bluuebunny/crossref_metadata_2025_split huggingface dataset:
P421 Prognostic and therapeutic long-term outcome of patients with ulcerative proctitis: analysis from a large referral centre cohort study
Authors: Dubois E , Moens A , Sabino J , Ferrante M , Vermeire S 
Published: January 2020

Abstract

Background
Data about long-term prognostic and therapeutic outcome of patients with ulcerative proctitis (UP) are scarce. Real-world data are very important as these patients are usually excluded from participation in randomised controlled clinical trials.

Methods
All patients diagnosed with ulcerative colitis limited to the rectum (further defined as UP) and followed at our referral centre between 1998 and 2018, were identified via an automated search of electronic medical records and were reviewed for long-term therapeutic outcome. Treatment success was defined as clinical remission (complete disappearance of UP-related symptoms as judged by the treating physician) and endoscopic inactive disease (Mayo endoscopic sub-score of 0 or 1 on sigmoidoscopy) if available at last follow-up.

Results
From a total of 1561 patients with ulcerative colitis (UC), 168 patients with UP were identified (54% female, mean age at diagnosis 36 years). While the majority (118 patients or 70%) had proctitis since diagnosis, another 50/168 (30%) were diagnosed with left-sided colitis or extensive colitis but had a predominant disease course of proctitis afterwards. Nearly, all patients received treatment with 5-ASA but 71 patients (42%) were refractory to rectal ± oral therapy with 5-ASA and corticosteroids necessitating azathioprine in 41 patients (24%) and/or biological therapies in 59 patients (35%). Azathioprine was started as monotherapy in 34 patients. Anti-TNF was the first-line biological in 45 and vedolizumab in 14 patients. After a median follow-up of 76.5 months (IQR 34.3–143.8), clinical remission was observed in 143 patients (85%) and in 52/71 patients with 5-ASA refractory proctitis (73%). In this last group, clinical remission rates were significantly higher for patients treated with biologicals (44/59 or 75%) as compared with patients treated with azathioprine (8/34 or 24%; p &lt; 0.0001).

Conclusion
Ten per cent of patients with ulcerative colitis from our referral centre cohort had disease confined to the rectum. With a median follow-up of more than 6 years, good clinical outcomes were recorded with 85% of patients achieving clinical remission. Nevertheless, more than one third needed escalation to biologicals to control the proctitis. Long-term outcome in patients on biologicals was superior to azathioprine. Our data do not suggest inferior outcomes for patients with proctitis compared with left-sided or extensive colitis.
P430 Feasibility and reliability of gastrointestinal ultrasound in pregnant inflammatory bowel disease patients
Authors: de Voogd F , Joshi H , Van Wassenaer E , D’Haens G , Gecse K 
Published: January 2020

Abstract

Background
Disease activity during pregnancy in women with inflammatory bowel disease (IBD) is associated with miscarriage, preterm delivery and low birth weight. Monitoring disease activity throughout the pregnancy is therefore important. Gastrointestinal ultrasound (GIUS) has a high potential as a point-of-care tool for monitoring disease activity in IBD as it has been shown to correlate well with endoscopy and magnetic resonance imaging. However, data are scarce on the use of GIUS in IBD throughout pregnancy. The aim of this prospective study is to determine the feasibility and reliability of GIUS in pregnant IBD patients.

Methods
Patients were included when visiting the outpatient IBD pregnancy clinic. At each trimester, clinical and biochemical disease activity was evaluated and GIUS was performed. Feasibility was assessed by the ability to visualise each bowel segment (terminal ileum (TI), ascending (AC), transverse (TC), descending (DC) and sigmoid colon (SC)). Reliability was evaluated by using clinical and biochemical disease activity as a gold standard. This was defined as a Harvey–Bradshaw Index ≥4 in Crohn’s disease (CD) or a Simple Clinical Colitis Activity Index ≥5 in ulcerative colitis and a faecal calprotectin (FCP)³ 250 mg/g. Bowel wall thickness (BWT) of &gt; 3 mm in the colon and &gt; 2mm in the terminal ileum was considered as signs of active inflammation on ultrasound. A Mann–Whitney U-test and chi-square were used for statistical analysis.

Results
Thirty-two IBD patients (54% CD) were studied. Both a GIUS and FCP was available in 18, 11 and 6 patients for the first, second and third trimester, respectively. Eleven of 32 (34%) patients had clinically active disease at least at one time point during the pregnancy. Table 1 shows the visibility per segment. When the active disease was defined as an FCP ≥ 250 mg/g, GIUS could distinguish active from the non-active disease in the first, second and third trimester with a sensitivity of 80%, 75% and 75% and specificity of 85%, 86% and 100%, respectively.
FCP levels were significantly higher in patients with an active disease on GIUS regardless of the trimester (mean 1095.5 ± 1453.8 mg/g vs. 265.25 ± 649.8 mg/g, p &lt; 0.0001).

Conclusion
GIUS is accurate to distinguish active from the quiescent disease in pregnancy. Feasibility to visualise the TI and the SC decreased during the second and third trimester, although active disease could still be detected. Consequently, GIUS is feasible and reliable to assess disease activity throughout pregnancy in IBD.
P432 Effects and safety of a colon-long absorbing budesonide product in patients with mild to moderate ulcerative colitis
Authors: Pigniczki D , Szántó K , Rutka M , Farkas K , Bálint A , Bor R , Fábián A , Szepes Z , Molnár T 
Published: January 2020

Abstract

Background
Budesonide is an oral corticosteroid, which is widely used in moderate-to-severe ulcerative colitis (UC) to obtain and maintain remission in those cases, where 5-aminosalicylic-acid was ineffective. Unlike previous forms of budesonide absorbing from the ileal and ascending colon region, the new-generation budesonide-MMX contains a formula, that allows absorption throughout the whole colon, and therefore in the whole potentially inflamed area in UC. We aimed to evaluate the effects and safety of budesonide-MMX in our UC patients who meet the above mentioned therapeutic demands in a real-life study.

Methods
We enrolled 22 patients with mild to severe UC in this single-centre prospective study until August of 2019. Patients received 9 mg oral budesonide-MMX once daily until 8 weeks. Laboratory parameters (cholesterol, triglyceride, CRP) and serum hormone levels (parathormone [PTH], dehydroepiandrosterone [DHEA] and cortisol) were monitored before and after the 8-week therapy to follow metabolic and hormonal changes. During these visits, body composition analysis was also performed with InBody 770 machine to observe the adverse steroid effects of budesonide-MMX in respect of body fat mass, body mass index, protein content of the body and bone mineral content. Disease activity was followed by the partial Mayo (pMayo) score. Statistical analysis was performed by paired t-test and Wilcoxon signed-rank test with SigmaPlot 1.25.

Results
The total of 22 patients (age: 44.4 ± 15.1 years, 6 male and 16 female patients) had received the 2-month budesonide-MMX therapy (2.0 ± 0.3 months). Mean disease duration was 8.3 years. By the end of follow-up, 15 (68.2%) patients experienced remission and 7 patients (31.8%) were primary non-responders. The disease activity decreased significantly from the mean of 3.95 to 1.64 (p &lt; 0.001). No significant changes were observable in case of any body composition analysis parameter. Regarding the laboratory parameters, serum cholesterin level showed a significant increase (p &lt; 0.001), while triglyceride and CRP showed did not show significant changes. Serum cortisol levels were elevated (p &lt; 0.001), while PTH and DHEA showed no significant decrease. Only two patients experienced side effects: one of them hypertonia, headache and acnes, while the other patient experienced mild diarrhoea. One patient had a relapse during the treatment.

Conclusion
In our study, budesonide-MMX proved to be safe by bringing up a low number of side effects, while more than two-thirds of the patients could reach remission with this short-term therapy. Hormonal changes were not mentionable, although the drug’s effects on serum lipid content have to be examined further.
P444 The impact of azathioprine on inflammatory bowel disease patients’ overall health-related quality of life: a single-centre retrospective cohort study
Authors: ALRUTHIA Y , Alsharif W , Almuaythir G , Alrasheed H , Alharbi O , Azzam N , Almadi M , Saeed M , HajkhderMullaissa B , Aljebreen A 
Published: January 2020

Abstract

Background
The Ulcerative Colitis (UC) and Chron’s Disease (CD) are two debilitating Inflammatory Bowel Diseases (IBD) with an immense negative impact on patients’ health-related quality of life (HRQoL). Although several studies have examined the efficacy of different drugs in the management of IBD, none of these studies has assessed their impact on HRQoL among IBD patients in low incidence areas, such as Saudi Arabia. Therefore, the aim of this study was to examine the impact of Azathioprine, which is one of the commonly utilised immunosuppressive drugs, on HRQoL among a sample of IBD patients in Saudi Arabia.

Methods
This was a single-centre retrospective cohort study in which adult patients (≥18 years) with a confirmed diagnosis of UC or CD and no malignancies were identified in the hospital IBD registry. Patients’ HRQoL was assessed using the EuroQol five-dimensions- 3-level (EQ5D) at baseline as well as six months after initiation of therapy. The overall HRQoL was assessed using the Visual Analogue Scale (VAS) of the EQ5D. Multiple linear regression analysis was conducted to examine the impact of Azathioprine on patients’ EQ5D VAS scores at the six-month follow-up visit controlling for their baseline EQ5D VAS scores, duration of illness, sex, diagnosis (CD or UC), comorbidities, number of prescription medications, and the use of biologics (e.g., infliximab, adalimumab), 5-aminosalicylic acid (5-ASA), and steroids.

Results
Out of 220 IBD patients who were recruited, 160 patients met the inclusion criteria and were included in the study. About 56% of the patients had CD and 44% had UC. The mean age of the patients was 27 years and 54% of them were female. The majority of the patients (77%) did not have any comorbidities. Approximately 63% of the patients were on Azathioprine, and only 4% of them were on Azathioprine monotherapy. The majority of those on Azathioprine were on combination therapy with 5-ASA (78%), steroids (80%), and biologics (69%). Patients on Azathioprine were more likely to report higher overall HRQoL scores at the six-month follow-up visit compared with their counterparts on other therapies (β = 9.35; 95% CI: 0.486–18.22; p = 0.003).

Conclusion
The use of Azathioprine was associated with a positive impact on IBD patients’ HRQoL controlling for their baseline overall HRQoL scores as well as a myriad of covariates. Future studies should examine the cost-effectiveness of Azathioprine in comparison to other therapeutic agents in the management of IBD.
P448 Dose adjustment in patients with moderate-to-severe ulcerative colitis: results from the UNIFI maintenance study long-term extension
Authors: Danese S , Panaccione R , Peyrin-Biroulet L , Marano C , O’Brien C D , Zhang H , Zhou Y , Johanns J , Scherl E , Leong R W L , Rowbotham D S , Arasaradnam R P , Sands B E 
Published: January 2020

Abstract

Background
The UNIFI randomised-withdrawal maintenance study evaluated the safety and efficacy of subcutaneous (SC) ustekinumab (UST) in patients (patients) with moderately to severely active ulcerative colitis (UC) who had responded to intravenous (IV) UST during induction. We evaluated the efficacy of UST dose adjustment during the long-term extension (LTE).

Methods
At Week (Week) 0 of the 44 weeks maintenance study, 523 patients who had responded to IV UST induction were randomly assigned in a 1:1:1 ratio to placebo (PBO) SC, UST SC 90 mg q12w, or 90 mg q8w. Patients who completed the maintenance study were eligible to enter the LTE if the investigator thought they would benefit from continued treatment. PBO patients were discontinued from the LTE after the maintenance study was unblinded and the analysis was complete. Based on investigator’s clinical judgement of UC disease activity, patients in the LTE were eligible to receive dose adjustment starting at Week 56: PBO to q8w, q12w to q8w, and q8w to q8w (sham adjustment). PBO patients were only eligible for dose adjustment before unblinding. Patients were assessed for symptomatic remission (SR), partial Mayo scores, and inflammatory markers ≥16 weeks after dose adjustment.

Results
Symptomatic remission was maintained through Week 92 among patients treated with UST regardless of dose adjustment in the LTE (Figure). Overall, 40 (28.4%) and 37 (25.9%) patients in the q12w and q8w groups, respectively, underwent dose adjustment (or sham dose adjustment) prior to Week 92 of the LTE. Among patients who received dose adjustment at Week 76 or before and had data ≥16 weeks after dose adjustment, symptomatic remission was observed in 70.0% in the q12w-to-q8w group and 71.4% in the q8w-to-q8w group, the majority of whom were in symptomatic remission at the time of the dose adjustment (Table). The safety profile of UST in patients who received dose adjustment was generally consistent with the overall safety profile of UST.

Conclusion
Patients may benefit from UST dose adjustment to q8w. However, the majority of UST-treated patients were in SR at the time of dose adjustment in this study. No new safety signals were observed among patients who dose adjusted.
P462 Efficacy of ustekinumab for the prevention of postoperative recurrence in crohn’s disease. Data from clinical practice from the eneida registry
Authors: Mañosa Ciria M , Fernandez-Clotet A , Hernández-Camba A , Muñoz Pérez R , Iborra M , Sierra M , Márquez L , Delgado-Guillena P , Busquets D , Van Domselaar M , Girona E , Sánchez-Rodríguez E , Martín-Arranz M D , Lorente R , Casas-Deza D , Boscá M , Cañete F , Calafat M , Domènech E 
Published: January 2020

Abstract

Background
Anti-TNF and thiopurines are the only drugs that demonstrated efficacy in preventing postoperative recurrence (POR) in Crohn’s disease (CD). However, in some cases these drugs are contraindicated or have previously failed. Recently, ustekinumab was licensed for CD but no data on its efficacy in the prevention of POR is still available.

Methods
All CD patients in whom ustekinumab was prescribed for primary prevention of POR within the first 3 months after ileocecal or ileocolonic resection with anastomosis were identified from the ENEIDA registry (a prospectively maintained database of the Spanish Working Group in IBD –GETECCU-). We evaluated the rates of endoscopic, clinical or surgical POR in the first 18 months. Endoscopic POR was defined by a Rutgeerts score &gt;i1 and advanced endoscopic POR by &gt;i2.

Results
Thirty patients were included; ustekinumab was started after a median time of 60 days (IIQ 31–90). Concomitant immunosuppressants were used in 17%, 27% received an additional 3-month course of metronidazole after surgery. Regarding risk factors for POR: 23% were active smokers, 62% had prior resections, 33% had penetrating CD behaviour, and 22% had a history of perianal disease. In total, 36% of them had more than one risk factor. 50% had been exposed to ustekinumab prior to the index surgery (46% within the last 6 months). The median time of follow-up on ustekinumab was 17 months (IQR 11–21). Fifty-six per cent of patients had at least one endoscopic assessment within 18 months after surgery: 58% had endoscopic POR and 23% advanced endoscopic POR. Additionally, 13% presented clinical POR at the discretion of the treating physician and none developed surgical POR.

Conclusion
In a small clinical practice cohort, ustekinumab showed similar efficacy as that reported with anti-TNF in the prevention of endoscopic POR. Unfortunately, the lack of early endoscopic monitoring is still frequent despite the recommendations from guidelines.
P472 Optimising the development of apps for the management of inflammatory bowel disease and participation in clinical trials
Authors: Hussain F , DeLegge M , Copeman M , Gallagher M B , Stewart T , Georgiev G 
Published: January 2020

Abstract

Background
Patients interested in participating in Ulcerative Colitis (UC) and Crohn’s Disease (CD) clinical trials must be in the flare to qualify for enrollment. Digital technology can be used to help detect flares based on patient-reported symptoms, share information electronically with their physicians, and increase the likelihood of eligibility on clinical trials. Moreover, early detection and treatment of flares is key to patient management and outcomes.

Methods
IQVIA utilised an electronic survey to solicit input from adult patients with UC and CD, in the USA, regarding the optimum design of an app to both detect flares for participation on clinical trials and assist physicians with patient management. Patient input was critical to designing the app with features that would help manage disease, increase communication with their physicians, and increase opportunities for participation in clinical trials.

Results
Data were collected for 134 patients with IBD (70% 46 years or older and 28% 26–45 years old). Only 23% of respondents had previously downloaded an app to help manage their IBD, however, 78% were interested. 85% would find capturing flares and electronically sharing symptom information with their doctors useful to monitoring and managing their IBD. And 88% would find notifications about clinical research studies useful. More than 61% would be likely to go to this app when they first have symptoms of a flare and enter symptoms every day. 55% would be likely to download an app that would monitor IBD flares to see if they may qualify for a clinical research study. Of those with an interest in participation in clinical research, 27% had already participated in a study. Of this same group, 92% would be likely to download an app if it would also track IBD symptoms. Inclusion of functionality for food, stress, mood, exercise and compliance were recommended by patients to assist in elucidating factors that may cause flares.

Conclusion
Patients are very interested in using an app that would help detect flares, though only a minority do so at present. They are supportive of entering symptoms and related information on a daily basis, but also expanding to inclusion of other factors which may be relevant to flares for individuals. The results of this survey were influential in the recent development of an IBD app.
P486 Assessing the efficacy of biologics in ucerative colitis: a real-life, observational retrospective multicentre study with propensity score analysis (AURORA): Focus on patients naive to biologics
Authors: Cassinotti A , Mezzina N , Di Paolo D , Lenti M V , Bezzio C , Stradella D , Mauri M , Zadro V , Cortellezzi C , Ricci C , Casini V , Radice E , Massari A , Ardizzone S , Pastorelli L , Di Sabatino A , Manes G , Caprioli F , Vecchi M , Tari R , Occhipinti P , Fichera M , Invernizzi P , Parravicini M , Segato S , Pace F , Testoni P A , Tinelli C , De Silvestri A 
Published: January 2020

Abstract

Background
Recently, comparative trials among biologics in ulcerative colitis (UC) provided conflicting results on their reciprocal superiority or equivalence. Therefore, in patients naive to biologics, the first-choice biological drug is uncertain.

Methods
In a retrospective, real-life, multicentre inception cohort study involving 11 Italian IBD tertiary centres, all consecutive patients, naive to biologics, treated with adalimumab (ADA), infliximab biosimilar (CTP-13), golimumab (GOL) or vedolizumab (VDZ) after their postmarketing approval (2014–2018) for moderate–severe active UC, were followed up for 1 year or until relapse. All drugs were compared with each other and to naive patients treated with IFX-originator (IFX-O, Remicade) in 2013–2014 as a reference group. A propensity score analysis was performed. The primary endpoint was the 1 year relapse-free, optimisation-free, steroid-free remission, defined as Mayo score ≤2, with bleeding subscore = 0, no relapse after first clinical remission and no optimisation with dose intensification or steroids courses. Multiple further secondary endpoints were analysed (Table 1).

Results
Two hundred ninety-six naive patients (ADA = 56, CTP-13 = 73, GOL = 60, VDZ = 34, IFX-O = 73) were included. The primary end-point was achieved in similar percentages in all groups, irrespective of optimisation. IFX-O and ADA had similar rates of clinical remission achieved once during the follow-up but higher rates than GOL and VDZ. The 1-year relapse rate, however, was lower with VDZ than ADA, GOL and IFX-O. Treatment failure for primary/secondary no response was higher with GOL than IFX-O and ADA. Treatment failures for intolerance were similar among all drugs. CTP-13 performed differently than the originator for some secondary end-points.

Conclusion

Based on a strict definition of clinical remission, all biologics appear equally effective at 1 year in patients naive to these drugs. IFX originator and ADA appear more effective in the induction phase, while patients responders to VDZ had more prolonged clinical remission. Some differences on secondary questionable outcomes between IFX biosimilar and originator have been observed.
P487 Development and validation of a new patient-reported outcome measure for Crohn’s perianal fistula: Crohn’s anal fistula quality-of-life (CAF-QoL) scale
Authors: Adegbola S , Dibley L , Sahnan K , Tozer P , Wade T , Verjee A , Sawyer R , Mannick S , McCluskey D , Yassin N , Phillips R , Norton C , Hart A 
Published: January 2020

Abstract

Background
Crohn’s perianal fistulas are challenging for patients and clinicians. Many do not respond to available treatments, and despite recommendations by a recent global consensus, there are currently no specific patient-derived quality of life (QoL) tools to measure outcomes including response to treatment, in patients with Crohn’s perianal fistulas. Exploratory qualitative work has demonstrated that Crohn’s perianal fistulas reduce QoL far beyond restricting daily and sexual activities, and a patient-centred, patient-derived tool is needed. We present a patient-reported outcomes measure (PROM) for this complicated disease phenotype.

Methods
A 35 item draft questionnaire was generated using information from: (a) unstructured qualitative patient interviews, exploring the experience of living with Crohn’s perianal fistulas; (b) a consensus exercise analysing outcomes from a systematic review of studies assessing medical, surgical and combined (medical/surgical) treatment of Crohn’s perianal fistula; and (c) a patient and public involvement meeting. Psychometric properties were assessed including construct validity (by comparison with the Hospital Anxiety and Depression Scale, HADS and the United Kingdom version of the Inflammatory Bowel Disease Questionnaire, UK-IBDQ), and reliability and responsiveness assessed by test-retest analysis.

Results
Data from 211 patients contributed to the development of the CAF-QoL scale, following the collation of items including patient experience interviews, a systematic review and a consensus exercise involving 187 stakeholders (patients, gastroenterologists, surgeons, IBD specialist nurses, radiologists). Internal consistency was good with Cronbach’s α of 0.88. Analysis aided reduction of the questionnaire to 26 items that demonstrated good internal consistency, good stability (intra-class correlation 0.98) and good construct validity and responsiveness with positive correlation with the UK IBDQ and HADS.

Conclusion
A disease-specific PROM to assess clinical outcome (i.e. QoL) as baseline and following interventions in patients with Crohn’s anal fistula—the CAF-QoL—is ready for use. Translation and cross-cultural validation will aid wider international dissemination.