bluuebunny/crossref_metadata_2025_split huggingface dataset:
P461 Vedolizumab Dose Escalation in a Real-World Cohort of IBD Patients
Authors: Zelinkova Z , Kadleckova B , Lucenicova J 
Published: May 2021

Abstract

Background
Vedolizumab (VDZ) effectively induces and maintains remission in inflammatory bowel disease (IBD). The loss of response to VDZ has been shown to be recaptured with dose escalation but the data in this field are still scarce. In addition, data on pharmacokinetics (PK) of dose escalation are limited and it is unclear whether PK should used in decision-making algorithm in adjusting VDZ dose regimen. Therefore, the aim of our study was to assess clinical efficacy and pharmacokinetic profile of VDZ dose escalation.

Methods
All IBD patients treated with VDZ in one tertiary IBD centre were retrospectively retrieved from the database. According to local protocol, non-responders to standard dosing of 300 mg i.v. of VDZ every 8 weeks, received escalated dose of 300mg i.v. every 6 or 4 weeks. Disease activity was assessed by Harvey-Bradshaw index (HBI) and partial Mayo score in Crohn’s disease (CD) and ulcerative colitis (UC) pts; respectively. VDZ dose was escalated in case of clinically assessed primary non response by week 22 of the treatment or in case of secondary loss of response. Response to dose escalation was defined as a decrease of HBI of ≥2 points, partial Mayo score ≥3 points or endoscopic improvement. VDZ through levels were assessed at the completion of induction and in dose escalated patients after at least two VDZ administrations in shortened interval.

Results
In total, 75 IBD patients were included (mean age 47 years, range 20–90; 36 men; 35 CD/39UC/1 IBD-U). Fifty two pts (69%) were primary responders, out of these 23 pts (44%) required dose escalation at some point of the treatment due to secondary loss of response. Out of 23 primary non-responders, 10 stopped the treatment, the remaining 13 received escalated dose of VDZ.
Altogether, dose escalation was used in 36 pts (48%). There were no differences in the proportion of CD and UC between conventional and escalated dose regimen groups. Among secondary loss of response, the response was recaptured in 15 out of 23 pts (65%} while only two out of thirteen primary non-responders responded to dose escalation.
There were no significant differences in VDZ levels between pts requiring dose escalation and pts with stable response to conventional regimen (mean levels 9,97±1,276 vs. 12,79±1,771 µg/mL; p=n.s.). VDZ levels increased significantly in patients who responded to dose escalation (from 10,12±3,460 to 20,81±3,326 µg/mL; p=0.0497).

Conclusion
Response to vedolizumab can be successfully recaptured in two thirds of secondary non responders by dose escalation. Patients requiring dose escalation do not seem to differ from stable responders with regards to vedolizumab pharmacokinetics.
P481 Effectiveness and safety profile of biological therapy in inflammatory bowel disease: real life data from an active pharmacovigilance project
Authors: Viola A , Barbieri M A , Pisana V , Cutroneo P M , Fries W , Spina E 
Published: May 2021

Abstract

Background
Biological therapies are now the mainstay for the treatment of Inﬂammatory bowel disease (IBD). Post-marketing activities become crucial for monitoring the long-term safety. Aim of this project was to evaluate the eﬀectiveness and the safety proﬁle of biologics for the treatment of IBD patients during a prospective pharmacovigilance study.

Methods
From January 2017 to December 2020, all patients with Crohn’s Disease (CD) and Ulcerative Colitis (UC) treated with at least one biologic agent at the start of the study or commenced a biologic during the study period were enrolled. Demographic, clinical, and disease-related data were collected. A descriptive analysis of patients’ characteristics at the index date was performed. Moreover, an analysis of all adverse events (AEs) and all primary/secondary failures expressed as number of AEs or failures/10 treatment years was carried out taking into account the total years of treatment for each biologic including all patients treated with a biologic at least once during the follow-up period.

Results
A total of 654 patients were enrolled, 58.4% with CD and 41.6% with UC. Mean age (±SD) was 44 ± 17 years and 59.0% were males. At the index date, the following treatments were used: 40.8% adalimumab (ADA), 33.3% inﬂiximab (IFX), 21.3% vedolizumab (VED), 2.4% ustekinumab (UST), and 2.1% golimumab (GOL). Patients naïve for biologic therapy were 79.1%. The total years of treatment were 887 yrs for ADA, 663 yrs for IFX, 309 yrs for VED, 89 yrs for UST, and 51 yrs for GOL. Data for AEs and failures were the following: IFX – 1.1 AEs and 0.8 failures, ADA – 0.8 and 0.9, VED – 1.1 and 1.8, GOL – 1.2 and 3.4, and UST - 1.4 and 0.9, respectively (Tab.1). During follow-up, 196 AEs were reported. Infections mainly occurred in patients treated with GOL and ADA (8.7% and 7.6%, respectively), skin reactions in patients treated with ADA (7.6%), while infusion related reactions with IFX (12.6%). A higher frequency of malignancies was observed in patients on treatment with VED (3.4%).

Conclusion
There were no major differences for AEs between the different treatments, but a higher frequency of failures with GOL and VED, both rarely used as first line therapies. Nevertheless, the acquisition of data from clinical practice should be endorsed to better define the safety and efficacy profile of new biologic agents in IBD.
P487 The feasibility of a digital platform for improving disease management among patients with Ulcerative Colitis
Authors: Oddsson S , Gunnarsdottir T , Ylanne K , Molander P , Thorgeirsson T 
Published: May 2021

Abstract

Background
Ulcerative colitis is an idiopathic inflammatory condition of the colon and is the most common form of inflammatory bowel disease worldwide. It is a systemic disorder with no cure and therefore needs lifelong monitoring and management. This study’s objective was to assess the feasibility and preliminary effectiveness of using a digital therapeutic intervention to improve disease management among patients with ulcerative colitis.

Methods
Nine patients were recruited by the Finnish Crohn’s and Colitis Patient Association to participate in a 4-week intervention via a digital platform (Sidekick Health). The primary outcomes included patient ratings of the platform and its therapeutic effects and patient reports of quality of life, physical activity, and medication adherence (on a scale from 0–10). Questionnaires were administered before and after the intervention. The study was conducted during the spring of 2019.

Results
All nine participants completed the intervention (age-range=25–45, eight females and one male). Although not statistically significant, on average, all measures showed improvements from pre to post-intervention: quality of life improved for 7/9 participants (an average improvement of 10.3%), physical activity increased for 6/9 participants (an average of 3.3% increase). Also, medication adherence improved among 6/9 participants (improvement by 6.4% on average), supported by platform data indicating that 8/9 participants had used the platform medication reminders. In 86% of the daily reminders, they were acted upon and rewarded within the platform. Post-program, patients reported their experience of the program and when asked if they would recommend the program to others, the average score was 8.67 out of 10 possible. Also, 8/9 participants agreed or strongly agreed with the statement that the program had changed their health for the better.

Conclusion
This small feasibility study suggests a digital therapeutic intervention is feasible and possibly an effective way to improve disease management among patients with ulcerative colitis. A more extensive study of this intervention is warranted.
P499 Use of an Inflammatory Bowel Disease illustrated guide as a patient education tool
Authors: Murray J , Lindsay J 
Published: May 2021

Abstract

Background
Inflammatory bowel disease (IBD) is a lifelong condition with a major impact on QOL. Patient education and empowerment are cornerstones of high quality IBD patient care 1 and IBD clinical nurse specialists (CNS) play a key role in patient education within IBD. Multiple barriers to effective patient education exist and tools which overcome these are required. We explored IBD CNS’s opinion on (i) the barriers to effective education of patients, (ii) tools they use to overcome these barriers and (iii) the effectiveness of the use of an IBD illustrated guide.

Methods
We studied a guide developed by PostScript Medical™. An illustrative guide to Inflammatory Bowel Disease contained 20 anatomical illustrations related to IBD and its management (Figure 1). The guide and participation in the study were advertised online via UK IBD nursing networks and sent out to those who registered interest. Participants were encouraged to use the guide as frequently as possible in patient consultations. 8 weeks later an electronic survey was sent to all those who received the guide.

Figure 1. IBD multi-disciplinary team (MDT) members were involved in guide development, it can be personalised during each consultation using the attached dry wipe pen

Results
68 UK IBD CNS registered interest in the study and were sent a guide, 47 follow-up survey responses were received (response rate 69%). The top 3 reported barriers to effective patient education were complex terminology (81.63%), time limitations (81.63%) and existing patient knowledge (69.39%). The most frequent tools used to overcome these included patient information leaflets (63.27%), own drawings or sketches (57.14%) and print outs from websites (57.14%). 100% of respondents felt easily accessible visual support tools would help overcome some of these challenges. Responses on the effectiveness of the guide are shown in table 1 and 2. 100% of respondents would use the guide again in future consultations.

Table 1. Responses on effectiveness of guide during patient consultations

Table 2. IBD CNS perception on how guide may affect patient outcomes

Conclusion
This study identified key barriers to IBD CNS based patient education and common tools used to overcome them. It demonstrated the perceived benefit on patient understanding and engagement of using the PostScript Medical™ guide during patient consultations. This should be further explored by analysing patients’ perspective along with other members of the IBD MDT as we seek to explore tools that enhance IBD patient understanding and improve the personalised care we deliver to our patients.

Reference
1. Kapasi R. et al. Consensus standards of healthcare for adults and children with IBD in the UK. Frontline Gastroenterology 2020;11:178–187.
P523 Survey to identify patient characteristics, treatment preferences and impact of inflammatory bowel disease (IBD) on quality of life across 7 countries in Europe
Authors: Fiorino G , Bent-Ennakhil N , Varriale P , Braegger F , Hoefkens E 
Published: May 2021

Abstract

Background
The treatment paradigm for inflammatory bowel disease (IBD) is becoming increasingly diverse and complex. It is suggested that engaging patients through shared decision-making optimises treatment selection in line with clinical need and patient preference and expectations. This patient survey aimed to explore patients’ preferences towards attributes of currently available advanced therapies for IBD as well as the impact of IBD on patients’ quality of life (QoL) across 7 countries in Europe. The demographic profile of the study cohort and findings on the patient-rated impact of IBD on QoL are reported here.

Methods
An online, cross-sectional survey (October 2020 to January 2021) enrolling adults aged ≥18 years who self-reported having and being previously/currently treated for Crohn’s disease (CD) or ulcerative colitis (UC) was conducted across Europe (France, the UK, Spain, Italy, Belgium, Switzerland and the Netherlands). Patient perspectives on IBD care and preferences regarding specific attributes of existing treatment options were explored using the Carenity platform and via partnerships with local organisations. This descriptive analysis evaluated the demographic and clinical profile of respondents, treatment management and impact on QoL.

Results
Overall, 686 patients (CD: 360; UC: 326) across 7 countries completed the survey. Among CD and UC patients, respectively, 71.9% and 57.7% were females; mean age (range) was 48.0 (19.0–77.0) and 50.0 (19.0–82.0) years; and mean disease duration (range) was 13.6 (0.2–49.1) and 11.0 (0.1–68.7) years. Overall, 37.5% of CD patients reported fistulising CD, and 9.4% (CD) and 10.1% (UC) of patients had a stoma or pouch; 76.7% (CD) and 78.5% (UC) of patients were being treated for IBD. Approximately 50.0% of patients with IBD were full-time or part-time employed at the time of survey. Abdominal pain, fatigue, and stool frequency were ranked by 83%, 79%, and 73% patients with CD, respectively, as the symptoms most impacting QoL; 79%, 71%, and 61% patients ranked energy status, general well-being and daily activities, respectively, as the most impacted aspects. Abdominal pain, stool frequency and fatigue were ranked by 73%, 72% and 67% patients with UC, respectively, as the symptoms most impacting QoL; the most impacted aspects were similar to those of patients with CD. Patients in both groups prioritised general well-being, energy status and daily activities as aspects for improvement through treatment.

Conclusion
This large European survey highlights the most impactful symptoms and QoL aspects from the patient perspective. These findings can support clinical decision-making and treatment strategies to improve treatment outcomes and patient QoL.
P561 Ulcerative Colitis Endoscopic Index of Severity (UCEIS) and Mayo Endoscopic Score (MES) in predicting the therapeutic effect of mesalazine in UC patients
Authors: Wu L , Zhang Y , Cao Q 
Published: May 2021

Abstract

Background
The Ulcerative Colitis Endoscopic Index of Severity (UCEIS) and the Mayo Endoscopic Score (MES) were developed as an objective method of the endoscopic severity in ulcerative colitis (UC); however, it was still unclear whether UCEIS and MES could guide the mesalazine treatment in UC.

Methods
Consecutive UC patients who had undergone colonoscopy within 1 month before starting mesalazine between October 2011 and July 2016 were retrospectively evaluated. Demographic data, previous therapy, clinical observations, laboratory parameters, medical therapy and endoscopic assessments were documented. The primary outcome was the need for ‘step up’ treatment (containing the use of corticosteroids, immunomodulatory or surgery.) during admission and follow-up.

Results
Sixty-five patients were enrolled, 12(18.5%) needed ‘step up’ treatment’ due to primary or secondary nonresponse to mesalazine. UCEIS score is a predictor of primary or secondary nonresponse to mesalazine in multivariate analysis (OR, 25.65; 95% CI, 3.048–45.985; P =0.003). Receiver-operator characteristic (ROC) area of UCEIS is 0.95, with a sensitivity of 100% and specificity of 84.6%, using cut-off value of 6, which outperforms MES with the ROC area of 0.70; When UCEIS score ≥6, 60% of patients eventually need ‘step up’ treatment.

Conclusion
UCEIS score is a useful instrument for evaluating endoscopic improvement in UC patients treated with mesalazine. The high probability of mesalazine treatment failure and benefits of other therapy should be discussed in patients with baseline UCEIS ≥ 6.
P567 Pharmacist-managed immunomodulator clinic in titration and monitoring of immunosuppressants in Inflammatory Bowel Disease
Authors: Ng V , Lim T G , Ong W C , Wong S Y A , Salazar E , Chan P W W 
Published: May 2021

Abstract

Background
Immunomodulators (IMs) such as azathioprine are the cornerstone in the treatment of inflammatory bowel disease (IBD). However, they are associated with significant toxicity and requires close monitoring for side effects, which puts a stretch on our physician clinics. The pharmacist-run Immuno Clinic (IMC) was set up in 2016 to assist in the monitoring of stable patients and initial titration phase of IMs so that physicians are able to focus their time and energy on patients with more complex diseases. The objective of this study is to demonstrate that IMC is able to effectively and safely carry out its purpose for patient’s disease management, medication adherence and adverse events management, resulting in time and cost savings.

Methods
This is a retrospective study looking at IBD patients who attended IMC from Aug 2016 to July 2019. Patients’ demographics, disease control, medication adherence and adverse effects were obtained from the IMC database. Descriptive data were analyzed using frequency distribution for categorical variables. Continuous variables were expressed as median and interquartile range (IQR).

Results
A total of 73 patients were included. Thirty-six (49.3%) patients had CD, while 37 (50.7%) patients had UC. A total of 185 actions were executed over 173 IMC sessions, including dose adjustment (57), recommending additional medications (14), discontinuation or restarting IM (12), side effects detection (25), monitoring recommendations (10), non-adherence detection (39), referral to physician (23), and others (5). In 2 out of 173 visits (1.1%), severe disease flare requiring hospitalization was detected and referred back to the primary physician for inpatient admission. Thirty ADRs were detected (17.3 %) and managed promptly. There were 24 cases of non-adherence detected and counselled (13.9%). Out of 38 patients who were referred for titration of IM, 28 patients (73.7%) achieved the target dose of IM. Patient visits were largely independently managed by pharmacists (150 out of 173, 86.7%).

Conclusion
Implementation of pharmacist-led IMC is a safe and cost-effective alternative to conventional gastroenterology clinic for monitoring and titration of IMs, enabling physicians to focus on more complicated cases and thus improving access to the IBD ambulatory care service.
P578 Adriatic-Balkan regional survey on COVID-19 in Inflammatory Bowel Disease patients
Authors: Borzan V , Orsic Fric V , Borzan B 
Published: May 2021

Abstract

Background
COVID-19 pandemic completely changed the world during the past year, but its’ greatest impact was on healthcare system. As inflammatory bowel diseases (IBD) are chronic conditions, and patients are in constant interaction with healthcare system and are treated with immunosuppressive therapies, they present a particularly vulnerable group of patients during the pandemic.

Methods
Aim of this study was to survey IBD patients’ opinion on the impact of COVID-19 on their mental health, availability and quality of healthcare and their opinion on vaccination. We created a questionnaire that was posted to web based IBD patient group that gather patients from our geographical, Adriatic-Balkan, region (Croatia, Bosnia and Hercegovina, Serbia, Macedonia and Montenegro). Patients answered questions anonymously. Answers were created as yes/no, in grades from 1 (no impact/fear) to 5 (very large impact/very severe fear) or by choosing one of the offered answers. In total, 167 responses were received between December 2020 and March 2021, and were analyzed by descriptive statistics.

Results
A total of 167 IBD patients filled the questionnaire, of which 116 (69,5%) were female. Median age was 36 years (min. 15, max. 62 ys). Most patients did not have COVID-19 (82,6%). A little over half of patients believe that IBD patients are at higher risk of developing COVID-19 (n=97, 58,1%). COVID-19 pandemic has a moderate to large impact on their mental health in majority of patients (n=106, 63,5%) and 99 patients (59,3%) feel moderate to severe fear for their own health because of the pandemic. Most of the information about COVID-19 patients found on the internet (44,3%), from patients’ associations (26,3%) and from their IBD doctor (22,8%). Same number of patients (n=48, 28,7%) feel no impact or very large impact of pandemic on availability to IBD team. Most of patients did not change their IBD therapy during the pandemic (86,8%), and majority (62,3%) felt there was no impact of pandemic on the availability to their therapy. Almost half of patients (49,7%) feel that the quality of healthcare system is worse since the beginning of the pandemic. More than half of patients (57,5%) do not want to be vaccinated against COVID-19.

Conclusion
COVID-19 pandemic had a moderate to large impact on mental health in majority of patients. It is particularly important that patients receive correct information about COVID-19 from medical professionals, and patients’ association groups are very useful channel for patient education that should be used more. More than half of patients do not want to be vaccinated, showing the importance of patient education even more.
P581 Pre-operative prolonged antibiotic treatment in ileocecal Crohn’s disease: single center non-randomized prospective study
Authors: Vardanyan A , Ovsyannikova V , Peda E , Nanaeva B , Achkasov S 
Published: May 2021

Abstract

Background
Patients with complicated Crohn’s disease are the most difficult cohort to make right decision in treatment and timing surgery. These patients are at risk for the long duration of operations, length of hospital stay, repeated urgent interventions because of complications and the need for a temporary stoma. In literature there is lack of information concerning the usage of prolonged antibiotics in such cases and results are conflicting in some studies. Single center non-randomized prospective study was held.

Methods
120 patients were evaluated from 2012 to 2017. All patients had a complicated Crohn’s disease with abdominal mass, fistulas and stricture of the terminal ileum and all of them were operated on. In the first group there were 48 patients who received preoperative treatment with ciprofloxacin and metronidazole for at least 2.5 (1–4) months. In the second group patients also received the same treatment for the median time of 13 (1–33) days. Our hypothesis has been that prolonged treatment allows to reduce postoperative complications and the risk of stoma formation. To prove this statement, we did Chi-squared and Fisher’s exact test, univariant and multivariant analyses. The following criteria were included: prolonged treatment, gender, age, perianal lesion, laparoscopic operation, blood loss and duration of surgery.

Results
In the first group the complication rate was 4 (8.3%) and in 27 (56.2%) patients there was the need for stoma formation. In the second group – 18 (25%) and 58 (80.5%), respectively. First, we used Fisher’s test to see some correlations between the treatment and complications and the need of stoma formation. Prolonged treatment reduces the rate of complications in 4-fold (OR 0.25; x2= 5.34; p=0.02) and the need of stoma in 3-fold (OR 0.3; x2=8.24; p=0.004). In uni- and multivariant analyses prolonged treatment significantly reduces the complication rate and the risk for stoma creation (OR 2.73 CI 0.037–0.86; p= 0.02 and OR 0.310 CI 0.02–0.72 p=0.004, respectively). Gender, age, perianal lesion, laparoscopic operation, blood loss and duration of surgery were not statistically significant in multivariant analysis.

Conclusion
preoperative prolonged antibiotic treatment in complicated Crohn’s disease significantly reduced complications rate and the risk of stoma creation.