bluuebunny/crossref_metadata_2025_split huggingface dataset:
P561 The management of Crohn’s disease (CD) patients post ileocaecal resection: a multicentre, regional audit in Northern England
Authors: BATCHELOR S , Speight A 
Published: January 2020

Abstract

Background
70% of patients with Crohn’s disease (CD) require intestinal resection.1 Post-operative recurrence (POR) is common with 70% of patients requiring further surgery in the pre-biologic era.2 ECCO guidelines suggest identifying patients at risk of recurrence (disease phenotype, smoking, prior resection), the use of imidazole antibiotics following surgery and assessment for recurrence within 12 months. The ECCO guidelines recommend ileocolonoscopy, although alternative modalities can be used. The Rutgeerts score predicts POR and is recommended to establish the need for preventative treatment.3 The aim of this study was to undertake a region-wide audit of practice with regards to post-operative CD in the Northern region.

Methods
A regional, multicentre, retrospective audit was conducted by GRANT, a network of gastroenterology trainees in Northern England. Data collection was performed for CD patients who had an ileocaecal resection between 1/9/16 and 1/9/17. Patients with an end-ileostomy were excluded. Patients were identified using clinical coding and data collection sheets were completed.

Results
Seven of 9 Hospital Trusts returned data. The number of eligible patients was 38 with a mean age of 41 years. Seventy-six per cent (29/38) patients had at least one risk factor rendering them ‘high-risk’ for POR (Figure 1). Only 13% (5/38) of patients received imidazole antibiotics postoperatively and only 29% (11/38) had an ileocolonoscopy within 12 months. However, 32% (12/38) had an alternative assessment of POR, with calprotectin being the most popular. An escalation in treatment following assessment was required in 25% (9/38) of patients. Postoperatively, 40% (15/38) of patients had no maintenance therapy before POR assessment; 26% (10/38) continued on the same therapy as preoperatively and34% (13/38) had augmented pre-operative therapy.

Conclusion
The majority of patients in Northern England who have an ileocaecal resection for CD are high risk for recurrence and many patients are not being assessed. Endoscopic POR predates clinical POR [4] and, without monitoring, the opportunity to augment therapy and prevent clinical recurrence can be missed. In Northern England, less invasive disease monitoring is being used to assess for POR and this audit would suggest that these have a comparable rate of identifying a need to escalate maintenance therapy. A postoperative CD management bundle is being developed and will be implemented to assess whether this drives improvement.
P563 Shared decision-making in pregnancy in inflammatory bowel disease: Design of a pregnancy in IBD decision aid (PIDA)
Authors: Williams A J , Leung Y , O’Connor K , Huang V 
Published: January 2020

Abstract

Background
A lack of IBD-specific reproductive knowledge has been associated with increased ‘voluntary childlessness’.Furthermore, a lack of patient and clinician knowledge may contribute to inappropriate medication changes during or after pregnancy that may lead to a flare of disease. Evidence exists for the benefit of decision aids to support decision-making in pregnancy in general, as well as in multiple other chronic disease; however, such a resource for pregnancy in IBD has not been identified.

Methods
Using International Patient Decision Aids Standards, we have commenced design of our Pregnancy in IBD Decision Aid (PIDA). A steering committee consisting of Canadian and Australian Healthcare professionals with an interest in IBD management in pregnancy, in addition to a patient representative was established. Initial patient and clinician focus groups were conducted. Themes prospectively chosen for discussion included inheritance, fertility, nutrition, medications, mode of delivery, breastfeeding, infant infections and vaccinations. We designed an electronic PIDA draft that incorporates individualised information (for example, type of IBD, pre-conception or pregnant, surgical history and current medications) in personalised decision-making. Further patient focus groups and interviews were conducted to obtain user opinion of the PIDA draft.

Results
In July 2017, patient and clinician focus groups were conducted at a Canadian site. Patient concerns regarding pregnancy included the impact of disease, previous surgical history on fertility, preterm delivery; the potential impact of current and past drug therapies on the fetus/ infant; and the negative impact of active disease on both maternal and fetal/infant health. Clinician concerns included the absence of pre-conception counselling and potential for lack of patient understanding about the impact of disease activity and IBD medication use in pregnancy. Patient feedback (n = 15) obtained through interviews at two Canadian and one Australian site regarding the current electronic PIDA draft was predominantly positive, with comments pertaining to the adequacy of content coverage, personalisation, readability and unbiased information presentation. Suggestions were made for inclusion of further content such as the impact of IBD on sexual function, expected laboratory changes and the timing of recommencement of medications post-partum.

Conclusion
The completion of pre and post-PIDA design focus groups and interviews affirmed the role for PIDA. Main decisions that were considered necessary to address included ideal timing of conception pending disease activity, management of medications and delivery methods. Ongoing user feedback is being obtained at Australian and Canadian sites currently.
P564 Psychological acceptance of surgery in patients with inflammatory bowel disease undergoing intestinal resection
Authors: Hirano Y , Itabashi M , Saito T , Uchida K , Inoue M , Katsuhiro A , Atsuhiro H , Araki K , Nishikawa Y , Tatsuno M , Hideaki K , Reiko K 
Published: January 2020

Abstract

Background
To decision to undergo surgical intestinal resection is among the most difficult that patients with inflammatory bowel disease (IBD) may be required to make during the disease course. Although the clinical outcomes and QoL after intestinal resection are well established, few studies have focused on psychological acceptance of the surgery, that is, how patients feel about the results of intestinal resection. The aim of this study was therefore to evaluate psychological acceptance of the surgical outcome in patients undergoing intestinal resection.

Methods
We administered a cross-sectional questionnaire survey to patients at five IBD centres in Japan who had undergone intestinal resection at least 1 month before the survey. Patients were asked to complete a visual analogue scale (VAS) questionnaire, consisting of 20 questions related to surgical acceptance and concerns related to IBD (body image, burden of treatment, interpersonal relationships), before and after surgery. The VAS scores before surgery were described by the patient looking back on recollection. Pre- and post-surgical VAS scores were compared using a Wilcoxon’s rank-sum test.

Results
A total of 64 patients participated in this study (median age at surgery 37.9 (range 12–67) years, median years after surgery 5.0 (range 0.1–21) years). The VAS scores before and after surgery were summarised in the figure. The score for ‘pleased to have surgical resection of my intestine’ improved significantly after the surgery in both UC and CD (p &lt; .0001).Furthermore, the score for ‘burdened with treatment for my IBD’ improved significantly after surgery in UC patients (p &lt; .0001).

Conclusion
Our findings indicate that surgical intestinal resection outcomes were psychologically well accepted by most IBD patients.
P573 Frequency and effectiveness of empirical anti-TNF dose intensification in inflammatory bowel disease: an on-going systematic review with meta-analysis
Authors: Guberna Blanco L , Nyssen O P , Chaparro M , Gisbert J P 
Published: January 2020

Abstract

Background
Loss of response to anti-TNF therapies in inflammatory bowel disease occurs in a high proportion of patients. However, the precise incidence of dose intensification (DI) and its effectiveness remain unclear. Our aims were: (1) To evaluate the need of DI of anti-TNF therapy either by increasing the dose or decreasing doses’ interval; (2) To evaluate possible variables influencing its requirement; (3) To assess the effectiveness of empirical DI.

Methods
Bibliographical searches were performed until January 2019. Selection: prospective and retrospective studies assessing the loss of response to anti-TNF therapy, considered as the need of DI, in Crohn’s disease (CD) and ulcerative colitis (UC) patients treated for at least 12 weeks with an anti-TNF drug. Exclusion criteria: Studies using anti-TNF as prophylaxis for postoperative recurrence in CD or those where DI was based on therapeutic drug monitoring. Data were analyzed by means of the inverse variance method using a random effect model and stratifying by medical baseline condition (UC vs. CD), anti-TNF drug and follow-up. Effectiveness was assessed by intention-to-treat analysis.

Results
Up to now, 107 studies (11,377 patients) were included. The overall rate of DI requirement for naïve patients after 12 and 36 months of follow-up was 35% (95% CI=26–45%, I2=95%, 15 studies) and 48% (41–55%, I2= 77%, 9 studies); respectively. Frequencies of DI requirement stratified by subgroup analysis are presented in the table (all patients being naïve except CD patients treated with adalimumab (ADA), including naïve and no naïve).
The overall short-term response and remission rates to empirical DI were 67% (95% CI: 63–72%; I2=73%; 31 studies) and 45% (95% CI: 35–55%; I2=9%; 23 studies), respectively; subgroup analyses are summarised in the table.

Conclusion
Loss of response to anti-TNF agents and consequent DI occurs frequently in both UC and CD, with an overall rate of DI requirement of 35% at one year and 48% at 3 years. Empirical DI is a relatively effective therapeutic option. Further data extraction and analysis is necessary to confirm these findings.
P575 Real-world effectiveness and safety of ustekinumab for the treatment of refractory Crohn’s disease: The Scottish ustekinumab cohort
Authors: PLEVRIS N , Robertson A , Fulforth J , Hall R , Campbell I , Kane C , Veryan J , Lam W , Saunders J , Jenkinson P , Chuah C , Kelly C , Watts D , Gaya D , Macdonald J , Jafferbhoy H , Seenan J P , Mowat C , Sutherland D , Naismith G , Bain G , Arnott I , Jones G , Lees C 
Published: January 2020

Abstract

Background
Ustekinumab (UST) is an anti-IL12/23 biologic licensed for the treatment of moderate to severe Crohn’s disease (CD). The aims of this study were to establish the long-term real-world effectiveness and safety of UST for the treatment of CD in a large UK cohort.

Methods
This was a multicentre retrospective cohort study , including 7 NHS health-boards in Scotland. Patients treated with UST between November 2015 and June 2019 were identified. Inclusion criteria included: a diagnosis of CD; active symptoms attributed to CD with objective evidence of mucosal inflammation (CRP &gt;5mg/l or faecal calprotectin ≥250 µg/g or inflammation on endoscopy/ MRI); and completion of induction with a minimum of 8 weeks follow-up. Clinical assessments were performed based on physician global assessment (response was defined as ≥50% reduction in CD-related symptoms and remission defined as complete resolution of all CD-related symptoms). Mucosal healing was defined as the absence of ulceration/erosions on ileo-colonoscopy or no inflammation on MRI if ileo-colonoscopy was not possible (eg. B2 disease). Deep remission was defined as clinical remission plus mucosal healing. Rates of serious adverse events (discontinuation of UST, hospitalisation or death) during follow-up were described quantitively.

Results
A total of 207 patients (43% male; median age 39.2 years, IQR 28.9–51.4; median disease duration 10.0 years, IQR 5.7–16.6) with a median follow-up of 34.6 weeks (IQR 16.9–52.1) were included. The majority of patients had ileocolonic disease (L1, 19.3%; L2, 23.7%; L3, 57%) and an inflammatory phenotype (B1, 43.0%; B2, 41.1%; B3, 15.9%). A total of 98.6% of patients had previously been exposed to a biologic and 55.1 % had undergone previous surgery. Seventy-one per cent of patients received Q8 maintenance dosing, whilst 25.6% and 42.0% of patients were also receiving an immunomodulator (IMM) and steroids at initiation, respectively. At week 8, clinical response and remission rates were 51.7% and 5.8%, respectively. Twelve-month cumulative rates of clinical remission, mucosal healing (n = 116) and deep remission (n = 116) were 29.8%, 35.3% and 17.9%, respectively (Figure 1). During 155 patient-years of follow-up (PYF), 11 patients experienced a serious adverse event (7.1 per 100 PYF).

Conclusion
We have shown in a large real-world cohort of complex, treatment-refractory CD patients that UST is a safe and effective treatment option.
P576 The value of small bowel capsule endoscopy in the change of therapeutic management in patients with established Crohn’s disease
Authors: Viazis N , Tsoukali E , Pontas C , Karampekos G , Gkeros F , Filippidis G , Vraka M , Koustenis K , Mountaki K , Mitselos I , Mela M , Christidou A , Archavlis E , Vienna E , Christodoulou D , Mantzaris G 
Published: January 2020

Abstract

Background
Small bowel capsule endoscopy (SBCE) is widely used for various indications in patients with established Crohn’s disease (CD). Our aim was to investigate whether SBCE can lead to changes in the therapeutic management of CD patients.

Methods
Retrospective analysis of prospectively collected data [September 2003 - September 2019] from patients with established CD subjected to SBCE in two tertiary referral centres for inflammatory bowel diseases. All patients were tested with the Pillcam SB. Findings consistent with small bowel CD involvement were the presence of aphthoid or larger ulcers with or without inflammation of the adjacent mucosa.

Results
In total, 839 patients [median age (range) 36 (17–78) years, 471 (56.41%) men, median disease duration 6 years] diagnosed with CD according to established criteria underwent SBCE in the participating centres for the evaluation of disease extent and mucosal healing or the investigation of clinical relapse or iron deficiency anaemia. Based on ileo-colonoscopy findings disease location was documented in 618 patients (73.65%) as follows: colitis in 219 (26.10%), ileo-colitis in 253 (30.15%), and terminal ileitis in 146 (17.40%) patients; in contrast, full disease location was not documented in 221/839 (26.34%) patients who had colonic involvement but the ileocaecal valve could not be intubated. In the latter group, SBCE revealed small bowel involvement in 96 (43.43%) patients. In addition, SBCE revealed more proximal lesions in 105/618 (16.99%) patients with ileo-colonoscopy documented colitis, ileo-colitis or terminal ileitis. These findings led to a change in therapeutic management in 98 patients (11.68%): 36 patients (4.29%) received biologics, 21 patients (2.50%) received intensified doses of or changed the administered biologic, 39 patients (4.64%) received corticosteroids and/or conventional immunosuppressants and 2 patients (0.23%) underwent surgery. Therapeutic management changes were commoner in patients in whom small bowel lesions were found during SBCE and in whom the terminal ileum had not been examined during colonoscopy (57/96 patients vs. 41/105, p = 0.003]. Capsule retention occurred in 9 patients (1.07%) and passed after administration of corticosteroids (n = 6), or the capsule was retrieved with push enteroscopy (n = 1) or surgery (n = 1).

Conclusion
SBCE is a valuable tool in the management of patients with established CD, especially in those whom the terminal ileum has not been examined during the preceding colonoscopy.
P582 Adalimumab therapeutic drug monitoring: Does time of testing matter?
Authors: Shields S , Seenan J P , Dunlop A , Galloway P , Macdonald J 
Published: January 2020

Abstract

Background
Whilst anti-TNF drugs such as adalimumab (ADL) have revolutionised the management of inflammatory bowel disease treatment outcomes are not universally favourable with 30% primary non-response (PNR) and 46% secondary loss of response (SLOR) rates reported.1,2 Therapeutic drug monitoring (TDM)—the measurement of serum drug levels and anti-drug antibodies—has become popular with clinicians who use it to optimise biologic therapy through serum drug-level guided dose adjustment. Conventionally TDM is based on the interpretation of trough drug levels (DL) which are obtained by drawing a blood sample immediately prior to the next drug dose. Obtaining an ADL trough DL can be challenging as the drug is administered as a subcutaneous injection usually in the patient’s own home. The aim of this project was to determine the current use of non-trough ADL TDM in clinical practice and determine whether timing of ADL TDM in relation to the next planned dose is clinically important.

Methods
All ADL DLs performed in 2018 in the Scottish Biologic TDM service3 were identified. DLs were included for patients in sustained clinical remission (SCR), on 40mg every other week dosing, and if the time from the last dose was ≤14 days. TDM performed during induction and for PNR or SLOR were excluded, as were patients on nonstandard dosing or with missing data on dose and interval. Results were analysed by quartile according to time from the last drug dose.

Results
338 DLs were included. Median DL is 8µg/ml (range &lt;0.4–36). Median time from last dose is 12 (range 0–14) days. The first quartile (n = 83, median 5 (range 0–7) days) had a median DL of 8.2µg/ml (&lt;0.4–28.1). The second quartile (n = 90, median 11 (8–12) days) had a median DL of 7.9µg/ml (&lt;0.4–36). The third quartile (n = 80, 13 days from last dose) had a median DL of 8µg/ml (&lt;0.4 – 28.1). fourth quartile samples (n = 85, 14 days from last dose – true trough DLs) had a median DL of 8 µg/ml (&lt;0.4–34.8). No relationship was identified between observed DL and the time of DL testing (ρ= -0.3162, p = 0.23).

Conclusion
It is not necessary to use trough DLs when performing ADL TDM for individuals in SCR. These data should give clinicians the confidence to use opportunistic ADL TDM testing in a clinical setting. Further work should be undertaken on non-trough testing of ADL DLs in other clinical scenarios.

Disclosure
Biogen GmbH contributed funding for this research. Authors had full editorial control and approval of all content.

References
P585 Evaluation and comparison of the safety profiles of different intravenous iron preparations and oral iron for treatment of iron deficiency anaemia: Preliminary results from the IBD subgroup analysis
Authors: Aksan A , Işık H , Aksan S , Tuğal D , Dignass A , Stein J M 
Published: January 2020

Abstract

Background
Current ECCO guidelines state that intravenous (IV) iron should be considered first-line treatment in patients with clinically active IBD, previous intolerance to oral iron, Hb below 100 g/l and patients who need erythropoiesis-stimulating agents. Several different IV iron products are available with differing therapeutic effectiveness and tolerability. In this ongoing study, we compare their safety profiles to establish whether any IV iron carries an increased risk compared with other IV iron products or with oral iron, and to determine which, if any, has a superior safety profile. We report preliminary results from an IBD subgroup analysis.

Methods
We performed a systematic review and network meta-analysis (NMA), searching PUBMED, SCOPUS, WoS and Cochrane Library up to July 2019. The primary outcome measure was the pooled total of drug-related adverse events (AEs) and serious AEs (SAEs) in proportion to the safety population. The secondary outcome measure was identification of the most common AEs.

Results
8086 distinct publications were found. Of 171 relevant full-text articles on IBD, 5 RCTs (n = 1143) were eligible. Bayesian NMA was performed using a fixed effects model. Low statistical heterogeneity was determined (I2= 9%). AE rates did not differ significantly between the different IV iron products (ferric carboxymaltose/FCM; iron sucrose/IS; iron isomaltoside/IIM) or oral iron. Compared with oral iron; OR=0.69, 95% CrI [0.29;1.7] for FCM, OR=0.52, 95% CrI [0.22;1.2] for IS, OR=1.5, 95%CrI [0.80;3.1] for IIM. Compared with FCM; OR=0.74, 95% CrI [0.45;1.2] for IS, OR=2.2, 95% CrI [0.74;6.7] for IIM. Compared with IS; OR=0.1.3, 95% CrI [0.82;2.2] for IS, OR=3.0, 95% CrI [1.0;9.1] for ISM. Compared with IIM; OR=0.45, 95% CrI [0.15;1.3] for FCM, OR=0.33, 95% CrI [0.11;1.0] for IS. The most common AEs were headache (1.8%) and transient hyperferritinaemia (1.8%) for FCM; headache (1.5%), hyperferritinaemia and rigors (both 1.2%) for IS; flushing (2.7%), hypersensitivity and hepatic enzyme increase (both 1.8%) for IIM; diarrhoea (8.0%) and abdominal pain (7.7%) for oral iron. Hypophosphataemia was reported in only 1 RCT of FCM, here transient and clinically asymptomatic. Seven SAEs were recorded; 1/381 for FCM, 1/223 for IIM and 5/238 for oral iron.

Conclusion
None of the IV iron products was associated with an increased risk of AEs or SAEs compared with oral iron and all showed similarly low rates of AEs. However, their safety profiles differed: Whereas with FCM or IS, headaches were most commonly reported, IIM was more frequently associated with hypersensitivity reactions or increase in hepatic enzymes. On this evidence, while FCM, IS and IIM are all safe, their differing safety characteristics should be considered in therapeutic decision-making.