bluuebunny/crossref_metadata_2025_split huggingface dataset:
P497 Is early bowel resection better than medical therapy for ileocolonic Crohn’s disease? A systematic review and meta-analysis
Authors: Husnoo N , Gana T , Hague A G , Khan Z , Morgan J L , Wyld L , Brown S R 
Published: January 2023

Abstract

Background
At least one third of patients with Crohn's disease (CD) have isolated ileocaecal disease. For a long time, surgery in this context has been seen as the "last resort" measure that is adopted when medical options have been exhausted. There is emerging evidence supporting early bowel resection (EBR) for ileocaecal CD as an alternative to conventional escalation of medical therapy (MT). We present a systematic review and meta-analysis of studies comparing the outcomes of EBR with those of MT in ileocolonic CD, with a focus on ileocaecal disease.

Methods
The MEDLINE, Embase, CINAHL and Cochrane Central Register of Controlled Trials databases were searched for studies reporting the outcomes of EBR versus MT for ileocolonic CD. The Cochrane tools for assessment of risk of bias were used to assess the methodological quality of studies. The primary outcomes were recurrence rate and time to recurrence. Data on factors influencing duration of treatment effect, morbidity (including stoma rates), mortality and quality of life were extracted where available.

Results
Nine records (from 8 studies, with a total of 1867 patients) were included in the analysis. Six studies were observational and two were randomised controlled trials. Three observational studies were at serious risk, and one RCT was at high risk of bias. There was a reduced need for drug therapy in the EBR arm. The rate of intestinal resection at 5 years was 7.8% in the EBR arm and 25.4% in the MT group with a pooled OR of 0.32 (95% CI 0.19, 0.54; p&lt;0.0001). The EBR group had a longer resection-free survival (HR 0.56, 95% CI 0.38, 0.83; p=0.004). The time to repeat resection following the initial surgery was longer also in the EBR group (HR 0.65, 95% CI 0.47, 0.91; p=0.01). The need for surgery at 5 years remained in favour of EBR in a subgroup analysis of patients with ileocaecal disease (HR 0.18; 95% CI 0.04, 0.88; p=0.03). Morbidity and quality of life scores were similar across the two groups.

Conclusion
EBR is associated with a more stable remission compared to initial MT for Crohn’s disease. Despite the paucity of relevant studies within the literature, and the studies being of variable methodological quality, there is enough evidence to support EBR as an alternative to escalation of medical therapy in selected patients with limited ileocaecal disease. EBR should be discussed with patients at an early stage to allow them to make an informed treatment choice.
P499 Exclusive enteral nutrition induces transmural healing in adults with active Crohn’s disease
Authors: Chu M , Day A , Mathias R , Direen T , Broad L , Lynch K , Bryant R 
Published: January 2023

Abstract

Background
Exclusive enteral nutrition (EEN) is a nutrition-based therapy for active Crohn’s Disease (CD). Transmural healing is a novel therapeutic paradigm in CD, holding benefit beyond endoscopic mucosal healing. There are limited data exploring EEN and transmural healing in CD. We aimed to examine the effect of EEN on inducing transmural response and healing as assessed by intestinal ultrasonography (IUS).

Methods
This was a prospective, multi-centre, open-label cohort study. Adults ≥18 years with active CD were enrolled between March to September 2022. Eligible, consenting participants were nutritionally assessed by a specialised IBD dietitian and prescribed 6 weeks of EEN therapy. A 1.5kcal/ml polymeric, low lactose, fibre-free formula was used and EEN prescriptions were personalised to 25-30kcal/kg IBW and 1.2-1.5g protein/kg IBW/day. Patients were allowed concurrent tapering corticosteroid therapy and biological therapy. Participants completed clinical, biochemical and nutritional assessments at weeks 0, 3 and 6 and IUS at weeks 0 and 6. This included Harvey Bradshaw Index (HBI), C-Reactive protein, faecal calprotectin (FCP), body mass index (BMI). IUS assessment was conducted at baseline and at week 6 and images were centrally read by a blinded, IUS-trained gastroenterologist. Transmural response was defined by ≥25% bowel wall thickness (BWT) reduction from baseline. Transmural healing was defined as BWT≤3mm, Doppler signal score≤1, normal bowel wall stratification, and absence of inflammatory fat.

Results
Fourteen patients, 9 were female (64.3%) and mean age of 44.4 years, were consecutively enrolled and completed 6-weeks of EEN therapy. Ten patients (71.4%) had ileal disease (L1), 4/10 had ileocolonic (L3) and predominant phenotype was inflammatory (B1, 7/14) and stricturing (B2, 6/14) disease. Mean disease activity was HBI 5.1±4.0.Two patients had perianal disease (14.3%). Nine patients (64.3%) reported 100% adherence and 4 patients (28.6%) reported 75-99% adherence to the exclusive diet by predefined adherence categories. At week 6, 11/14 (78.6%) of patients achieved clinical remission with 12/14 (85.7%) showing clinical response. Reductions in CRP and FCP were not statistically significant. Numerical reduction in BWT was observed 5.6±1.4mm vs 4.8±2.1mm (95% CI -1.94, 0.265, p = 0.124). Transmural response was achieved in 8/14 (57.1%) and transmural healing was reached in 2 (14.3%) patients. Most common side effect was constipation (42.9%).

Conclusion
EEN was identified to induce early transmural response and healing in patients with active CD. Further studies are required to evaluate the capacity for EEN to induce transmural healing and the role of IUS as an early assessment tool in monitoring therapeutic response in CD.
P501 Safety of peri-operative biologics in patients with IBD undergoing resective bowel surgery: experiences of a single center cohort
Authors: Ochsenkuehn T , Tillack-Schreiber C , Bader F , Maximilian S , Szokodi D , Tomelden J , Waggershauser C , Braun I , Schnitzler F 
Published: January 2023

Abstract

Background
Despite good safety data, the risk of peri-operative treatment with biologics in IBD is still discussed controversially. Recently, the prospective PUCCINI trial demonstrated that direct exposure to TNF-blockers within 12 wks. of abdominal surgery was not associated with more infectious complications. However, in daily clinical practice experiences on biological treatment peri-operatively are limited. In our current retrospective trial, we addressed the safety of different biologicals in a peri-operative setting.

Methods
Eligible pat. in this single center study were recruited from our IBD center between 2012 and 2022. Direct exposure to biologics was defined as exposure to biologics within 12 wks. before resective bowel surgery performed at our surgical department. To evaluate safety, the post-operative outcome focused on minor complications, defined as infectious complications, wound healing complications and major complications, defined as insufficiency of the anastomosis and abscess formation at surgery site post-operatively.

Results
A total of 447 IBD pat. (334 CD, 113 UC, 51.9% female) were included and followed for a median of 45 mo. [range 0-113]. Median age was 44 yrs. [19-89], median age at diagnosis was 24 yrs. [5-84] and median age at surgery was 41 yrs. [16/85]. Median disease duration until surgery was 11 yrs. [0-47]. 74.3% of pat. had moderate to severe disease activity at date of surgery. A total of 73.9% of pat. (326/447) had medical treatment at date of surgery, 61.5% of pat. (275/447) were treated with biologics within 3 mo. before surgery and 42.3% (189/447) had biologic treatment within 4 wks. before surgery. Overall, 36.9% of pat. (164/447) received infliximab, 13.0 % (58/447) adalimumab, 1.1% (6/447) golimumab, 5.8% (26/447) vedolizumab, and 6.5% (29/447) ustekinumab, peri-operatively. Most surgeries were planned electively (97.1%, 434/447) and performed laparoscopically (67.8%, 303/447). Minor and major post-operative complications occurred in 20.8% (93/447) of patients. Serious complications were observed in 9 pat., six had acute bleeding, one developed peritonitis and two died post-operatively (one with and one without biologics). Using logistic regression models, no significant differences regarding complications and safety were observed between pat. with versus without biologic treatment. Interestingly, CD pat. with direct exposure to biologics within 4 wks. were more likely to undergo minimal-invasive surgery (68.6%, 107/156) than pat. with biologics within 3 mo. before surgery (48.28%, 28/58, p=0.02).

Conclusion
This retrospective single center study of 447 IBD patients could demonstrate that biologic treatment before surgery, even within 4 wks, is not associated with a higher risk of complications.
P502 Application of an algorithm-based precision-dosing model to a real-world cohort of patients on infliximab maintenance therapy: implications for drug usage and cost
Authors: Nguyen A , Gibson P , Upton R , Mould D , Sparrow M P 
Published: January 2023

Abstract

Background
Infliximab is registered for use in patients with inflammatory bowel disease (IBD) at an intravenous maintenance dose of 5 mg/kg eight-weekly. Secondary loss of response during maintenance therapy occurs in up to 50% of patients. New precision dosing models, which forecast infliximab doses to achieve targeted trough levels, reduce non-response and improve patient outcomes. Aim: To compare standard 5 mg/kg eight-weekly infliximab dosing to the infliximab doses theoretically required to achieve predefined infliximab trough target levels, as determined by the iDOSE® precision dosing dashboard model.

Methods
IBD patients treated with eight-weekly maintenance infliximab therapy dosed at 5 mg/kg were included. A recorded infliximab dose was considered dose X if the following was available: three previous infliximab doses, albumin and C-reactive protein at time of dose X, trough infliximab level immediately preceding dose X and the patient’s weight. The Baysient LLC iDOSE® software was then used to predict dose X to maintain therapeutic infliximab trough levels of ≥ either 5-10 or 3-7 µg/ml until the next eight-weekly dose. The predicted dose X was compared to the actual dose X given.

Results
174 patients (56% male) were included with 417 dose X recordings. Of those, 135 had Crohn’s disease, 31 ulcerative colitis and 8 IBD-unclassified. Median age was 36 (IQR 29-47) years with a disease duration of 5 (1-13) years. 76% of patients were receiving immunomodulators and 6% were smokers. Duration of infliximab therapy before dose X was 2 (0-4) years. Trough infliximab levels were 5.0 (2.5-7.6) µg/ml, serum albumin was 38 (35-40) g/L and C-reactive protein 3 (3-4) mg/L. Comparing actual dose X with predicted dose X, 52% and 32% of doses were subtherapeutic when aiming for trough levels of 5-10 and 3-7 µg/ml respectively. The underdosing occurred by 5.6 and 5.3 mg/kg per dose, respectively. Cost analysis showed total costs increased by 102% and 29% when aiming for trough levels 5-10 and 3-7 µg/ml. On multivariable regression analysis, significant associations with subtherapeutic infliximab levels were ulcerative colitis compared to Crohn’s disease [OR: 9.81, 95% CI: 1.28-75.40, p = 0.028] and pre-dose X infliximab trough level [OR: 0.07, 95% CI: 0.03-0.15, p &lt; 0.001].

Conclusion
More than half of maintenance infliximab drug doses given at our institution were too low to achieve therapeutic infliximab blood levels of at least 5 µg/ml. These patients would likely benefit from an increased dose or reduced dosing interval of infliximab. These findings need to be confirmed prospectively.
P505 Real word long-term efficacy and safety of vedolizumab in managing ulcerative colitis versus crohn’s disease: results from “long vedo” italian multicenter study
Authors: Mocci G , Maconi G , Onidi F M , Cataletti G , Elisei W , Scaldaferri F , Lorenzetti R , Pagnini C , Scarcelli A , Graziani M G , Di Paolo M C , Pranzo G , Luppino I , Monterubbianesi R , Faggiani R , Ferronato A , Savarino E , Pica R , Cocco A , Rodino S , Sebkova L , Zampaletta C , Gaiani F , Fanigliulo L , Allegretta L , Cuomo A , Donnarumma L , Della Valle N , Forti G , Antonelli E , Bassotti G , Iannelli C , Aragona G , Lauria A , Piergallini S , Colucci R , Binaghi L , Meucci C , Papa A , Tursi A 
Published: January 2023

Abstract

Background
Current data about long-term use of vedolizumab (VDZ) in ulcerative colitis (UC) versus Crohn’s disease (CD) patients are limited. We aimed to assess whether there are differences in term of long-term efficacy and safety of VDZ in UC vs. CD patients.

Methods
Clinical activity was scored according to the Mayo score in UC and to the Harvey-Bradshaw Index (HBI) in CD. The primary endpoints were the achievement of clinical remission within 6 month of treatment, maintenance of clinical remission during a long follow-up, and safety. Secondary endpoints were clinical response to treatment, achievement of mucosal healing (MH), steroid discontinuation, and treatment optimization during the follow-up.

Results
The study group consisted of 729 patients (475 patients with UC and 254 CD patients with CD) with a median follow-up of 18 (interquartile range 6-36) months. Clinical remission at the 6th month of treatment was achieved in 488 (66.9%) patients, higher in CD patients (74.4 vs. 62.9, p&lt;0.000) while, at the maximal follow-up, it was achieved and maintained in 81.5% of patients (UC vs. CD, p=0.667). At uni- and multivariate analysis, reaching clinical remission at the 6th month of treatment (p=0.001) and being naïve to biologics were significantly associated with longer clinical remission (p&lt;0.0001). Long-term follow up clinical response was significantly higher in UC vs. CD (p=0.023) and surgery occurred more frequently in CD (p=0.04), while no difference were found between UC and CD about the other secondary endpoints

Conclusion
Overall, no significant differences were found about the long-term use of VDZ in UC vs. CD. However, we identified some parameters the can help the physician to predict the long-term efficacy of this drug.
P507 United States and European patient perspectives on the impact of moderate-to-severe Ulcerative Colitis on sexual activity: Communicating Needs and Features of IBD Experiences (CONFIDE) survey
Authors: Travis S , Bleakman A , Dubinsky M , Rubin D , Panaccione R , Hibi T , Kayhan C , Gibble T H , Sapin C , Flynn E , Atkinson C , Schreiber S 
Published: January 2023

Abstract

Background
Patients with ulcerative colitis (UC) report that UC negatively affects their quality of life (QoL), including sexual functioning, satisfaction, and drive.1,2 These effects are rarely discussed with or by gastroenterologists in clinical practice. The CONFIDE study aims to elucidate the impact of symptoms on the lives of patients with moderate-to-severe UC in the United States (US), Europe (EU5; France, Germany, Italy, Spain, and UK), and Japan. Data presented here are from the US and EU5.

Methods
Online, quantitative, cross-sectional surveys were conducted (July–September 2021). Criteria based on previous treatment, steroid use, and/or hospitalization were used to define moderate-to-severe UC. Data collected included patient perspectives on the impact of UC on sexual activity. Sexual activity was not limited to intercourse and included activities such as masturbation.

Results
Surveys were completed by 200 US patients (male [M]=62%, mean age 40 years) and 556 EU5 patients (M=57%, mean age 39 years). Of these, 77% US and 54% EU5 patients were receiving advanced therapy (biologic/novel oral) and 52% and 73% were receiving steroids at the time of survey completion, respectively. Overall, 63% US patients (M=55%, female [F]=77%) and 53% EU5 patients (M=47%, F=60%) reported avoiding or decreasing sexual activity due to UC in the 3 months prior to the survey (Figure 1a). Among these patients (US: N=126; EU5: N=292), most frequently reported reasons for avoidance of sexual activity were bowel urgency (BU; 41%), decreased sexual desire (37%), and fear of BU-related accidents (34%) in the US and fear of faecal seepage (37%), fear of BU-related accidents (36%), and BU itself (31%) in EU5 (Figure 1b). Although reasons for avoiding sexual activity were broadly similar between sexes, higher percentage of male patients from both US and EU5 (US: M=33%, F=24%; EU5: M=42%, F=33%) reported fear of faecal seepage as a factor affecting sexual activity. Conversely, higher percentages of female patients reported perianal pain (M=13%, F=19%) and self-consciousness (M=13%, F=24%) as reasons for avoiding sexual activity in the US and decreased sexual desire (M=16%, F=26%), BU (M=26%, F=36%) and fatigue (M=14%, F=22%) in EU5 (Figure 2).

Conclusion
In both US and EU5 populations, &gt;50% patients with moderate-to-severe UC reported avoiding or decreasing sexual activity due to UC, with bowel urgency and bowel urgency-related accidents being among the top three reasons. In addition to other QoL parameters, impact of UC on patients’ sexual health needs to be assessed in routine clinical practice.
References:
1Bulut AE, et al. Turk J Gastroenterol. 2019;30:33-39.
2Jedel S, et al. Inflamm Bowel Dis. 2015;21:923-38.
P508 Sarcopenia is associated with increased rates of infectious post-operative complications in Crohn’s disease patients
Authors: Simpson K , Inniss S , Fragkos K C , Wood C P J , Smith A , Rahman F Z 
Published: January 2023

Abstract

Background
More than one fifth of Crohn’s disease patients will require surgery within 5 years of diagnosis, rising to over 90% throughout their lifetime. Sarcopenia is defined as a disease process of skeletal muscle decline in mass, function, and physical performance. Emerging evidence suggests sarcopenia may be implicated with Crohn’s disease severity and poorer outcomes. Several sarcopenia assessment tools exist with varying accuracy, however CT or MR images at the level of the third lumbar vertebra (L3) can reliably predict whole-body composition. Our aim was to assess the prevalence of sarcopenia via L3 scores in pre-operative Crohn’s disease patients and examine its impact on post-operative outcomes.

Methods
This single-centre, retrospective study collected data from 95 Crohn’s disease patients undergoing surgery between 2015-2021 and followed up for 12 months. Pre-operative baseline characteristics and post-operative outcomes were recorded immediately after surgery and at 30 days, 1, 6 and 12 months. Infectious and non-infectious complications were recorded, including but not limited to: abscess, collection, wound site infection, anastomotic leak, venous thromboembolism, haemorrhage. Sarcopenia was assessed from CT and MR imaging at the level of L3 within 3 months of surgery, and was defined as per the Martin et al. equation.

Results
Of 58 Crohn’s disease patients with pre-operative imaging, sarcopenia was prevalent at 74.1% (43/58). Pre-operative Harvey-Bradshaw Index was significantly higher in those with sarcopenia (sarcopenic group: 8, non-sarcopenic: 4, p&lt;0.001). In addition, anaemia adjusted for gender was more prevalent in the sarcopenic group versus non-sarcopenic (56.1% [23/41] versus 25% [3/15], p=0.058). Sarcopenic patients experienced higher rates of infective complications within 30 days of surgery (22.5% [9/40] versus 0, p=0.052).

Conclusion
The prevalence of sarcopenia is higher in Crohn’s disease patients undergoing surgery than first thought and may be implicated in disease severity. Our study found that sarcopenia is associated with increased rates of infective post-operative complications. Further studies are required to corroborate our findings and identify appropriate interventions for sarcopenia. In conclusion, sarcopenia in Crohn’s disease may reflect a phenotype of aggressive disease implicated with worse post-operative outcomes.
P511 Evaluation of home faecal calprotectin testing to aid remote management and enhanced self-management of Inflammatory Bowel Disease.
Authors: Allen K , Munuswamy P 
Published: January 2023

Abstract

Background
Faecal calprotectin (FC) is an established biomarker for patients with irritable bowel disease (IBD). A treat to target strategy has been shown to be successful in managing these patients and the development of a home FC test (IBDoc) opens the door to a more patient centred approach for IBD management.

Methods
IBD patients in the IBD database at Basildon and Thurrock University Hospital with a compatible smart phone who had previously agreed to monitor FC at home using IBDoc were eligible for inclusion. Usability, patient experience, engagement and understanding of the IBDoc, along with satisfaction with enhanced remote and self-management, were assessed using a mixed methods approach via an online questionnaire consisting of Likert scale questions and a limited number of free text questions.

Results
47 participants were enrolled in the study. Over 85% of responses showed patients found the IBDoc to be user friendly. Over 80% of responses indicated patients were happy with their understanding of the result and what it meant for their disease status. Thematic analysis revealed a personalised care plan for each patient is of crucial importance. Clinicodemographic variables found to influence patient satisfaction with use of the IBDoc and enhanced remote and self-management were treatment type, education history and disease type.

Conclusion
Results demonstrate excellent acceptance of the IBDoc system with good scores for usability and patient understanding. This shows that the home test can be used as an objective patient reported outcome within a treat to target approach. Better educational materials and clinically guided personalised care plans, along with the IBDoc home FC test, make IBD a viable candidate for self-management at the same level as traditionally self-managed diseases such as diabetes.