bluuebunny/crossref_metadata_2025 huggingface dataset:
P105 Coping in Inflammatory Bowel Disease: insights from the Crohn’s and Colitis UK national survey
Authors: Marshall Mr J , Rowse G , Hollobone S , Afhim S , Oliver P
Published: May 2021

Background

Inflammatory bowel disease (IBD) is a chronic condition that adversely affects quality of life (QoL) and well-being. Factors associated with coping in IBD include disease activity, the presence of arthropathy and illness perceptions such as personal control. The evidence in this field is, however, limited by small sample sizes. The aim of this study was to use data from a national survey to identify factors associated with coping in a large sample of IBD patients. Identification of factors associated with coping may help inform the development of targeted interventions to improve psychological well-being.

Methods

A national postal and online survey was conducted by the charity Crohn’s & Colitis UK of its members in 2018. Participants were asked to complete a questionnaire which was co-produced by the charity and University of Sheffield, following focus groups of key stakeholders. The survey collected demographic and disease-related information as well as Likert item responses to questions relating to well-being, including coping. The response rate was 22.2%. To examine factors associated with coping, ordinal regression analysis was performed. Results are presented as adjusted odds ratios (ORs).

Results

8012 respondents were included in the analyses. The mean age of respondents was 45 years (SD =16 years) with 69% being female. The majority of respondents had a diagnosis of Crohn’s disease (78%) with 53% of participants self-reporting that they were in remission at the time of the survey. In multivariable analyses, the adjusted odds of females reporting difficulty in coping was 1.6 times higher than that for males (95% CI 1.43–1.79). The odds of those with active disease reporting more difficulty in coping were approximately twice that of those in remission (95% CI 2.38–2.93). Several well-being factors were found to be associated with coping, even after adjusting for personal and disease related characteristics (such as severity of symptoms and disease activity). Participants who had reported less understanding and felt they had less control of their IBD, had higher odds of difficulty in coping with their disease (95% CI 0.76–0.85 & 0.64–0.72 respectively). Participants who experienced disease-related stigma were also more likely to have difficulty in coping (95% CI for 1.99–2.26).

Conclusion

In this large survey of IBD patients, coping was associated with gender, disease characteristics and a number of psychological factors, which may be amenable to intervention to improve the QoL and well-being of patients with IBD. Efforts are required to improve public awareness of the impact of IBD in order to reduce stigma. Further research is required to understand these relationships and constructs through the use of validated measures.
P155 Bowel preparation is valued more than colorectal cancer risk and interval by patients in colitis-associated colorectal cancer surveillance: a discrete choice experiment
Authors: Wijnands A M , te Groen M , Peters Y , Kaptein A A , Oldenburg B , Hoentjen F , Lutgens M W M D
Published: May 2021

Background

Patients with inflammatory bowel disease (IBD) undergo surveillance colonoscopies at fixed intervals to reduce the risk of colorectal cancer (CRC). Taking patients’ preferences for determining surveillance strategies into account could improve adherence and patient satisfaction. This study aimed to determine patient preferences and preference heterogeneity for CRC surveillance in IBD.

Methods

We conducted a web-based, multicentre, discrete choice experiment among adult IBD patients with an indication for surveillance, treated in two academic and one general teaching hospital in The Netherlands. Individuals were repeatedly asked to choose between three hypothetical surveillance scenarios and indicate if they would prefer this option in real-life. The choice tasks were based on bowel preparation (0.3-4L), CRC risk reduction (8% to 1–6%), and interval (1–10 years). Attribute importance scores, trade-offs, and willingness to participate were calculated using a multinomial logit model. Latent class analysis was used to identify subgroups with similar preferences.

Results

In total, 301 of 386 questionnaires sent out were completed and included in the study. The attributes and levels in the choice tasks significantly affected patients’ preferences. Bowel preparation was the most valued attribute (importance score 40.0%), followed by surveillance interval and CRC risk reduction (respectively 30.9% and 29.0%). Maximal CRC risk reduction, low-volume bowel preparation (0.3L laxative with 2L clear liquid) with two-yearly surveillance was the most preferred combination. Patients were willing to exchange a surveillance interval from three-yearly to annually for a CRC risk reduction of 2.9%. In latent class analysis, three subgroups were identified (figure 1). Willingness to participate in CRC surveillance was high, with only five patients (1.7%) always choosing ‘no surveillance’. Perceived high burden of bowel preparation and lower age were significantly associated with the ‘laxative avoidant’ group compared to the reference group ‘surveillance preferent’ (univariable odds ratio (OR) 2.92, 95% CI (confidence interval) 1.63–5.23 and OR 0.96, 95% CI 0.94–0.98, respectively). High level of education and age significantly differed in the ‘CRC risk avoidant’ group (univariable OR 3.77, 95% CI 2.11–6.75 and 0.94, 95% CI 0.92–0.96).

Figure 1: Attribute importance scores

Higher scores indicate more relative importance [0=not important at all; 100=most important]

Conclusion

Bowel preparation is seen as the most important factor by patients in CRC surveillance in IBD. Heterogeneity in preferences can be explained by three latent subgroups. Surveillance adherence could benefit from these findings.
P199 Analysis of clinical features of asymptomatic perianal fistulizing Crohn’s disease
Authors: Wu T , Huang L , Cao Q
Published: May 2021

Background

Perianal fistula represents an aggressive phenotype of Crohn’s disease (CD), and is detected in CD patients without perianal complains. Data of CD patients with asymptomatic perianal fistula is scarce. Our study targets to assess the clinical characteristics of adult CD patients with asymptomatic perianal fistulas in adults with CD.

Methods

This retrospectively study collected data from Sir Run Run Shaw Hospital. Newly diagnosed CD patients undergoing magnetic resonance imaging examinations during 2014–2019 were enrolled. The perianal fistulizing CD patients were divided into two groups: 1) symptomatic perianal fistula group, 2) asymptomatic perianal fistula group, then we analyze the features of clinical features, medication and prognosis of each group.

Results

Among 437 CD patients, 346 (79.2%) had perianal fistulas whereas 91 (20.8%) did not. In patients with perianal fistulas, 89 (25.7%) did not have perianal symptoms. Comparing to symptomatic perianal fistula group, asymptomatic perianal fistula group combined with lower perianal abscess incidence (73.9% vs. 25.8%, p < 0.001). According to Park’s classification, the most common type of fistula in these two groups was intersphincteric fistula (73.2% vs. 53.2% p=0.094). Patients with asymptomatic perianal fistulas were described by the following features when compared with patients with symptomatic perianal fistulas: higher rate of female sex (38.2% vs. 17.9%, p < 0.001), shorter disease duration at enrolment (0.8 vs. 1.0 years, p = 0.001), higher rate of stricturing behavior (32.6% vs. 18.7%, p < 0.01), worse outcomes of laboratory examinations at diagnosis, including hemoglobin (119.0 vs. 131.0 g/dL, p < 0.001), platelet (333.0 vs. 283.0 *10^9, p < 0.001), ESR (20.0 vs. 14.0 mm/H, p < 0.01), albumin (35.6 vs. 37.5 g/L, p = 0.001), C-reactive protein (27.3 vs. 15.7 mg/L, p = 0.001). The age at diagnosis and disease locations were not different. For asymptomatic perianal fistula patients, antibiotics (57.3%) and surgery (6.7%) were taken at diagnosis. The usage of biologics at diagnosis showed no difference (59.6% vs. 40.4% p=0.108). Regarding clinical outcomes, the cumulative probabilities for bowel surgery (p < 0.05) and bowel obstruction (p < 0.01) in asymptomatic perianal fistula group were higher than symptomatic perianal fistula group.

Conclusion

Asymptomatic perianal fistulas account for a certain proportion. Female sex, shorter disease duration, stricturing behavior and poor outcomes of laboratory examinations at diagnosis are associated with detection of asymptomatic perianal fistulas. We should pay more attention to CD patients with asymptomatic perianal fistulas because they may have poor prognosis or even worse as patients with symptomatic perianal fistulas.
P218 Assessment of the degree of intestinal destruction in Crohn’s disease at the time of diagnosis
Authors: Hassine A , Akkari I , Mrabet S , Ben Jazia E
Published: May 2021

Background

Certainly the presence of advanced intestinal lesions in Crohn’s disease (CD) is associated with a more frequent recourse to surgical resection. However, in general, the degree of intestinal destruction in patients with CD is not assessed at the time of diagnosis, and the natural history of CD may differ phenotypically from patient to patient. The aim of this study was to assess the degree of intestinal destruction in patients with CD at the time of diagnosis, using the Lemann Index (LI), and to identify the associated factors.

Methods

A retrospective study was conducted involving all patients with CD followed in our center over a period of 4 years (2016- 2020), and who were evaluated by endoscopy and MRI at baseline. The Lemann Index is a score that measures cumulative damage to digestive tissue from entero-MRI and endoscopy data. A LI score > 2.0 was set as a cutoff to define advanced bowel injury. Hypothesis tests were applied to identify associations.

Results

112 patients with CD were included in this study, of which 53.6% were female. The mean age at diagnosis was 33.29 years [15–63]. Regarding the localization of CD, it was ileal, colonic, and ileocolonic in respectively 16.1%, 42.9% and 41%. The disease phenotype was inflammatory in 60.7%, stricturing in 21.42%, and penetrating in 17.85%. The initial flare was judged to be severe in 33.9%, moderate in 55.4% and mild in 10.7% of cases, with a mean CDAI of 305.21 [115–493]. 12 patients had already undergone bowel resection. As for the biological data, the mean value of C-Reactive Protein (CRP) at the time of diagnosis was 74.08 +/- 54.05 mg / l, and that of the sedimentation rate (ESR) was 62, 13 +/- 36.49 (the 1st hour). The mean LI was 3.14 (± 2.28) with 64 patients (57.1%) presenting an LI score indicating advanced bowel injury at diagnosis. In univariate analysis, the factors associated in a statistically significant way, with a more important Lemann Index were: the male sex (p = 0.037), the history of intestinal resection (p = 0.009), a severe initial flare (p = 0.049). Similarly, a strong correlation was observed with the initial CDAI score (p = 0.024, r = 0.05) and the initial value of ESR (p = 0.001, r = 0.01). In addition, the duration of symptoms, age at diagnosis, initial disease location and phenotype, presence or absence of anoperineal manifestations, and CRP value at diagnosis were not correlated to the degree of intestinal destruction according to the LI score, with respectively: p = 0.43, p = 0.12, p = 0.19, p = 0.49, p = 0.34 and p = 0.063.

Conclusion

In our series, advanced intestinal lesions are present at the time of diagnosis in a significant proportion of patients. Thus, the use of the Lemann score from the diagnosis of Crohn’s disease is necessary.
P223 Degree of Histological Activity is not Associated with Vedolizumab Therapy Outcome in Ulcerative Colitis
Authors: Doherty J , Brennan S , Dinneen K , Muldoon C , Mc Kiernan S , Dunne C , Mac Carthy F , Hartery K , Ciara R , Kevans D
Published: May 2021

Background

Histological inflammation is known to be associated with increased risk of disease relapse in patients with ulcerative colitis (UC). Vedolizumab (VDZ) is a gut selective anti-integrin which inhibits intestinal immune cell-trafficking. Whether the degree of histological activity at the time of VDZ therapy initiation is associated with therapy outcome is not known. We aimed to determine if there is an association between histological activity at the time of VDZ initiation and outcome of therapy.

Methods

A retrospective review was performed to identify UC patients treated with VDZ who had undergone an endoscopic assessment prior to therapy commencement. Baseline demographic data, information on therapy outcome and Mayo endoscopic sub score (MES) was collected for all patients. Endoscopic biopsies were retrieved and were scored for histological activity using the Geboes Score (GS). For Kaplan Meir analyses of primary endpoint, the cohort was dichotomised around a GS grade of 5. Primary endpoint was VDZ therapy outcome defined as persistence on VDZ therapy over time. Secondary endpoints included association between GS and MES and the association between a combined endoscopic and histological endpoint (MES = 3 & GS grade 5) and VDZ therapy outcome.

Results

33 patients were included [median age 44.3 years (range 17.2 -84.3); 36% male gender]. 24%, 43% and 33% of the cohort had proctitis, left-sided colitis and extensive colitis respectively. 67% of subjects had prior anti-TNF exposure. Median time from endoscopy to commencement of VDZ was 9 weeks. Median study follow-up was 68 weeks (range 6.1 – 228.7). 3%, 21%, 42% and 33% had MES of 0, 1, 2 and 3 respectively. GS grade was significantly associated with MES (p = 0.04) (Figure 1). GS grade was not associated with time to discontinuation of VDZ (p=0.64) (Figure 2). Combined endoscopic and histological endpoint was not associated with time to discontinuation of VDZ (p=0.43) (Figure 3). The presence of lamina propria eosinophils was not associated with time to discontinuation of VDZ (p=0.92).

Conclusion

GS grade is associated significantly with MES which has been demonstrated previously. Neither histological activity alone nor in combination endoscopic activity were associated with outcome of VDZ therapy. Assessment of histological activity does not appear to provide additional information when selecting patients for VDZ therapy.
P229 Standardization of Quantum Blue® rapid TDM assays with WHO international standards for adalimumab and infliximab
Authors: Afonso J , Ricken B , Schuster T , Guschin D , Schneider M
Published: May 2021

Background

Therapeutic drug monitoring of inflammatory bowel disease (IBD) patients under anti-TNF therapy is based on trough level determination of the drug. Rapid assays and multiple ELISAs are available that measure anti-TNF biologics. An international standard is required to improve comparability among different assays. Recently, WHO introduced anti-TNF standards for adalimumab (ADL) and infliximab (IFX). A WHO international reference material (IRM) based standardization is crucial for the harmonization of assays available on the market.

Methods

The aim of the study was to standardize the BÜHLMANN Quantum Blue® ADL and BÜHLMANN Quantum Blue® IFX based on the WHO IRM for ADL and IFX, respectively. A value transfer from the WHO reference material to the internal calibrator sets for both assays was based on a protocol previously described by Blirup-Jensen et al. (Clin Chem Lab Med 2001; 39(11):1110–1122) and by means of a commercially available ELISA. A method comparison of the ELISA and the rapid test was carried out before the value transfer to guarantee comparability of both assays. Additionally, the correlation of the WHO IRM with the currently used calibrator material was determined for ADL. The correlation of the WHO IFX standard (NIBSC 16/170) with the currently used calibrator material was presented recently (Keller et al. 2020, UEGW 2020). Calibration curves were generated with BÜHLMANN ADL calibrators and with calibrators made from WHO IRM for ADL (NIBSC 17/236). Serum samples, covering a concentration range from 1.0 to 35 µg/mL, were analysed with both calibration curves and compared by Bland-Altman and Passing-Bablok analysis.

Results

A preliminary value transfer study revealed an relative uncertainty of 12.3% for both drugs. A good comparison of the ADL and IFX rapid test and the ELISA is given: Passing-Bablok correlation coefficient (R) of 0.953 (ADL) and 0.942 (IFX), and a mean bias determined by Bland-Altman of 1.59 µg/mL (ADL) and -0.5 µg/mL (IFX), respectively. The sample values gained with BÜHLMANN calibrators showed an excellent correlation with values gained with the WHO international standard for ADL as calibrator. Passing-Bablok regression analysis revealed a slope of 1.3 and correlation coefficient (R) of 1.0.

Conclusion

To the best of our knowledge, the Quantum Blue® ADL and Quantum Blue® IFX, are the first commercially available quantitative lateral flow assays comprising a WHO based standardization. Additionally, it was demonstrated that the current standardizations of Quantum Blue® ADL correlates very well with the WHO international standard for ADL.
P268 Ileal Pouch-Anal Anastomosis Complications and Pouch Failure: A Systematic Review and Meta-Analysis
Authors: Heuthorst L , Wasmann K , Reijntjes M , Hompes R , Buskens C , Bemelman W
Published: May 2021

Background

Previous studies demonstrated wide variation in postoperative complication rates following ileal pouch-anal anastomosis (IPAA). This systematic review aims to assess the incidence of pouch failure and the correlation between IPAA-related complications and pouch failure.

Methods

A systematic review was performed by searching the MEDLINE, EMBASE, and Cochrane Library databases for studies reporting on pouch failure published from 1 January 2010 to 6 May 2020. A meta-analysis was performed using a random effects model. The relationship between pouch-related complications and pouch failure was assessed using Spearman’s correlations.

Results

Thirty studies comprising 22,978 patients were included. Included studies contained heterogenic patient populations, different procedural stages, varying definitions for IPAA-related complications, and different follow-up periods. The pooled pouch failure rate was 7.7% (95%CI5.56–10.59) and 10.3% (95%CI7.24–14.30) for studies with a median follow-up of ≥5 years and ≥10 years, respectively. Observed IPAA-related complications were anastomotic leakage (1–17%), pelvic sepsis (2–18%), fistula (1–30%), stricture (1–34%), pouchitis (11–61%) and Crohn’s disease of the pouch (0–18%). Pelvic sepsis (r=0.51, p<0.05) and fistula (r=0.63, p<0.01) were correlated with pouch failure. A sensitivity analysis including studies with a median follow-up of ≥5 years indicated that only fistula was significantly correlated with pouch failure (r=0.77, p<0.01).

Conclusion

Long-term pouch failure was correlated with fistula, suggesting that early septic complications may result in fistula formation during long-term follow-up, leading to increased risk of pouch failure. Pouch survival may be improved through standardized assessment of anastomotic integrity for early identification and adequate management of anastomotic leaks.
P303 Local Application of Autologous Platelet-rich Plasma leads to Sustained Healing of Crohn’s Perianal Fistulae – One Year follow-up Results from a Single Center Pilot Study
Authors: Podmanicky D , Jezberova M , Lucenicova J , Bak V , Kadleckova B , Zelinkova Z
Published: May 2021

Background

Failure of wound repair and dysregulated inflammation in considered to play a key role in the persistence of Crohn’s perianal fistulae (pCD). Few preliminary reports suggest that autologous platelet-rich plasma (PRP) can enhance wound repair and may be effective in treating pCD. Therefore, the aim of our study was to determine the efficacy of autologous PRP in the treatment of pCD.

Methods

A prospective, uncontrolled, single center study in a referral IBD center was conducted between July 2018 and March 2021. Adult Crohn′s disease patients with pCD failing on antibiotics, immune suppression and/or biologics were eligible for the study. All patients had non-cutting setons for a minimal period of 6 weeks prior study intervention. Autologous PRP was separated by centrifugation 60 ml of peripheral blood in Harvest SmartPrep© System at the time of operation. After the seton removing, internal openings were closed by PDS 2/0 single suture and PRP was injected close to internal openings and fistula tracts. Patients were examined at outpatient clinic at week 1, month 1, 3, 6 and 12. Any suspected side-effects of the treatment were noted. Treatment effect was assessed by perianal Crohn Disease Activity Index (PCDAI assessed at baseline, month 1, 3, 6, 12) and van Assche MRI score (assessed at baseline and month 6 and 12). The primary end-point was complete healing at month 6 defined as closure of all external fistula openings and absence of abscess on MRI. The secondary end-point was sustained response at month 12.

Results

In total, 25 patients (pts) with pCD were included (mean age 36 years, range 21-61; 15 men). The majority of pts were using antiTNF biologics (9 adalimumab, 9 infliximab), 4 pts were treated by ustekinumab, one by vedolizumab, two patients were on immunomodulators monotherapy. By March 2021, 24 patients finished the 6 months and 21 patients the 12 months follow-up. The primary end-point of complete healing at month 6 was reached by 18 out of 24 pts (75%). All but one patients with complete healing had persistent complete healing at 12 months follow-up. Baseline PCDAI (median 5, range 2-15) decreased significantly as early as at month 1 (median 1, range 0-8; p<0.001) and remained further stable over 12 months. Van Assche MRI score decreased significantly from median of 9 (range 3-18) at baseline to 5 (range 0-18) and 5.5 (range 0-18) at month 6 (p=0.001) and 12 (p=0.03); respectively.

Conclusion

Local application of autologous platelet-rich plasma leads to rapid healing of difficult-to-treat Crohn’s perianal fistulae in 75% of patients and this effect is sustained up to minimal period of one year.
P327 Long-term effectiveness of ustekinumab in refractory Crohn’s disease: an Italian multicenter real-life study
Authors: Scribano M L , Aratari A , Neri B , Bezzio C , Balestrieri P , Falasco G , Camastra C , Pantanella P , Monterubbianesi R , Tullio A , Saibeni S , Papi C , Biancone L , Cosintino R , Faggiani R
Published: May 2021

Background

Ustekinumab (UST) is increasingly used in Italy for the treatment of refractory Crohn’s disease (CD), however very few data concerning real-life experience has been reported. Therefore, the aim of this study was to assess the long-term effectiveness of UST in refractory CD patients treated in a large Italian cohort.

Methods

A retrospective study was conducted in 5 Italian tertiary centers. All adult CD patients who started UST because of anti-tumor necrosis factor (TNF) failure were included. The co-primary outcomes were steroid-free clinical remission (defined as Harvey Bradshaw Index, HBI ≤4) at weeks 26 and 52. Secondary outcomes were changes in HBI score, changes in C-reactive protein (CRP) values, normalization of CRP (≤0.5 mg/dl) at weeks 8, 26, and 52, and adverse events. Categorical variables were expressed as frequency and percentage. Unpaired t-test was used to compare variables. A p-value <0.05 indicated statistical significance. Continuous variables were expressed as mean and standard deviation (SD), and median with interquartile range (IQR).

Results

Between Nov 2018 and Feb 2020,140 patients (51.4% male; median age 45.0 years, IQR 36.3-54.0; median disease duration 16.0 years, IQR 8.0-22.0) were included. The majority of patients had ileocolonic disease (L1, 38.6%; L2, 11.4%; L3, 50.0%) and an inflammatory phenotype (B1, 50.7%; B2, 31.0%; B3, 18.3%). All patients had previously been exposed to at least one anti-TNF agent, 27.1% to 2 anti-TNF agents, and 20.0% to vedolizumab . At inclusion 15.7% of patients received corticosteroids and 8.6% immunomodulators. All patients received an intravenous dose of 6 mg/kg, followed by subcutaneous administration of 90 mg every 8 (90%) or 12 weeks (10%) according to clinical judgment. The proportion of patients achieving steroid-free clinical remission was 61.0% and 64.2% at weeks 26 and 52 respectively. A significant decrease in the mean HBI was reported from baseline to week 8 (6.8 ± 3.6 vs 4.5 ± 3.1; p <0.001), week 26 (3.5 ± 2.9; p <0.001), and week 52 (3.1 ± 2.4; p <0.001). The mean CRP values was also significantly decreased from baseline to week 8 (4.6 ± 7.3 vs 2.8 ± 7.1; p <0.001), week 26 (1.7 ± 3.8; p <0.001), and week 52 (1.1 ± 2.2; p<0.001). At baseline 93 of 119 patients had high CRP value: a normal CRP value was observed in 34.9%, 37.8%, and 49.3% of patients at weeks 8, 26, and 52 respectively. Overall, 11 patients (7.9%) discontinued UST within 1 year: primary failure (n=2), secondary failure (n=6), adverse events (n=3: 2 allergic reactions, and 1 arthralgia).

Conclusion

To our knowledge this is one of the largest Italian cohort followed up to 1 year, and the results confirm that UST is an effective and safe treatment in refractory CD patients.
P360 Aggressive Inflammatory Bowel Disease is associated to Hermansky-Pudlak Syndrome: Characterization of a Puerto Rican Cohort
Authors: Marrero Torres R , Coste-Sibilia S , Nieves-Jimenez H , Torres G , Rivera E , Torres E A
Published: May 2021

Background

Hermansky-Pudlak Syndrome (HPS), a rare autosomal recessive disorder, is the most common single-gene disorder in Puerto Rico. It is characterized by an aberrant biogenesis of lysosome-related organelles inducing oculocutaneous albinism, bleeding diathesis, and damage to other organs. Around 30% of patients with HPS develop granulomatous enterocolitis, a Crohn’s-like inflammatory bowel disease (IBD). The mutant HPS1 gene is associated with a more severe Early Onset IBD (EO-IBD). We wish to describe a group of patients with HPS-associated IBD.

Methods

Puerto Ricans with HPS and concomitant IBD were recruited in our IBD clinic for a prospective cohort study. After informed consent, demographic and medical data were collected from the patient and the medical record. Variables included sex, HPS genotype, age at the time of IBD diagnosis, IBD location and behavior according to Montreal and Paris Classification, surgical interventions, medications, and extra-intestinal manifestations (EIM). Descriptive analysis was performed calculating mean and standard deviations. This study is approved by the MSC IRB.

Results

13 patients with HPS and IBD, 9 with confirmed genotype 1, were identified: 8 males and 5 females. The mean age at the time of IBD diagnosis was 22 ± 11 years. 6 were diagnosed at ≤ 16 y/o (A1), 6 were diagnosed between 17-40 years (A2) and 1 patient was in the range of EO-IBD (7 y/o). 9 patients had advanced penetrating behavior (B3) of which 7 had concomitant perianal involvement. Most patients (9) had a surgical intervention; 8 have an ostomy. The majority (10) are using biologics (4 with concurrent immunomodulators). The most frequent EIM was peripheral arthropathy seen in 45%.

Conclusion

HPS patients had a severe course of IBD, as shown by age at diagnosis, phenotype, the prevalence of perianal disease, surgery and use of biologics. In comparison to a database of 836 Puerto Ricans with non HPS Crohn’s Disease, those with HPS were more likely to have surgeries (69% vs 55%, P=.303) and use biologics (77% vs 43%, P=.015). Gastrointestinal symptoms including bleeding may be overlooked by the primary physician. Proactive vigilance in patients with HPS to make an early diagnosis of IBD and aggressive medical treatment may result in better outcomes for these patients.
P385 Results of a teleconsultation campaign for Inflammatory Bowel Disease (IBD) patients to check their treatment adherence and assess their level of anxiety during the first COVID-19 lockdown
Authors: Paupard T , Richez C , Verlynde J , Zaharia O , Quartier G , Hudziak H , Delhoustal L
Published: May 2021

Background

Long-term treatment adherence of patients treated for IBD is quite low, around 50% according to literature. Patients are often suspicious of the infectious risks vis-à-vis immunosuppressants and in particular biotherapies.

Methods

Analysis of the treatment adherence and the level of anxiety of IBD patients treated by immunosuppressants during the first French COVID-19 lockdown.

Monocentric prospective observational study.

Teleconsultations were made by the same gastroenterologist not usually involved in patient care, using randomly an active file of 96 IBD patients monitored in a database (Focus MICI®). Treatments: Corticosteroids n = 0; Azathioprine n = 2; Adalimumab n = 9; Infliximab n= 44 (53%); Golimumab n = 1; Vedolizumab n = 11; Tofacitinib n = 0; Methotrexate n = 3; Ustekinumab n = 5; Combotherapy n = 20.

Results

Calls from 09/4 to 07/5 2020. 13/96 (13.5%) unreachable patients (answering machine, wrong number, no answer, working, etc.). No call was refused when patients were reached. Analysis on 83 patients. Average age: 41.7 years; M / F (55/41) [20-80]. Crohn / RCH: 72/24. Call duration: 5 to 22 minutes. Clinical remission estimated by the patient: Yes / No: 73/10 (88%). Clinical signs possibly linked to Covid: 9/86 (10.4%); discontinuation of treatment: 2/9 (22%). Finally, the treatment was stopped for 11/83 (13%) patients in this IBD population, most of them were in remission. Only 2/9 (22%) with potential Covid symptoms had stopped their treatment. On an anxiety scale from 1 to 10, 41% of patients were moderately to very worried. Among the main fears: increased risk of Covid-19 infection during treatment and fear of coming to the hospital during the epidemic (nosocomial risk). None of the patients spontaneously took the initiative to call first their referent gastroenterologist to discuss the situation. For the others (87%), continuation of treatment with an adherence estimated between 8 and 10 on a scale from 1 to 10.

Results of the call

the phone call was generally much appreciated by IBD patients. Most of the patients were reassured and convinced to continue their treatment and to contact their referent gastroenterologist.

Conclusion

Our results show that the first Covid-19 lockdown was responsible for a high level of anxiety among patients (41%) and a negative effect on patient compliance (not necessarily potential Covid + patients). Advantages of teleconsultation: good acceptability, excellent effectiveness in terms of reassurance and treatment adherence. The cessation of the treatment was in most cases hidden to the doctor. We think that there is a subsequent interest in maintaining tele/visio consultations in addition to face-to-face consultations.
P467 Perception Gap between Patients with Inflammatory Bowel Disease (IBD) and Physicians in China: A Cross-sectional Study
Authors: Liang J , Cao Q , Chen M , Wu K
Published: May 2021

Background

The aim of the study was to assess the perception of inflammatory bowel disease (IBD) among Chinese patients and physicians.

Methods

Data in this cross-sectional study was collected from 6/2020 to 8/2020, which covered 24 provinces/cities in China and based on two surveys that was designed for collecting information from patients with Crohn’s disease (CD)/ulcerative colitis (UC) and the physicians.

Results

Surveys were completed by 1058 patients (601 CD and 457 UC patients) and 351 physicians (181 treating CD and 170 treating UC). For the control of disease symptoms over the past 12 months, physicians believed that 65.19% and 57.65% of CD and UC patients, respectively, were managed without affecting their quality of life. Meanwhile, 56.07% and 49.46% of CD and UC patients, respectively, reported that disease control did not affect their quality of life. Physicians estimated that 87.85% of CD and 88.24% of UC patients were satisfied with treatment results. And 86.36% of CD and 79.43% of UC patients were satisfied with the current medications. Physicians prescribed biologics for 69.52% of IBD patients, and 48.3% of IBD patients actually used them. Repeated medication (30.95%), diarrhea (27.95%) and abdominal pain (25.29%) were most frequently ranked as most bothersome symptoms by CD patients. For physicians, abdominal pain (42.54%) was the most bothersome symptoms, followed by repeated medication (23.76%) and diarrhea (17.13%). Regarding UC symptoms, 51.18% of physicians believed that bloody stool was the most bothersome symptom for patients, and 41.58% of patients held this view. The sense of urgency was concerned as one bothersome symptom by 19.69% patients, while only 4.12% of physicians held the same views (Fig 1). Regarding the efficacy evaluation, in view of the CD physicians, 42.5% of CD patients were believed achieving completely or mostly controlled, while from the patients’ perception, only 32.6% of CD patients agreed. Similarly, the proportion of UC patients who was believed by physicians that achieving completely or mostly controlled (40.0%) was also higher than that of UC patients who believed by themselves (Fig 2).

Conclusion

Most of the IBD patients and physicians were satisfied with the treatment results and the current medications. The disease control expectation of the patients was slightly more than that of the physicians. Further studies are needed to explore factors that associated with the treatment expectation of the patients.
P479 Biological therapies and bio-microbial dynamics in inflammatory bowel diseases
Authors: Tavakoli Medical scientist P , Vollmer-Conna U , Hadzi-Pavlovic D , Grimm M C , Vázquez-Campos X
Published: May 2021

Background

Therapeutic aims in IBDs are to induce remission through rapidly effective treatment. Conventional therapeutic methods including immunosuppression have been available for more than half a century with biological therapies the treatment of choice in patients who fail immunosuppressive drugs. There has been little attempt to longitudinally examine the differences in biopsychological factors and their associations with treatment modalities in IBD patients.

Methods

50 IBD participants (24 UC, 26 CD) in clinical remission were followed for 12 months. Complete longitudinal datasets and monthly stool and blood samples for inflammatory biomarkers were collected for analysis of association. Microbiome analysis was performed using V4 16SrRNA for identification of microbial phylogenetic relationships. Patients were grouped on whether or not they were in remission and on biological agents.

Results

At the baseline there were similar ecological indices between the two treatment options in both disease classes; (Shannon, p = 0.380; Pielou’s, p = 0.246; Chao1, p = 0.934). At family level, the CD group showed significant differences (Wilcoxon, p ≤ 0.05) between the treatment received (biologics vs non-biologic) in the abundance of Barnesiellaceae, Bifidobacteriaceae, unclassified Clostridia, and Clostridiaceae (Figure 1A). Results showed similar ecological index values in samples from the two treatment options.

Samples in UC groups on biological and non-biologic treatment modes were found to have significantly different microbial communities based on Bray-Curtis dissimilarity (PERMANOVA, p = 0.0031). Microbial family composition in UC group and on two treatment modalities showed a total of 12 families that were significantly different (Wilcoxon, p ≤ 0.05): Acidaminococcaceae, unclassified Bacteroidales, Barnesiellaceae, Christensenellaceae, Clostridiales vadinBB60 group, Coriobacteriaceae, Defluvitaleaceae, Eggerthelaceaem Fusobacteriaceae, Muribaculaceae, Prevotellaceae, and Streptococcaceae (Figure1B). Results identified significant differences in microbial diversity (Shannon index, p = 0.041), and evenness (Pielou’s evenness, p = 0.045) between the two treatment modes. No differences were identified in richness (Chao1) in UC participants.

Conclusion

Conclusion: Baseline biological indices were mostly similarly distributed between the two treatment options in remissive IBD patients, however biological therapy significantly influenced longitudinal trends of some microbiome dynamics, especially in UC. This suggests an underlying interrelationship between mode of treatment and biopsychological trajectories which might overshadow response to the treatment, requiring further assessment.
P510 Postoperative enterocoutaneous fistula after surgery for Crohn’s disease performed in a tertiary centre over 15 years: analysis of the long-term outcomes and predictors of fistula closure
Authors: Parlanti1 D , Poggioli G , Cardelli S , Tanzanu M , Boschi L , Rottoli M
Published: May 2021

Background

Patients with Crohn’s disease (CD) have an increased risk to develop enterocoutaneous fistula (ECF) after surgery. Although conservative therapy could be advisable, in some cases surgery is unavoidable, despite there might be greater risks of intestinal failure associated with redo surgery.

Methods

CD patients affected by postoperative ECF (within 90 days from surgery) between 2004 and 2020, and followed for at least 3 months after the onset of the ECF, were retrospectively included. Variables were presented as median (range) or number (%).Chi-square, Fisher’s exact and Wilcoxon rank sum tests were used as appropriate. The Kaplan-Meier method was performed to analyse the rate of ECF closure over the follow-up time, and to compare the outcome between subgroups of patients.

Results

Eighteen patients were included in the study. The perioperative variables are reported in Figure 1.

The median follow-up time was 29.5 months (range 0–204), and the median time to ECF closure was 104 days (24–954), although a clinical remission (defined as an ECG non requiring hospitalization) was obtained after a median time of 41 days (15–768). The comparison of the rates of ECF closure between subgroups of patients over the follow-up are reported in Figure 2 and 3.

Conclusion

The ECF output is the only variable which is significantly associated with the rate of ECF closure. The origin of ECF from an ileo-colic or a colo-colic anastomosis seems to be associated with a faster progression towards fistula healing as compared to an origin from the small bowel (ECF closure at 3 and 6 months: 56.3% vs 22.2% and 70.8% vs 33.3%, respectively; p=0.19). The use of NPWT and, when feasible, an early surgical treatment, might increase the chance of ECF closure within 3 months (55.5% vs 12.5%, p=0.43 and 66.7% vs 29.9%, p=0.32, respectively).

Although postoperative ECF represents a challenging complication in CD, the present study shows that a complete closure is obtainable in the long-term in all patients treated in a referral centre.
P558 Medication Preference of 400 patients with mild to moderate Ulcerative Colitis
Authors: Mackenzie-Smith L , Wüthrich H , Laoun R
Published: May 2021

Background

Patient adherence to his/her medication is a major challenge in the successful management of any chronic disease and it is a major challenge in Ulcerative Colitis (UC). Patient adherence is thought to be closely related to patient preference of medication and formulation used.

We wanted to investigate the patient preference between tablets and granules of mesalazine and compare it to the physician perception.

Methods

We conducted an online survey between November and December 2020 in 4 EU countries (France, Germany, Spain, and the UK). In addition to patients and physicians from these 4 countries, the questionnaire was also addressed to IBD nurses from the UK. Patients were included if they had mild or moderate UC.

Results

400 patients, 160 physicians, 20 nurses participated in this survey. 68% patients were taking tablets and 32% granules. 62% of the patients who answered the survey admitted their preference for tablet while only 38% for granules (figure 1). 63.9% of the physician would prefer to prescribe tablets for their patients.

Physicians stated that patients tend to be more adherent to tablets than granules (69% vs. 31%) and patients tend to find this the most convenient formulation.

When patients were asked about some positive attributes of tablets, the highest agreement was with “good size, easy to see and handle” (7.6/10) while for granules “no problem to take granules in public” (8.4/10).

When asked about some negative attributes of tablets, the highest agreement was with “I would like to take fewer each day” (6.1/10) and “I wish I could take fewer at a time” (5.4/10) while for granules “you have to drink a lot of liquid for them to go down” (6.6/10) and “I wish I could take fewer” (5.1/10).

50 patients were switched to tablets after trying granules first and 45 to granules after trying tablets. Treatment changes were initiated mainly by the physician (57% of the time). Patients switching to granules almost all agreed that they wanted to take fewer tablets each day (8.1/10). Patients switching to tablets complained about the need to drink a lot of water with granules (6.5/10) or to mix them with food (6.3/10).

This is also reflected in the way patients take tablets (figure 2) or granules (figure 3). While 71% of the patients swallow the tablets whole only 35% of the patients swallow all the granules at once. 37% mix the granules with food or liquid, 20% divide the portions to be able to swallow them and 8% chew the granules.

Asked about adherence, only 21% (85 patients) admitted taking less than 80% of prescribed medication.

Conclusion

The majority of the patients prefer the tablet formulation. A high strength tablet overcoming the pill burden could be a good solution to address patient expectations.
P614 A strategy to solve complexity of physician diagnosis using a mixture of Patient Reports and Provider Reports: A Case Study of Crohn’s Disease Phenotypes
Authors: Zhang L , Fan Y , Thompson J , Bohn R , Negar O , Brodovicz K , Parakkal D
Published: May 2021

Background

The IBD Plexus® Registry, established by the US Crohn’s & Colitis Foundation, combines patient and provider reported survey data collected from doctors’ visits and historical data in electronic medical record (EMR) systems. This multi-resource dataset presents data discrepancies in assessing phenotypes of Crohn’s disease (CD). The aim of this analysis is to describe a strategic process to solve data challenges related to CD phenotype definitions based on the IBD Plexus data.

Methods

This cross-sectional, multicenter, US based study used data from 11/2016 to 06/2020 from the IBD Plexus® Sparc program to assess demographics, symptoms and treatments among CD patients. Data discrepancies between CD phenotype status reported and as described in historical EMRs were identified. Physicians may use the Montreal classification with/without the Paris modification for phenotype evaluation. To resolve this discrepancy, we explored and evaluated several study phenotype definitions: 1) using phenotypes at visits, the registry suggested method; 2) using phenotype and history of fistula/abscess or stricture in EMR; and 3) using definition 2 without anal stricture. The implementation included two steps: 1) severe conditions (penetrating, stricturing or both) were considered irreversible and defined using the data at any time before 30 days after the registry consent date; 2) the inflammatory condition was positive in the absence of any other reported severe condition during the entire study period.

Results

The frequency results by phenotypes show small differences across definitions (Figure 1). The discrepancy in frequency by definition1 demonstrated the phenotypes recorded at visits contradicted phenotypes in the EMR. For instance, 0.1%-3.2% or 0.1–0.7% of CD inflammatory patients had subtypes of stricture and subtypes of fistula/abscess, respectively. About 0.5% of CD stricturing patients had intra-abdominal abscess or other fistula (Figure 2). Among CD penetrating patients, 32.0% had history of ileal stricture (Figure 3). Including EMR phenotype variables in definition 2, all discrepancies were resolved. With verification, anal strictures are due to perianal disease which should not be used in the stricturing definition; therefore, the anal stricture was exempt from definition 3. All subtype phenotypes showed 0% discrepancy with study phenotype. A small percentage of positive anal stricture patients was allowed in definition 3.

Figure 1.

Figure 2.

Figure 3.

Figure 4.

Conclusion

When handling the mixture of patient reported and provider-reported data, data discrepancies have many causes. Clarifying the clinical rationale is a key process to resolve discrepancies and accurately define measures of interest.
P617 Trends in Pediatric Inflammatory Bowel Disease-attributable direct costs: A Canadian population-based analysis
Authors: El-Matary W , Nugent Z , Witt J , Bernstein C
Published: May 2021

Background

Background: In addition to its symptomatic burden, inflammatory bowel disease (IBD) has a major financial burden on patients and healthcare systems. However, there is a paucity of evidence on IBD-attributable costs in children. In a population-based analysis, we determined the trends of IBD-attributable direct costs over 22 years.

Methods

Data were extracted from Manitoba Health Provider Claims, and other population registry datasets from 1995 to 2017. Children with IBD were matched by age, sex, and location with children without IBD. IBD-attributable direct costs were calculated using utilization counts from the administrative data and cost estimates from different sources. Inpatient hospitalization and outpatient procedure costs were estimated using the resource intensity weight (RIW) that is attached to each record in the data. Costs were expressed in 2018 Canadian dollars.

Results

We included 733 (428 with Crohn’s disease) prevalent cases who were diagnosed with IBD before the age of 18 years and were followed for 2450 person-years. An age, sex and geography matched control group of 6763 persons without IBD who were followed for 21558 person-years was included. The median annual physician’s billing fees increased from $381 (IQR 215–1064) in 1995 to $936 (IQR 579–1932) in 2017 (p<.001). The annual ambulatory care days for persons with IBD also significantly increased from a median of 8 days per year (IQR 5–13) in 1995 to 12 days per year (IQR 8–17) in 2017 (p < 0.0001) while they remained stable (median 2 days per year) in the control group (p=0.12). The annual medication costs per patient increased from a median of $270.9 in 1995 to $7944 in 2017 (p<.0001). Between 2012 and 2017, the median annual medication costs for all persons on anti-tumor necrosis factor (TNF) medications were $28,582 (IQR 21854–36736)compared to $861for persons with IBD not on an anti-TNF agent (IQR 355–1,714) (p<0.0001) with a relatively stable costs over the 5-year period. The median annual direct costs per patient with IBD was $1810.716 in 2004 as compared to $14791.55 (p<.0001) in 2017.

Conclusion

Over 2 decades, there was a significant increase in the pediatric IBD-attributable direct costs mainly driven by medication costs mainly anti-TNF biologics.