bluuebunny/crossref_metadata_2025_split huggingface dataset:
P571 Self-Medication with steroids in ulcerative colitis: Results of a patient survey
Authors: Mesonero Gismero F , Rodriguez-Lago I , Cañas M , Claudia S , Saldaña R , Feo-Lucas L , Fernandez S , Cea-Calvo L , Juliá B 
Published: January 2020

Abstract

Background
Medical treatment of mild-to-moderate flares of ulcerative colitis (UC) is based on topical and oral mesalazine, steroids or a combination of both. Sometimes self-medication with any of them can occur during a flare and it could interfere with clinical practice. Our aim was to assess the prevalence of self-medication with steroids in UC-patients and the reasons for this behaviour.

Methods
An anonymous cross-sectional survey was developed by representatives of the Spanish working group on Crohn’s disease and UC (GETECCU), the Spanish nursing working group on Inflammatory bowel disease (IBD) (GETEII) and the Spanish associations of patients with CD and UC (ACCU). A link to the online survey was distributed to adult UC patients through 50 Spanish IBD units as well as in the ACCU webpage. Participants voluntarily answered to the survey based on their own experiences.

Results
A total of 546 patients were included, 61% women, mean age 40 years old. Half of them (51%) were followed-up by IBD specialists, while 47% by general gastroenterologists. Thirty-six (6.6%) patients self-medicated with steroids. The main reasons to self-medicate with steroids were the need for quick relief of symptoms (n = 20, 56%), fear of worsening (n = 17, 47%) and difficulty for getting a medical appointment or being previously prescribed by the doctor (n = 9, 25%, both). Sixty-four per cent of them self-medicate once per year, while 8% self-medicate more than three times per year. Of these patients, 175 (32%) reported that self-medication lasted less than one month, while in 9 (18%) lasted for more than 3 months. Factors related to self-medication with steroids were the increased number of flares (p &lt; 0.001), living with someone who uses oral steroids (p = 0.04), keeping the steroids left after finishing the treatment (p &lt; 0.001), and prescription of corticosteroids in case of worsening by the primary care doctor (p = 0.02). Self-medication was less frequent in those patients who were attended by an IBD specialist (11, 3%), compared of those followed by an internal medicine physician (2, 33%), (p = 0.007), or by a general gastroenterologist (n = 23, 9%), (p = 0.02). Multivariate analysis showed that a higher number of flares [OR 7 (95% CI: 1–32), p &lt; 0.001] and being attended by a general gastroenterologist [OR 0.08 (95% CI=0.01–0.5), p = 0.007] were both associated with a greater frequency of self-medication.

Conclusion
Self-medication with steroids is not a common practice in patients with UC from Spain. However, there is still room for improvement in clinical practice. Characteristics of the healthcare system and the disease may influence the rate of self-medication in UC patients.
This project was endorsed by GETECCU, GETEII, ACCU and funded by MSD Spain.
P578 Inter-observer agreement of an expert panel for gastrointestinal ultrasound in ulcerative colitis
Authors: de Voogd F , Wilkens R , Gecse K , Allocca M , Novak K , Lu C , D’Haens G , Maaser C 
Published: January 2020

Abstract

Background
Gastrointestinal ultrasound (GIUS) is increasingly performed in inflammatory bowel disease to assess disease activity and treatment response. It is promising as an effective point-of-care imaging tool since it correlates well with endoscopy and other cross-sectional imaging modalities. Previous studies showed moderate to substantial interobserver agreement in Crohn’s disease. However, in ulcerative colitis (UC) inter-observer agreement for GIUS has not yet been evaluated. Therefore, we conducted a study to assess inter-observer agreement in UC.

Methods
Thirty patients with UC (five with clinically quiescent and 25 with active disease) were included in this study. Cine-loops were recorded for the sigmoid colon (SC) in a longitudinal and cross-sectional axis in B-mode and in colour Doppler mode. Cine-loops were scored by five independent raters blinded for clinical disease activity. The cine-loops were scored for bowel wall thickness (BWT), Doppler activity (0=no activity, 1=small spots limited to the bowel wall, 2=long stretches within the bowel wall, 3=long stretches within and outside of the bowel wall), inflammatory fat, bowel wall stratification, loss of haustration and lymph nodes (present or absent). The intraclass correlation coefficient was used for the assessment of bowel wall thickness. Fleiss’ kappa was used for all nominal variables and weighted Cohen’s kappa was used for all ordinal variables.

Results
Inter-observer agreement was good for bowel wall thickness (ICC: 0.7, 95% CI: 0.51–0.83, p &lt; 0.0001) [1] and moderate for Doppler signal (k=0.57, 95% CI: 0.37–0.77, p &lt; 0.0001) [2]. When Doppler signal was interpreted as absent (0) or present (1–3) the observed agreement was almost perfect (k=0.81, 95% CI: 0.69–0.92). For inflammatory fat the observed agreement was moderate (k=0.42, 95% CI: 0.29–0.58, p &lt; 0.0001). Inter-observer agreement was fair for the presence of lymph nodes (k=0.35, 95% CI:0.20–0.49, p &lt; 0.0001) and loss of stratification (k=0.22 95% CI: 0.09–0.35, p &lt; 0.001). Agreement was slight for loss of haustrations (k=0.15, 95% CI: 0.00–0.29, p = 0.046).

Conclusion
GIUS is a reliable imaging modality with good to moderate interobserver agreement for BWT, vascularisation and fatty wrapping in UC. These ultrasonographic parameters are important features to distinguish active from quiescent disease.

References
P581 Allogeneic expanded adipose-derived mesenchymal stem cell therapy for perianal fistulas in Crohn’s disease: First real-life experiences
Authors: Schreiner P O , Biedermann L , Rogler G , Turina M , Cabalzar D 
Published: January 2020

Abstract

Background
Since treatment of perianal fistulas in patients with Crohn’s disease (CD) has low durable fistula closure rates even with optimal medical and surgical therapy, new therapies are needed. According to a pivotal phase 3 study program, darvadstrocel, a mesenchymal stem cell therapy, appears to be a promising new treatment option after failure or incomplete response to biologics and immunosuppressive agents. However, until now, no data on the real-life efficacy of darvadstrocel is available.

Methods
A total of 7 CD patients with complex perianal fistulas without luminal disease were treated with local injection of 120 million allogenic adipose-derived stem cells at our academic tertiary referral centre on an outpatient basis. MRI and fistula conditioning with seton loop placement were performed at least 6 weeks pre-operatively. Furthermore, CD remission was confirmed endoscopically in advance.

Results
The mean age of patients was 39.4 years, 86% were male and 29% smokers. The mean duration of fistula manifestation was 8.1 years. All patients (except one treated with tacrolimus) had previously received anti-TNF treatment without fistula healing. One patient had CD of an ileoanal pouch following restorative proctocolectomy. Postoperatively, the secretion from the wounds stopped after a few days and in 2 patients clinically fistula healing occurred already after 4 weeks. In 3 patients the fistulas healed after 6 weeks. One patient developed repeated abscesses without fistula healing. Another patient showed improvement of symptoms but without healing of the fistula at 8 weeks. Interestingly, symptomatic CMV viremia occurred two weeks after darvadstrocel injection in one patient, but his two fistulas healed.

Conclusion
Our initial experience of seven patients treated with darvadstrocel for perianal CD fistulas demonstrates promising results with rapid resolution of local complaints and full clinical healing in five patients until now. Taken together, darvadstrocel appears to be a promising therapeutic option for the challenging group of patients suffering from complex perianal CD fistulas.
P587 Adalimumab in pediatric Crohn’s disease: A long-term multi-centre real-world experience
Authors: Lawrence S , Huynh H , El-Matary W , DeBruyn J , Carroll M , Wine E , Chan J , Jacobson K 
Published: January 2020

Abstract

Background
There is a paucity of data regarding long-term outcomes for adalimumab (ADA) in pediatric Crohn’s disease (CD). We describe the long-term effectiveness of ADA, in achieving clinical and biochemical remission in a Canadian multi-centre pediatric CD cohort. Moreover, we report the effects of prior anti-TNF exposure and use of a concomitant immunomodulator (IM) on durability of clinical and biochemical response. The primary outcome was 24-month corticosteroid (CS) free remission. Secondary objectives included biochemical and faecal calprotectin response over the study period.

Methods
Retrospective review of electronic records of all children aged 3–18 years with CD requiring ADA at 4 centres across Canada (Vancouver, Edmonton, Winnipeg and Calgary) between January 2005 and December 2017.

Results
One hundred and nine children (68% male; median age 13.07 [IQR 10.6–15.1]) with CD (L1 21.7%, L2 28.3%, L3 50%) were included with a median follow-up of 15.9 months [IQR 7.6–24]. Seventy-four patients (67.9%) were anti-tumour necrosis factor (TNF) naïve. Concomitant IM therapy was used in 51 (46.8%). CS free clinical remission at 24 months was observed in 45/66 (68%). Over time, the median PCDAI, CRP, ESR and faecal calprotectin significantly improved (Table 1). During follow-up, 36 (33%) patients discontinued ADA; 6 (5.5%) had primary non-response, 28 (25.7%) had secondary LOR and 2 (1.8%) had intolerance. At 24 months, clinical remission was achieved more frequently in patients who were Anti-TNF naïve (81% vs. 43.5% p 0.002). There was no significant difference in biochemical or faecal calprotectin outcomes between those who were bio-naive or experienced. There was no significant difference in the time to loss of response between those on monotherapy and combination therapy with an IM and ADA (HR 0.64 [95% CI 0.33–1.26] p0.2).

Conclusion
This study demonstrates that ADA is effective and durable in pediatric CD. Over 24 months, clinical, biochemical and faecal calprotectin improvement was seen. In our cohort, clinical response to ADA was greater in anti-TNF naïve compared with anti-TNF experienced patients; however,, biochemical and faecal calprotectin outcomes did not differ. ADA response appears durable with no significant difference in patients on monotherapy or combination therapy.
P591 Therapeutic management in inflammatory bowel disease: Differences in two IBD inception cohorts: 1991–93 and 2010–11 enrolled in the north-west of Spain
Authors: De Castro Parga M L , Hernández V , Sanroman L , Pineda J R , Figueira M , Martinez-Cadilla J , Pereira S , Rodriguez-Prada J I 
Published: January 2020

Abstract

Background
The treatment of IBD has dramatically changed in the last two decades, with the advent of immunosuppressive and biological drugs. The goal of therapy remains to achieve and maintain disease remission, diminishing disease outbreaks as well. Our aim was to show the changes in the therapy management of IBD between 1991 and 2011 at the first disease outbreak and during the first years.

Methods
Retrospective and descriptive study of two inception cohorts of IBD patients aged 15 years or more that were enrolled in the area of Vigo (north-west of Spain) in two European epidemiological studies: EC-IBD performed from 1991 to1993, and EpiCom performed in 2010 and 2011. First disease outbreak includes treatments employed in the first four months from diagnosis of IBD, We review the therapies that were used at 12, 24 and 36 months from These data, and the successive disease flares as well.

Results
Regarding the management of the first outbreak of UC, we found an increase in the use of topical 5-aminosalicylic acid (5-ASA) and a decrease of topical steroids (p = 0.001) in 2010–2011 cohort. Sulfasalazine was only used in 1991–1993 cohort, and immunosuppressive or biological drugs in 2010–2011 (p = 0.004). Neither ciclosporine nor surgical therapy was used in both cohorts. In the first outbreak of CD there was an increase in the utilisation of systemic steroids (p = 0,004) and a reduction in oral 5-ASA (p = 0,02)) in 2010–2011 cohort. The use of immunosuppressive or biological drugs was found only in 2010–2011 (Table 1). At 12, 24 and 36 months after diagnosis of IBD, more patients had received an immunosuppressive drug, or were in a higher therapeutic step in the 2010–2011 cohort, compared with 1991–93 cohort (p = 0,0001) both in CU and CD (Figure 1). There were no differences in the number of disease outbreaks suffered in these periods of time between both cohorts (Figure 2).

Conclusion
The progressive early use of immunosuppressive therapies at the initial outbreak of IBD, and during the first 3 years of disease is clearly demonstrated, although it was not related to a decrease in disease outbreaks.
P596 Risk of colorectal cancer and other malignancies in association with the use of thiopurines, tumour necrosis factor antagonists or mesalazine
Authors: Timeus S , Laoun R 
Published: January 2020

Abstract

Background
Mesalazine, thiopurines and TNF antagonists play an important role in management of inflammatory bowel disease (IBD). It is generally accepted that longstanding ulcerative colitis (UC) is associated with an increased risk of colorectal cancer (CRC). In addition to colorectal cancer, there are data that suggest that IBD is also associated with an increased risk of extra-intestinal malignancies but the results are inconclusive. The evidence concerning the effects of mesalazine on the risk of CRC in IBD patients remains conflicting.

Methods
In this review, cancer-reported outcomes with IBD drugs reported to FAERS (USA) were extracted for adalimumab, infliximab, thiopurines and mesalazine and compared with all other 25’382 drugs in the database. The data were used to calculate reporting odds ratio (ROR) and 95% CI for CRC, lymphoma, Hodgkin’s disease and all cancers outcomes. A sub-analysis was conducted to include patients exposed to mesalazine alone without IBD co-medications.

Results
The databases contained approximately 17 million reports for all drugs of which 401’084 were for adalimumab, 121 562 for infliximab, 11’985 for mesalazine, and 25’286 for thiopurines. Of these, a total of 259 757 concerned cancer-related AEs associated with the drugs under consideration. All IBD drugs were associated with a positive ROR for CRC with infliximab presenting the highest point estimate 8.01 (CI 95% 7.48–8.59) and adalimumab the lowest 2.52 (CI 95% 2.35–2.69). Considering patients exposed to only mesalazine, this association remained positive at 2.39 (CI 95% 1.58–3.59). For lymphoma, all IBD drugs also showed a positive ROR where thiopurines were associated with the highest 7.25 (CI 95% 6.69–7.84) and mesalazine with the lowest 1.46 (CI 95% 1.14 -2.73) point estimate. With regards to patients only exposed to mesalazine, the association showed protective effect, 0.24 (CI 95% 0.13–0.47). For Hodgkin’s disease again all IBD drugs showed a positive ROR where thiopurines were associated with the highest 34.65 (CI 95% 28.88–41.59) and adalimumab with the lowest 4.98 (CI 95% 4.39 -5.65) point estimate. In patients only exposed to mesalazine, no association 0.66 (CI 95% 0.09–4.66) was observed. Considering all cancers only positive ROR were observed where infliximab was associated with the highest 7.31 (CI 95% 7.17–7.45) and mesalazine with the lowest 1.33 (CI 95% 1.17–1.51) point estimate. In patients only exposed to mesalazine, a protective effect 0.73 (CI 95% 0.61–0.88) was observed.

Conclusion
FAERS data showed an association between reported occurrence of cancer and the drugs under consideration. Considering patients only exposed to mesalazine the odds ratio was positive only for colorectal cancer but lower than all other IBD drugs.
P600 Vedolizumab dose optimisation: Findings from a Belgian registry
Authors: Louis E , Muls V , Bossuyt P , Colard A , Nakad A , Baert D , Mana F , Caenepeel P , Vanden Branden S , Vermeire S , D’Heygere F , Strubbe B , Cremer A , Coche J C , Setakhr V , Baert F , Vijverman A , Coenegrachts J L , Flamme F , Hantson A , Wijnen K , Piters E , Hantsbarger G , Dolin P 
Published: January 2020

Abstract

Background
Vedolizumab (VDZ) dose optimisation (DO), by interval shortening from 8-weekly (Q8W) to 4-weekly (Q4W) dosing, is used for patients with secondary loss of response. This report presents outcome data on patients receiving DO in real-world clinical practice in Belgium.

Methods
The Belgian VDZ Registry (ENcePP EUPAS6469) enrolled 202 VDZ-treated ulcerative colitis (UC) or Crohn’s disease (CD) adult patients (26% with no prior use of anti-TNF therapy) from 19 centres. The median length of VDZ therapy prior to enrolment was 11 months. Patients were followed-up every 6 months with the assessment of IBD features, use of biologics, and disease activity. Clinical remission was defined as Harvey–Bradshaw Index (HBI) &lt;5 or partial Mayo Score (pMS) &lt;2, and clinical response as a 2+ point improvement in pMS or a 3+ improvement in HBI.

Results
During a median follow-up of 19 months from enrolment, 57 (28%) patients (41 CD and 16 UC) received VDZ Q4W due to secondary loss of response. Q4W was mostly used in patients with CD or with prior anti-TNF therapy failure. The median starting point for Q4W dosing was 16 months after the start of VDZ (interquartile range (IQR) 8–27 months) and median duration of Q4W dosing was 4 months (IQR 2–8 months). After changing to Q4W dosing 44% achieved clinical remission, 3% clinical response, and 53% showed no improvement (Table 1).
Among the 17 patients with clinical remission/response on Q4W dosing, 53% de-escalated back to Q8W, and continued with Q8W for a median duration of 12 months, 23.5% remained on Q4W with clinical remission, and 23.5% eventually stopped VDZ due to loss of response. A limitation of this study is that it did not systematically collect data on DO prior to recruitment, hence the proportion of patients receiving DO may be higher than reported here.

Conclusion
These real-world data show DO plays an important role in management of UC and CD. In this study, 28% of patients received DO following the secondary loss of response to Q8W therapy. Forty-seven per cent of patients receiving Q4W subsequently returned to clinical remission or had a clinical response, and half of these patients successfully returned to Q8W VDZ therapy. Controlled studies are warranted, ideally blinded, using more objective endpoint to reveal the true success rate of dose-optimisation.
P606 Exclusive enteral nutrition with a polymeric diet is efficacious in inducing remission in adults with active Crohn’s disease
Authors: Kakkadasam Ramaswamy P , Mutsekwa R , Lan X , Chen Y , Angus R , Moattar H , Edwards J , Shukla D 
Published: January 2020

Abstract

Background
Exclusive Enteral nutrition (EEN) is not routinely used as induction therapy for adults with active Crohn’s disease (CD)due to limited adherence and palatability. The aim of this study was to assess the efficacy, tolerability and safety of EEN in adult patients with CD.

Methods
Retrospective analysis of data from patients with active CD who underwent induction therapy with EEN at a single centre from January 2018 to July 2019. All patients who completed at least 4 weeks of polymeric EEN diet were included in the final analysis. Primary Endpoint (PE) was steroid-free clinical remission (CDAI ≤150) or response (100 point decrease in CDAI) at the end of therapy. Secondary endpoint (SE) was achievement of biochemical remission (CRP &lt;5 mg/l or Calprotectin &lt;150 μg/g) at 8–10 weeks.

Results
Sixty-three patients were initiated on EEN, 50 patients who completed at least 4 weeks of EEN were included in the final analysis. Mean age was 42.4 years, 25 (50%) were females. Mean CDAI score at baseline was 260. Forty per cent of patients were on concurrent biologics and 66.6% were on concurrent immunomodulators. At the completion of EEN, 72% (36/50) of patients achieved PE (29 remission, 7 response). SE was achieved in 65.7% (23/35) of patients. EEN duration ≥ 6 weeks was more likely to achieve PE (75% vs. 55.5%, OR 2.7, P 0.01) and SE (71% vs. 25%, OR 7.3, P 0.001).EEN duration &lt; 6 weeks and current smoking were less likely to achieve PE and SE. Patients with concomitant steroid use at baseline had PE of 77.7% (vs. 68.8% with EEN alone; OR 0.9, P 0.5), and SE of 66.6% (vs. 60.9% with EEN alone, OR 0.77, P 0.74). Disease location, behaviour, sex, disease duration, concurrent biologic use or concurrent immunomodulator use did not affect the PE or SE. Six patients reported adverse effects (3 nausea,2 diarrhoea,1 constipation). Male sex, ileal location, B2/B3 phenotype were more likely to complete a 6 week EEN course.

Conclusion
Polymeric EEN is well-tolerated, safe and efficacious in inducing remission in adults with active CD. EEN duration of ≥ 6 weeks has better outcomes. EEN alone or in combination with steroids induces remission in adult patients with active CD. Further controlled trials using polymeric EEN are necessary.
P617 Mesenchymal stromal cells of bone marrow reduce the risk of postoperative recurrence of Crohn’s disease
Authors: Knyazev O , Kagramanova A V , Lishchinskaya A , Parfenov A 
Published: January 2020

Abstract

Background
Crohn’s disease (CD) in the form of terminal ileitis occurs in approximately 1/3 of CD patients and is often complicated by the formation of ileum stricture or ileocecal valve. The operation of choice is resection of ileocecal Department with the formation of ileo of ascendants. Depending on the combination of risk factors, as well as on the effectiveness of previous anti-relapse therapy, patients after surgery should be stratified into groups with different risks of postoperative recurrence. The objective of the study was to evaluate the effectiveness of mesenchymal stem/stromal cells (MS/SC) as anti-relapse therapy in patients with low-risk CD after ileocecal resection.

Methods
Thirty-six patients with CD in the form of terminal ileitis with a stricture of the terminal ileum with signs of intestinal obstruction after the ineffectiveness of the course of conservative therapy (application of GCS) underwent resection of the ileocecal Department with the formation of ileo-ascendoanastomosis. All patients had a low risk of postoperative recurrence of Crohn’s disease. However, the first group of patients aged 19 to 58 years (Me-29) (n = 18) received MS/SC. The second group of patients aged 20 to 68 years (Me-36) (n = 18) received mesalazine 4 gr/day. The follow-up period was 60 months. The monitoring was carried out by endoscopic picture and/or CT-enterography, C-RP level, faecal calprotectin (FCP). Average baseline CRP in the first group was 29.5 ± 3.2 mg/l, in the second – to 27.75 ± 3.0 (p = 0.73), the level of the FCP in the first group 1019.4 ± 97.2 mkg/g, in the second – 998.8±127.3 mkg/g (p = 0,9).

Results
After 24 months in the first group of patients the average level of C-RP was 9.5 ± 1.9 mg/l, in the second group 17.8 ± 3.3 mg/l (p = 0.027). The level of the FCP in the first group 98.0 ± 12.1 mkg/g, in the second 121.7 ± 14.2 mkg/g (p = 0.27). After 24 months of follow-up, 1 (5.5%) patient from the first group (n = 18) had a relapse that required the appointment of GCS. In the second group, relapse occurred in 4 (22.2%) patients out of 18 (RR 0.25; 95% CI 0.031–2.025; p = 0.15). After 60 months in the first group of patients, the average level of C-RP was 10.76 ± 2.1 mg/l, in the second group 19.2 ± 3.5 mg/l (p = 0.039). The level of the FCP in the first group of 100.4 ± 13.7 per mkg/g, in the second 191.7 ± 24.9 mkg /g (p = 0.002). After 60 months of follow-up, 1 (5.5%) patients from the first group had a relapse. In the second group, relapse occurred in 8 (22.2%) patients out of 18 (RR 0.125; 95% CI 0.017–0.9; p = 0.008).

Conclusion
The use of mesenchymal stem/stromal cells (MS/SC) as anti-relapse therapy in patients with low-risk CD after ileocecal resection significantly reduces the risk of postoperative recurrence of CD.