bluuebunny/crossref_metadata_2025 huggingface dataset:
P984 VEST: The UK vedolizumab real life experience study in Inflammatory Bowel Disease
Authors: Bodger K , Booker C , Kok K , Lobo A , Ahmad T , Bloom S , Butterworth J , Irving P , Cummings F
Published: January 2024

Background

The characteristics and outcomes of patients treated with vedolizumab in routine healthcare settings have not been widely evaluated in the UK.

Methods

Prospective, multicentre observational study of 364 patients started on vedolizumab in UK practice from January 2017 until February 2019 using the UK IBD Registry clinical web-based tool. For the present analysis, the primary outcome was drug survival (persistence) at 1-year, defined as attendance for infusion ≥48 weeks after the first dose. Secondary outcomes were: Clinical remission (CR, based on partial Mayo score [≤1] or Harvey Bradshaw index [≤4]), physician global assessment (PGA), IBD-Control Questionnaire (IBD-Control-8, IBD-Control-VAS and individual item scores), laboratory parameters and adverse events.

Results

Age (mean): 44 yrs; Males: 48%; IBD duration (mean): 6 yrs; Prev. resection: 18%; Steroids at baseline: 39%; Outcomes are summarized in Table 1. 37% of CD patients were assessed as being in clinical remission at baseline. Overall, 210 (58%) continued treatment beyond 48 weeks. At 1 year, 67.1% and 52.3% of CD and UC patients were in clinical remission with a clear improvement in QoL as assessed by IBD-Control -8. There were significant improvements across each IBD-Control-8 domain, including fatigue, with few patients considering switching treatment at that point (Figure 1).

Conclusion

Vedolizumab was effective in clinical practice with 58% of patients remaining on treatment at one-year. Baseline status differed significantly from those recruited into RCTs. Patient reported outcomes demonstrated significant and meaningful improvements across physical, psychological, social and treatment domains.
P990 A Multi-center, Single-arm, Prospective, Observational, Real-world Study in China to Evaluate Effectiveness of Vedolizumab in the Treatment of Inflammatory Bowel Diseases: First Interim Analysis of Patient-reported Outcomes
Authors: Hong Y , Li L , Hong G , Chen Y , Hu Y , Xie L , Liu M , Chen M
Published: January 2024

Background

Crohn’s disease (CD) and ulcerative colitis (UC) are types of inflammatory bowel disease (IBD), causing abdominal pain, diarrhea, rectal bleeding and weight loss which is concerning due to increased prevalence and morbidity. As IBD affects quality of life (QoL), improving it is a major treatment goal. Current therapy in IBD includes corticosteroids, immunomodulators, biologics, small molecule drugs, etc. Vedolizumab (VDZ), a gut-specific antibody against α4β7 integrin, is approved in China in moderate to severe UC/CD treatment. This multi-center, single arm, prospective, observational, real-world study (NCT04872491) evaluated safety and effectiveness of VDZ in Chinese UC/CD patients. This first interim analysis presented changes in symptomatic relief and QoL. Safety results are shown separately.

Methods

Enrolled UC/CD patients (>18 years) were treated with 300 mg VDZ by intravenous infusion at week 0, 2, 6, and every 8 weeks till 54 weeks. At data cut-off (October 21, 2022), 307 patients were assessed for symptomatic relief and QoL by patient reported outcomes (PRO) scores, partial Mayo score rectal bleeding sub-score [RBS], stool frequency sub-score [SFS]) in UC; abdominal pain sub-score [APS], loose stool frequency sub-score [LSFS]) in CD at days 3, 7 and 14 and IBD questionnaire (IBDQ), EuroQol-5-Dimension-5-Level index (EQ-5D-5L) and EQ-visual analog scale (VAS) scores in UC and CD from baseline to week 14. Descriptive statistics summarized the effectiveness.

Results

Of 265 patients (UC: 211, CD: 54) analysed for effectiveness, 62.9% were males with mean(±SD) age 43.1±15.0 years and median IBD duration of 883 days. At baseline, mean(±SD) for partial Mayo and HBI scores were 5.185±1.936 and 5.362±3.674 for UC and CD patients respectively.

Compared to baseline, UC patients showed significant difference in RBS and SFS scores from days 3 and 7 respectively reflecting rapid onset effect of VDZ (Figure 1). Patients with RBS=0 and SFS≤1 scores improved from 34.78% at baseline to 62.79% at day 14 after treatment. IBDQ, EQ-5D-5L and EQ-VAS mean±SD score changes of 38.853±39.569, 0.046±0.125 and 10.258±14.756 signified improved QoL (Table 1).

At baseline, mean±SD APS and LSFS scores in CD patients were 0.692±0.832 and 1.462±1.570 (n=39), which decreased to 0.425±0.594 and 1.325±1.207 (n=40) at day 14 with a mean change of -0.211±0.528 and -0.105±0.981 (Figure 1). VDZ effectively maintained remission in patients with APS≤1 and LSFS≤3 which increased from 35.90% at baseline to 50.00% at day 14. Improved QoL was observed with changes in IBDQ (13.194±31.592) (Table 1).

Conclusion

VDZ effectively improved and maintained symptomatic relief and QoL in Chinese UC/CD patients in real-world settings.
P1009 Efficacy and safety of 4 years of continuous ozanimod treatment: an interim analysis of the True North open-label extension study
Authors: D'Haens G , Sands B E , Ferrante M , Matsuoka K , Lindsay J O , Blumenstein I , Mehra D , Charles L , Cetin V , Petersen A , Wu H , Wang D , Jain A , Hanauer S B
Published: January 2024

Background

The phase 3 True North (TN) study demonstrated the efficacy and safety of ozanimod (OZA) over 52 wk in patients (pts) with moderately to severely active ulcerative colitis (UC); the ongoing TN open-label extension (OLE) is assessing long-term efficacy and safety. This interim analysis of the TN OLE assessed pts with up to ~4 y of continuous OZA treatment.

Methods

Clinical responders after 52 wk of continuous OZA treatment (0.92 mg/d) during TN who subsequently entered the TN OLE were included in this analysis. Data were analysed up to OLE Week (W) 142, representing up to ~4 y of continuous OZA treatment. Symptomatic response (≥1-point and ≥30% decrease from baseline [BL] in the combined 6-point rectal bleeding subscore [RBS] + stool frequency subscore [SFS] and ≥1-point decrease in RBS or absolute RBS ≤1) and symptomatic remission (RBS=0 and SFS ≤1 [and ≥1-point decrease from BL SFS]) were evaluated from OLE W5 through OLE W142. Clinical remission, clinical response, endoscopic improvement, and corticosteroid (CS)-free remission were evaluated at OLE W46, W94, and W142. Endpoints were evaluated using observed case (OC) and nonresponder imputation (NRI) analyses. Adverse events were monitored throughout TN and the OLE.

Results

In all, 131 pts entered the OLE after achieving clinical response on OZA at W52 in TN. At the data cutoff, 87.0% of pts completed OLE W46, 71.8% completed OLE W94, and 64.1% completed OLE W142. Most (67.9%) pts had left-sided UC disease, 23.7% had concomitant CS use at TN BL, and 32.1% had prior exposure to tumour necrosis factor inhibitors. Symptomatic response and symptomatic remission were observed in 100.0% and 84.4% of pts, respectively, at OLE W5 in the OC analysis (93.1% and 78.6%, respectively, in the NRI analysis). By OLE W142, symptomatic response and symptomatic remission rates were 98.7% and 88.3%, respectively, in the OC analysis and 58.0% and 51.9%, respectively, in the NRI analysis. Rates of clinical and endoscopic endpoints during the OLE are shown in Figure 1A (OC) and 1B (NRI). Of note, 65.3% of TN W52 clinical responders achieved clinical remission and CS-free remission at OLE W142 in the OC analysis (35.9% in the NRI analysis). With this additional year of follow-up in the OLE, there were no new cases of bradycardia, third-degree atrioventricular block, hypertension, herpes zoster, or macular oedema, and no clinically meaningful change in malignancy exposure-adjusted incidence rates (Table). No serious hepatic events occurred.

Conclusion

Clinical responders after 1 y on OZA sustained response for an additional 3 y and achieved clinical remission with continuous OZA exposure. OZA is a safe, tolerable, and durable therapy for pts with UC.
P1022 One-year safety and effectiveness of ustekinumab in patients with Crohn’s disease: The K-STAR study
Authors: Lee C K , Moon W , Chun J , Kim E S , Kim H W , Yoon H , Kim H S , Lee Y J , Choi C H , Jung Y , Park S C , Song G A , Lee J H , Jung E S , Kim Y , Jung S Y , Choi J M , Ye B D
Published: January 2024

Background

We aimed to investigate the safety and effectiveness of ustekinumab (UST) for Korean patients with Crohn’s disease (CD).

Methods

Adult patients with CD treated with UST were prospectively enrolled in the K-STAR (Post-MarKeting Surveillance for Crohn’s Disease patients treated with STelARa) study from April 2018 to April 2022. After single intravenous infusion of UST ~6 mg/kg, UST 90 mg subcutaneous injection was followed at week 8 and then maintenance treatment with subcutaneous UST 90 mg every 8 or 12 weeks were given, following up to week 52 to 66. Both adverse events and clinical effectiveness of UST therapy were analyzed (ClinicalTrials.gov Identifier: NCT03942120).

Results

Of the 464 patients enrolled from 44 medical centers across South Korea, 457 and 428 patients (Crohn’s disease activity index 150 or over) were included in the safety analysis and effectiveness analysis set, respectively (Table 1). At week 16–20 after starting UST, rates of clinical response, clinical remission and corticosteroid-free remission were 75.0% (321/428), 64.0% (274/428), and 61.9% (265/428), respectively (Figure 1A). At week 52–66, rates of clinical response, clinical remission and corticosteroid-free remission were 62.4% (267/428), 52.6% (225/428), and 50.0% (214/428), respectively (Figure 1B). Combined effectiveness (clinical response + biochemical response) was achieved in 40.0% (171/428) and 41.6% (178/428) of patients at week 16–20 and week 52–66, respectively. Bio-naïve patients exhibited significantly higher rates of combined effectiveness than bio-experienced patients (50.3% vs. 30.7% at week 16–20, p<0.001; 47.7% vs. 36.0% at week 52–66, p=0.014) (Figure 1A;1B). No additional benefits were observed with the concomitant use of immunomodulators. Using a multivariable analysis using backward selection, colonic involvement (vs. ileal involvement, odds ratio [OR], 0.32; 95% confidence interval [CI], 0.12–0.89; p=0.028), ileocolonic involvement (vs. ileal involvement, OR, 0.45; 95% CI, 0.23–0.89; p=0.021), baseline C-reactive protein levels (OR, 0.90; 95% CI, 0.84–0.97; p=0.009), and the exposure to two or more biologics (vs. bio-naïve, OR, 0.38; 95% CI, 0.20–0.73; p=0.003) were inversely associated with achieving clinical remission at week 52–66. Any adverse events and serious adverse events were observed in 28.2% (129/457) and in 12.7% (58/457), respectively with no new safety signal associated with UST treatment.

Conclusion

UST was well-tolerated, effective, and safe as induction and maintenance therapy for patients with CD in Korea. The results from this study enhance our understanding of the role of UST in managing CD patients with diverse characteristics and may help inform clinical decisions.
P1040 Comparative effectiveness of upadacitinib versus ustekinumab in patients with moderately to severely active Crohn’s disease: a matching-adjusted indirect comparison
Authors: Ma C , Dubinsky M C , Axelrad J , Anyanwu S , Tran J , Lacerda A , Joshi N , Griffith J
Published: January 2024

Background

Upadacitinib (UPA), an oral Janus kinase inhibitor, and ustekinumab (UST), a parenteral IL 12/23 antagonist, are effective treatments for moderately to severely active Crohn’s Disease (CD). In the absence of head-to-head data, a placebo (PBO)-anchored matching-adjusted indirect comparison (MAIC) was conducted to indirectly compare efficacy of UPA vs UST.

Methods

Individual patient (pt)-level data from phase 3 UPA trials and published data from phase 3 UST trials were used. For induction, pts received UPA 45mg daily or PBO for 12 weeks or UST ~6mg/kg IV or PBO IV at week 0 with 8-week follow-up. For maintenance, UPA clinical responders were re-randomized to UPA 15mg, 30mg, or PBO daily for 52 weeks. UST clinical responders were re-randomized to 90mg SC (every 8 or 12 weeks) or PBO SC for 44 weeks. UPA pts had baseline (BL) CD Activity Index (CDAI) 220-450; those with prior UST or vedolizumab exposure were excluded. Treatment effect modifiers, including BL mean CDAI, Simple Endoscopic Score for CD (SES-CD), median C-reactive protein, prior biologic(s) failure, and disease location, from UPA data were weighted to match the UST population. Outcomes assessed were CDAI response (≥100-point decrease or CDAI <150), CDAI remission (CDAI <150), endoscopic response (SES-CD ≥50% decrease), and SES-CD ≤2. Separate MAICs were conducted for induction and maintenance; data reported for induction clinical outcomes are stratified by prior inadequate response to tumor necrosis factor inhibitors (TNFi-IR).

Results

A greater proportion of UPA- vs UST-treated pts achieved endoscopic response (difference 26.3%, P<0.001) and SES-CD ≤2 (difference 9.9%, P<0.05) at the end of induction. In TNF-IR patients, a greater proportion of UPA- vs UST-treated pts achieved CDAI response at the end of induction (difference 18.2%, P<0.05) and at the end of Week 8 (difference 26.0%, P<0.001). CDAI remission rates were also higher at end of Week 8 for UPA- vs UST-treated pts (difference 13.3%, P<0.05). Rates of achieving CDAI response and remission were similar between UPA- and UST-treated pts at the end of induction and Week 8 among bio-naïve pts. Following maintenance treatment, similar rates of SES-CD ≤2, endoscopic response, and CDAI remission were obtained in the total population of UPA and UST-treated pts.

Conclusion

Pts with moderately to severely active CD treated with UPA achieved higher rates of endoscopic (total population) and clinical (TNFi-IR population) outcomes during induction compared to UST-treated pts. Outcomes at the end of maintenance were similar for UPA and UST, however, results should be interpreted with caution due to low sample size.
P1075 Outcomes in patients stopping biologic during the first trimester of pregnancy : a retrospective monocentric study
Authors: Monin L , Reenaers C , Grandfils S , Latour P , Van Kemseke C , Kropp S , Louis E , Vieujean S
Published: January 2024

Background

Both the American Gastroenterological Association (AGA) and the European Crohn's and Colitis Organisation (ECCO) recommend to continue biologic during the whole pregnancy and until the third trimester, respectively. However, these positions are associated with a baby's exposure to the drug and from our clinical practice are not necessarily in line with patients' wishes and fears. In patients in full clinical and biologic remission, stopping biologic before it is actively transported through the placenta (around the week 20) would be a possible approach to get around these drawbacks. We aimed to assess the outcome of disease activity and pregnancies in patients stopping biologic before the week 20.

Methods

We performed a retrospective monocentric study. All patients who gave birth between 2010 and 2023 were included. The following parameters were collected: clinical and demographic characteristics, biomarkers (CRP and faecal calprotectin before pregnancy and during the 3 trimesters), IBD treatment at time of pregnancy, whether it was stopped during pregnancy, when and in what circumstance (patient versus medical agreement). We also looked at the disease course, whether a relapse occurred (defined as the need to take corticosteroids, a biologic, or surgical resection), and the pregnancy outcome.

Results

A total of 185 pregnancies were reported in 143 patients (73.4% Crohn disease and 26.6% ulcerative colitis). Patient's characteristics are shown in Table 1. Among these women, 106 (74.1%), 32 (22.4%) and 5 (3.5%) reported one, two or 3 or more pregnancies, respectively. Figure 1 summarises the treatments during these reported pregnancies, disease activity outcomes and pregnancy outcomes. The biologic was stopped before conception for 9 pregnancies and 90 pregnancies started under biologics (anti-TNF, vedolizumab or ustekinumab). Of these, biologic was continued until delivery in 10 (11.1%) patients, whereas it was stopped before the week 20 for the others (88.9%). Among patients who stopped biologics before conception, before the week 20, and those who continued biologics through delivery: 3/9 (33.3%), 13/80 (16.3%; including 10/66 or 15.2% among those stopping on medical agreement) and 4/10 (40%) relapsed, respectively. Among the 10 relapses in patients who stopped in first trimester on medical agreement, 6 had normal biomarkers before cessation (unknown for the others).

Conclusion

Biologic discontinuation before week 20 on medical agreement was associated with relapse in 15.2% of cases. Fate of disease activity and pregnancies in patients stopping biologic before week 20 should be studied prospectively in a dedicated study.
P1109 Differences of Clinical Phenotype Between Familial and Sporadic Crohn's Disease in East China
Authors: Dong S , Xiang X , Zhang Y , Liu R , Ye L , Cao Q
Published: January 2024

Background

Family history is one of the strongest risk factors for Crohn's disease (CD) while few studies have focused on whether family history influences the clinical features, disease course, and severity of CD. There is still controversy about the difference between sporadic and familial CD. This study aimed to compare the phenotypic features of familial CD with sporadic CD in Chinese populations.

Methods

We included 2,043 patients diagnosed with CD. Familial CD was defined as CD patients having one or more first-, second-, third-, fourth-degree or above relatives with CD. Sporadic CD patients hospitalized during the same period were matched 1:3 by age and gender. Differences in clinical characteristics, phenotype distributions, extra-intestinal manifestations, and complications at diagnosis, as well as treatment regimens and surgeries, were compared between familial and sporadic CD.

Results

A total of 55 familial CD and 165 sporadic CD were identified. The familial CD was associated with a higher rate of past appendectomy history (20.00% vs 6.67%, P=0.009), more intestinal perforation at onset (12.73% vs 3.03%, P=0.012), more anal lesion (85.45% vs 68.48%, P=0.023) and gastrointestinal perforation (14.55% vs 5.45%, P=0.040) at diagnosis, higher rate of past intestinal surgery history (50.91% vs 29.70%, P=0.007), more number of intestinal surgeries (1.50[IQR 1.00-2.00] vs 1.00[IQR 1.00-1.00], P=0.037), longer duration of follow-up (54.00 months[IQR 21.50-125.00] vs 41.00 months[IQR 14.00-79.00], P=0.017), lower rate of taking biologicals for current maintenance (61.82% vs 76.97%, P=0.043), lower tendency to upgrade to biologicals during follow-up (69.09% vs 85.37%, P=0.013), higher possibility to experience gastrointestinal obstruction (23.64% vs 11.52%, P=0.047) and abdominal abscess during follow-up (9.09% vs 2.42%, P=0.045).

Conclusion

Familial CD is associated with a more aggressive clinical phenotype compared with sporadic CD.
P1132 Fecal incontinence in Inflammatory Bowel Disease (IBD): associated factors and impact on the quality of life of patients in an IBD clinic in Switzerland
Authors: Hammond P , Marques Santos J D M S , Alhassan J , Matter C , Seibold F
Published: January 2024

Background

Literature on prevalence of fecal incontinence (FI) in inflammatory bowel disease (IBD) and associated factors has not been thoroughly studied. IBD is a chronic disease with high morbidity and significant impact on quality of life. Awareness of prevalence and associated factors of FI would make gastroenterologists more conscious of its burden, leading to targeted clinical assessment and treatment.

Methods

We conducted a cross-sectional study, looking at risk factors for FI and its impact on quality of life. The study population consisted of IBD patients aged from 16 to 80 years old in an IBD clinic in Switzerland. Patients with a stoma, a J-Pouch and an unspecified IBD were excluded. The survey had 53 questions, with demographics and main clinical variables. The quality of life of patients was assessed using the World Health Organization quality of life scale. Disease severity was measured based on the short Crohn’s disease activity index (SCDAI) for Crohn’s disease (CD) and using the simple clinical colitis activity index (SCCAI) for Ulcerative colitis (UC). Logistic regression was used to calculate crude and adjusted odds ratio (OR), applying 95% confidence intervals (CI).

Results

450 questionnaires were randomly distributed. 392 patients met the inclusion criteria. 116 patients (29.5%) reported FI. Factors associated with FI included: age > 50 years old [OR 2.74 (CI: 1.57-3.89)]; one or more vaginal delivery [OR 2.49 (CI: 1.32-4.71)];disease duration > 15 years [OR 2.04 (CI: 1.31-3.16)], abdominal pain [OR 2.56 (CI: 1.60-4.09)], diarrhea [OR 3.70 (CI: 2.26-6.04)], blood in stool [OR 3.33 (1.88-5.89)], more than 3 bowel movements/day [OR 4.50 (CI: 2.79-7.26)],night bowel movements [OR 3.98 (CI: 2.36-6.71)] and an SCCAI ≥ 3 [OR 6.06 (CI: 2.62-14.02)]. There was also a positive association between the presence of one or more extraintestinal manifestation (EIM) [OR 1.64 (CI: 1.03-2.61)] and FI. General well-being [OR 2.61 (CI: 1.65-4.14)] was inversely associated with FI. Similarly, depression and anxiety were associated with FI, respectively; [OR 2.43 (CI: 1.27-4.68) and OR 1.88 (CI: 1.07-3.30)]. Noticeably, 35.3% of patients with FI could not hold their stools for more than 5 minutes, and 14.7% were unable to hold their stools for more than a minute.

Conclusion

FI was highly prevalent (29.5%) in our survey. Age, vaginal delivery, disease duration >15 years, abdominal pain, diarrhea, blood in stool, >3 bowel movements /day, night bowel movement, SCCAI ≥ 3, ≥ 1 EIM were associated with FI. The quality of life was significantly impacted, and anxiety and depression were associated with FI. These implications highlight the need for interventions aimed at enhancing physical and mental health outcomes among individuals with IBD.
P1155 Impact of COVID19 pandemic and vaccination among IBD patients: a multinational cross sectional survey
Authors: Alavi Nejad P , Mokhtare M , Farsi F , Arshadzadeh M , Shetty S , Eslami O , Arefi M , Emara M H , Abdelsameea E , Rezaei J , Alavi S M A , Tran Q T , Salma R , Parsi A , Ahmed M H , Monged A , Quadri A , Jawad A , Rehman A U , Lee S H , Behl N S , Ghoneem E
Published: January 2024

Background

The aim of current study is to evaluate impact of COVID19 pandemic and vaccination against it on the course and symptoms of IBD.

Methods

During a six months’ period, all of the IBD cases who attend in outpatient clinics of nine referral centers in 6 countries include and request to fill a questionnaire about their demographic characters and pattern of IBD, any history of involvement with COVID19 and their vaccination history.

Results

overall 812 cases from 16 countries included (52.4% male) with average age of 36.8 y (range 7 – 76). 68.5% of participants diagnosed as UC and 29.5% as CD. 80% of participants have vaccinated against COVID19 (average 2.3 times, range 1 – 5). Among those who vaccinated (group A) 31.6% experienced side effects and complication without any mortality. The most common complications of vaccination include fever (24%), fatigue (20.1%) and anorexia 8.6%. The most common reasons for vaccination refusal (group B) were fear of vaccine complication (55.5%), no believe in vaccine protection (29.6%) and fear of immunocompromised condition (17.9%). In group A overall 61% of participants involved with COVID 19 (36.2% after vaccination) in comparison with 48.1% in group B (P = 0.0052). Most of the involvements in both groups were not sever and just a minority of patients admitted to hospital (10% in group A and 6.4% in group B). Following COVID involvement, 45.1% of cases suffered with GI symptoms (mostly diarrhea (72.5%) and abdominal pain (64.5%)). In group A, 37.3% of involvements have happened before vaccination.

Conclusion

Vaccination against COVID19 is safe and effective among IBD patients and following vaccination, most of complications are minor and negligible. In case of COVID involvement, it would not be serious and there is no need to hold the medications. Among IBD patients, the most common reason for vaccination refusal is fear of vaccine side effect.
P1171 The impact of biological and small molecule therapy on time to colonic resection and cancer rates in patients with Ulcerative Colitis
Authors: Visser E , Luberto A , Heuthorst L , Bislenghi G , Hompes R , Vermeire S , D'Haens G R , Bemelman W A , Buskens C J , D'Hoore A
Published: January 2024

Background

The expanding medical armamentarium in ulcerative colitis (UC) has contributed to increased control of inflammation. However, simultaneously, postponed colonic resection with an accumulative inflammatory burden might lead to an increased risk of CRC. Recent studies have reported conflicting results regarding the incidence of colorectal cancer (CRC) in UC patients.

Aim

To analyse the impact of advanced medical therapies (defined as biologicals and small molecules) on time to colonic resection and risk of CRC in UC patients.

Methods

Consecutive patients ≥18 years with established UC who underwent colonic resection between January 2003 and October 2022 at the Academic Medical Centre Amsterdam or the University Hospital Leuven were included. Primary outcomes were time to colonic resection and CRC rate in colonic specimens, compared between four time periods: P1 (2003-2007), P2 (2008-2012), P3 (2013-2017) and P4 (2018-2022). Secondary outcomes were the effect of advanced medical therapy on time to resection, cancer stage and risk of CRC. CRC was staged according to the AJCC TNM classification (advanced cancer defined as T3/T4, N1/2 or M1).

Results

A total of 716 patients were included. The usage of advanced medical therapies prior to surgery increased from 38.2% in P1 to 90.2% in P4 (p<0.001). However, this did not result in an increased time to colonic resection (P1: 7 years (2-12) vs P2: 6 years (2-14) vs P3: 7 years (3-14) vs P4: 7 years (2-14), p=0.94). CRC was diagnosed in 72 (10.1%) patients, and this incidence did also not change over time. Time to resection was significantly longer (median 18 years, IQR 10-24) in CRC patients compared to the overall cohort. The majority of CRC patients (64.8%) were diagnosed with advanced cancer, which did not decrease over time. Patients using advanced medical therapies had significantly shorter follow-up compared to therapy-naïve patients (6 years vs. 10 years, p<0.001), which resulted in a decreased risk of CRC (OR 0.17, p=<0.001). However, the finding of an incidental carcinoma rate (i.e. not preoperatively diagnosed) in this group was 18% whereas this was only 4% in patients without advanced medical therapy (p=0.08). Moreover, the incidence of advanced CRC was numerically higher in UC patients who received ≥2 therapies (83.3% vs 61.0%, p=0.14).

Conclusion

This study demonstrated that in the last two decades, the increased usage of advanced medical therapies did not result in an increased time to resection, nor in a decreased CRC rate in UC patients undergoing colonic resection. A higher incidence of incidental and advanced cancers was seen in patients with ≥2 therapies. Therefore, care should be taken with improved tailored surveillance in this group.
P1172 Epidemiology and initial presentation of newly diagnosed inflammatory bowel diseases in a Danish population-based inception cohort – results from the IBD Prognosis Study
Authors: Attauabi M , Roager Madsen G , Bendtsen F , Seidelin J , Burisch J
Published: January 2024

Background

It is unclear whether the incidence of inflammatory bowel diseases (IBD), including ulcerative colitis (UC) and Crohn’s disease (CD), continues to increase. In this study, we aimed to investigate the occurrence and initial disease presentation of IBD in a population-based setting. In addition, we aimed to identify predictors of an early severe disease presentation.

Methods

The study was conducted as part of IBD Prognosis Study, an ongoing Danish prospective population-based inception cohort study that includes incident patients with IBD according to the Copenhagen Diagnostic Criteria since May 2021, covering the catchment areas of approximately 20% of the Danish population (1.1 million). In this analysis, cutoff for data analysis was in May 2023. Crude incidence rates and European Standard Population (ESP)-adjusted rates were calculated. A multivariable logistical regression model was constructed to identify predictors of a severe disease presentation, defined as the composite need for systemic steroids, immunomodulators, biologics, or IBD-related surgery within three months of disease.

Results

In total, 554 patients (UC: 344, CD: 210) fulfilled the inclusion criteria, resulting in the following crude incidence rates per 100,000 person-years: IBD 23.4 (95% CI 21.5-25.4), UC 14.0 (12.6-15.6), and CD 8.6 (7.4-9.8). ESP-adjusted rates were: IBD 20.4 (18.2-22.9), UC 11.8 (10.2-13.0), and CD 7.9 (6.5-9.9) (Figure 1).

Among patients with UC, 81 (26.3%) and 95 (30.8%) had left-sided or extensive colitis at disease onset, respectively, while 61 (30.3%) and 62 (30.8%) patients with CD had ileal or ileocolonic disease. Stricturing or penetrating CD behaviour was observed in 24 (11.9%) and 11 (5.5%) patients, respectively. A high proportion of patients needed hospitalization (CD: 68 (33.8%), UC: 60 (19.5%), p=0.001) and IBD-related surgery (CD: 21 (10.4%), UC: 10 (3.2%), p=0.004) at the time of diagnosis.

In multivariable analysis, a severe disease presentation of UC at the time of diagnosis was associated with left-sided or extensive disease distribution, thrombocytosis, and increased levels of C-reactive protein (CRP) (Table 1). In patients with CD, stricturing, or perianal disease, as well as anemia, levels of albumin, CRP, and calprotectin were predictive of this endpoint (Table 1).

Conclusion

The incidence of UC and CD in Denmark appears stable compared to historical data from the previous decades.1 The study identified clinical predictors of a severe disease presentation from the time of diagnosis, emphasizing the critical need for early risk stratification and intervention strategies.

Reference:

1 Dorn-Rasmussen M et al., J Crohns Colitis. doi: 10.1093/ecco-jcc/jjac138.
P1175 Abdominal Pain is Associated with Poor Quality of Life in Quiescent Inflammatory Bowel Disease: A Cross-sectional Study of the SPARC Inflammatory Bowel Disease Cohort
Authors: Dilmaghani S , Dunleavy K , Fehlmann T , Raffals L , Chedid V
Published: January 2024

Background

Abdominal pain (AP) is common in patients with active inflammatory bowel disease (IBD) and has been associated with poor quality of life (QOL). Despite greater therapeutic options, symptoms persist in a subset of patients. Data is lacking regarding AP in patients with objectively documented quiescent disease. Among endoscopic quiescent disease: (1) estimate prevalence of AP, (2) assess predictors of worse AP, (3) describe its impact on validated QOL measures.

Methods

This cross-sectional study used prospectively collected data from SPARC (Study of a Prospective Adult Research Cohort) IBD, a multicenter longitudinal study of well-phenotyped adult IBD patients initiated by the Crohn’s & Colitis Foundation in 2016. Quiescent IBD was defined as Mayo endoscopy score <2 for ulcerative colitis (UC) and SES-CD score <3 for Crohn’s disease (CD). Patient reported outcomes (PROs) within 30 days of endoscopy were analyzed. Patients with ostomy or IPAA were excluded. Self-reported AP was categorized as none, mild, or moderate/severe. Univariate statistics used Pearson’s Chi-square and Kruskal-Wallis tests.

Results

A total of 973 patients with quiescent IBD (606 CD; 367 UC) were included in the study (Table 1). AP was more commonly reported in quiescent CD (31.2% mild, 15.5% moderate/severe) as compared to quiescent UC (23.4% mild, 10.1% moderate/severe) (p<0.001). In the entire quiescent cohort, those with mild or moderate/severe AP were more likely to be female sex (63.1% mild; 67.4% moderate/severe; p<0.001), higher BMI (28.4 mild; 30.0 moderate/severe; p=0.008) and have more recent tobacco use (p=0.004). Ileocolonic involvement was more commonly seen in moderate/severe AP. Mild and moderate/severe AP was associated with subjective fecal urgency, stool frequency, and bloody stool (all p<0.001). Disease behavior in CD was not associated with abdominal pain.

General well-being was poorer for those with more severe AP (p<0.001), though this did not appear to result in more frequent recent ED visits or hospitalizations. Figure 1 depicts the PROMIS responses. Overall, worse AP was associated with universal worse scores on all PROMIS measures and subscales (all p<0.001). Data suggested that more severe AP had the greatest impacts on the "Fatigue" subscale.

Conclusion

In this study of patients in SPARC IBD with endoscopic quiescent IBD the overall prevalence of AP was 41.7% overall and more commonly reported in CD as compared to UC. AP was associated with a greater prevalence of other symptoms, worse general well-being, and poorer quality of life across all measures. Further research is needed to elucidate the pathophysiology for presence of AP in quiescent IBD and develop personalized management approaches.
P1183 Perception of the role of diet on symptom exacerbation in patients with Inflammatory Bowel Disease
Authors: Deiana S , Biancheri P , Imbesi V , Gabbani T , Zadro V , Soriani P , Gionchetti P , Manno M
Published: January 2024

Background

A substantial proportion of patients with inflammatory bowel disease (IBD) believe that diet plays an important role in disease activity. As a result, IBD patients often change their dietary regimen in order to improve their symptoms and to prevent recurrences, however most of them choose self-imposed dietary restrictions that may lead to malnutrition and to a significant reduction in quality of life. The aim of our study was to evaluate dietary habits and the perception of the relationship between diet and symptoms in IBD patients.

Methods

A semi-structured questionnaire assessing demographics, clinical features, perception of the role of diet on symptom exacerbations and dietary habits including adoption of food restrictions was developed by our gastroenterologists and dietitians and was administered to patients with IBD.

Results

85 patients with IBD (56 with Ulcerative Colitis and 29 with Crohn’s Disease, mean age 55.0 ± 15.9 years, 43 males) were enrolled in the study. Most IBD patients did not perceive diet as a possible cause of disease (68/85 patients, 80.0%) or relapses (70/85 patients, 82.3%), but the majority of them (55/85 patients, 64.7%) believed that certain foods and drinks could worsen disease symptoms. Alcohol, carbonate drinks, milk, spicy and fat foods were often considered as a possible cause of symptom deterioration. Although 50/85 patients (58.8%) stated that they changed their diet after the diagnosis, only 19/85 patients (22.3%) declared to adopt a "restrictive" diet by reducing or avoiding some foods. However, 64/85 patients (75.3%) showed low/intermediate adherence to Mediterranean Diet (MD) (calculated with the MediLite Score), and no patient had high adherence to MD. Finally, the majority of IBD patients declared that they would like to receive more information on diet in relation to their disease.

Conclusion

In our study, the majority of IBD patients perceived that certain foods and drinks could worsen disease symptoms and accordingly changed their diet after the diagnosis. The adoption of restrictive diets is probably more frequent than declared by IBD patients, as suggested by the high prevalence of low/intermediate adherence to MD. Education of healthcare providers is important to improve knowledge and quality of nutrition in IBD patients.
P1186 Unveiling the reality of Collagenous colitis: Beyond its Benign Façade
Authors: Kottwitz J , Mudege T , Giaslakiotis K , Hoque S S
Published: January 2024

Background

Microscopic colitis is a cause of chronic watery, non-bloody diarrhoea diagnosed mainly on histology after taking biopsy from essentially normal colonoscopy. Thereby mainly two subtypes can be identified: Lymphocytic and collagenous colitis. So far, no biomarkers for the diagnosis of microscopic colitis have been identified. Hower, despite being benign nature of this disease .it often trigger Two weeks wait (cancer path way) of the in the UK.

Methods

In this study, we analysed all cases of collagenous colitis diagnosed from 2018-2022 in the Northeast London from 5 different teaching hospitals. 104 cases were identified and their electronic health record from hospital and from the primary care physicians (GP) were manually reviewed.

Results

In this cohort, 24% male, 76% female with ratio of (1:3), with mean age of 65 years. Forty percent were active or ex-smoker.

Painless watery diarrhoea was the main cause for referral in 90% of cases, 7% had painless bloody diarrhoea, whilst 3% complaint painful bloody diarrhoea. Abdominal pain noted in only 39% cases. Thirty-five (35%) cases noted to have history of weight loss. Among these patients, 27% had Haemoglobin < 130g/L, including 7% had <105g/L. Twenty nine percent had Faecal calprotectin (FCP) > 50 microgram/gm of stool and 14% had FCP >200. Seventeen percent had serum inflammatory marker raised CRP (normal 0-10).

Thirteen percent (13%) of these patient trigger two weeks pathway referral as they had positive Faecal immunochemical test (FIT) which used for bowel cancer screening test,

Twenty-seven (27%) presents did not require any treatment, got better after stopping suspected medication as a cause, while 73 % require treatment, of whom 5% require treatment with immunomodulator/ Biologics.

Conclusion

In this large series of collagenous colitis, we found that, despite being benign condition, it can present with alarming features which both health care provider and patient should be aware of, in order to avoid unnecessary anxiety. Further studies are needed to identify biomarker of this condition.
P1215 Blastocystis is very rare in faeces of children with Crohn’s disease: quantity, subtyping and association with the faecal bacteriome
Authors: Hurych J , Hlináková L , Lerchová T , Kubát M , Malcová H , Cebecauerová D , Hradský O , Bronský J , Cinek O
Published: January 2024

Background

Blastocystis is a single-cell gut protist, presumably an indicator of gut health. We aimed to assess its occurrence and subtypes in a longitudinal set of faecal samples from recently diagnosed paediatric patients with Crohn's disease (CD) and compare it to similar longitudinal collections from children having other chronic immunopathological diseases without gut pathology (type 1 diabetes, T1D, and juvenile idiopathic arthritis, JIA), as well as to control subjects.

Methods

At a single tertiary centre, 626 samples were collected from 156 subjects: 40 with CD (mean age 12.5 years), 57 with T1D, 10 with JIA and 49 healthy. Specific real-time PCR detected and quantified Blastocytis, whereas massively parallel amplicon sequencing showed its subtype. The relationship between Blastocystis and the bacterial community was assessed by 16S rDNA amplicon profiling.

Results

Blastocystis was detected in 4.0% (9/223) stool samples in CD, six of them being of a very high quantity and originating from a single patient in long-term remission with a less common CD phenotype (L2, colonic, according to Paris classification). Subject-wise positivity of Blastocystis in CD (3/40, 7.5%) was significantly lower than in either T1D (21/57, 37%), JIA (2/10, 20%), or in healthy children (14/49, 29%). There was no notable difference in the subtype repertoires among diagnoses. The faecal bacteriome had higher alpha diversity in Blastocystis-positive samples. The Blastocystis-positive bacteriomes had slightly yet significantly (p<0.001) different overall community composition across all diagnoses (Figure 1), which was also reflected by the suggestive differential abundance of several taxa (e.g. Ruminococcaceae and Prevotellaceae increased, Bacteroidaceae and Rikenellaceae decreased).

Conclusion

We performed a large molecular survey on Blastocystis in longitudinal samples of three different paediatric diagnoses and healthy subjects. We document an unusual long-term carriage of very high loads of Blastocystis in a patient with colonic CD phenotype in clinical remission. Otherwise, however, Blastocystis is very rare among paediatric patients with CD, in contrast to two other chronic immunopathologic childhood diagnoses (T1D, JIA). Further longitudinal observation will show whether Blastocystis might return in patients with well-controlled CD upon ameliorating their bacteriome composition.

Institutional Grants/Research Supports

Supported by Ministry of Education, Youth and Sports of the Czech Republic, programme INTER-EXCELLENCE II, project LUC23165.
P1236 Oral microbiota dysbiosis in Inflammatory Bowel Disease patients
Authors: Rodrigues C , Gomes A , Mendes K , Correia M J , Pereira P , Lopes P C , Martins R , Veiga N , Rosa N , Soares C , Ministro P
Published: January 2024

Background

Recent data pointed that IBD is strictly related to gut microbiota although less is known about the connection between oral microbiota and IBD. It is also known that dysbiosis can lead to oral pathologies. Moreover, microbiome changes under therapeutic agents’ administration for IBD treatment have been described, including the identification of some bacteria as potential predictive markers for treatment effectiveness. The aim of our study was the quantification of salivary Firmicutes and Bacteroidetes in a cohort of IBD patients compared with a control group without IBD.

Methods

This was a collaborative transversal cohort study between an IBD consultation in a tertiary hospital and a faculty of dental medicine. Patients from IBD consultation were invited to participate and gave their informed consent. The exclusion criteria were the incapacity of mouth opening or give a written informed consent. Demographic and clinical data was collected. Oral health status was accessed to determine the periodontal diagnosis. Unstimulated saliva samples were collected before the oral examination for the quantification by quantitative real-time PCR. Statistical analysis was performed with SPSS 29.0 using Kruskal–Wallis H and Mann-Whitney U tests, and p values ≤ 0.05 were considered statistically significant.

Results

IBD patients presented an increased abundance of Firmicutes, both for UC (3.4 x10-5) and CD (4.9x10-5) as well as an increased abundance of Bacteroidetes for both UC (1.6 x10-5) and CD (1.4x10-5), when compared to the control group (figure 1).

No significant differences were found between different treatments groups or no treatment (table 1) in abundance of Firmicutes and Bacteroidetes, respectively, of UC (p = 0.292 and p = 0.912) and CD (p=0.413 and p=0.254) patients. Additionally, no significant differences were found for Firmicutes and Bacteroidetes abundances, respectively, regarding: CD versus UC (p=0.600 and p=0.971), active disease and remission (based on a composite criterion for inactive disease considering HBI <5 for CD or a PMS ≤ 2 for UC, and FCP cut-off value of 150 mg/Kg), (p= 0.071 and p=0.242), smoking status (p=0.558 and p=0.488) and presence or absence of oral health (p=0.260 and p=0.556).

Conclusion

The oral microbiota characterization of IBD patients showed an elevated abundance of Firmicutes and Bacteroidetes when compared with healthy controls. These findings are valuable indicators of dysbiosis, emphasizing the intricate interplay between gut and oral microbiome in the context of inflammatory conditions. Future research is needed to clarify the oral-gut microbiome axis in IBD.
N01 “Just Live with it”- Exploring patients’ experience of using IBD-F scale in clinical practice – A mixed methods study using focus groups and cross-sectional questionnaires
Authors: Watson N , Chalmers D , Czuber-Dochan W
Published: January 2024

Background

Inflammatory bowel disease (IBD) related fatigue is one of the most common, yet debilitating symptoms reported by patients with IBD. The causes for the issue are not fully understood, and patients and clinicians alike struggle to communicate about this topic in consultations. In 2014, the IBD-F scale was created to assist this communication, and this study aimed to explore its role in the experiences of patients assessing and managing their IBD fatigue with Health Care Professionals (HCP’s).

Methods

A mixed methods study was conducted consisting of an online survey and 3 online patient focus groups. The survey was advertised through patient charities and explored individual fatigue assessment and management. 24 patients from across the UK were recruited to participate in the online focus groups, providing 243 minutes of discussion. This data was recorded, transcribed, and anonymised before being coded by two independent researchers.

Results

The online survey received 426 responses. 272 (64%) respondents reported fatigue levels between 7-10 on a scale of 0-10. When the medical assessment of their fatigue was explored, only 41(10%) respondents reported a medical assessment of the fatigue, 27 (6%) reported being offered support or advice, and 5 (1%) reported that the fatigue had been reassessed. 162 (38%) respondents said they would use the IBD-F on a regular basis and wanted this information to be shared with their medical teams, and 136 (32%) requested the results be attached to their clinical record.

The topics arising from the patient focus groups support the notion that fatigue is both overwhelming, and underserved. The main findings are collated into three main themes or “desires”, constructed to represent the patient’s call to HCP's; 1) The desire to “Give up”, 2) The desire to be heard, 3) The desire to change their situation. All groups reported a desire to improve clinical and public education around IBD fatigue and introduce communication tools like the IBD-F into clinical consultations and medical notes.

Conclusion

This mixed methods exploration highlights a significant, perceived gap in clinical provision for patients experiencing IBD related fatigue. IBD patients are reporting a sense of alienation and abandonment from HCP’s, but also a resounding desire to utilise their voices to educate their medical teams and a willingness to take advantage of additional resources to help improve education, communication and treatment of this symptom. Further research is needed to explore this phenomenon from the HCP’s perspective, and to explore the practical implications of the suggested changes to IBD fatigue education, assessment, and management within these clinical settings.

Figure 1: