bluuebunny/crossref_metadata_2025_split huggingface dataset:
P220 Patient-entered symptoms scores collected using a new IBD patient portal correlate closely with clinical assessment and can optimise delivery of IBD care
Authors: Carlson S , Harrow P , McCartney S 
Published: May 2021

Abstract

Background
Patient healthcare portals can empower IBD patients by allowing access to their electronic health record and provide opportunities for active participation in their care.
We built 3 patient-entered symptom questionnaires in EPIC MyChart using existing validated IBD symptom scores (HBI, SCCAI, IBD Control). Patients were invited to complete these prior to clinic using the MyChart patient portal. In this study we examine the feasibility and accuracy of patient entered scores compared to the physician’s impression of disease activity and the potential impact on healthcare delivery.

Methods
Between September 2020 and January 2021 consecutive patients were invited to complete 2 questionnaires reporting disease activity on the EPIC MyChart portal using the IBD Control (Bodger et al. 2014) and either HBI or SCCAI (for Crohn’s disease and UC respectively). Only patients who completed these scores were included in this study. A retrospective review of the notes was completed to determine the physician’s impression of disease activity and actions taken by the physician in the outpatient clinic.

Results
107 patients with Crohn’s and 80 with UC were included in the study. 60% of CD and 56% of UC patients were in remission by HBI (&lt;5) or SCCAI (&lt;3). Patient reported disease activity correlated well with clinical impression of disease activity. 88% of CD patients and 98% of UC patients in HBI or SCCAI remission were also deemed to be in remission on physician’s clinical impression (r= 0.54, p &lt;0.001 and r= 0.74, p &lt;0.001). Both CD and UC had lower rates of remission by IBD Control (49% and 53%). This score also captures fatigue and mood. Furthermore, the IBD Control identified a specific question to be addressed at the upcoming clinic visit for 76% of patients with CD and 64% with UC.
Importantly, 24% of all UC patients (n=19) in remission by SCCAI and IBD Control, had no questions they wanted addressed, and all of these patients had no further actions triggered by clinic attendance. Conversely in the 18% patients with moderate to severe disease by HBI or SCCAI, 50% required a blood test or calprotectin prior to further clinical decisions.

Conclusion
Patient-entered symptom scores correlate closely with physician’s impression of disease activity and patients are able to accurately record these using the EPIC MyChart portal. Importantly, it is possible to identify a cohort of patients who are well, where there are opportunities to optimise follow-up, and conversely a group of patients with active disease where key investigations can be arranged prior to clinical review to prevent delays in treatment. These patients can also be prioritised for face-to-face clinics, at a time when reducing social contacts is imperative.
P250 Does Ethnicity Influence Patient’s Preferences for Treatment Outcome? The Israeli Experience
Authors: Broide E , Richter V , Mari A , Khoury T , Shirin H , Naftali T 
Published: May 2021

Abstract

Background
IBD behaves differently among different ethnic groups. Patients perceptions and priorities for treatment outcome may well be influenced by their culture and beliefs. However, data on the impact of ethnicity on IBD patient’s attitude and expectation for treatment outcomes are still scares. We aimed to compare patient’s preferences and priorities for treatment outcomes among Jewish and Muslims IBD patients in Israel.

Methods
A prospective survey was conducted among Muslims IBD patients and compared to historical data set of Jewish IBD patients. Data included demographics and socioeconomics parameters as well as clinical data. Patients were asked to rank ten items regarding their preferences for treatment outcome, based on the ten IBD disk items. Cluster analysis was used to classify both patient’s groups into homogeneous subgroups according to their preferred IBD items.

Results
391 patients were included in our analysis; 121 Muslims patients were compared to historical data base of 240 Jewish patients, 67.9% CD patients and 33.5% UC patients. Both groups were similar regarding age, disease activity and treatment, but the duration of disease was longer in the Jewish population (a median of 9 vs 6 years, p=0.01). As a group, Muslim patients ranked the priorities for treatment outcome lower compared to the Jewish population. The items with the highest priority were the same in both groups with abdominal pain, energy, and regular defecation ranking highest. There were no differences between Muslims men and women, but the Jewish women attached higher priority to abdominal pain, energy, sleep, joint pain, education and work. The cluster with the higher scores was characterized by more females (p&lt;0.001), Jews (p&lt;0.001), urban residency (p&lt;0.001), working hours per week (p=0.003), lower income (p= 0.011) CD patients (p=0.011), active disease (p&lt;0.001), and lower response to treatment (p=0.002). Multivariable regression analysis revealed an association between higher patient’s ranking and Jewish religion (OR 4.77) male gender (OR 0.5), income level (OR 0.2), active disease (OR 5.29) and CD (OR 0.4).

Conclusion
The ethnic difference has a high impact on patient’s ranking of priorities for treatment outcome. These differences can be explained by socioeconomic factors. Despite the ethnic and cultural differences, symptoms relief is in the highest priority in both patient groups.
P284 Drug survival and remission rates in ustekinumab treated ulcerative colitis: Results from the Swedish Inflammatory Bowel Disease register (SWIBREG)
Authors: Thunberg J , Björkqvist O , Olén O , Ludvigsson J F , Eriksson C , Halfvarson J 
Published: May 2021

Abstract

Background
Randomised controlled trials may not correctly reflect clinical practice. We aimed to assess the clinical effectiveness of ustekinumab in a real-world cohort of patients with ulcerative colitis (UC).

Methods
This observational, multi-centre cohort study explored ustekinumab treated patients with UC from the Swedish inflammatory bowel disease register (SWIBREG), a nationwide quality register. Prospectively collected clinical data were extracted December 2020. The primary outcome was the 16-week ustekinumab continuation rate. Secondary outcomes included A) drug continuation rate at the end of follow-up, B) corticosteroid-free biochemical remission, defined as f-Calprotectin&lt;250µg/g, and C) corticosteroid-free clinical remission per patient-reported Mayo score, i.e. a rectal bleeding subscore &lt;1 and a stool frequency subscore ≤1 and not greater than baseline. Continuous data are presented as median and (interquartile range). Differences between baseline and follow-up visits were assessed by the Wilcoxon signed-rank test.

Results
In total, 145 patients were included and followed for a median period of 32 (19-56) weeks. Baseline characteristics are presented in Table 1. The drug continuation rate was 87% (126/145) at 16 weeks and 69% (100/145) at end of follow-up (Figure 1-2). Corticosteroid-free clinical and biochemical remission rates at follow-up visits are shown in Figure 3. The 6-point Mayo score decreased from 5 (3-6) at baseline to 2 (2-4) at 16 weeks (p&lt;0.01) and to 3 (2-4) at last follow-up (p&lt;0.01). F-calprotectin levels decreased from 779 (252-1530) µg/g to 246 (56-844) µg/g at week 16 (p=0.02) and to 142 (36-935) µg/g at last follow-up (p&lt;0.01).

Conclusion
Ustekinumab was associated with clinical effectiveness in this nationwide real-world treatment refractory cohort.
P286 Ustekinumab for Crohn’s Disease: Two-Year Results of the Initiative on Crohn and Colitis (ICC) Registry, a Nationwide Prospective Observational Cohort Study
Authors: Straatmijer T , Biemans V B C , Hoentjen F , de Boer N K H , Bodelier A G , Dijkstra G , van Dop W , Haans J J L , Jansen J M , Maljaars P W J , van der Marel S , Oldenburg B , Ponsioen C Y , Visschedijk M C , de Vries A C , West R , van der Woude C J , Pierik M , Duijvestein M , van der Meulen- de Jong A E 
Published: May 2021

Abstract

Background
Ustekinumab is a monoclonal antibody that selectively targets p40, a shared subunit of the cytokines interleukin (IL)-12 and IL-23. It is registered for the treatment of Crohn’s disease (CD) and ulcerative colitis. We assessed the two-year efficacy and safety of ustekinumab in a real world, prospective cohort of CD patients.

Methods
CD patients who started ustekinumab in regular care were prospectively enrolled in the nationwide Initiative on Crohn and Colitis Registry. At week 0, 12, 24, 52 and 104, clinical remission (HBI ≤ 4 points), biochemical remission (fecal calprotectin (FC) ≤200 μg/g and/or CRP ≤5 mg/L), peri-anal fistula remission, extra-intestinal manifestations, ustekinumab dosage and safety outcomes were determined. Patients starting therapy less than two years ago were excluded for the current evaluation. The primary outcome was corticosteroid-free clinical remission at week 104.

Results
In total, 252 CD patient with at least two years of follow up were included. Of all included patients, the proportion of patients in corticosteroid-free clinical remission at week 12, 24, 52 and 104 was 32.3% (81/251), 41.4% (104/251), 39% (97/249) and 34.0% (84/247), respectively. Of the 97 patients in corticosteroid free clinical remission at week 52, 58 (59.8%) were still in corticosteroid-free clinical remission at week 104. In patients with combined clinical and biochemical disease activity at baseline (n=122), the corticosteroid-free clinical remission rates were 23.8% (29/122), 35.2% (43/122), 40.0% (48/120) and 32.8% (39/119) at week 12, 24, 52 and 104, respectively. The probability of remaining on ustekinumab treatment after 52 and 104 weeks was 64.3% and 54.8%, respectively. There were no predictive factors associated with corticosteroid-free clinical remission at week 104 on univariate and multivariate analysis. Most common adverse events were headache, skin reaction and musculoskeletal complaints. Two patients stopped ustekinumab due to an infection after 8 and 30 weeks of treatment (mild fever syndrome and moderate upper airway infection, respectively). The main reason for discontinuing treatment after 52 weeks was loss of response (66.7%).

Conclusion
Ustekinumab was effective and relatively safe in our real world, prospective cohort of CD patients. After 104 weeks of ustekinumab treatment, one third of patients were in corticosteroid-free clinical remission.
P293 Local Mesenchymal Stem Cells injection in Crohn’s disease strictures: a phase I-II, open-label clinical study
Authors: Vieujean S , Loly J P , Boutaffala L , Pariente B , Reenaers C , Briquet A , Lechanteur C , Beguin Y , Louis E 
Published: May 2021

Abstract

Background
Intestinal fibrosis is a common complication of Crohn’s disease (CD) leading to progressive bowel stricture formation. Mesenchymal stem cells (MSCs), known for their immunomodulatory, anti-inflammatory and anti-fibrotic properties, could be a potential therapy in this frequently fibro-inflammatory condition. In this phase I–II open-label pilot trial, we aimed to assess safety and efficacy of local MSCs injection in CD strictures.
Methods: CD patients with a non-passable stricture, length from 2 to 5 cm, accessible by ileocolonoscopy, but without intestinal obstruction, fistulas, or abscess, could be included. A total of 3X107 allogenic bone-marrow derived MSCs were equally injected in the 4 quadrants of the strictured bowel wall during an ileocolonoscopy. Adverse events and clinical scores (Crohn Disease Activity Index, Short Health Scale and Crohn Disease Obstructive Score) were evaluated at each follow-up visit (at week 4, 12, 24 and 48) while endoscopy was performed at baseline, W12 and W48. The main judgement criteria for efficacy was the complete (defined by the ability to pass the ileocolonoscope) or partial (defined by a diameter increase) resolution of the stricture at 12 weeks. Other efficacy criteria included complete or partial resolution of the stricture at 48 weeks as well as the evolution of clinical scores between weeks 0, 12 and 48.

Results
Between 2018 and 2020, we performed 11 local MSCs injections in 10 CD patients (6 female; aged to 38-65 years; median 45 years old; 70% were smoker). The strictures’ (3 primary, 7 anastomotic) location was as follows: 7 at an ileo-colonic or ileo-rectal anastomosis, 1 colonic and 2 of the ileocecal valve. MSCs injections were well tolerated but a total of 5 hospitalizations for occlusion were reported (2 secondary to a different stricture than the injected one) leading to a surgical resection for one patient and an endoscopic dilatation for another one. Neither intestinal perforation nor intra-abdominal fistula or abscess was reported. At 12 weeks, 5 patients (45%) presented a stricture improvement with a complete resolution for 2 and a partial resolution for 3. Of the 11 MSCs injections, 6 patients were re-evaluated at week 48 (2 patients still undergoing follow-up, 1 operated, 1 dilated, and 1 lost to follow-up), 4 patients had a complete resolution and 1 had a partial resolution. The evolution of clinical scores between weeks 0, 12 and 48 (Figure 1) was not statistically significant.

Conclusion
Local MSCs injection in non-passable CD stricture was well tolerated over the short term but several occlusions were reported in the follow-up. Combining the effects of MSCs with the proven effect of endoscopic balloon dilatation could possibly improve the outcome of CD stricture.
P344 Effectiveness and safety of switching patients with inflammatory bowel disease from originator infliximab to CT-P13: systematic review and meta-analysis
Authors: Hanzel J , Strik A , Gecse K , D’Haens G , Dreesen E 
Published: May 2021

Abstract

Background
Switching from originator infliximab (IFX) to the CT-P13 biosimilar is a widespread practice, although some concerns persist, particularly about long-term outcomes. We performed a systematic review and meta-analysis to assess the effectiveness and safety of switching from originator IFX to CT-P13 in patients with inflammatory bowel disease (IBD).

Methods
We systematically searched electronic databases for randomised controlled trials and prospective observational studies of adult patients with IBD who had switched from originator IFX to CT-P13 and were followed up for at least 12 months. The main outcomes were the pooled rate of clinical remission (as defined by the included studies) and adverse events at 12 months. Secondary outcomes included the rate of treatment discontinuation and de novo immunogenicity. A DerSimonian-Laird random-effects meta-analysis of proportions with double arcsine transformation was performed. Variables judged to be clinically important were studied in an exploratory random-effects meta-regression analysis.

Results
Eleven studies with 1204 patients (71% with Crohn’s disease [CD]) switching from originator IFX to CT-P13 were identified. Pooled rates of clinical remission at 12 months were 83.6% in ulcerative colitis (UC), 75.9% in CD, and 79.6% in mixed cohorts (Figure 1). Clinical remission at 12 months was negatively associated with combined immunosuppression at switch (7% decrease in remission at 12 months per 10% increase in patients receiving combination therapy) and positively associated with remission at switch (6% increase in remission at 12 months per 10% increase in remission at switch). The pooled rate of adverse events at 12 months was 21.0% (95% confidence interval [CI] 10.4–34.1%). Pooled rates of treatment discontinuation at 12 months were 24.4% (95% CI 12.0–39.4%) in UC, 18.6% (95% CI 8.8–30.9%) in CD, and 13.1% (95% CI 0.7–35.6%) in mixed cohorts. De novo immunogenicity was rare (3.3%, 95% CI 1.5–5.6%). All estimates had at least moderate heterogeneity.
Figure 1: Meta-analysis of clinical remission rates at 12 months after switching from originator infliximab to CT-P13 in ulcerative colitis and Crohn’s disease.

Conclusion
Switching from originator IFX to CT-P13 appears to be effective and safe, although these findings should be interpreted in the context of the limitations of the primary publications which lacked control arms. Combined immunosuppression at switch, potentially as a marker of disease severity, was negatively associated with clinical remission at 12 months after the switch.
P354 Early treatment versus active surveillance after ileocolic resection in Crohn’s disease: a retrospective cohort study
Authors: Haenen S , Sabino J , Bislenghi G , D’Hoore A , Ferrante M , Vermeire S 
Published: May 2021

Abstract

Background
Patients with Crohn’s disease (CD) often require ileocolic resection (ICR) due to refractory disease or disease-related complications, such as intestinal strictures, enteric fistulae or intra-abdominal abscesses. Up to 70% of patients will develop new endoscopic lesions in the neoterminal ileum within the first year after surgery. We assessed if the timing of postoperative treatment can reduce postoperative recurrence (POR) rate.

Methods
We performed a retrospective, single-center observational cohort study in a tertiary hospital. All CD patients undergoing abdominal surgery from January 1st 2015 until June 30th 2019 were screened. Patients with CD who underwent ileocolic resection with ileocolic anastomosis were included. Depending on the postoperative management patients were divided in two groups: “wait and see” if medical treatment was not initiated before endoscopic evaluation 6 months after surgery (n=109), “treat” if medical treatment was initiated directly after surgery (n=49). Patients whose postoperative follow-up occurred in another center were excluded. Data were collected by review of the electronic medical charts and included patient demographics, disease characteristics (Montreal classification), medication, indication for surgery and POR assessment. POR was defined as clinical (PRO2 pain &gt;1 or loose stool frequency &gt;1.5), endoscopic (Rutgeerts score &gt; i2a) or radiologic (disease activity on MR enterography necessitating treatment). Survival analysis was performed with Kaplan-Meier and Cox proportional hazards model.

Results
In total 158 patients met the inclusion criteria: 109 patients in the “wait and see” group and 49 in the “treat” group. The main baseline characteristics of the cohorts are summarized in figure 1. The main indication for surgery was stricturing disease in both groups (69.7% and 65.3%) followed by penetrating disease (42.2% and 24.5%) and refractory disease (6.4% and 20.4%). Postoperative management did not significantly influence the risk for POR (figure 2). The same was also observed in patients with known risk factors for POR (figure 3). Patients with a high body mass index (&gt;25 kg/m²) had a significant greater risk for developing POR (HR 1.65, CI 1.09-2.5, p=0.019; figure 4).

Conclusion
There was no statistical significant difference in POR between immediate treatment after ICR and active surveillance with endoscopy 6 months after surgery. Prospective randomized trials with long follow-up are needed to further explore the use of adjuvant postoperative treatment to prevent POR.
P384 Therapeutic drug monitoring: performance of the first lateral flow-based Point of Care test for the quantification of infliximab in a finger prick
Authors: Ametzazurra A , Pascual J , Del Rio L , Maguregui A , Nagore D , Ruiz-Argüello M B 
Published: May 2021

Abstract

Background
Promonitor Quick IFX is a lateral flow test (LFT) for the quantification of infliximab (IFX) in human whole blood (finger prick or venous) or serum in 20 minutes. This LFT is based on a sandwich immunoassay to quantify either the reference IFX or biosimilars. This abstract describes the studies performed to establish the analytical specifications of the product.

Methods
Clinical and Laboratory Standards Institute (CLSI) guidelines were followed for the evaluation of the analytical specifications of the LFT in whole blood and serum matrices: Linearity (EP-06-A), Detection capability (EP17-A2), Interfering substances (EP07, 3rd Edition), Intermediate precision (EP05-A3) and Bias evaluation study for Biosimilars (EP10-A3). Results were obtained in combination with the automated portable reader PQreader. A Datamatrix provided with each Promonitor Quick IFX kit contains the calibration information required for the PQreader to measure the Control and Test lines and report the IFX concentration.

Results
The linear assay range was determined to be 1-58 µg/mL in whole-blood and 0.6-67 µg/mL in serum according to the processes indicated in the Package Insert. The Limit of Blank is 0.8 μg/mL, the Limit of Detection and Lower Limit of Quantification (LLoQ) are 1.1 μg/mL, and the Upper Limit of Quantification (ULoQ) is 15.4 μg/mL.
There was no effect on assay performance when each of the following substances were added to samples with 0, 3, and 7 μg/mL of IFX: Haemoglobin (&gt;1000 mg/dL), Bilirubin (&gt;40 mg/dL), Triglycerides (&gt;1500 mg/dL), HAMA (160 AU/mL), Rheumatoid factor (200 IU/mL), EDTA (5.4 mg/mL), Heparin (51 U/mL), Citrate (11.4%), Vedolizumab (60 μg/mL) and Adalimumab (20.25 μg/mL).
Repeatability and within-device precision results obtained for the positive samples are shown in the table below.

The negative samples showed a negative result in all the measurements.
A bias study showed that Promonitor Quick IFX can quantify CT-P13, SB2 and GP1111 biosimilars throughout the measurement range with a maximum bias of 14%.

Conclusion
Promonitor Quick IFX is the first LFT available for true Point of Care testing of patients treated with IFX with just a finger prick sample. It provides quick turnaround time to facilitate therapeutic drug monitoring and aid immediate decision making in the doctor office or hospitals with an excellent analytical performance.