bluuebunny/crossref_metadata_2025 huggingface dataset:
P691 Disparate care: rates of treat to target among patients with inflammatory bowel disease
Authors: Haydek J , Oonk A , Cheng D , Ahmed W , Click B , Fennimore B , Gerich M , Hou J , Scott F
Published: January 2023

Background

Inflammatory bowel diseases (IBD) therapies are limited by low response rates and risks of loss of response. Treat to target (T2T) algorithms aim to maximize the benefit of therapies by establishing a framework for assessing patient reported outcomes, biochemical evaluation (C-reactive protein (CRP) or fecal calprotectin (FC)), and structural assessment via endoscopy or enterography. There are limited data on adoption rates of T2T in real-world clinical practice. We aimed to describe rates of T2T utilization in a large regional medical system in the United States.

Methods

A retrospective cohort study was conducted from 2015-2021. Individuals with IBD starting a new biologic therapy were identified. Collected data included demographics, laboratory data, current medications, and procedure and imaging data. Patients were categorized based on whether they completed T2T, defined as CRP or FC testing at 2-4 months after starting a new therapy, and structural assessment, defined as colonoscopy, sigmoidoscopy, capsule endoscopy, or enterography within 6-12 months after starting a new therapy. Complete adherence was defined as both of these criteria being met. Social deprivation index (SDI), with higher values associated with higher rates of social deprivation, was derived using mail codes. T-tests, Pearson chi-square tests, ANOVA and multivariable logistic regression were used for comparisons.

Results

7,962 patients were identified (Table 1). Rates of T2T were low; only 7.81% of patients completed biochemical monitoring at 2-4 months (0.83% FC, 8.65% CRP, 1.76% both), 9.80% completed structural assessment, and 3.43% completed both. In univariable logistic regression, higher age (OR 0.98, p<0.01), IBD type (UC OR: 0.69, p<0.01), having no insurance (OR 0.84, p=0.02) and low social deprivation index (SDI) (OR 1.004, p<0.01) were associated with lower T2T completion rates.

In multivariable logistic regression, ulcerative colitis (UC), younger age, and lower SDI score were significantly associated with likelihood of completing any T2T (Table 2). When considering biochemical monitoring at 2-4 months, Asian race, UC diagnosis, age, SDI score and year were significantly associated with completion (Table 3). UC diagnosis, year and age were significantly associated with completion of structural assessment (Table 4).

Conclusion

Treat to target completion rates among patients with IBD starting biologic therapies were low in this large cohort. Age and UC diagnosis were negatively associated with completing T2T. Social deprivation score was positively associated with biochemical monitoring. Further research is required to understand barriers to T2T monitoring.
P695 Effectiveness and Safety of Combination Biologic or Small Molecule Therapy in Inflammatory Bowel Disease
Authors: McShane C , Varley R , Fennessy A , Campion J , Ring E , Kelly O , Slattery E , Doherty G , McCarthy J , Kevans D ,   INITIative Network
Published: January 2023

Background

Biologic and small molecule therapies have revolutionised the treatment of inflammatory bowel disease (IBD). Despite these advances, there appears to be a therapeutic ceiling with single agent therapy with up to 50% of patients failing to achieve long term remission. Combination of two biologic therapies or a biologic therapy and small molecule agent, with differing mechanisms of action, has the potential to improve IBD therapy outcomes. Information on the effectiveness and safety of this treatment strategy in IBD remains limited.

Methods

A retrospective, multicentre study was carried out at five Irish Academic Centres within the Initiative Network. Combination biologic or small molecule use was defined as concomitant use of two biologics or one biologic and small molecule therapy licenced or undergoing clinical trial assessment for treatment of IBD. Patients who had received combination therapy were identified from institutional databases. Review of clinical records was performed and demographic data collected. Combination therapy persistence was considered a proxy for successful therapy outcome. Adverse events were documented. P values < 0.05 were considered significant in analyses.

Results

The study cohort included 85 patients; 70% Crohn’s disease (CD), 30% ulcerative colitis (UC); median (IQR) number of prior biologic therapies 3 (2 – 3); median (IQR) study follow up 40.71 weeks (13.68 – 82.86). Further baseline characteristics are described in Figure 1. 97 combination therapy trials were undertaken in 85 patients. 13 different combination therapy regimes were utilised with ustekinumab & vedolizumab being the most common regimen. 76.5% (n=65 patients) remained on combination therapy at last follow up. Higher rates of combination therapy discontinuation (p=0.04) and shorter time to combination therapy discontinuation were observed in UC compared with with CD (HR 0.48 [95% CI 0.21-1.11], p<0.05). 3.1% of the study cohort developed a serious or opportunistic infection. No deaths or intensive care unit admissions occurred during study follow up.

Conclusion

Combination therapy is an effective therapeutic strategy with an acceptable safety profile in refractory IBD patients. Randomised controlled trials are required to clearly define the role of combination therapy in the management of IBD.
P697 De-escalating therapy in inflammatory bowel disease: Results from an observational study in clinical practice.
Authors: Arenas A , Moreta M J , Ordás I , Fernández-Clotet A , Caballol B , Gallego M , Vara A , Barastegui R , Giner A , Prieto C , Masamunt M C , Ricart* E
Published: January 2023

Background

Combination therapy with an immunomodulator (IMM) and an anti-TNF agent (specifically infliximab) is recommended in Crohn’s disease (CD) and ulcerative colitis (UC) patients to improve efficacy and reduce anti-TNF immunogenicity. Combo therapy increases the risk of adverse events and therefore attempts are made to de-escalate therapy in clinical practice. There are scarce data about relapse rates after discontinuation of either IMM or anti-TNF among patients with long-term remission under combination therapy. The aims of this study were to assess the risk of relapse in a cohort of UC and CD patients with long-standing remission after discontinuation of IMM or anti-TNF and to identify predictive factors for relapse.

Methods

This is a retrospective unicentric study that included patients with UC or CD on combination therapy and sustained clinical remission at least for 6 months. IMM or anti-TNF were stopped upon treating-physician decision and data were collected until relapse or last follow-up. Relapse was defined as the onset of clinical, biological, endoscopic or radiological activity, leading to therapeutic intervention. The survival without relapse is represented by Kaplan–Meier curve and analyzed by log rank test. Hazard ratios (HR) for relapse were estimated by Cox proportional hazard regression analyses and are reported with 95% confidence intervals (CI).

Results

Eighty-eight patients (60 CD (68.2%), 28 UC (31.8%) were included. Demographic data and clinical characteristics are shown in tables 1 and 2. Forty-eight patients (54.5%) discontinued IMM and 40 (45.5%) anti-TNF. Median time of follow-up was 33 months (IQR 18.00-55.75). During follow-up, relapse rate was 16.7% in the IMM discontinuation group and 52.5% in the anti-TNF discontinuation group (p<0.001) (Figure 1). Median time without relapse after discontinuation of IMM and anti-TNF was 38.50 (IQR 19.75-58.5) and 24.50 months (IQR 10.25-42.75), respectively (p=0.036). In the multivariate analysis, only discontinuation of anti-TNF was a predictive factor for relapse (HR=4.99; 95% CI=1.11–14.07) (Table 3). Among patients who relapsed after anti-TNF discontinuation, clinical response after reintroduction of the drug was achieved in 78.6% (11/14) without safety issues.

Conclusion

Discontinuation of anti-TNF in patients on combination therapy with IMM and anti-TNF and long-standing remission led to significantly higher relapse rates compared to discontinuation of IMM. Retreatment after anti-TNF discontinuation was effective and safe.
P700 Perceptions towards established and emerging dietary therapies for Crohn’s disease management among the adult patients: results from a questionnaire survey
Authors: Jatkowska A , White B , Jaskolski P , Brownson E , Clowe J , Seenan J P , Gerasimidis K , MacDonald J
Published: January 2023

Background

Exclusive enteral nutrition (EEN) and partial enteral nutrition (PEN), replacing at least 50% of the energy intake with formula, remain the only evidence-based dietary therapies in the management of Crohn’s disease (CD). Nonetheless, emerging solid food-based dietary therapies are being researched to offer equally effective, but more palatable alternatives. We assessed the perceptions of adults with CD towards EEN, 50% PEN, and novel dietary therapies within a cross-sectional questionnaire survey.

Methods

The 26-question anonymous survey with a pre-paid return envelope was mailed to 300 adult patients with CD treated with biologics under the care of the NHS Greater Glasgow & Clyde. A reminder was resent three months later. Responses to open-ended questions regarding concerns about 50% PEN use were analysed independently by two researchers using thematic analysis.

Results

One-hundred and sixty patients (85/160, 53% female) completed and returned the survey (response rate: 53%). Forty-two percent (67/158) had already followed some form of an exclusion diet, with low spice (32/158, 20%) and low fibre (24/158, 15%) diets being the most popular. Although only a quarter of patients believed that EEN or PEN could help with their CD (42/157, 27%), the majority believed that diet could help (84/157, 54%), with another 13% (21/157) reporting already using diet for CD management. Although only around half of the patients were willing to try EEN (80/157, 51%), the majority were willing to try PEN instead (124/157, 79%) (EEN vs. PEN chi-square: P<.001). Most patients preferred to follow an exclusion diet meal plan to prepare at home (65/154, 42%) compared to EEN or PEN (53/153, 34%). Similarly, most patients preferred to follow a meal plan to prepare at home (76/151, 50%) rather than a meal plan with pre-made meals delivered (59/151, 39%). When asked about preferences related to PEN use, most patients reported that they would prefer to follow a flexible meal plan, allowing them to choose meals to replace to fit their lifestyle (92/153, 60%). The most commonly reported concerns about PEN identified within the thematic analysis were taste/palatability (25%, 34/136), satiety/hunger (22%, 30/136), taste fatigue (14%, 19/136), and impact on social life (14%, 19/136).

Conclusion

Most adult patients would prefer to follow an exclusion diet meal plan rather than EEN or 50% PEN. However, the majority would try 50% PEN which allows for more flexibility and may be easier to comply with than EEN.
P715 Achievement and maintenance of endoscopic, histologic, and combined outcomes after extended induction in Week 10 nonresponders of ozanimod: 2-year interim analysis of the True North open-label extension study
Authors: Vermeire S , Colombel J F , Rubin D T , Ghosh S , Jain A , Lawlor G , Osterman M T , Wu H , Canavan J B , Chiorean M V
Published: January 2023

Background

Ozanimod, a novel oral therapeutic option for patients with moderately to severely active ulcerative colitis, demonstrated significant improvements in clinical, endoscopic, and histologic endpoints in the phase 3, 52-week, double-blind True North (TN) study. Approximately one-third of the patients did not achieve clinical response to ozanimod after 10 weeks of TN induction therapy. However, a delayed response was observed in a subset of these nonresponders upon extended induction with ozanimod. The present analysis evaluated ozanimod efficacy on endoscopic and histologic endpoints in these delayed responders in the TN open-label extension (OLE) study.

Methods

Data were analysed for the overall delayed responder population and separately for the blinded (Cohort 1) and open-label (Cohort 2) cohorts (data cutoff: 10 January 2022, the point at which patient disposition was available for all patients up to OLE Week 94). Endpoints included endoscopic improvement (defined as an endoscopy subscore of ≤1 point), histologic remission (defined as Geboes index score <2.0), and mucosal healing (defined as endoscopy subscore of ≤1 point and Geboes index score of <2.0) up to OLE Week 94. The endpoints were evaluated using observed case (OC) and nonresponder imputation (NRI) analyses.

Results

A total of 226 patients (Cohort 1, n=150; Cohort 2, n=76) were nonresponders at Week 10 and entered the OLE (67% male; mean [standard deviation] age, 39.6 [13.6] years). At OLE entry, 24% of patients had moderate disease (Mayo endoscopic score [MES]=2) and 73% had severe disease (MES=3). Approximately half of these patients achieved symptomatic clinical response as early as 5 weeks of ozanimod open-label treatment. In OC analysis at OLE Week 46, 30% of patients achieved endoscopic improvement, 42% achieved histologic remission, and 24% achieved mucosal healing that further increased to 48%, 48%, and 39%, respectively, by OLE Week 94 (Figure 1A). In NRI analysis, the following patient proportions were observed at OLE Weeks 46 and 94: 18% and 19% (endoscopic improvement), 22% and 14% (histologic remission), and 13% and 11% (mucosal healing) (Figure 1B). Data were generally similar in Cohorts 1 and 2.

Conclusion

Delayed responders to ozanimod achieved and maintained mucosal healing over 2 years of continuous ozanimod treatment. Ozanimod treatment resulted in the healing of intestinal mucosal lesions, even in patients with moderate to severe disease who may have an initial delayed response to ozanimod.
P719 Symptomatic improvement and long-term stability of ulcerative colitis symptoms over 3 years of ozanimod treatment
Authors: Danese S , Abreu M T , Afzali A , Canavan J B , Jain A , Wu H , Petersen A , Panaccione R , Wolf D C
Published: January 2023

Background

The phase 3 True North (TN) study demonstrated the efficacy and safety of ozanimod over 52 weeks in patients (pts) with moderately to severely active ulcerative colitis (UC). Pts completing 52 weeks of TN were eligible for the ongoing TN open-label extension (OLE) assessing the long-term efficacy and safety of ozanimod. Presented here is the interim analysis of the TN OLE focused on the symptomatic efficacy of ozanimod in pts with approximately 3 years of continuous ozanimod treatment.

Methods

Pts who achieved clinical response after receiving 52 weeks of continuous ozanimod during TN and subsequently entered the TN OLE were evaluated (data cutoff: 10 January 2022, at which point the OLE Week 94 disposition was available for pts). Patient-reported (rectal bleeding subscore [RBS] and stool frequency subscore [SFS]) and clinician-reported (Physician’s Global Assessment) symptomatic outcomes were determined. Symptomatic clinical response (partial Mayo score [PMS] ≥1 point and ≥30% reduction in PMS with ≥1-point decrease in RBS or absolute RBS of ≤1) and symptomatic clinical remission (RBS=0 and SFS ≤1 [and decrease of ≥1 point from baseline SFS]) were evaluated at OLE Week 5 through OLE Week 94 (146 weeks of continuous ozanimod treatment) using observed case (OC) and nonresponder imputation (NRI) analyses. PMS, RBS, and SFS were assessed from TN baseline to OLE Week 94.

Results

In all, 131 pts entered the OLE after achieving clinical response following 52 weeks of continuous ozanimod during TN. At data cutoff, 87.0% completed OLE Week 46 (98 weeks of continuous ozanimod) and 71.8% completed OLE Week 94 (146 weeks of continuous ozanimod). Pts had a mean age of 44 years and 52% were female. Most (68%) had left-sided UC disease, 24% had concomitant corticosteroid use at TN baseline, and 32% had prior exposure to tumor necrosis factor inhibitors. Symptomatic clinical response and symptomatic clinical remission were observed in 100.0% (Figure 1A) and 84.4% (Figure 2A) of pts, respectively, at OLE Week 5 in the OC analysis (93.1% [Figure 1B] and 78.6% [Figure 2B] in the NRI analysis). Rates of symptomatic clinical response and symptomatic clinical remission were maintained through OLE Week 94 in the OC analysis and decreased slightly over time in the NRI analysis. Reductions in mean PMS from baseline were observed during TN and sustained through OLE Week 94. Reductions from TN baseline in RBS (Figure 3) and SFS (Figure 4) were also observed through OLE Week 94.

Conclusion

This interim analysis of the TN OLE focusing on symptomatic endpoints found that most pts who achieved clinical response after 1 year of ozanimod sustained symptom control for another 2 years.
P720 Drug survival of first-line biologics in inflammatory bowel disease: large single-centre experience from UR-CARE
Authors: Hanzel J , Supovec E , Smrekar N , Koželj M , Kurent T , Štabuc B , Novak G , Drobne D ,   SING (Slovenian National IBD Study Group)
Published: January 2023

Background

The expanding therapeutic armamentarium for inflammatory bowel disease (IBD) has led to uncertainty about the optimal first-line biological therapy for a given patient. Given the paucity of dedicated head-to-head trials, treatment decisions can be supported by network meta-analyses or real-world data. Our aim was to assess the drug survival of first-line biologics by drug class (anti-tumour necrosis factor [TNF] agents, anti-integrin, anti-interleukin [IL]-12/23) and identify potential predictors for prolonged drug survival in our cohort of IBD patients, supported by the United Registries for Clinical Assessment and Research (UR-CARE).

Methods

We prospectively included all adult patients with IBD treated with biological drugs and at least one follow-up visit between October 2021 and August 2022 at our tertiary referral centre. Patient data were collected retrospectively from records and included demographics, disease characteristics and drug survival. Data were collected in UR-CARE with data lock on August 1, 2022. Cox regression was used to assess the association of patient and disease characteristics with drug survival of first-line biologic drugs by drug class.

Results

We included 1047 adult patients with IBD (644 Crohn’s disease [CD], 403 ulcerative colitis [UC]) (Table 1). Among TNF antagonists, adalimumab was most frequently used in CD (280/644, 43.5%; infliximab: 241/644, 37.4%), infliximab was most frequently used in UC (169/403, 41.9%; adalimumab: 55/403, 13.6%; golimumab: 52/403, 12.9%). Unadjusted median drug survival of the first-line biologic did not differ by medication class in CD, but was significantly longer for vedolizumab than for anti-TNF agents in UC (hazard ratio [HR] for discontinuation 0.585, 95% confidence interval [CI] 0.41–0.84; P = 0.003) (Table 2). Disease duration and extent were not associated with drug survival. In CD, isolated ileal disease was associated with longer drug survival (HR 0.83, 95% CI 0.70–0.99; P = 0.04). Findings for both CD and UC were consistent in a sensitivity analysis of patients (CD 228, UC 202) started on biologics after January 1, 2019 when all three drug classes could be prescribed first line without limitations.

Conclusion

In our cohort of 1047 patients with IBD, the drug survival of first-line biologics was comparable regardless of drug class in CD. In UC, first-line vedolizumab was associated with longer drug survival. Disease location and duration did not impact drug survival.
P731 Effect on direct and indirect costs of switching Inflammatory Bowel Disease patients from intravenous to subcutaneous infliximab (CT-P13)
Authors: Carbery I , Broglio G , Clark T , Greer D , Alakkari A , Selinger C P
Published: January 2023

Background

Infliximab has transformed the management of Inflammatory Bowel Disease (IBD) however it has a significant cost burden. Additionally, demand on our IBD day case infusion unit has tripled in the last 7 years leading to long delays in treatment initiation. Switching patients from intravenous (IV) to subcutaneous (SC) infliximab reduces the demand on infusion units and offers patients more flexibility. We aim to compare the real-life direct (drug price and administration costs) and indirect costs (travel costs and time lost to work for patients) associated with switching patients from IV to SC CT-P13, an infliximab biosimilar, in a tertiary UK IBD centre.

Methods

We analysed data from all adult IBD patients at Leeds Teaching Hospitals Trust who had been identified as eligible to switch from IV to SC CT-P13. All patients were on a standard dosing regimen (5mg/kg 8 weekly) and were invited to switch via a letter from the IBD lead clinician. Patients were classified as IV or SC based on their decision to switch within 3 months. Figure one demonstrates how direct and indirect costs were calculated. We then compared the calculated annual costs by intention-to-treat (i.e. if all patients had switched from IV to SC) and as-treated (comparing all on IV pre-switch to some on IV and some SC post switch).

Results

169 patients were identified as eligible to switch to SC CT-P13, 98 (58%) switched within 3 months. One patient was excluded as they had subsequently moved out of area. Prior to switching, total annual IV cost for 168 patients was calculated as £689,507.04 (direct = £653,671.20, indirect = £35,835.84). In the as-treated analysis after the switch, IV cost for 70 patients was £285,490.02 (direct = £272,363, indirect = £13,127.02) and SC cost for 98 patients was £389,432.81 (direct = £382,200, indirect = £7,232.81) giving a total annual cost for 168 patients of £674,922.83. In this analysis, after a proportion of patients switched to SC CT-P13, annual direct costs to the health service were £891.80 more per year, however indirect costs or cost to the patient were lower resulting in a lower total spend. See figure 2 for a breakdown of direct and indirect costs.

Conclusion

Our real-world analysis demonstrates that a switch from IV to SC CT-P13 is broadly cost neutral to the health service. Whilst the SC option has higher drug costs, a switch to SC allows for more efficient running of IV induction therapies by reducing demand on the infusion unit and reduces costs to the patient in terms of travel, parking and potential loss of working hours.
P754 Beyond Paneth cell metaplasia: Small intestinal metaplasia of the sigmoid colon in patients with Inflammatory Bowel Disease
Authors: Koehne de Gonzalez A , del Portillo A
Published: January 2023

Background

Paneth cells are normally found in the small intestine, and when found in the left colon, they represent Paneth cell metaplasia (PCM). This finding indicates a chronic inflammatory state and is seen in some patients with inflammatory bowel disease (IBD). However, small intestinal differentiation beyond PCM has not been reported. We report a broader range of small intestinal metaplasia in the sigmoid colon in patients with IBD, including loss of expression of the colonic marker SATB2, presence of a brush border and villous architecture, and gain of expression of the small intestinal markers CD10 and HepPar1. We perform a pilot study to investigate the frequency, staining patterns, and clinical correlates of this metaplastic phenomenon.

Methods

A database search for sigmoid biopsies for the words “Paneth cell metaplasia” from 2010-2018 returned 862 cases. The 100 most recent consecutive cases with a history of IBD were reviewed and confirmed to have PCM in non-neoplastic sigmoid biopsies in 96 cases. Of these, 94 blocks from 91 patients (age range 7-88, median age 43, 53% male, 74% ulcerative colitis (UC), 23% Crohn’s disease, 3% IBD) were on file. IHC staining for HepPar1, CD10, and SATB2 was performed on each case.

Results

Of the 94 cases, 13 (13.8%) had HepPar1 positivity, 5 (5.3%) had CD10 positivity, 2 (2.1%) had SATB2 loss, 1 (1.1%) had reduced SATB2 expression, and 2 showed villous architectural features. Extensive positivity for CD10 was seen in 3 (3.2%) cases, and one case showed all 3 IHC markers of small intestinal metaplasia. Of the CD10+ cases, there were 3 UC, 1 Crohn's, and 1 IBD (Table 1). The index case (sigmoid colon) showed a brush border (Figure 1) and intermixed small (Figure 2, red arrows) and large bowel (Figure 2, black arrows) differentiation.

Conclusion

A range of small intestinal differentiation may be seen in the left colon in IBD patients, including PCM, the presence of brush border, villous architecture, CD10 and HepPar1 positivity, and reduced or lost SATB2 expression. Since the frequency of HepPar1+>CD10+>SATB2 loss, there may be a sequence of small intestinal metaplasia, with PCM occurring first, and loss of SATB2 reflecting more advanced metaplasia. Previous studies suggest that SATB2 and HepPar1 are helpful in distinguishing between inflamed ileal pouch vs rectal cuff in patients with IBD, and that CD10 could be used to distinguish between ileum and colon in anastomoses, but our data refute these claims. SATB2 loss has been described in dysplastic lesions in patients with IBD, and thus these markers could serve as biomarkers of progression to dysplasia.
P763 Role of quality of life in patients with Inflammatory Bowel Disease
Authors: Kaltenbach T , Schulte L A , Kranzeder A , Klaus J , Sularz M
Published: January 2023

Background

Complaints like diarrhea, incontinence, frequent hospitalizations etc. can affect quality of life (QoL) in IBD patients (IBDP). QoL plays a central role in patient care. We investigated in which aspects patients with high quality of life (HQL) differ from patients with low quality of life (LQL).

Methods

This study was based on an anonymous questionnaire. IBDP of specialized outpatient clinics in three hospitals in Germany participated. Using questions about IBD/ lifestyle, disease activity (Harvey-Bradshaw-Index (HBI)/ Partial Mayo Score (PMS)) and psychological tests (Hospital Anxiety and Depression Scale (HADS), State-Trait-Anxiety Inventory (STAI), Social Support Questionnaire (F-SozU), Complaints-list (BL-R'), NEO-Five-Factor Inventory (NEO-FFI), differences between IBDP with HQL (SIBDQ≥50) vs. LQL (SIBDQ<50) were investigated.

Results

Overall, 103 (36%) patients had LQL and 183 (64%) had HQL. In general, LQL patients are more likely to be female (p=0.013), to worry about course of disease (p<0.001), to engage in irregular or no exercise (p=0.044), to have anal discomfort (p<0.001), to have extraintestinal symptoms, such as joint (p<0.001) or eye (p=0.004) disorders, and they are more likely to be taking cortisone (p<0.001).Furthermore LQL patients have higher number of general complaints (p<0.001) and are more often in active state of disease (HBI/CAI) (p<0.001 / p<0.001) or have higher disease activity than HQL patients. LQL patients rated the effect of their current medication poorer (p<0.001).Investigation of psychological parameters showed that LQL patients had higher scores on depression scale (p<0.001) and anxiety scale (p<0.001) of HADS-D. Both trait anxiety (p<0.001) and state anxiety (p<0.001) of STAI are significantly higher in LQL patients and they experience less social support (p=0.011). LQL patients are particularly likely to exhibit the personality trait neuroticism (p<0.001) in NEO-FFI, whereas HQL patients exhibit extraversion (p<0.001) and conscientiousness (p=0.007).

Conclusion

IBD patients with LQL differ from IBD patients with HQL in several factors. Inter alia, concerning disease in terms of higher disease activity, poorer effect of medication and additional extraintestinal manifestations. But also in terms of psychological factors such as anxiousness, depressiveness, and regarding extend of social support. By paying attention to and working on these factors affecting QOL physician and IBD-patient may improve this very important therapeutic goal together.
P766 Practical application of evidence-based dietary therapy into inflammatory bowel disease care shows high patient satisfaction, compliance, and efficacy. The Delectable Program
Authors: Russell E , Trakman G , Hamilton A L , Wilson-O’Brien A , Hendricks N , Simmance N , Thompson E , Niewiadomski O , Kamm M
Published: January 2023

Background

Diet is an accepted therapy for Inflammatory Bowel Disease (IBD). Controlled trials have demonstrated that exclusive enteral nutrition (EEN) and the Crohn’s Disease Exclusion Diet (CDED) induce remission in Crohn’s disease. Low sulphur and plant-based diets are being investigated in ulcerative colitis (UC). Reducing ultra-processed, additive-containing food intake is emerging as important, given its role in initiating and perpetuating disease. IBD patients believe in the value of the diet, but there is no evidence for diet tolerability and benefit outside of clinical trials. The DELECTABLE program, a dietitian-led telehealth service, aims to evaluate structured, evidence-based dietary therapy as part of routine clinical care. Here we present satisfaction, compliance and efficacy results.

Methods

In this open-label, prospective, observational program, Crohn’s disease and pouchitis patients were offered the CDED or a wholefood additive-free diet, UC patients were offered a low-sulphur plant-based diet or wholefood diet, and patients with microscopic colitis were offered the wholefood diet. The primary outcome was diet satisfaction (modified DSAT-28; possible range: 28 to 140). Dietitian-rated compliance, patient-rated compliance, disease activity score (CDAI, partial Mayo score), CRP, and faecal calprotectin were secondary outcomes. Baseline to week 12 differences were assessed using the Mann-Whitney-U-test or Wilcoxon-sign-test for continuous variables and McNemar’s test for categorical variables.

Results

Of 165 patients referred, 79 enrolled in the program. Fifty-seven (72%) enrolled patients have completed 12 weeks of diet therapy. Across all diet arms combined, diet satisfaction score increased from week 1 (89.3) to week 12 (93.7; P<0.001). Dietitian and patient-rated compliance were 4/6 and 3/5, respectively, at week 1 and did not change at week 12. CDAI was reduced on all diet arms combined (60.0 to 41.5, P=0.003) and on the CDED (128.9 to 46.6, P=0.004), with a trend for reduced CDAI on the wholefood diet. There was a trend towards reduced CRP across all diet arms and on the wholefood diet (49.5 to 25.3, P=0.363). The proportion of patients in remission, based on CDAI, increased when all diet arms were combined and on the CDED and wholefood diet (P<0.001). Faecal calprotectin was numerically reduced on the CDED (95.0 ug/g to 53.5 ug/g) and UC diet (184.0 ug/g to 159.0 ug/g), but these results did not reach statistical significance.

Conclusion

Half of the referred patients are interested in pursuing a supervised, long-term diet program. Implementation of well-balanced, effective diet therapies is feasible and well-accepted by patients, with a promising impact on disease activity.
P768 The prevalence and risk factors for malignancies in patients with inflammatory bowel disease in Crete : a case control study
Authors: Foteinogiannopoulou K , Nicolaou P , Mala A , Theodoraki E , Orfanoudaki E , Theodoropoulou A , Karmiris K , Koutroubakis I
Published: January 2023

Background

There is evidence that about 30% of the patients with inflammatory bowel disease (IBD) develop malignancies whichconstitute the second cause of death, after cardiovascular diseases, such as in general population.

Methods

The aim of this study was to investigate the prevalence and risk factors for malignancies in IBD patients followed in two tertiary centers. It was a retrospective analysis of prospectively recorded data in an established IBD registry for seven years (06/2015 to 06/2022). IBD patients with malignancies were compared with controls-IBD patients without malignancies [matching 1:3 according to sex, IBD diagnosis (Ulcerative Colitis; UC, Crohn’s Disease; CD) and age (±5 years)] so as to elucidate possible risk factors for cancer (CA) development in these individuals.

Results

From a total of 2.382 IBD patients of the IBD registry in University Hospital and Venizeleio General Hospital of Heraklion in Crete, 107 (4.5 %) were diagnosed with CAs during their follow-up whereas 22 (0.92 %) had a history of CA before IBD diagnosis. Demographic, clinical and therapeutic data for the total of 428 patients (107 with CA and 321 without CA) are presented in Table 1. Among patients with CA, 49 (45.8%) were females, 54 (50.5%) had CD, the median age of CA diagnosis was 61 years (51.3-69.8) and the median IBD duration was 10 years (3-20). Thirty-two (29.9 %) of the CA-IBD patients had known familial history of CA and 28 (26.1 %) were active smokers whereas 46 (42.9 %) were ex-smokers. Twenty-nine patients (27.1 %) were exposed to immunomodulators, 32 (29.9 %) to anti-TNFs, 20 (18.7 %) to other biologics and 16 (14.9 %) to combination treatment. The majority of CA cases were extra-intestinal, only 12 (11.2 %) had colorectal cancer (CRC) and 11 (10.3 %) had a CA recurrence whereas 19 (17.8 %) died from the CA. In the univariate analysis the median IBD duration (OR 0.96, CI 95%0.94- 0.99), inflammatory phenotype in CD (OR 0.46, CI 95% 0.23-0.93) and treatment with other biologics (other than ant-TNFs) (OR 0.50, CI 95%0.29- 0.86) were protective factors, whereas colonic location in CD (OR 3.24, CI 95% 1,49-7,04) found to be a risk factor for CA development(Table 1). No association with disease characteristics, smoking habits, family history of CA and extra intestinal manifestations was found. In the multivariate analysis only CD inflammatory phenotype (OR 0.28, CI 95%0.09-0.58) was a protective factor whereas colonic location (OR 4.8, CI 95% 1.81-12.79) remained a risk factor for malignancies (Table 2).

Conclusion

The prevalence of malignancy in IBD patients in Crete is 4.5%. It seems that in CD disease phenotype is associated with the development of malignancies. Non association with the used medications was found.
P769 Randomised feasibility study of preoperative medical nutrition therapy in adults undergoing surgery for Crohn’s disease
Authors: Wall C , Glyn T , Rowbotham D , Haines M , Bissett I , Eglinton T , Gearry R
Published: January 2023

Background

Preoperatively patients with Crohn’s disease are at high risk of malnutrition. Patients requiring surgery to manage stricturing disease are often advised to follow a low residue/low fibre diet to reduce risk of bowel obstruction. This diet is usually nutritionally inadequate and may negatively affect nutritional status. Research suggests that preoperative exclusive enteral nutrition (EEN) improves nutritional status, reduces intestinal inflammation and consequently improves surgical outcomes. Recently the Crohn’s disease exclusion diet has been shown to reduce intestinal inflammation in adults but its use preoperatively has not been reported. This research aimed to determine whether it is feasible to recruit and retain patients with Crohn’s disease in a single-blinded, multicentre, randomised controlled trial of three preoperative nutritional therapies.

Methods

Patients undergoing elective surgery to manage Crohn’s disease at three New Zealand tertiary care hospitals (Christchurch, Auckland and Waikato hospitals), aged >18 years old, with body mass index (BMI) > 18.5 kg/m2 and without recent significant weight loss were eligible to participate. Patients were randomised to six weeks of preoperative EEN, partial enteral nutrition with Phase-1 Crohn’s Disease Exclusion Diet (CDED) or standard care. Nutritional and radiological assessment at baseline and preoperatively was completed and surgical outcomes recorded. Descriptive statistical analysis was undertaken. Health and Disability Ethics Committee approval was given (20/NTB/134).

Results

Over 18 months (September 2020 to March 2022), 48 patients were screened and 17 were randomised. Patient characteristics were: median age 37.9 (range, 28-68) years, 9 (53%) female, 10 (59%) on biologic medication, median BMI 25.7 (range, 19.7-38.6) kg/m2 and 2 (12%) had low fat-free mass index. Medical nutrition therapy was completed by 13/17 (76%) patients (EEN n=4, CDED n=4 and standard care n=5) and four withdrew. BMI and simplified magnetic resonance index of activity (MaRIA) score changed by a median of -0.3 (range, -1.8 to 2.1) kg/m2 and 0.5 (range, -3 to 2) points respectively. At day 30, 10 patients had no surgical complications. Three patients had Clavien Dindo Grade 2 complications; one (standard care group) experienced fever treated with antibiotics, one (standard care group) had postoperative ileus requiring total parenteral nutrition and one (CDED group) required a blood transfusion postoperatively and antibiotics for a wound infection.

Conclusion

Patients who need elective Crohn’s disease surgery tolerate preoperative EEN or CDED. Use of preoperative nutrition therapies are feasible and the impact on surgical outcomes should be assessed in a larger study.
P775 Disease activity and treatment patterns of newly diagnosed adult patients with Crohn's disease in Japan: Interim analysis of inception cohort registry study of patients with Crohn's disease (iCREST-CD)
Authors: Shinzaki S , Matsuoka K , Fujii T , Okamoto R , Yamada A , Kunisaki R , Matsuura M , Watanabe K , Shiga H , Takatsu N , Bamba S , Mikami Y , Yamamoto T , Shimoyama T , Motoya S , Torisu T , Kobayashi T , Ohmiya N , Saruta M , Matsuda K , Matsumoto T , Nakase H , Maemoto A , Murata Y , Yoshigoe S , Tsuchiya H , Hisamatsu T
Published: January 2023

Background

Biologics are commonly used for the treatment of Crohn’s disase (CD); however, the proportion of biologics used and their initiation time from diagnosis differs widely between different regions. There is limited information about the patient characteristics and the treatment persistence of each initial biologics, and the treatment persistence of top-down and step-up therapy. iCREST-CD is a prospective, non-interventional, longitudinal, observational registry study conducted at 19 tertiary centres to understand the characteristics of CD treatments in actual clinical settings in Japan. We conducted an interim analysis (cutoff date: 30 June 2022) of iCREST-CD to mainly evaluate the indication and outcomes of initial biologic therapy.

Methods

Patients newly diagnosed with CD after June 2016 based on the diagnostic criteria of the Japanese Guidelines, aged ≥16 years at the time of informed consent with no prior exposure to biologics were enrolled. Patient demographics, clinical data, disease activity and medical treatment were recorded. Biologic use without prior steroid use was defined as top-down and biologic use with prior steroid use was defined as step-up.

Results

A total of 672 eligible patients (68.2% male) with mean age (±SD) of 29.4 (13.1) years were analysed. Cumulative proportion of patients prescribed 5-aminosalicylic acid, steroids, immunomodulators, and biologics at 6- and 12-months from diagnosis were 71.3%, 40.6%, 31.4%, and 47.5%; and 75.0%, 43.6%, 36.0%, and 59.7%, respectively (Figure 1).

A total of 498 patients received biological therapy—infliximab (IFX; 121 [24.3%]), adalimumab (ADA; 244 [49.0%]), ustekinumab (UST; 107 [21.5%]), and vedolizumab (VDZ; 26 [5.2%]). The mean age (±SD) at the initiation of biologic treatment was IFX: 28.2 (11.3), ADA: 26.6 (10.8), UST: 30.4 (14.1), and VDZ: 36.2 (17.4), and the mean (±SD) levels of C-reactive protein (CRP) (mg/L) was IFX: 25.9 (26.8), ADA: 18.9 (26.0), UST: 13.5 (17.9), and VDZ: 9.5 (19.0) (Table.1). The initial biologic treatment persistence rates of IFX, ADA, UST and VDZ at 36-months were 77.5%, 75.8%, 79.8%, and 49.0%, respectively (Figure 2).

Patients receiving top-down and step-up therapy were 284 (57.0%) and 214 (43.0%), respectively. The treatment persistence rate of initial biologics by top-down and step-up therapy at 36-months from diagnosis was 81.6% and 66.9%, respectively (P=0.001) (Figure 3).

Conclusion

This registry study that demonstrated the treatment persistence rate of initial biologic therapy was significantly higher in the top-down than the step-up approach.
P776 Polymeric exclusive enteral nutrition induces biochemical remission in adults with active Crohn’s Disease irrespective of disease location or concomitant steroid use
Authors: Kuo H , Tognolini K , Willmann L , Haig A , Subhaharan D , Mutsekwa R , Shukla D , Moattar H , Dorrington A , Ishaq N , Bhullar M , Edwards J , Mohsen W , Kakkadasam Ramaswamy P ,   Gold Coast Inflammatory Bowel Diseases Research Group
Published: January 2023

Background

Data on the effectiveness of polymeric Exclusive Enteral nutrition (EEN) in inducing biochemical remission in adult patients with active Crohn’s disease (CD) is scarce. Our aim was to assess the effectiveness of polymeric EEN in inducing biochemical remission in adults with active CD.

Methods

Single tertiary centre retrospective study of patients with active CD who received induction therapy with EEN from January 2018 to September 2022. Active CD was defined as CRP ≥ 10mg/L or faeces calprotectin (FC) ≥ 250mcg/g. Primary endpoint (PE) was biochemical remission at 8 weeks. Biochemical remission was defined as CRP < 6 mg/L in patients with CRP ≥ 10mg/L at baseline OR FC <150 mcg/g in patients with an FC ≥ 250mcg/g at baseline.

Results

Sixty-one patients were included, 32 (52.4%) females, median age 53 years (IQR: 28-62). Median disease duration was 6 years (IQR: 1-20), median duration of EEN was 7 weeks (IQR: 5.5-8 weeks). 34 (55.7%) patients received steroids concurrently. PE was achieved in 35 (57.4%) patients overall; 20 (58.8%) with concurrent steroid and 15 (55.6%) without steroid use at baseline achieved PE, p=1. 43.7% (7/16) of patients with ileal, 50% (4/8) with colonic and 64.9% (24/37) with ileo-colonic (p=0.33) disease phenotype achieved PE. Significantly fewer patients with baseline concurrent biologic achieved PE [12/29 (41.38%) vs 23/32 (71.9%), p=0.021]. On univariable analysis, absence of biologic therapy at baseline was a predictor for achieving PE [OR 3.6 (1.23-10.6), p=0.019]. Age, disease location, age at diagnosis, behaviour, sex, disease duration, smoking status, concurrent steroid use or concurrent immunomodulator use did not predict achieving PE. 40 patients had CRP ≥ 10mg/L at baseline, of whom 25 (62.5%) achieved CRP < 6 mg/L. 49 patients with ≥ 250mcg/g at baseline, of whom 22 (45%) achieved FC <150 mcg/g.

Conclusion

Polymeric EEN is effective in inducing biochemical remission in adults with active CD irrespective of disease location or concurrent steroid use. Significantly fewer patients on concurrent biologics at baseline achieved biochemical remission.
P781 Treatment outcome of tofacitinib dose reduction to 5 mg BID vs remaining on 10 mg BID in patients with Ulcerative Colitis who were in stable remission on 10 mg BID: Updated 30-month data from the double-blind, randomised RIVETING study
Authors: Rubin D T , Panés J , Torres J , Kobayashi T , Su C , Lawendy N , Modesto I , Segovia M , Gardiner S , Wang W , Vermeire S
Published: January 2023

Background

Tofacitinib is an oral small molecule Janus kinase inhibitor for the treatment of ulcerative colitis. The long-term, Phase 3b/4 RIVETING study (NCT03281304) assessed the efficacy and safety of tofacitinib dose reduction from tofacitinib 10 mg twice daily (BID) maintenance therapy to 5 mg BID in patients (pts) in stable remission.1 We present a final analysis of the RIVETING study after ≥30 months of treatment.

Methods

RIVETING was a double-blind, randomised, parallel-group study with a 42-month (M) duration. Eligible pts had received tofacitinib 10 mg BID for ≥2 consecutive years in an open-label, long-term extension study (NCT01470612), had been in stable remission for ≥6 months and corticosteroid-free for ≥4 weeks prior to baseline. The primary efficacy endpoint was remission at M6 based on modified Mayo (mMayo) score (endoscopic and stool frequency subscores of ≤1 and rectal bleeding subscore of 0).1 RIVETING was terminated (primary objective met) when all pts had passed M30 (or discontinued); some pts had already completed all visits up to M42. Here, we assess efficacy at M30 and safety throughout.

Results

Overall, 140 pts were randomised (1:1) to tofacitinib 5 or 10 mg BID; 50.0% and 62.9% were in remission based on mMayo score at M30 in the 5 and 10 mg BID dose groups, respectively, with consistent findings observed for other secondary efficacy endpoints (Table 1). At M30, observed differences for mMayo remission between tofacitinib 10 and 5 mg BID were generally greater in the subgroup with a baseline endoscopic subscore of 1 vs 0 and in the subgroup with vs without prior tumour necrosis factor inhibitor (TNFi) failure (Table 1). The percentage of pts who experienced loss of remission by M30, as estimated from Kaplan-Meier curves, was numerically higher in the 5 vs the 10 mg BID dose group (28.1%; 95% confidence interval [CI], 17.68–39.49 vs 21.7%; 95% CI, 12.21–32.95, respectively). Table 2 shows adverse events of special interest, by dose group. One death occurred due to fatal coronavirus disease 2019 pneumonia (10 mg BID).

Conclusion

These long-term data showed that most pts in stable remission on tofacitinib 10 mg BID maintenance therapy maintained mMayo score remission through M30 after dose reduction to 5 mg BID. Dose group difference in remission at M30 was consistent with that at M6.1 Differences in remission between the tofacitinib 5 and 10 mg BID groups were greater in subgroups with an endoscopic subscore of 1 vs 0 and in subgroups with vs without prior TNFi failure. Overall, safety findings were consistent with tofacitinib’s known safety profile; incidence of serious infections and herpes zoster was numerically higher in the tofacitinib 10 vs 5 mg BID group.

1. Vermeire S et al. J Crohns Colitis 2021;15:1130-41.
P790 Examining mental health disease burden among Crohn’s Disease (CD) patients in Europe
Authors: Thoo M , Baynton E
Published: January 2023

Background

Mental health is an overlooked aspect of inflammatory bowel disease (IBD) patient care and the most common psychological conditions in patients with IBD are anxiety and depression1. The objective of this study was to examine the possible factors that will impact mental health burden of CD patients in Europe.

Methods

A multi-centre online medical chart review study of patients with CD was conducted between Jul – Sep 2022 among UK, FR, DE, IT & ES gastroenterologists practicing across hospital and private practices. Physicians were screened for practice duration and patient volume. Charts of patients prescribed with advanced therapy were included in the analysis.

Results

206 sampled physicians collectively reported 1178 CD patients. From the reported CD patients, 190 suffered mental health burden (depression or anxiety) and 988 CD patients did not suffered any mental health burden. Among CD patients suffered mental health burden, a higher proportion of CD patients are female vs those who did not suffered any (55% vs 46%). ‘Family history of IBD’ was the co-morbidity more likely to experience in reported CD patients suffered mental health burden vs those who did not (11% vs 7%).

When looking at employment status between these two patient groups, reported CD patients suffer mental health burden was less likely to be in full-time employment vs those not suffered mental health burden. A higher proportion of reported CD patients suffered mental health burden were in part-time employment or housewife/househusband.

CD patients with mental health burden had greater CRP level than patients without mental health burden (CRP mean: 16 vs 12). This aligns with reported CD patients with mental health burden had frequent surgery times vs without mental health burden (Mean surgery times: 2 vs 1) and had greater steroid usage (% reported patients currently on steroids – 18% vs 13%).

Conclusion

Comparisons in this study cohort highlight there are other factors could impact CD patients’ mental health burden other than IBD itself. This coincided with low full-time employment rate that attributed to financial stress may increase CD patients’ mental health burden. Also, higher rate of surgery and steroid usage in CD patients experienced mental health burden might suggest they had more severe or complications with their disease that will impact overall mental health. Further investigation using comparator cohort is warranted.