bluuebunny/crossref_metadata_2025_split huggingface dataset:
P554 Dietary practices and beliefs of patients with inactive ulcerative colitis: A prospective UK study
Authors: Crooks B , McLaughlin J , Limdi J K 
Published: January 2020

Abstract

Background
Our understanding of the aetiopathogenesis of inflammatory bowel disease (IBD), in particular the impact of environmental factors, remains limited. The role of diet in IBD appears to be of particular importance to patients. The dietary habits of the IBD population with inactive disease have scarcely been reported. We describe the dietary practices of patients with inactive ulcerative colitis (UC) and the information resources which guide these beliefs.

Methods
We developed a questionnaire assessing demographics, dietary practices and the use of information resources in patients with inactive UC (defined as a PRO2 score ≤ 1 (rectal bleeding subscore = 0)). This is being prospectively administered to 200 consecutive patients with inactive UC.

Results
Data from 168 patients are available to date. Mean patient age is 54 years, 58% male and 89% Caucasian. Mean disease duration is 12 years. Disease extent is 20% E1, 43% E2 and 29% E3. Sixty-three per cent of patients report no relapse in the last year. 32% consider diet to be an initiating factor for their UC and this is based on their own experience (93%), the internet (30%) and a gastroenterologist’s advice (22%). 39% of patients feel that diet has previously triggered a relapse of their disease, the most commonly reported triggers being spicy foods (45%), alcohol (38%), fatty foods (38%), coffee (27%) and milk products (26%). Fifty-four per cent of patients avoid certain foods, at least sometimes, to prevent relapse. Spicy foods are most frequently avoided (76%) followed by fatty foods (65%), alcohol (53%), coffee (46%), carbonated drinks (44%), milk products (42%) and red meat (36%). Female patients are significantly more likely to restrict their diet in an attempt to prevent a relapse of their UC (p = 0.002). A fifth of patients consume specific foods or nutritional supplements to prevent a UC relapse, most commonly probiotics or turmeric. Fifty-seven per cent of patients believe that the recommended diet in disease remission is different to that in relapse however less than half of patients report being able to find specific dietary advice for UC. Dietary recommendations are most commonly sourced via the internet.

Conclusion
A significant proportion of patients with inactive UC have strong beliefs pertaining to diet and specific dietary triggers. Credible sources of dietary information for IBD patients remain lacking. A high prevalence of self-imposed dietary restriction may risk nutritional deficiency in such patients and impact upon the quality of life. More data and mechanistic explanations are needed to understand the complicated relationship between dietary components and gut inflammation. A larger dataset will be presented at conference proceedings.
P555 Frequent disease relapse after withdrawal of infliximab in IBD patients with sustained remission
Authors: Gordon H , Murray J , Tailor F , Goh S A , Lindsay J O 
Published: January 2020

Abstract

Background
In the UK, NICE guidance requires an annual review of TNF antagonists with the withdrawal of therapy in patients in confirmed remission. This study assesses the outcome of this practice in patients with Crohn’s disease (CD) and ulcerative colitis (UC) who received infliximab at a large referral centre. The primary outcome is relapse-free survival. Secondary objectives include evaluation of predictors of relapse, and response to subsequent therapy.

Methods
IBD patients who ceased infliximab due to remission at annual review were identified. Demographics and clinical characteristics were collected from electronic patient records. Disease activity from 3 months prior to cessation and throughout follow-up was recorded; active disease was defined as CRP&gt;10, faecal calprotectin&gt;50, endoscopic activity or radiological activity. Relapse was defined as the aforementioned markers of activity with clinician documentation of relapse. Immunomodulator use, active disease prior to cessation, age at diagnosis and ethnicity were analysed in patients who had completed 6, 12, 18 and 24 months of follow-up. Survival analysis and logistical regression were undertaken with SPSS®. In patients who relapsed, steroid use and future biologic use was evaluated. Analysis was undertaken for total IBD, CD and UC.

Results
66 cases were identified (CD:UC = 40:26, F:M =28:38, Asian:Black:Caucasian:Multiracial/Unknown = 13:3:45:5). Median follow-up was 18.1 months (IQR 9.07–41.71). Failure free survival was: all IBD; 14.65 months (IQR 8.38–25.23), CD; 13.08 months (IQR 7.66–25.23) and UC; 14.65 months (IQR 5.91–22.47). Relapse rates of patients who completed follow-up at each time point are presented in Table 1:
No predictors of disease relapse were identified at any time point. Thirty-seven patients experienced relapse, of whom 40.5% (15/37) were prescribed steroids, 86.5% (32/37) restarted a biologic and 67.7% (25/37) restarted infliximab. Of those who have completed infliximab induction, 56.5%(13/23) recaptured response to standard dose and a further 13.0% (3/23) required 10mg/kg. Alternative therapy was required in 30.4% (7/23).

Conclusion
Within 24 months of cessation 73.1% patients relapsed. The majority of these restarted a biologic. However, only 56.5% of patients who restarted infliximab responded to standard dose. With additional costs of newer biologics and morbidity of disease flare and steroid use, routine withdrawal of TNF antagonists should only occur after careful consideration.
P565 Efficacy and safety of long-term treatment with ustekinumab in moderate–severe ulcerative colitis patients with delayed response to ustekinumab induction: Results from UNIFI 2-year long-term extension
Authors: Sands B E , Abreu M T , Leong R W L , Marano C , O’Brien C D , Zhang H , Zhou Y , Johanns J , Rowbotham D , Hisamatsu T , Arasaradnam R P , Scherl E , Danese S , Peyrin-Biroulet L 
Published: January 2020

Abstract

Background
Ustekinumab (UST) has been shown to induce and maintain clinical response and remission in moderate–severe UC patients in the UNIFI study. In the UNIFI maintenance study, the primary randomised population consisted of patients who were in clinical response 8weeks after UST induction treatment. Patients who had a delayed response to induction were also eligible for the maintenance study but were not included in the randomised analysis set. Here, we present the efficacy and safety of UST maintenance among delayed responders who were treated in the UNIFI long-term extension(LTE).

Methods
UNIFI was a single protocol of induction and randomised withdrawal maintenance studies in patients with moderate–severe UC who failed conventional or biologic therapy(including TNF antagonists and/or vedolizumab). Delayed responders were patients who were not in clinical response to UST IV induction at Week8 but achieved response at Week16 following a single UST90mg SC dose at Week8. These patients entered the maintenance study and continued to receive UST90mg SC q8w. Patients who completed Week44 evaluations were eligible to enter LTE continuing to receive UST90mg SC q8w. Efficacy in delayed responders to UST(who were treated in LTE) was evaluated over time through Week92 and safety through Week96.

Results
116 delayed responders to UST induction were treated in the LTE, including 58 who had previously failed biologic therapy and 58 who had not failed biologic therapy, 54 of whom were bio-naïve. Symptomatic remission(defined as stool frequency subscore of 0 or 1 and a rectal bleeding subscore of 0) rates in delayed responders to UST induction increased from maintenance baseline to Weeks 44 and 92 (Table 1). Similar trends were seen within the biologic failure subgroups; although, rates among patients who had not failed biologics (primarily bio-naïve) were greater than those of patients who had failed biologics. Among the 79.3% (n = 92/116) of delayed responders to UST in symptomatic remission at Week 92, 94.6% (n = 87/92) were corticosteroid free. Safety data for randomised and non-randomised patients treated in UNIFI LTE is in Table2. The safety profile for UST in delayed responders was generally similar to that observed among patients randomised to UST; no new safety signals were observed.

Conclusion
Delayed responders to UST treatment maintained symptomatic remission through Week 92 with UST90mg SC q8w and the majority did so in the absence of corticosteroids.
P570 The burden of anaemia remains significant over time in patients with inflammatory bowel disease at a tertiary referral centre
Authors: Singh Singh K , Al-Khoury A , Kurti Z , Gonczi L , Golovics P , Kohen R , Afif W , Wild G , Seidman E , Bitton A , Bessissow T , Lakatos P 
Published: January 2020

Abstract

Background
Anaemia is an important complication and/or extra-intestinal manifestation of inflammatory bowel disease (IBD), as well as a predictor of poor outcomes. The aim of this study was to determine the occurrence of anaemia and the frequency of anaemia screening over time, at a tertiary referral IBD centre.

Methods
We retrospectively reviewed the occurrence of anaemia at the time of referral or diagnosis and during follow-up at the McGill University Health Centre (MUHC) IBD centre. Consecutive patients presenting with an outpatient visit (‘index visit’) between July and December 2016 and between December 2018 and March 2019 were included. Disease characteristics, biochemistry and medical management, including the need for intravenous iron therapy were captured.

Results
1356 and 1293 CD and UC patients [disease duration: 12 (IQR:6–22) and 10 (IQR: 5–19) years] were included in the 2 periods. The prevalence of moderate or severe anaemia at referral/diagnosis (15.4% and 8.5%) and during the follow-up (11.1% and 8.1%) was higher in CD than in UC patients, with a decrease of anaemia in CD patients between the 2 periods. The prevalence of any anaemia at follow-up was 22.4% and 18.7% in CD and in UC, while 82.7% of patients were tested at least once for anaemia during a 6-month period. UC patients with more extensive disease, treated with steroids or biologics at the time of referral but not during follow-up, active disease, or an elevated calprotectin at the time of assessment, and CD patients with active disease, elevated CRP or calprotectin at the time of assessment, with complicated disease, perianal involvement, previous respective surgery or colonic disease location, had a higher risk of anaemia. Intravenous iron therapy was prescribed in 46 patients (46.8% patients (37/79) with moderate or severe anaemia) with 72.3% having active disease (CD: 65.2%, steroid 83.3%, biological therapy: 78.6%, CRP: 97.8%, FCAL: 73.9%) in the second cohort. 91.3% of patients receiving intravenous iron had an extensive evaluation of anaemia pre- and post-therapy (CBC, ferritin, transferrin, TSAT, B12, folate). Anaemia improved by &gt;2g/l in 56.5% after 4–6 weeks (intravenous iron dose &gt;1000mg in 87% of patients). Four patients required a blood transfusion.

Conclusion
Anaemia occurred frequently in this IBD cohort, at referral to the centre and during follow-up, and contributes to the burden of IBD in referral populations. Most patients were assessed for anaemia regularly and with accurate anaemia workup in patients prescribed intravenous iron therapy, yet the targeted management of moderate to severe anaemia was suboptimal.
P579 Randomised open-label controlled trial of ciprofloxacin/doxycycline/hydroxychloroquine combination compared with standard budesonide in active Crohn’s disease (APRICOT)
Authors: Rhodes J M , Subramanian S , Flanagan P , Horgan G , Martin K , Mansfield J , Parkes M , Hart A , Dallal H , Iqbal T , Butterworth J , Culshaw K , Probert C 
Published: January 2020

Abstract

Background
Mucosal E. coli are increased in Crohn’s disease (CD). They replicate within macrophages where they are inaccessible to penicillins and gentamicin. Hydroxychloroquine is successfully used together with doxycycline, typically for 12 months, to treat Whipple’s disease. It raises macrophage intra-vesicular pH and inhibits replication of bacteria , including E. coli that require an acid pH. Ciprofloxacin and doxycycline are also effective against E. coli replicating inside macrophages.

Methods
Adult patients with active CD (CDAI&gt;220 plus CRP≥5mg/l and/or faecal calprotectin &gt;250 μg/g) were randomised to receive either standard oral budesonide (Entocort CR 9mg/day for 8 weeks, 6mg/day for 2 weeks, 3mg/day for 2 weeks) or antibiotics/hydroxychloroquine (AB/HCQ) - oral ciprofloxacin 500mg bd, doxycycline 100mg bd, hydroxychloroquine 200 mg tds for 4 weeks, followed by continuation of doxycycline 100 mg bd and hydroxychloroquine 200 mg tds for a further 20 weeks. The use of anti-TNF in the previous 3 months was an exclusion. Primary endpoint parameters were remission at 10 weeks, remission maintained through to 24 weeks, and remission maintained through to 52 weeks. Secondary endpoints included remission and/or response (fall in CDAI of &gt;70) at 10 weeks and remission at 4 weeks. Patients who failed to respond by 10 weeks were invited to cross-over onto the alternative therapy.

Results
59 patients were recruited across 8 sites, lower than target (100) because recruitment slowed due to widening access to biologics. Including cross-over, 39 patients received AB/HCQ and 39 received budesonide. No significant differences were seen comparing AB/HCQ with budesonide at 10, 24 or 52 weeks on either intention-to-treat or per-protocol analysis (see table). Withdrawals by 10 weeks due to adverse events were seen in 16 AB/HCQ, - including nausea (3), photosensitivity (2), Achilles pain (2) and activity of CD (4); and 7 budesonide. Although not significant when analysed per protocol, when patients on AB/HCQ who responded at 10 weeks and later remitted were included, 9/24 patients were in remission at 24 weeks and 4/23 at 52 weeks. No correlation was seen between response to AB/HCQ and ASCA/OmpC status.

Conclusion
The longer-term remissions seen in some patients receiving AB/HCQ are encouraging and a larger phase 3 study is justified.
P583 The prevalence of side effects to immunomodulators and biologics in patients with Crohn’s disease intestinal failure compared with Crohn’s disease without intestinal failure
Authors: Bouri S , Geldof J , Willsmore J , Donnelly S , Gabe S , Hart A 
Published: January 2020

Abstract

Background
Treatment of Crohn’s disease (CD) involves medications and surgery but experiencing medication side effects (SE) limits medical options. The aim of this study was to compare SE experienced by patients with CD and intestinal failure (CD-IF) vs. CD without IF as this may contribute to a higher surgical requirement.

Methods
A single tertiary centre retrospective analysis was performed on CD-IF patients on parenteral nutrition due to short-bowel syndrome vs. small bowel CD without IF. Patients with CD without IF were selected from consecutive clinics who lived in the local catchment area.

Results
94 CD-IF and 94 CD patients were included. The proportion of female patients was 56.4% (CD-IF) and 46.8% (CD); mean age was 51.2 (CD-IF) and 41.5 years (CD); mean duration of disease 24 years (CD-IF) and 16 years (CD). Most CD-IF patients had multiple resections. In the CD group, 50 patients never had surgery, 22 had 1 resection, and 9 had 2 or more. From the past medication history for these patients, the proportion in whom a medication was stopped due to SE was similar for CD-IF and CD for azathioprine, mercaptopurine and vedolizumab (Table 1). There were no SE to ustekinumab. Patients in the CD-IF group had a preceding history of significantly more SE to anti-TNF therapy and methotrexate were observed in CD-IF group, of which allergies were most frequent. In the CD group, 2 patients previously had an allergic reaction to infliximab whereas, in the CD-IF group 6 patients had a history of anaphylaxis and 5 an allergy to infliximab, 1 had an allergy to adalimumab and 3 to methotrexate (Table 2). Data on drug levels amongst those with allergy events were limited (due to prior availability of testing); of those tested, 1 had positive antibodies and 1 did not. The frequency of non-response and loss of response was similar between the two groups for each medication.

Conclusion
The frequency of SE to immunomodulators and biologics was similar between CD and CD-IF, except for anti-TNF therapy and methotrexate due to more allergy/anaphylaxis events in CD-IF. The frequency of these reactions may have caused an earlier shift towards surgical treatment. 92/94 CD-IF patients were diagnosed prior to 2014; it would be useful to review the incidence of CD-IF before 2014 (pre-vedolizumab and ustekinumab) vs. the new biological era.
P592 Frequency and causes of prolongation of the induction course of tofacitinib in patients with ulcerative colitis in conditions of real clinical practice
Authors: Knyazev O , Kagramanova A , Lishchinskaya A , Parfenov A 
Published: January 2020

Abstract

Background
Tofacitinib is a selective immunosuppressant, the first representative of the Janus kinase family inhibitors, which has a high selectivity against other kinases of the human genome. According to the results of the study, tofacitinib inhibits JAK-1, JAK-2 and in high concentrations-JAK-3 and tyrosine kinase-2. The drug is registered in Russia for the treatment of patients with ulcerative colitis. According to the instructions for medical use, in patients with incomplete response to the induction course, it is possible to conduct an additional 8 weeks of therapy at an induction dose of 10 mg 2 times a day. The objective of the study was to identify the frequency and reasons for the need to prolong the induction course of tofacitinib in patients with ulcerative colitis.

Methods
35 patients with ulcerative colitis (UC) who received tofacitinib were observed in the Department of inflammatory bowel diseases. Patients were divided into two groups. Group 1 (n = 10) of patients were bionaive. The second group of patients (n = 25) had previous experience of treatment with one or more anti-TNF-α drugs. The necessity of prolongation up to 16 weeks of induction course of tofacitinib was assessed in patients with an insufficient clinical response at week 8 of therapy (reduction of partial index of Mayo less than 30%) and lack of normalisation of laboratory parameters (CRP, haemoglobin, FCP). The comparative analysis was carried out by the method of four-field tables using nonparametric statistical criteria.

Results
In the follow-up period among group 1 UC patients (n = 10) who had not previously received anti-TNF-α drugs, the need for a prolonged induction course of tofacitinib was not required in any patient (0%). In the second group of patients (n = 25), previously treated with anti-TNF-α drugs, a prolonged induction course of tofacitinib was required in 9 (36%) patients (x2-4.484; p = 0.028).

Conclusion
The need for prolongation up to 16 weeks of the induction course of tofacitinib in patients with ulcerative colitis b is significantly higher in patients who have previously received one or more anti-TNF-α drugs.
P605 Eight-year efficacy and safety of azathioprine treatment in the maintenance of steroid-free remission in inflammatory bowel disease patients
Authors: Cassieri C , Pica R , Avallone E V , Brandimarte G , Zippi M , Crispino P , De Nitto D , Lecca P G , Vernia P , Pica R , Corazziari E S 
Published: January 2020

Abstract

Background
Azathioprine (AZA) and thiopurine are widely used for induction and maintenance of remission in steroid-dependent patients with inflammatory bowel disease (IBD). The aim of this study has been to investigate its efficacy and safety in maintaining steroid-free remission in steroid-dependent IBD patients eight years after the institution of treatment.

Methods
Data from consecutive IBD outpatients referred in our Institution, between 1985–2017, were reviewed and all patients treated with AZA were included in this retrospective study. AZA was administered at the recommended dose of 2–2.5 mg/kg.

Results
Out of 2992 consecutive IBD outpatients visited in the index period, AZA was prescribed to 446 patients, 245 (54.9%) were affected by Crohn’s disease (CD) and 201 (45.1%) by ulcerative colitis (UC). One hundred and ninety-six patients with a follow-up &lt; 96 months were excluded from the study. Two hundred and fifty patients were evaluated, 140 (56%) with CD and 110 (44%) with UC. One hundred and thirty-eight (55.2%) were male and 112 (44.8%) female (average age of 35.48 ± 14.26 SD years, range 14–74 years). Eight year after the institution of treatment, 123 (49.2%) patients still were in steroid-free remission (82 CD vs. 41 UC, 58.6% and 37.3%, respectively, p = 0.0009), 71 (28.4%) had a relapse requiring retreatment with steroids (29 CD vs. 42 UC, 20.7% and 38.2%, respectively, p = 0.0030), 56 (22.4%) discontinued the treatment due to side effects (29 CD vs. 27 UC, 20.7% and 24.5%, respectively). The loss of response from first to eighth year of follow-up was low, about 21%.

Conclusion
Eight years after the onset of treatment about 50% of patients did not require further steroid courses. After the first-year loss of response was low in seven subsequent years. In the present series, the maintenance of steroid-free remission was significantly higher in CD than in UC patients. The occurrence of side effects leading to the withdrawal of AZA treatment has been low.