infliximab as induction therapy in severe steroid-refractory colitis. CT-P13 was effective and safe in hospitalised patients with severe steroid-refractory colitis.
P442 Long-term quality of life after surgery for perianal Crohn’s disease
Authors: Angriman I , Tomassi M , Bordignon G , Bardini R , Ruffolo C , Scarpa M 
Published: January 2020

Abstract

Background
Perianal disease is rather common among Crohn’s disease (CD) patients and quality of life is often worsened by disease activity. This study aimed to assess the possible predictors of long-term quality of life after surgery for perineal CD.

Methods
Data of 50 consecutive patients operated on from 2014 to 2018 for perianal fistula or abscess were retrieved. Thirty-three of them had perianal CD while 17 of them had a sporadic perianal fistula and were enrolled as controls. Patients were interviewed with the Cleveland Global Quality of Life (CGQL) and SF-12 quality of life questionnaires. Disease activity was defined as the Harvey–Bradshaw Index (HBI) and Perianal Disease Activity Index (PDAI). Comparisons between CD and sporadic groups were carried out with non-parametric tests and log-rank test and multiple regression models were used to assess predictors of quality of life.

Results
The total CGQL score and that of all its items were significantly lower in CD patients compared with patients with the sporadic perineal disease (p &lt; 0.05) while SF12 sub total did not differ in the two groups. At multivariate analysis, CD diagnosis and perineal disease activity index confirmed to be independent predictors of long-term overall quality of life measured with CGQL. SF-12 mental component (MCS) was predicted by PDAI (p = 0.005) and by HBI (p = 0.03) while SF-12 Physical Component (PCS) was independently predicted by PDAI (p = 0.008), oozing perineal fistulae (p = 0.01) and age at disease onset (p = 0.0003).

Conclusion
Long-term quality of life after surgery for perineal disease is worse in CD patients than in patients with sporadic perianal disease. Quality of life is predicted by local and systemic disease activity and age at disease onset.
P443 Magnetic resonance imaging after ligation of the intersphincteric fistula tract for high perianal fistulas in Crohn’s disease: a retrospective cohort study
Authors: Van Praag E , van Rijn K , Monraats M , Stoker J , Buskens C 
Published: January 2020

Abstract

Background
Surgical closure of high perianal fistulas using the ligation of the intersphincteric fistula tract (LIFT) procedure is increasingly used in Crohn’s disease. Currently, data on MRI findings after the procedure is lacking, while this is the most important modality to assess deep fistula healing. Therefore, we aimed to evaluate pre- and postoperative fistula characteristics on MRI and the relation with clinical outcomes after LIFT procedure.

Methods
Consecutive Crohn’s patients treated with LIFT between 2007 and 2018 for high perianal fistulas who underwent a baseline and follow-up (FU) MRI were included in this retrospective study. MRI’s were scored by two radiologists according to a composed score based on the original and modified Van Assche scores with the addition of several items (Table 1). Findings at MRI and the relation to clinical healing were described.

Results
A total of 12 patients were included (4 male, median age 34 years (IQR 28–39)). The FU MRI was performed a median 5.5 months (IQR 2.5–6.0) after the LIFT procedure. At this time eight patients (67%) reached clinical healing, which increased to ten patients (83%) during follow-up. None had a recurrence. Three patients (25%) needed a re-intervention after the FU MRI due to inflammatory masses and/or persisting fistula tracts. At baseline, all patients showed a tract predominantly filled with granulation tissue, which changed to predominantly fibrotic in seven patients (58%) (Figure 1). All clinically responding patients showed a decrease in tract volume and/or hyperintensity (i.e. activity) with an absence of hyperintensity on T1 and T2 in four (33%) patients.

Conclusion
Clearly decreased fistula activity can be observed on MRI after LIFT surgery in Crohn’s patients. A large proportion of patients develops a fibrotic tract relatively soon after the procedure and shows no clinical recurrences, suggesting a highly effective therapy and prognostic value of MRI.
P455 Adherence to enteral nutrition therapy by adults with active Crohn’s disease is associated with conscientiousness personality trait
Authors: Wall C , McCombie A , Mulder R , Day A , Gearry R 
Published: January 2020

Abstract

Background
Conscientiousness is a personality trait characterised by the ability to control impulses, delay gratification, set and reach goals, and plan in advance. Conscientious people are more likely to be non-smokers, do physical activity and practice healthy eating behaviours. They are also more likely to be adherent to medication. The aim of this study was to assess whether people with Crohn’s disease who score high on conscientiousness are more likely to be adherent to enteral nutrition (EN) therapy than low scorers.

Methods
Adults aged 16 to 40 years with newly diagnosed Crohn’s disease or having a flare of disease were invited by their gastroenterologist to use nutrition therapy to induce disease remission. Nutrition therapy was either eight weeks of exclusive enteral nutrition (EN) or two weeks of exclusive EN followed by six weeks of partial EN and one meal per day. A convenience control group of healthy participants with no history of gastrointestinal symptoms was also recruited to use exclusive EN for two weeks. Adherence to EN was self-reported fortnightly using a standardised questionnaire. Non-adherence was defined as patients who repeatedly ate foods while using EN or ate more than one meal per day on partial EN. Patients who could not initiate or did not tolerate the EN formula were included in the non-adherent group. Prior to starting nutrition therapy, conscientiousness was measured using the well-validated conscientiousness subset of the Big Five Inventory.

Results
Twenty-three (59%) of the 39 patients recruited with Crohn’s disease completed and adhered to the eight-week treatment. Reasons for non-adherence by the 14 patients who did not complete treatment included: could not initiate EN (n = 4), non-response at week 4 (n = 2), intolerance of EN (n = 7) or repeated eating of food or started eating food again prior to the end of treatment (n = 2). Seventeen (81%) of the 21 healthy controls completed and adhered to 2 weeks of exclusive EN. Reasons for non-adherence were could not initiate EN (n = 3) or intolerance of the formula (n = 1). Adherence and completion of EN therapy were associated with a greater mean conscientiousness score 35.57 (95% CI: 32.88, 38.25) compared with the non-adherence group mean 30.13 (95% CI: 26.53, 33.73), p = 0.014. Mean conscientiousness score of the healthy controls who completed exclusive EN was similar to the Crohn’s disease group (36.65 (95% CI: 33.53, 39.77), p &gt; 0.05).

Conclusion
Conscientiousness was associated with adherence to EN therapy. EN therapy can be a cognitively and emotionally demanding treatment and this personality trait should ideally be considered when determining suitable candidates for EN therapy.
P459 The impact of latent cytomegalovirus infection on the disease behaviour in patients with ulcerative colitis
Authors: Långvall P , Shi C , Karling P 
Published: January 2020

Abstract

Background
Cytomegalovirus (CMV) infection has been associated with steroid-refractory disease and risk for colectomy in patients with Ulcerative Colitis (UC). We aimed to study if patients with latent CMV infection more often needed systemic steroids, immunomodulators, biologics and surgery than patients negative for CMV infection.

Methods
From the national IBD register (SWIBREG) all patients with UC (n = 404) treated at Umeå University Hospital in Sweden, and who were tested for CMV infection were included. A latent CMV infection was defined if a patient had at least one positive serology and/or a positive PCR for CMV. A retrospectively medical chart review between the years 2006 and 2019 was performed to check for medical therapy and surgery due to UC.

Results
One hundred and thirty-one patients (32%) had at least on one occasion been tested for CMV infection and of these patients, 88 (67%) had evidence of a latent CMV infection. There were no differences in the use of systemic steroids, in the use of immunomodulators/biologics or in colectomy rate between patients with latent CMV infection and patients with no infection (table). There were no differences between patients with latent CMV infection vs. no infection in median faecal calprotectin (FC) levels the first five years after diagnosis (302 vs. 457 µg/g; p = 0.301) or at the last recorded FC test (62 vs. 82 µg/g; p = 0.317).

Conclusion
Patients with latent CMV infection do not differ from CMV negative patients in the use of medical therapy for UC nor in colectomy rate.
P461 Intolerance to 5-aminosalicylate is a risk of poor prognosis in ulcerative colitis patients
Authors: Fujii T , Hibiya S , Maeyashiki C , Saito E , Takenaka K , Motobayashi M , Shimizu H , Nagahori M , Ohtsuka K , Kurosaki M , Yauchi T , Watanabe M 
Published: January 2020

Abstract

Background
5-Aminosalicylates (5-ASA) are the key drugs in induction and maintenance therapy in ulcerative colitis (UC). Some UC patients are involved in 5-ASA intolerance after induction of oral 5-ASA compounds. There is no evidence of the prognosis including the risk of colectomy in 5-ASA intolerant UC patients.

Methods
The aim of this study is to establish the prognosis of 5-ASA intolerant UC patients in a multicenter cohort study. A retrospective review of a prospective multicenter database (2014–2018) of 1,574 UC patients was carried out and a total of 1,286 patients treated with oral 5-ASA compounds were enrolled. We compared the risk of colectomy and biologics induction between patients (i) tolerant to first 5-ASA compound (1079), (ii) intolerant to first 5-ASA compound but tolerant to other 5-ASA compound (107) and (iii) intolerant to 5-ASA compound and withdrawal of 5-ASA (100).

Results
We identified 1,286 patients with UC, of which 40 patients (3.1%) resulted in colectomy and 247 patients (19%) treated with biologics. Colectomy rate in patients (iii) intolerant to 5-ASA and withdrawal of 5-ASA were higher than (i) tolerant to first 5-ASA and (ii) intolerant to first 5-ASA but tolerant to other 5-ASA (9.0%, 2.7%, 1.9%, respectively). (iii) Patients withdrawal of 5-ASA showed higher risk of colectomy compared with (i) tolerant to first 5-ASA (Hazard ratio (HR) 4.71, 95% Confidence interval (CI): 2.04–10.8). The risk of colectomy among (ii) patients intolerant to first 5-ASA but tolerant to other 5-ASA showed no significant difference compared with (i) tolerant to first 5-ASA (HR 0.76, 95% CI: 0.43–1.35). The biologics induction rate in (iii) patients withdrawal of 5-ASA was significantly higher than (i) tolerant to first 5-ASA and (ii) intolerant to first 5-ASA but tolerant to other 5-ASA (37%, 18%, 16%, respectively). Also (iii) patients withdrawal of 5-ASA showed higher risk of induction with biologics compared with (i) tolerant to first 5-ASA (HR 2.35, 95% CI: 1.50–3.68). Those risk among (ii) patients intolerant to first 5-ASA but tolerant to other 5-ASA showed no significant difference compared with (i) tolerant to first 5-ASA (HR 0.76, 95% CI: 0.43–1.35).

Conclusion
Patients with UC who had 5-ASA intolerance and withdrew from 5-ASA showed poor prognosis. We should consider trying other 5-ASA compounds even if the patients had intolerance to one 5-ASA compound.